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• association label "hydrocortisone tablets are indicated in the following conditions primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the first choice synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance congenital adrenal hyperplasia non suppurative thyroiditis hypercalcemia associated with cancer as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in during an exacerbation or as maintenance therapy in selected cases of pemphigus bullous dermatitis herpetiformis severe erythema multiforme stevens johnson syndrome exfoliative dermatitis mycosis fungoides severe psoriasis severe seborrheic dermatitis control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as symptomatic sarcoidosis loeffler s syndrome not manageable by other means berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy aspiration pneumonitis idiopathic thrombocytopenic purpura in adults secondary thrombocytopenia in adults acquired autoimmune hemolytic anemia erythroblastopenia rbc anemia congenital erythroid hypoplastic anemia for palliative management of to induce a diuresis or remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus to tide the patient over a critical period of the disease in acute exacerbations of multiple sclerosis tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy trichinosis with neurologic or myocardial involvement" assertion.
• association label "doxorubicin hydrochloride hcl for injection is an anthracycline topoisomerase ii inhibitor indicated as a component of multiagent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer 1 1 for the treatment of acute lymphoblastic leukemia acute myeloblastic leukemia hodgkin lymphoma non hodgkin lymphoma metastatic breast cancer metastatic wilms tumor metastatic neuroblastoma metastatic soft tissue sarcoma metastatic bone sarcomas metastatic ovarian carcinoma metastatic transitional cell bladder carcinoma metastatic thyroid carcinoma metastatic gastric carcinoma metastatic bronchogenic carcinoma 1 2 doxorubicin hcl for injection is indicated as a component of multi agent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer see clinical studies 14 doxorubicin hcl for injection is indicated for the treatment of acute lymphoblastic leukemia acute myeloblastic leukemia hodgkin lymphoma non hodgkin lymphoma nhl metastatic breast cancer metastatic wilms tumor metastatic neuroblastoma metastatic soft tissue sarcoma metastatic bone sarcoma metastatic ovarian carcinoma metastatic transitional cell bladder carcinoma metastatic thyroid carcinoma metastatic gastric carcinoma metastatic bronchogenic carcinoma" assertion.
• association label "dorzolamide hydrochloride ophthalmic solution 2 is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open angle glaucoma dorzolamide hydrochloride ophthalmic solution 2 is a carbonic anhydrase inhibitor indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open angle glaucoma 1" assertion.
• association label "brimonidine tartrate ophthalmic solution 2 is indicated for lowering intraocular pressure iop in patients with open angle glaucoma or ocular hypertension the iop lowering efficacy of brimonidine tartrate ophthalmic solution diminishes over time in some patients this loss of effect appears with a variable time of onset in each patient and should be closely monitored brimonidine tartrate ophthalmic solution 2 is an alpha adrenergic agonist indicated for lowering intraocular pressure iop in patients with open angle glaucoma or ocular hypertension 1" assertion.
• association label "prednisolone sodium phosphate ophthalmic solution 1 or 1 8 is for the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva cornea and anterior segment of the globe such as allergic conjunctivitis acne rosacea superficial punctate keratitis herpes zoster keratitis iritis cyclitis selected infective conjunctivitis when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation corneal injury from chemical radiation or thermal burns or penetration of foreign bodies prednisolone sodium phosphate ophthalmic solution 1 is recommended for moderate to severe inflammations particularly when unusually rapid control is desired in stubborn cases of anterior segment eye disease systemic adrenocortical hormone therapy may be required when deeper ocular structures are involved systemic therapy is necessary" assertion.
• association label "intravenous theophylline is indicated as an adjunct to inhaled beta 2 selective agonists and systemically administered corticosteroids for the treatment of acute exacerbations of the symptoms and reversible airflow obstruction associated with asthma and other chronic lung diseases e g emphysema and chronic bronchitis" assertion.
• association label "primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the drug of choice synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance acute adrenocortical insufficiency hydrocortisone or cortisone is the drug of choice mineralocorticoid supplementation may be necessary particularly when synthetic analogs are used preoperatively and in the event of serious trauma or illness in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected congenital adrenal hyperplasia as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in post traumatic osteoarthritis during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus pemphigus control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in bronchial asthma severe acute and chronic allergic and inflammatory processes involving the eye such as herpes zoster ophthalmicus to tide the patient over a critical period of the disease in ulcerative colitis systemic therapy symptomatic sarcoidosis acquired autoimmune hemolytic anemia for palliative management of leukemias and lymphomas in adults to induce diuresis or remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy trichinosis with neurologic or myocardial involvement" assertion.
• association label "carefully consider the potential benefits and risks of indomethacin extended release capsules usp 75 mg and other treatment options before deciding to use indomethacin extended release capsules usp 75 mg use the lowest effective dose for the shortest duration consistent with individual patient treatment goals see warnings indomethacin extended release capsules usp 75 mg has been found effective in active stages of the following 1 moderate to severe rheumatoid arthritis including acute flares of chronic disease 2 moderate to severe ankylosing spondylitis 3 moderate to severe osteoarthritis 4 acute painful shoulder bursitis and or tendinitis indomethacin extended release capsules usp 75 mg are not recommended for the treatment of acute gouty arthritis indomethacin may enable the reduction of steroid dosage in patients receiving steroids for the more severe forms of rheumatoid arthritis in such instances the steroid dosage should be reduced slowly and the patients followed very closely for any possible adverse effects the use of indomethacin in conjunction with aspirin or other salicylates is not recommended controlled clinical studies have shown that the combined use of indomethacin and aspirin does not produce any greater therapeutic effect than the use of indomethacin alone furthermore in one of these clinical studies the incidence of gastrointestinal side effects was significantly increased with combined therapy see precautions drug interactions" assertion.
• association label "irbesartan tablet usp is an angiotensin ii receptor blocker arb indicated for treatment of hypertension to lower blood pressure lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events primarily strokes and myocardial infarctions 1 1 treatment of diabetic nephropathy in hypertensive patients with type 2 diabetes an elevated serum creatinine and proteinuria 1 2 irbesartan tablets usp are indicated for the treatment of hypertension to lower blood pressure lowering blood pressure lowers the risk of fatal and non fatal cardiovascular cv events primarily strokes and myocardial infarction these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug control of high blood pressure should be part of comprehensive cardiovascular risk management including as appropriate lipid control diabetes management antithrombotic therapy smoking cessation exercise and limited sodium intake many patients will require more than 1 drug to achieve blood pressure goals for specific advice on goals and management see published guidelines such as those of the national high blood pressure education program s joint national committee on prevention detection evaluation and treatment of high blood pressure jnc numerous antihypertensive drugs from a variety of pharmacologic classes and with different mechanisms of action have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality and it can be concluded that it is blood pressure reduction and not some other pharmacologic property of the drugs that is largely responsible for those benefits the largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly elevated systolic or diastolic pressure causes increased cardiovascular risk and the absolute risk increase per mmhg is greater at higher blood pressures so that even modest reductions of severe hypertension can provide substantial benefit relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk so the absolute benefit is greater in patients who are at higher risk independent of their hypertension for example patients with diabetes or hyperlipidemia and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal some antihypertensive drugs have smaller blood pressure effects as monotherapy in black patients and many antihypertensive drugs have additional approved indications and effects e g on angina heart failure or diabetic kidney disease these considerations may guide selection of therapy irbesartan tablets usp may be used alone or in combination with other antihypertensive agents irbesartan tablets usp are indicated for the treatment of diabetic nephropathy in patients with type 2 diabetes and hypertension an elevated serum creatinine and proteinuria 3 mg day in this population irbesartan tablet usp reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end stage renal disease need for dialysis or renal transplantation see clinical studies 14 2" assertion.
• association label "to reduce the development of drug resistant bacteria and maintain the effectiveness of penicillin v potassium tablets penicillin v potassium for oral solution and other antibacterial drugs penicillin v potassium tablets and penicillin v potassium for oral solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antimicrobial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy penicillin v potassium tablets usp and penicillin v potassium for oral solution usp are indicated in the treatment of mild to moderately severe infections due to penicillin g sensitive microorganisms therapy should be guided by bacteriological studies including sensitivity tests and by clinical response note severe pneumonia empyema bacteremia pericarditis meningitis and arthritis should not be treated with penicillin v during the acute stage indicated surgical procedures should be performed the following infections will usually respond to adequate dosage of penicillin v streptococcal infections without bacteremia mild to moderate infections of the upper respiratory tract scarlet fever and mild erysipelas note streptococci in groups a c g h l and m are very sensitive to penicillin other groups including group d enterococcus are resistant pneumococcal infections mild to moderately severe infections of the respiratory tract staphylococcal infections penicillin g sensitive mild infections of the skin and soft tissues note reports indicate an increasing number of strains of staphylococci resistant to penicillin g emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections fusospirochetosis vincent s gingivitis and pharyngitis mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin note necessary dental care should be accomplished in infections involving the gum tissue medical conditions in which oral penicillin therapy is indicated as prophylaxis for the prevention of recurrence following rheumatic fever and or chorea prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions although no controlled clinical efficacy studies have been conducted penicillin v has been suggested by the american heart association and the american dental association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients with congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract 1 oral penicillin should not be used in those patients at particularly high risk for endocarditis e g those with prosthetic heart valves or surgically constructed systemic pulmonary shunts penicillin v should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery lower intestinal tract surgery sigmoidoscopy and childbirth since it may happen that alpha haemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever prophylactic agents other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen note when selecting antibiotics for the prevention of bacterial endocarditis the physician or dentist should read the full joint statement of the american heart association and the american dental association the manufacturer s complete drug information can be viewed on the fda site here" assertion.
• association label "indications and usage prednisone tablets are indicated in the following conditions endocrine disorders primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the first choice synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance rheumatic disorders as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in collagen diseases during an exacerbation or as maintenance therapy in selected cases of dermatologic diseases pemphigus allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment ophthalmic diseases severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as respiratory diseases symptomatic sarcoidosis hematologic disorders idiopathic thrombocytopenic purpura in adults neoplastic diseases for palliative management of edematous states to induce a diuresis or remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus gastrointestinal diseases to tide the patient over a critical period of the disease in nervous system acute exacerbations of multiple sclerosis miscellaneous tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy" assertion.
• association label "bystolic is a beta adrenergic blocking agent indicated for the treatment of hypertension to lower blood pressure lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events primarily strokes and myocardial infarctions 1 1 bystolic is indicated for the treatment of hypertension to lower blood pressure bystolic may be used alone or in combination with other antihypertensive agents see clinical studies 14 1 see drug interactions 7 lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events primarily strokes and myocardial infarctions these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs there are no controlled trials demonstrating risk reduction with bystolic control of high blood pressure should be part of comprehensive cardiovascular risk management including as appropriate lipid control diabetes management antithrombotic therapy smoking cessation exercise and limited sodium intake many patients will require more than one drug to achieve blood pressure goals for specific advice on goals and management see published guidelines such as those of the national high blood pressure education program s joint national committee on prevention detection evaluation and treatment of high blood pressure jnc numerous antihypertensive drugs from a variety of pharmacologic classes and with different mechanisms of action have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality and it can be concluded that it is blood pressure reduction and not some other pharmacologic property of the drugs that is largely responsible for those benefits the largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly elevated systolic or diastolic pressure causes increased cardiovascular risk and the absolute risk increase per mmhg is greater at higher blood pressures so that even modest reductions of severe hypertension can provide substantial benefit relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk so the absolute benefit is greater in patients who are at higher risk independent of their hypertension for example patients with diabetes or hyperlipidemia and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal some antihypertensive drugs have smaller blood pressure effects as monotherapy in black patients and many antihypertensive drugs have additional approved indications and effects e g on angina heart failure or diabetic kidney disease these considerations may guide selection of therapy" assertion.
• association label "ranitidine tablets are indicated in 1 short term treatment of active duodenal ulcer most patients heal within 4 weeks studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks 2 maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers no placebo controlled comparative studies have been carried out for periods of longer than 1 year 3 the treatment of pathological hypersecretory conditions e g zollinger ellison syndrome and systemic mastocytosis 4 short term treatment of active benign gastric ulcer most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated studies available to date have not assessed the safety of ranitidine in uncomplicated benign gastric ulcer for periods of more than 6 weeks 5 maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers placebo controlled studies have been carried out for 1 year 6 treatment of gerd symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine tablets 15 mg twice daily 7 treatment of endoscopically diagnosed erosive esophagitis symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine tablets 15 mg 4 times daily 8 maintenance of healing of erosive esophagitis placebo controlled trials have been carried out for 48 weeks concomitant antacids should be given as needed for pain relief to patients with active duodenal ulcer active benign gastric ulcer hypersecretory states gerd and erosive esophagitis" assertion.
• association label "to reduce the development of drug resistant bacteria and maintain the effectiveness of achromycin v tetracycline hcl capsules usp and other antibacterial drugs achromycin v tetracycline hcl capsules usp should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antibacterial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy achromycin v tetracycline hcl capsules usp is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below upper respiratory tract infections caused by streptococcus pyogenes streptococcus pneumoniae hemophilus influenzae lower respiratory tract infections caused by streptococcus pyogenes streptococcus pneumoniae mycoplasma pneumoniae klebsiella sp skin and soft tissue infections caused by streptococcus pyogenes staphylococcus aureaus infections caused by rickettsia including rocky mountain spotted fever typhus group infections q fever rickettsialpox psittacosis of ornithosis caused by chlamydia psittaci infections caused by chlamydia trachomatis granuloma inquinale caused by calymmatobacterium granulomatis relapsing fever caused by borrelia sp bartonellosis caused by bartonella bacilliformis chancroid caused by hemophilus ducreyi tularemia caused by francisella tularensis plaque caused by yersinia pestis cholera caused by vibrio cholerae brucellosis caused by brucella species infections due to campylobacter fetus as adjunctive therapy in intestinal amebiasis caused by entamoeba histolytica urinary tract infections caused by susceptible strains of escherichia coli klebsiella other infections caused by susceptible gram negative organisms such as e coli enterobacter aerogenes shigella sp acinetobacter sp klebsiella sp bacteroides sp in severe acne adjunctive therapy with achromycin v tetracycline hcl capsules usp may be useful when penicillin is contraindicated tetracyclines are alternative drugs in the treatment of the following infections syphilis and yaws caused by treponema pallidum pertenue vincent s infection caused by fusobacterium fusiforme infections caused by neisseria gonorrhoeae anthrax caused by bacillus anthracis infections due to listeria monocytogenes actinomycosis caused by actinomyces infections due to clostridium" assertion.
• association label "hydrocortisone tablets usp are indicated in the following conditions endocrine disorders primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the first choice synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance congenital adrenal hyperplasia nonsuppurative thyroiditis hypercalcemia associated with cancer rheumatic disorders as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in psoriatic arthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy ankylosing spondylitis acute and subacute bursitis acute nonspecific tenosynovitis acute gouty arthritis post traumatic osteoarthritis synovitis of osteoarthritis epicondylitis collagen diseases during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus systemic dermatomyositis polymyositis acute rheumatic carditis dermatologic diseases pemphigus bullous dermatitis herpetiformis severe erythema multiforme stevens johnson syndrome exfoliative dermatitis mycosis fungoides severe psoriasis severe seborrheic dermatitis allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment seasonal or perennial allergic rhinitis serum sickness bronchial asthma contact dermatitis atopic dermatitis drug hypersensitivity reactions ophthalmic diseases severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as allergic conjunctivitis keratitis allergic corneal marginal ulcers herpes zoster ophthalmicus iritis and iridocyclitis chorioretinitis anterior segment inflammation diffuse posterior uveitis and choroiditis optic neuritis sympathetic ophthalmia respiratory diseases symptomatic sarcoidosis loeffler s syndrome not manageable by other means berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy aspiration pneumonitis hematologic disorders idiopathic thrombocytopenic purpura in adults secondary thrombocytopenia in adults acquired autoimmune hemolytic anemia erythroblastopenia rbc anemia congenital erythroid hypoplastic anemia neoplastic diseases for palliative management of leukemias and lymphomas in adults acute leukemia of childhood edematous states to induce a diuresis or remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus gastrointestinal diseases to tide the patient over a critical period of the disease in ulcerative colitis regional enteritis nervous system acute exacerbations of multiple sclerosis miscellaneous tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy trichinosis with neurologic or myocardial involvement" assertion.
• association label "hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure hepatic cirrhosis and corticosteroid and estrogen therapy hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome acute glomerulonephritis and chronic renal failure hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension use in pregnancy routine use of diuretics during normal pregnancy is inappropriate and exposes mother and fetus to unnecessary hazard diuretics do not prevent development of toxemia of pregnancy and there is no satisfactory evidence that they are useful in the treatment of toxemia edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy thiazides are indicated in pregnancy when edema is due to pathologic causes just as they are in the absence of pregnancy see precautions pregnancy dependent edema in pregnancy resulting from restriction of venous return by the gravid uterus is properly treated through elevation of the lower extremities and use of support stockings use of diuretics to lower intravascular volume in this instance is illogical and unnecessary during normal pregnancy there is hypervolemia which is not harmful to the fetus or the mother in the absence of cardiovascular disease however it may be associated with edema rarely generalized edema if such edema causes discomfort increased recumbency will often provide relief rarely this edema may cause extreme discomfort which is not relieved by rest in these instances a short course of diuretic therapy may provide relief and be appropriate" assertion.
• association label "stromectol is indicated for the treatment of the following infections strongyloidiasis of the intestinal tract strongyloides stercoralis this indication is based on clinical studies of both comparative and open label designs in which 64 1 of infected patients were cured following a single 2 mcg kg dose of ivermectin see clinical pharmacology clinical studies onchocerciasis onchocerca volvulus this indication is based on randomized double blind placebo controlled and comparative studies conducted in 1427 patients in onchocerciasis endemic areas of west africa the comparative studies used diethylcarbamazine citrate dec c note stromectol has no activity against adult onchocerca volvulus" assertion.
• association label "methotrexate is indicated in the treatment of gestational choriocarcinoma chorioadenoma destruens and hydatidiform mole in acute lymphocytic leukemia methotrexate is indicated in the prophylaxis of meningeal leukemia and is used in maintenance therapy in combination with other chemotherapeutic agents methotrexate is also indicated in the treatment of meningeal leukemia methotrexate is used alone or in combination with other anticancer agents in the treatment of breast cancer epidermoid cancers of the head and neck advanced mycosis fungoides cutaneous t cell lymphoma and lung cancer particularly squamous cell and small cell types methotrexate is also used in combination with other chemotherapeutic agents in the treatment of advanced stage non hodgkin s lymphomas methotrexate in high doses followed by leucovorin rescue in combination with other chemotherapeutic agents is effective in prolonging relapse free survival in patients with non metastatic osteosarcoma who have undergone surgical resection or amputation for the primary tumor methotrexate is indicated in the symptomatic control of severe recalcitrant disabling psoriasis that is not adequately responsive to other forms of therapy but only when the diagnosis has been established as by a biopsy and or after dermatologic consultation methotrexate is indicated in the management of selected adults with severe active rheumatoid arthritis acr criteria or children with active polyarticular course juvenile rheumatoid arthritis who have had an insufficient therapeutic response to or are intolerant of an adequate trial of first line therapy including full dose non steroidal anti inflammatory agents nsaids aspirin nsaids and or low dose steroids may be continued although the possibility of increased toxicity with concomitant use of nsaids including salicylates has not been fully explored see precautions drug interactions" assertion.
• association label "risedronate sodium tablets usp are a bisphosphonate indicated for treatment and prevention of postmenopausal osteoporosis 1 1 treatment to increase bone mass in men with osteoporosis 1 2 treatment and prevention of glucocorticoid induced osteoporosis 1 3 treatment of paget s disease 1 4 limitations of use optimal duration of use has not been determined for patients at low risk for fracture consider drug discontinuation after 3 to 5 years of use 1 5 risedronate sodium tablets usp are indicated for the treatment and prevention of osteoporosis in postmenopausal women in postmenopausal women with osteoporosis risedronate sodium tablets usp reduce the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis related fractures see clinical studies 14 1 14 2 risedronate sodium tablets usp are indicated for treatment to increase bone mass in men with osteoporosis risedronate sodium tablets usp are indicated for the treatment and prevention of glucocorticoid induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoid treatment daily dosage of greater than or equal to 7 5 mg of prednisone or equivalent for chronic diseases patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin d risedronate sodium tablets usp are indicated for treatment of paget s disease of bone in men and women the optimal duration of use has not been determined the safety and effectiveness of risedronate sodium tablets usp for the treatment of osteoporosis are based on clinical data of three years duration all patients on bisphosphonate therapy should have the need for continued therapy re evaluated on a periodic basis patients at low risk for fracture should be considered for drug discontinuation after 3 to 5 years of use patients who discontinue therapy should have their risk for fracture re evaluated periodically" assertion.
• association label "topotecan hydrochloride for injection is a topoisomerase inhibitor indicated for treatment of patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy as a single agent 1 1 patients with small cell lung cancer slsc platinum sensitive disease who progressed at least 6 days after initiation of first line chemotherapy as a single agent 1 2 patients with stage iv b recurrent or persistent cervical cancer which is not amenable to curative treatment in combination with cisplatin 1 3 topotecan hydrochloride for injection as a single agent is indicated for the treatment of patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy topotecan hydrochloride for injection as a single agent is indicated for the treatment of patients with small cell lung cancer sclc with platinum sensitive disease who progressed at least 6 days after initiation of first line chemotherapy topotecan hydrochloride for injection in combination with cisplatin is indicated for the treatment of patients with stage iv b recurrent or persistent cervical cancer of the cervix not amenable to curative treatment" assertion.
• association label "amphotericin b for injection usp should be administered primarily to patients with progressive potentially life threatening fungal infections this potent drug should not be used to treat noninvasive fungal infections such as oral thrush vaginal candidiasis and esophageal candidiasis in patients with normal neutrophil counts amphotericin b for injection usp is specifically intended to treat potentially life threatening fungal infections aspergillosis cryptococcosis torulosis north american blastomycosis systemic candidiasis coccidioido mycosis histoplasmosis zygomycosis including mucormycosis due to susceptible species of the genera absidia mucor rhizopus conidiobolus basidiobolus amphotericin b may be useful in the treatment of american mucocutaneous leishmaniasis but it is not the drug of choice as primary therapy" assertion.
• association label "diazepam is indicated for the management of anxiety disorders or for the short term relief of the symptoms of anxiety anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic in acute alcohol withdrawal diazepam may be useful in the symptomatic relief of acute agitation tremor impending or acute delirium tremens and hallucinosis as an adjunct prior to endoscopic procedures if apprehension anxiety or acute stress reactions are present and to diminish the patient s recall of the procedures see warnings diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology such as inflammation of the muscles or joints or secondary to trauma spasticity caused by upper motor neuron disorders such as cerebral palsy and paraplegia athetosis stiff man syndrome and tetanus diazepam injection is a useful adjunct in status epilepticus and severe recurrent convulsive seizures diazepam is a useful premedication the intramuscular route is preferred for relief of anxiety and tension in patients who are to undergo surgical procedures intravenously prior to cardioversion for the relief of anxiety and tension and to diminish the patient s recall of the procedure" assertion.
• association label "cefixime is a cephalosporin antibacterial drug indicated in the treatment of adults and pediatric patients six months and older with the following infections uncomplicated urinary tract infections 1 1 otitis media 1 2 pharyngitis and tonsillitis 1 3 acute exacerbations of chronic bronchitis 1 4 uncomplicated gonorrhea cervical urethral 1 5 to reduce the development of drug resistant bacteria and maintain the effectiveness of cefixime and other antibacterial drugs cefixime for oral suspension and cefixime capsules should be used only to treat infections that are proven or strongly suspected to be caused by bacteria 1 6 cefixime for oral suspension and cefixime capsule is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated urinary tract infections caused by susceptible isolates of escherichia coli proteus mirabilis cefixime for oral suspension and cefixime capsule is indicated in the treatment of adults and pediatric patients six months of age or older with otitis media caused by susceptible isolates of haemophilus influenzae moraxella catarrhalis streptococcus pyogenes streptococcus pyogenes note for patients with otitis media caused by streptococcus pneumoniae see clinical studies 14 cefixime for oral suspension and cefixime capsule is indicated in the treatment of adults and pediatric patients six months of age or older with pharyngitis and tonsillitis caused by susceptible isolates of streptococcus pyogenes note penicillin is the usual drug of choice in the treatment of streptococcus pyogenes infections cefixime for oral suspension and cefixime capsule is generally effective in the eradication of streptococcus pyogenes from the nasopharynx however data establishing the efficacy of cefixime for oral suspension and cefixime capsule in the subsequent prevention of rheumatic fever is not available cefixime for oral suspension and cefixime capsule is indicated in the treatment of adults and pediatric patients six months of age or older with acute exacerbations of chronic bronchitis caused by susceptible isolates of streptococcus pneumoniae haemophilus influenzae cefixime for oral suspension and cefixime capsule is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated gonorrhea cervical urethral caused by susceptible isolates of neisseria gonorrhoeae to reduce the development of drug resistant bacteria and maintain the effectiveness of cefixime and other antibacterial drugs cefixime for oral suspension and cefixime capsule should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antimicrobial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy" assertion.
• association label "escitalopram oxalate is a selective serotonin reuptake inhibitor ssri indicated for acute and maintenance treatment of major depressive disorder mdd in adults and adolescents aged 12 17 years 1 1 acute treatment of generalized anxiety disorder gad in adults 1 2 acute treatment of generalized anxiety disorder gad in adults 1 2 escitalopram tablets usp are indicated for the acute and maintenance treatment of major depressive disorder in adults and in adolescents 12 to 17 years of age see clinical studies 14 1 a major depressive episode dsm iv implies a prominent and relatively persistent nearly every day for at least 2 weeks depressed or dysphoric mood that usually interferes with daily functioning and includes at least five of the following nine symptoms depressed mood loss of interest in usual activities significant change in weight and or appetite insomnia or hypersomnia psychomotor agitation or retardation increased fatigue feelings of guilt or worthlessness slowed thinking or impaired concentration a suicide attempt or suicidal ideation escitalopram tablets usp are indicated for the acute treatment of generalized anxiety disorder gad in adults see clinical studies 14 2 generalized anxiety disorder dsm iv is characterized by excessive anxiety and worry apprehensive expectation that is persistent for at least 6 months and which the person finds difficult to control it must be associated with at least 3 of the following symptoms restlessness or feeling keyed up or on edge being easily fatigued difficulty concentrating or mind going blank irritability muscle tension and sleep disturbance" assertion.
• association label "fludarabine phosphate injection is a nucleotide metabolic inhibitor indicated for the treatment of adult patients with b cell chronic lymphocytic leukemia cll who have not responded to or whose disease has progressed during treatment with at least one standard alkylating agent containing regimen benefit in treatment naive or non refractory cll patients is not established 1 1 important limitations fludarabine phosphate should not be used in patients with severe renal impairment creatinine clearance less than 3 ml min 1 73 m 2 5 7 fludarabine phosphate injection is indicated for the treatment of adult patients with b cell chronic lymphocytic leukemia cll who have not responded to or whose disease has progressed during treatment with at least one standard alkylating agent containing regimen the safety and effectiveness of fludarabine phosphate injection in previously untreated or non refractory patients with cll have not been established fludarabine phosphate injection should not be used in patients with severe renal impairment creatinine clearance less than 3 ml min 1 73 m 2 see warnings and precautions 5 7" assertion.
• association label "prednisone tablets are indicated in the following conditions 1 endocrine disorders primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the first choice synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance congenital adrenal hyperplasia nonsuppurative thyroiditis hypercalcemia associated with cancer 2 rheumatic disorders as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in psoriatic arthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy ankylosing spondylitis acute and subacute bursitis acute nonspecific tenosynovitis acute gouty arthritis post traumatic osteoarthritis synovitis of osteoarthritis epicondylitis 3 collagen diseases during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus systemic dermatomyositis polymyositis acute rheumatic carditis 4 dermatologic diseases pemphigus bullous dermatitis herpetiformis severe erythema multiforme stevens johnson syndrome exfoliative dermatitis mycosis fungoides severe psoriasis severe seborrheic dermatitis 5 allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment seasonal or perennial allergic rhinitis bronchial asthma contact dermatitis atopic dermatitis serum sickness drug hypersensitivity reactions 6 ophthalmic diseases severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as allergic corneal marginal ulcers herpes zoster ophthalmicus anterior segment inflammation diffuse posterior uveitis and choroiditis sympathetic ophthalmia allergic conjunctivitis keratitis chorioretinitis optic neuritis iritis and iridocyclitis 7 respiratory diseases symptomatic sarcoidosis loeffler s syndrome not manageable by other means berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy aspiration pneumonitis 8 hematologic disorders idiopathic thrombocytopenic purpura in adults secondary thrombocytopenia in adults acquired autoimmune hemolytic anemia erythroblastopenia rbc anemia congenital erythroid hypoplastic anemia 9 neoplastic diseases for palliative management of leukemias and lymphomas in adults acute leukemia of childhood 1 edematous states to induce a diuresis or remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus 11 gastrointestinal diseases to tide the patient over a critical period of the disease in ulcerative colitis regional enteritis 12 nervous system acute exacerbations of multiple sclerosis 13 miscellaneous tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy trichinosis with neurologic or myocardial involvement" assertion.
• association label "dactinomycin for injection is an actinomycin indicated for the treatment of 1 1 1 2 1 3 1 4 1 5 1 6 dactinomycin for injection is indicated for the treatment of adult and pediatric patients with wilms tumor as part of a multi phase combination chemotherapy regimen dactinomycin for injection is indicated for the treatment of adult and pediatric patients with rhabdomyosarcoma as part of a multi phase combination chemotherapy regimen dactinomycin for injection is indicated for the treatment of adult and pediatric patients with ewing sarcoma as part of a multi phase combination chemotherapy regimen dactinomycin for injection is indicated for the treatment of adult and pediatric patients with metastatic nonseminomatous testicular cancer as part of a multi phase combination chemotherapy regimen dactinomycin for injection is indicated for the treatment of post menarchal patients with gestational trophoblastic neoplasia as a single agent or as part of a combination chemotherapy regimen dactinomycin for injection is indicated for the treatment of adult patients with locally recurrent or locoregional solid malignancies as a component of palliative or adjunctive regional perfusion" assertion.
• association label "doxycycline hyclate tablets are tetracycline class drugs indicated for rickettsial infections 1 1 sexually transmitted infections 1 2 respiratory tract infections 1 3 specific bacterial infections 1 4 ophthalmic infections 1 5 anthrax including inhalational anthrax post exposure 1 6 alternative treatment for selected infections when penicillin is contraindicated 1 7 adjunctive therapy for acute intestinal amebiasis and severe acne 1 8 prophylaxis of malaria 1 9 to reduce the development of drug resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets and other antibacterial drugs doxycycline hyclate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria 1 1 doxycycline hyclate tablets are indicated for treatment of rocky mountain spotted fever typhus fever and the typhus group q fever rickettsial pox and tick fevers caused by rickettsiae doxycycline hyclate tablets are indicated for treatment of the following sexually transmitted infections uncomplicated urethral endocervical or rectal infections caused by chlamydia trachomatis nongonococcal urethritis caused by ureaplasma urealyticum lymphogranuloma venereum caused by chlamydia trachomatis granuloma inguinale caused by klebsiella granulomatis uncomplicated gonorrhea caused by neisseria gonorrhoeae chancroid caused by haemophilus ducreyi doxycycline hyclate tablets are indicated for treatment of the following respiratory tract infections respiratory tract infections caused by mycoplasma pneumoniae psittacosis ornithosis caused by chlamydophila psittaci because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline culture and susceptibility testing are recommended doxycycline is indicated for treatment of infections caused by the following microorganisms when bacteriological testing indicates appropriate susceptibility to the drug respiratory tract infections caused by haemophilus influenzae respiratory tract infections caused by klebsiella species upper respiratory infections caused by streptococcus pneumoniae doxycycline hyclate tablets are indicated for treatment of the following specific bacterial infections relapsing fever due to borrelia recurrentis plague due to yersinia pestis tularemia due to francisella tularensis cholera caused by vibrio cholerae campylobacter fetus infections caused by campylobacter fetus brucellosis due to brucella bartonellosis due to bartonella bacilliformis because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline culture and susceptibility testing are recommended doxycycline hyclate tablets are indicated for treatment of infections caused by the following gram negative microorganisms when bacteriological testing indicates appropriate susceptibility to the drug escherichia coli enterobacter aerogenes shigella acinetobacter urinary tract infections caused by klebsiella doxycycline hyclate tablets are indicated for treatment of the following ophthalmic infections trachoma caused by chlamydia trachomatis inclusion conjunctivitis caused by chlamydia trachomatis doxycycline hyclate tablets are indicated for the treatment of anthrax due to bacillus anthracis bacillus anthracis doxycycline hyclate tablets are indicted as an alternative treatment for the following selected infections when penicillin is contraindicated syphilis caused by treponema pallidum yaws caused by treponema pallidum pertenue listeriosis due to listeria monocytogenes vincent s infection caused by fusobacterium fusiforme actinomycosis caused by actinomyces israelii infections caused by clostridium in acute intestinal amebiasis doxycycline hyclate tablets may be a useful adjunct to amebicides in severe acne doxycycline hyclate tablets may be useful adjunctive therapy doxycycline hyclate tablets are indicated for the prophylaxis of malaria due to plasmodium falciparum see dosage and administration 2 4 patient counseling information 17 to reduce the development of drug resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets and other antibacterial drugs doxycycline hyclate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antibacterial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy" assertion.
• association label "alomide r lodoxamide tromethamine ophthalmic solution 1 is indicated in the treatment of the ocular disorders referred to by the terms vernal keratoconjunctivitis vernal conjunctivitis and vernal keratitis" assertion.
• association label "felodipine extended release tablets usp are indicated for the treatment of hypertension to lower blood pressure lowering blood pressure lowers the risk of fatal and non fatal cardiovascular events primarily strokes and myocardial infarctions these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including felodipine control of high blood pressure should be part of comprehensive cardiovascular risk management including as appropriate lipid control diabetes management antithrombotic therapy smoking cessation exercise and limited sodium intake many patients will require more than 1 drug to achieve blood pressure goals for specific advice on goals and management see published guidelines such as those of the national high blood pressure education program s joint national committee on prevention detection evaluation and treatment of high blood pressure jnc numerous antihypertensive drugs from a variety of pharmacologic classes and with different mechanisms of action have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality and it can be concluded that it is blood pressure reduction and not some other pharmacologic property of the drugs that is largely responsible for those benefits the largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly elevated systolic or diastolic pressure causes increased cardiovascular risk and the absolute risk increase per mmhg is greater at higher blood pressures so that even modest reductions of severe hypertension can provide substantial benefit relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk so the absolute benefit is greater in patients who are at higher risk independent of their hypertension for example patients with diabetes or hyperlipidemia and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal some antihypertensive drugs have smaller blood pressure effects as monotherapy in black patients and many antihypertensive drugs have additional approved indications and effects eg on angina heart failure or diabetic kidney disease these considerations may guide selection of therapy felodipine extended release tablets usp may be administered with other antihypertensive agents" assertion.
• association label "carefully consider the potential benefits and risks of indomethacin extended release capsules usp 75 mg and other treatment options before deciding to use indomethacin extended release capsules usp 75 mg use the lowest effective dose for the shortest duration consistent with individual patient treatment goals see warnings indomethacin extended release capsules usp 75 mg has been found effective in active stages of the following 1 moderate to severe rheumatoid arthritis including acute flares of chronic disease 2 moderate to severe ankylosing spondylitis 3 moderate to severe osteoarthritis 4 acute painful shoulder bursitis and or tendinitis indomethacin extended release capsules usp 75 mg are not recommended for the treatment of acute gouty arthritis indomethacin may enable the reduction of steroid dosage in patients receiving steroids for the more severe forms of rheumatoid arthritis in such instances the steroid dosage should be reduced slowly and the patients followed very closely for any possible adverse effects the use of indomethacin in conjunction with aspirin or other salicylates is not recommended controlled clinical studies have shown that the combined use of indomethacin and aspirin does not produce any greater therapeutic effect than the use of indomethacin alone furthermore in one of these clinical studies the incidence of gastrointestinal side effects was significantly increased with combined therapy see precautions drug interactions" assertion.
• association label "this is not an innocuous drug it is not recommended for the treatment of asymptomatic hyperuricemia allopurinol reduces serum and urinary uric acid concentrations its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics see clinical pharmacology contraindications warnings precautions allopurinol is indicated in the management of patients with signs and symptoms of primary or secondary gout acute attacks tophi joint destruction uric acid lithiasis and or nephropathy the management of patients with leukemia lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels allopurinol treatment should be discontinued when the potential for overproduction of uric acid is no longer present the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 8 mg day in male patients and 75 mg day in female patients therapy in such patients should be carefully assessed initially and reassessed periodically to determine in each case that treatment is beneficial and that the benefits outweigh the risks" assertion.
• association label "prednisolone sodium phosphate oral solution 15 mg prednisolone per 5 ml is indicated in the following conditions 1 allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with seasonal or perennial allergic rhinitis asthma contact dermatitis atopic dermatitis serum sickness drug hypersensitivity reactions 2 dermatologic diseases pemphigus bullous dermatitis herpetiformis severe erythema multiforme stevens johnson syndrome exfoliative erythroderma mycosis fungoides 3 edematous states to induce diuresis or remission of proteinuria in nephrotic syndrome in adults with lupus erythematosus and in adults and pediatric populations with idiopathic nephrotic syndrome without uremia 4 endocrine disorders primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the first choice synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance congenital adrenal hyperplasia hypercalcemia associated with cancer nonsuppurative thyroiditis 5 gastrointestinal diseases to tide the patient over a critical period of the disease in ulcerative colitis regional enteritis 6 hematologic disorders idiopathic thrombocytopenic purpura in adults selected cases of secondary thrombocytopenia acquired autoimmune hemolytic anemia pure red cell aplasia diamond blackfan anemia 7 neoplastic diseases for the treatment of acute leukemia and aggressive lymphomas in adults and children 8 nervous system acute exacerbations of multiple sclerosis 9 ophthalmic diseases uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids temporal arteritis sympathetic ophthalmia 1 respiratory diseases symptomatic sarcoidosis idiopathic eosinophilic pneumonias fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy asthma as distinct from allergic asthma listed above under allergic states hypersensitivity pneumonitis idiopathic pulmonary fibrosis acute exacerbations of chronic obstructive pulmonary disease copd and pneumocystis carinii pneumonia pcp associated with hypoxemia occurring in an hiv individual who is also under treatment with appropriate anti pcp antibiotics studies support the efficacy of systemic corticosteroids for the treatment of these conditions allergic bronchopulmonary aspergillosis idiopathic bronchiolitis obliterans with organizing pneumonia 11 rheumatic disorders as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in psoriatic arthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy ankylosing spondylitis acute and subacute bursitis acute nonspecific tenosynovitis acute gouty arthritis epicondylitis for the treatment of systemic lupus erythematosus dermatomyositis polymyositis polymyalgia rheumatica sjogren s syndrome relapsing polychondritis and certain cases of vasculitis 12 miscellaneous tuberculous meningitis with subarachnoid block or impending block tuberculosis with enlarged mediastinal lymph nodes causing respiratory difficulty and tuberculosis with pleural or pericardial effusion appropriate antituberculous chemotherapy must be used concurrently when treating any tuberculosis complications trichinosis with neurologic or myocardial involvement acute or chronic solid organ rejection with or without other agents" assertion.
• association label "minocycline hydrochloride capsules usp are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms rocky mountain spotted fever typhus fever and the typhus group q fever rickettsialpox and tick fevers caused by rickettsiae respiratory tract infections caused by mycoplasma pneumoniae lymphogranuloma venereum caused by chlamydia trachomatis psittacosis ornithosis due to chlamydia psittaci trachoma caused by chlamydia trachomatis although the infectious agent is not always eliminated as judged by immunofluorescence inclusion conjunctivitis caused by chlamydia trachomatis nongonococcal urethritis endocervical or rectal infections in adults caused by ureaplasma urealyticum or chlamydia trachomatis relapsing fever due to borrelia recurrentis chancroid caused by haemophilus ducreyi plague due to yersinia pestis tularemia due to francisella tularensis cholera caused by vibrio cholerae campylobacter fetus infections caused by campylobacter fetus brucellosis due to brucella species in conjunction with streptomycin bartonellosis due to bartonella bacilliformis granuloma inguinale caused by calymmatobacterium granulomatis minocycline is indicated for the treatment of infections caused by the following gram negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug escherichia coli enterobacter aerogenes shigella species acinetobacter species respiratory tract infections caused by haemophilus influenzae respiratory tract and urinary tract infections caused by klebsiella species minocycline hydrochloride capsules usp are indicated for the treatment of infections caused by the following gram positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug upper respiratory tract infections caused by streptococcus pneumoniae skin and skin structure infections caused by staphylococcus aureus note minocycline is not the drug of choice in the treatment of any type of staphylococcal infection when penicillin is contraindicated minocycline is an alternative drug in the treatment of the following infections uncomplicated urethritis in men due to neisseria gonorrhoeae and for the treatment of other gonococcal infections infections in women caused by neisseria gonorrhoeae syphilis caused by treponema pallidum subspecies pallidum yaws caused by treponema pallidum subspecies pertenue listeriosis due to listeria monocytogenes anthrax due to bacillus anthracis vincent s infection caused by fusobacterium fusiforme actinomycosis caused by actinomyces israelii infections caused by clostridium species in acute intestinal amebiasis minocycline may be a useful adjunct to amebicides in severe acne minocycline may be useful adjunctive therapy oral minocycline is indicated in the treatment of asymptomatic carriers of neisseria meningitidis to eliminate meningococci from the nasopharynx in order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers diagnostic laboratory procedures including serotyping and susceptibility testing should be performed to establish the carrier state and the correct treatment it is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high oral minocycline is not indicated for the treatment of meningococcal infection although no controlled clinical efficacy studies have been conducted limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by mycobacterium marinum to reduce the development of drug resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules usp and other antibacterial drugs minocycline hydrochloride capsules usp should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antibacterial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy close" assertion.
• association label "when oral therapy is not feasible and the strength dosage form and route of administration of the drug reasonably lend the preparation to the treatment of the condition the intramuscular use of methylprednisolone acetate injectable suspension is indicated as follows allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma atopic dermatitis contact dermatitis drug hypersensitivity reactions seasonal or perennial allergic rhinitis serum sickness transfusion reactions dermatologic diseases bullous dermatitis herpetiformis exfoliative erythroderma mycosis fungoides pemphigus severe erythema multiforme stevens johnson syndrome endocrine disorders primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the drug of choice synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance congenital adrenal hyperplasia hypercalcemia associated with cancer nonsuppurative thyroiditis gastrointestinal diseases to tide the patient over a critical period of the disease in regional enteritis systemic therapy and ulcerative colitis hematologic disorders acquired autoimmune hemolytic anemia congenital erythroid hypoplastic anemia diamond blackfan anemia pure red cell aplasia select cases of secondary thrombocytopenia miscellaneous trichinosis with neurologic or myocardial involvement tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy neoplastic diseases for palliative management of leukemias and lymphomas nervous system acute exacerbations of multiple sclerosis cerebral edema associated with primary or metastatic brain tumor or craniotomy ophthalmic diseases sympathetic ophthalmia temporal arteritis uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids renal diseases to induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus respiratory diseases berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy idiopathic eosinophilic pneumonias symptomatic sarcoidosis rheumatic disorders as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis acute rheumatic carditis ankylosing spondylitis psoriatic arthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy for the treatment of dermatomyositis polymyositis and systemic lupus erythematosus see warnings methylprednisolone acetate injectable suspension is indicated as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis acute and subacute bursitis acute nonspecific tenosynovitis epicondylitis rheumatoid arthritis synovitis of osteoarthritis methylprednisolone acetate injectable suspension is indicated for intralesional use in alopecia areata discoid lupus erythematosus keloids localized hypertrophic infiltrated inflammatory lesions of granuloma annulare lichen planus lichen simplex chronicus neurodermatitis and psoriatic plaques necrobiosis lipoidica diabeticorum methylprednisolone acetate injectable suspension also may be useful in cystic tumors of an aponeurosis or tendon ganglia" assertion.
• association label "minocycline hydrochloride capsules usp are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms rocky mountain spotted fever typhus fever and the typhus group q fever rickettsialpox and tick fevers caused by rickettsiae respiratory tract infections caused by mycoplasma pneumoniae lymphogranuloma venereum caused by chlamydia trachomatis psittacosis ornithosis due to chlamydia psittaci trachoma caused by chlamydia trachomatis although the infectious agent is not always eliminated as judged by immunofluorescence inclusion conjunctivitis caused by chlamydia trachomatis nongonococcal urethritis endocervical or rectal infections in adults caused by ureaplasma urealyticum or chlamydia trachomatis relapsing fever due to borrelia recurrentis chancroid caused by haemophilus ducreyi plague due to yersinia pestis tularemia due to francisella tularensis cholera caused by vibrio cholerae campylobacter fetus infections caused by campylobacter fetus brucellosis due to brucella species in conjunction with streptomycin bartonellosis due to bartonella bacilliformis granuloma inguinale caused by calymmatobacterium granulomatis minocycline is indicated for the treatment of infections caused by the following gram negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug escherichia coli enterobacter aerogenes shigella species acinetobacter species respiratory tract infections caused by haemophilus influenzae respiratory tract and urinary tract infections caused by klebsiella species minocycline hydrochloride capsules usp are indicated for the treatment of infections caused by the following gram positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug upper respiratory tract infections caused by streptococcus pneumoniae skin and skin structure infections caused by staphylococcus aureus note minocycline is not the drug of choice in the treatment of any type of staphylococcal infection when penicillin is contraindicated minocycline is an alternative drug in the treatment of the following infections uncomplicated urethritis in men due to neisseria gonorrhoeae and for the treatment of other gonococcal infections infections in women caused by neisseria gonorrhoeae syphilis caused by treponema pallidum subspecies pallidum yaws caused by treponema pallidum subspecies pertenue listeriosis due to listeria monocytogenes anthrax due to bacillus anthracis vincent s infection caused by fusobacterium fusiforme actinomycosis caused by actinomyces israelii infections caused by clostridium species in acute intestinal amebiasis minocycline may be a useful adjunct to amebicides in severe acne minocycline may be useful adjunctive therapy oral minocycline is indicated in the treatment of asymptomatic carriers of neisseria meningitidis to eliminate meningococci from the nasopharynx in order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers diagnostic laboratory procedures including serotyping and susceptibility testing should be performed to establish the carrier state and the correct treatment it is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high oral minocycline is not indicated for the treatment of meningococcal infection although no controlled clinical efficacy studies have been conducted limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by mycobacterium marinum to reduce the development of drug resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules usp and other antibacterial drugs minocycline hydrochloride capsules usp should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antibacterial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy close" assertion.
• association label "carbidopa tablets are indicated for use with carbidopa levodopa or with levodopa in the treatment of the symptoms of idiopathic parkinson s disease paralysis agitans postencephalitic parkinsonism and symptomatic parkinsonism which may follow injury to the nervous system by carbon monoxide intoxication and or manganese intoxication carbidopa tablets are for use with carbidopa levodopa in patients for whom the dosage of carbidopa levodopa provides less than adequate daily dosage usually 7 mg daily of carbidopa carbidopa tablets are for use with levodopa in the occasional patient whose dosage requirement of carbidopa and levodopa necessitates separate titration of each medication carbidopa tablets are used with carbidopa levodopa or with levodopa to permit the administration of lower doses of levodopa with reduced nausea and vomiting more rapid dosage titration and with a somewhat smoother response however patients with markedly irregular on off responses to levodopa have not been shown to benefit from the addition of carbidopa since carbidopa prevents the reversal of levodopa effects caused by pyridoxine supplemental pyridoxine vitamin b6 can be given to patients when they are receiving carbidopa and levodopa concomitantly or as carbidopa levodopa although the administration of carbidopa tablets permits control of parkinsonism and parkinson s disease with much lower doses of levodopa there is no conclusive evidence at present that this is beneficial other than in reducing nausea and vomiting permitting more rapid titration and providing a somewhat smoother response to levodopa certain patients who responded poorly to levodopa alone have improved when carbidopa and levodopa were given concurrently this was most likely due to decreased peripheral decarboxylation of levodopa rather than to a primary effect of carbidopa on the peripheral nervous system carbidopa has not been shown to enhance the intrinsic efficacy of levodopa in deciding whether to give carbidopa tablets with carbidopa levodopa or with levodopa to patients who have nausea and or vomiting the physician should be aware that while many patients may be expected to improve some may not since one cannot predict which patients are likely to improve this can only be determined by a trial of therapy it should be further noted that in controlled trials comparing carbidopa and levodopa with levodopa alone about half the patients with nausea and or vomiting on levodopa alone improved spontaneously despite being retained on the same dose of levodopa during the controlled portion of the trial" assertion.
• association label "alimta r in combination with pembrolizumab and platinum chemotherapy for the initial treatment of patients with metastatic non squamous nsclc with no egfr or alk genomic tumor aberrations 1 1 in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic non squamous non small cell lung cancer nsclc 1 1 as a single agent for the maintenance treatment of patients with locally advanced or metastatic non squamous nsclc whose disease has not progressed after four cycles of platinum based first line chemotherapy 1 1 as a single agent for the treatment of patients with recurrent metastatic non squamous nsclc after prior chemotherapy 1 1 limitations of use 1 1 initial treatment in combination with cisplatin of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery 1 2 alimta r in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic non squamous non small cell lung cancer nsclc as a single agent for the maintenance treatment of patients with locally advanced or metastatic non squamous nsclc whose disease has not progressed after four cycles of platinum based first line chemotherapy as a single agent for the treatment of patients with recurrent metastatic non squamous nsclc after prior chemotherapy limitations of use see clinical studies 14 1 alimta is indicated in combination with cisplatin for the initial treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery" assertion.
• association label "rabeprazole sodium delayed release tablets is a proton pump inhibitor ppi indicated in adults for healing of erosive or ulcerative gastroesophageal reflux disease gerd 1 1 maintenance of healing of erosive or ulcerative gerd 1 2 treatment of symptomatic gerd 1 3 healing of duodenal ulcers 1 4 helicobacter pylori 1 5 treatment of pathological hypersecretory conditions including zollinger ellison syndrome 1 6 in adolescent patients 12 years of age and older for short term treatment of symptomatic gerd 1 7 rabeprazole sodium delayed release tablets is indicated for short term 4 to 8 weeks treatment in the healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease gerd for those patients who have not healed after 8 weeks of treatment an additional 8 week course of rabeprazole sodium delayed release tablets may be considered rabeprazole sodium delayed release tablets is indicated for maintaining healing and reduction in relapse rates of heartburn symptoms in patients with erosive or ulcerative gastroesophageal reflux disease gerd maintenance controlled studies do not extend beyond 12 months rabeprazole sodium delayed release tablets is indicated for the treatment of daytime and nighttime heartburn and other symptoms associated with gerd in adults for up to 4 weeks rabeprazole sodium delayed release tablets is indicated for short term up to four weeks treatment in the healing and symptomatic relief of duodenal ulcers most patients heal within four weeks rabeprazole sodium delayed release tablets in combination with amoxicillin and clarithromycin as a three drug regimen is indicated for the treatment of patients with h pylori h pylori h pylori see clinical studies 14 5 dosage and administration 2 5 in patients who fail therapy susceptibility testing should be done if resistance to clarithromycin is demonstrated or susceptibility testing is not possible alternative antimicrobial therapy should be instituted see clinical pharmacology 12 2 clinical pharmacology 12 2 rabeprazole sodium delayed release tablets is indicated for the long term treatment of pathological hypersecretory conditions including zollinger ellison syndrome rabeprazole sodium delayed release tablets is indicated for the treatment of symptomatic gerd in adolescents 12 years of age and above for up to 8 weeks" assertion.
• association label "dactinomycin for injection as part of a combination chemotherapy and or multi modality treatment regimen is indicated for the treatment of wilms tumor childhood rhabdomyosarcoma ewing s sarcoma and metastatic nonseminomatous testicular cancer dactinomycin for injection is indicated as a single agent or as part of a combination chemotherapy regimen for the treatment of gestational trophoblastic neoplasia dactinomycin for injection as a component of regional perfusion is indicated for the palliative and or adjunctive treatment of locally recurrent or locoregional solid malignancies" assertion.
• association label "amlodipine besylate tablet usp is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of hypertension 1 1 o amlodipine besylate tablet usp is indicated for the treatment of hypertension to lower blood pressure lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events primarily strokes and myocardial infarctions coronary artery disease 1 2 o chronic stable angina o vasospastic angina prinzmetal s or variant angina o angiographically documented coronary artery disease in patients without heart failure or an ejection fraction 4 amlodipine besylate tablet usp is indicated for the treatment of hypertension to lower blood pressure lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events primarily strokes and myocardial infarctions these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine besylate tablet usp control of high blood pressure should be part of comprehensive cardiovascular risk management including as appropriate lipid control diabetes management antithrombotic therapy smoking cessation exercise and limited sodium intake many patients will require more than one drug to achieve blood pressure goals for specific advice on goals and management see published guidelines such as those of the national high blood pressure education program s joint national committee on prevention detection evaluation and treatment of high blood pressure jnc numerous antihypertensive drugs from a variety of pharmacologic classes and with different mechanisms of action have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality and it can be concluded that it is blood pressure reduction and not some other pharmacologic property of the drugs that is largely responsible for those benefits the largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly elevated systolic or diastolic pressure causes increased cardiovascular risk and the absolute risk increase per mmhg is greater at higher blood pressures so that even modest reductions of severe hypertension can provide substantial benefit relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk so the absolute benefit is greater in patients who are at higher risk independent of their hypertension for example patients with diabetes or hyperlipidemia and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal some antihypertensive drugs have smaller blood pressure effects as monotherapy in black patients and many antihypertensive drugs have additional approved indications and effects e g on angina heart failure or diabetic kidney disease these considerations may guide selection of therapy amlodipine besylate tablet usp may be used alone or in combination with other antihypertensive agents chronic stable angina amlodipine besylate tablet usp is indicated for the symptomatic treatment of chronic stable angina amlodipine besylate tablet usp may be used alone or in combination with other antianginal agents vasospastic angina prinzmetal s or variant angina amlodipine besylate tablet usp is indicated for the treatment of confirmed or suspected vasospastic angina amlodipine besylate tablet usp may be used as monotherapy or in combination with other antianginal agents angiographically documented cad in patients with recently documented cad by angiography and without heart failure or an ejection fraction 4 amlodipine besylate tablet usp is indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure" assertion.
• association label "to reduce the development of drug resistant bacteria and maintain the effectiveness of demeclocycline hydrochloride tablets and other antibacterial drugs demeclocycline hydrochloride tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antibacterial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy demeclocycline hydrochloride is indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions below rocky mountain spotted fever typhus fever and the typhus group q fever rickettsialpox and tick fevers caused by rickettsiae respiratory tract infections caused by lymphogranuloma venereum due to psittacosis ornithosis due to trachoma due to although the infectious agent is not always eliminated as judged by immunofluorescence inclusion conjunctivitis caused by nongonococcal urethritis in adults caused by or relapsing fever due to chancroid caused by plague due to tularemia due to cholera caused by campylobacter fetus infections caused by brucellosis due to species in conjunction with streptomycin bartonellosis due to granuloma inguinale caused by demeclocycline hydrochloride is indicated for treatment of infections caused by the following gram negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug species species respiratory tract infections caused by respiratory tract and urinary tract infections caused by species demeclocycline hydrochloride is indicated for treatment of infections caused by the following gram positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug upper respiratory infections caused by pneumoniae skin and skin structure infections caused by note tetracyclines including demeclocycline are not the drugs of choice in the treatment of any type of staphylococcal infection when penicillin is contraindicated tetracyclines including demeclocycline hydrochloride are alternative drugs in the treatment of the following infections uncomplicated urethritis in men due to and for the treatment of other uncomplicated gonococcal infections infections in women caused by syphilis caused by subspecies yaws caused by subspecies listeriosis due to anthrax due to vincent s infection caused by actinomycosis caused by clostridial diseases caused by species in acute intestinal amebiasis demeclocycline hydrochloride may be a useful adjunct to amebicides in severe acne demeclocycline hydrochloride may be a useful adjunctive therapy mycoplasma pneumoniae chlamydia trachomatis chlamydia psittaci chlamydia trachomatis chlamydia trachomatis ureaplasma urealyticum chlamydia trachomatis borrelia recurrentis haemophilus ducreyi yersinia pestis francisella tularensis vibrio cholerae campylobacter fetus brucella bartonella bacilliformis calymmatobacterium granulomatis escherichia coli enterobacter aerogenes shigella acinetobacter haemophilus influenzae klebsiella streptococcus staphylococcus aureus neisseria gonorrhoeae neisseria gonorrhoeae treponema pallidum pallidum treponema pallidum pertenue listeria monocytogenes bacillus anthracis fusobacterium fusiforme actinomyces israelii clostridium" assertion.
• association label "allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment atopic dermatitis bronchial asthma contact dermatitis drug hypersensitivity reactions seasonal or perennial allergic rhinitis and serum sickness collagen diseases during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus and acute rheumatic carditis dermatologic diseases bullous dermatitis herpetiformis exfoliative dermatitis mycosis fungoides pemphigus severe erythema multiforme stevens johnson syndrome severe psoriasis and severe seborrheic dermatitis edematous states to induce a diuresis or remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus endocrine disorders primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the first choice synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance congenital adrenal hyperplasia hypercalcemia associated with cancer and nonsuppurative thyroiditis gastrointestinal diseases to tide the patient over a critical period of the disease in ulcerative colitis and regional enteritis hematologic disorders idiopathic thrombocytopenic purpura in adults secondary thrombocytopenia in adults acquired autoimmune hemolytic anemia erythroblastopenia rbc anemia and congenital erythroid hypoplastic anemia miscellaneous diagnostic testing of adrenocortical hyperfunction tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy and trichinosis with neurologic or myocardial involvement neoplastic diseases for palliative management of leukemia and lymphomas in adults and acute leukemia of childhood ophthalmic diseases severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as allergic conjunctivitis keratitis allergic corneal marginal ulcers herpes zoster ophthalmicus iritis and iridocyclitis chorioretinitis anterior segment inflammation diffuse posterior uveitis and choroiditis optic neuritis and sympathetic ophthalmia respiratory diseases symptomatic sarcoidosis loeffler s syndrome not manageable by other means berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy and aspiration pneumonitis rheumatic disorders as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in psoriatic arthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy ankylosing spondylitis acute and subacute bursitis acute nonspecific tenosynovitis acute gouty arthritis post traumatic osteoarthritis synovitis of osteoarthritis and epicondylitis" assertion.
• association label "sulfasalazine delayed release tablets are indicated a b c d 1 sulfasalazine delayed release tablets are particularly indicated in patients with ulcerative colitis who cannot take uncoated sulfasalazine tablets because of gastrointestinal intolerance and in whom there is evidence that this intolerance is not primarily the result of high blood levels of sulfapyridine and its metabolites e g patients experiencing nausea and vomiting with the first few doses of the drug or patients in whom a reduction in dosage does not alleviate the adverse gastrointestinal effects in patients with rheumatoid arthritis or juvenile rheumatoid arthritis rest and physiotherapy as indicated should be continued unlike anti inflammatory drugs sulfasalazine delayed release tablets do not produce an immediate response concurrent treatment with analgesics and or nonsteroidal anti inflammatory drugs is recommended at least until the effect of sulfasalazine delayed release tablets is apparent" assertion.
• association label "carefully consider the potential benefits and risks of indomethacin extended release capsules usp 75 mg and other treatment options before deciding to use indomethacin extended release capsules usp 75 mg use the lowest effective dose for the shortest duration consistent with individual patient treatment goals see warnings indomethacin extended release capsules usp 75 mg has been found effective in active stages of the following 1 moderate to severe rheumatoid arthritis including acute flares of chronic disease 2 moderate to severe ankylosing spondylitis 3 moderate to severe osteoarthritis 4 acute painful shoulder bursitis and or tendinitis indomethacin extended release capsules usp 75 mg are not recommended for the treatment of acute gouty arthritis indomethacin may enable the reduction of steroid dosage in patients receiving steroids for the more severe forms of rheumatoid arthritis in such instances the steroid dosage should be reduced slowly and the patients followed very closely for any possible adverse effects the use of indomethacin in conjunction with aspirin or other salicylates is not recommended controlled clinical studies have shown that the combined use of indomethacin and aspirin does not produce any greater therapeutic effect than the use of indomethacin alone furthermore in one of these clinical studies the incidence of gastrointestinal side effects was significantly increased with combined therapy see precautions drug interactions" assertion.
• association label "when oral therapy is not feasible and the strength dosage form and route of administration of the drug reasonably lend the preparation to the treatment of the condition the intramuscular use of methylprednisolone acetate injectable suspension is indicated as follows allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma atopic dermatitis contact dermatitis drug hypersensitivity reactions seasonal or perennial allergic rhinitis serum sickness transfusion reactions dermatologic diseases bullous dermatitis herpetiformis exfoliative erythroderma mycosis fungoides pemphigus severe erythema multiforme stevens johnson syndrome endocrine disorders primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the drug of choice synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance congenital adrenal hyperplasia hypercalcemia associated with cancer nonsuppurative thyroiditis gastrointestinal diseases to tide the patient over a critical period of the disease in regional enteritis systemic therapy and ulcerative colitis hematologic disorders acquired autoimmune hemolytic anemia congenital erythroid hypoplastic anemia diamond blackfan anemia pure red cell aplasia select cases of secondary thrombocytopenia miscellaneous trichinosis with neurologic or myocardial involvement tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy neoplastic diseases for palliative management of leukemias and lymphomas nervous system acute exacerbations of multiple sclerosis cerebral edema associated with primary or metastatic brain tumor or craniotomy ophthalmic diseases sympathetic ophthalmia temporal arteritis uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids renal diseases to induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus respiratory diseases berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy idiopathic eosinophilic pneumonias symptomatic sarcoidosis rheumatic disorders as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis acute rheumatic carditis ankylosing spondylitis psoriatic arthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy for the treatment of dermatomyositis polymyositis and systemic lupus erythematosus see warnings methylprednisolone acetate injectable suspension is indicated as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis acute and subacute bursitis acute nonspecific tenosynovitis epicondylitis rheumatoid arthritis synovitis of osteoarthritis methylprednisolone acetate injectable suspension is indicated for intralesional use in alopecia areata discoid lupus erythematosus keloids localized hypertrophic infiltrated inflammatory lesions of granuloma annulare lichen planus lichen simplex chronicus neurodermatitis and psoriatic plaques necrobiosis lipoidica diabeticorum methylprednisolone acetate injectable suspension also may be useful in cystic tumors of an aponeurosis or tendon ganglia" assertion.
• association label "hydrocortisone tablets are indicated in the following conditions primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the first choice synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance congenital adrenal hyperplasia non suppurative thyroiditis hypercalcemia associated with cancer as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in during an exacerbation or as maintenance therapy in selected cases of pemphigus bullous dermatitis herpetiformis severe erythema multiforme stevens johnson syndrome exfoliative dermatitis mycosis fungoides severe psoriasis severe seborrheic dermatitis control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as symptomatic sarcoidosis loeffler s syndrome not manageable by other means berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy aspiration pneumonitis idiopathic thrombocytopenic purpura in adults secondary thrombocytopenia in adults acquired autoimmune hemolytic anemia erythroblastopenia rbc anemia congenital erythroid hypoplastic anemia for palliative management of to induce a diuresis or remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus to tide the patient over a critical period of the disease in acute exacerbations of multiple sclerosis tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy trichinosis with neurologic or myocardial involvement" assertion.
• association label "cephalexin is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria respiratory tract infection 1 1 otitis media 1 2 skin and skin structure infections 1 3 bone infections 1 4 genitourinary tract infections 1 5 to reduce the development of drug resistant bacteria and maintain the effectiveness of cephalexin capsules cephalexin for oral suspension and cephalexin tablets and other antibacterial drugs cephalexin capsules cephalexin for oral suspension and cephalexin tablets should be used only to treat infections that are proven or strongly suspected to be caused by bacteria 1 6 cephalexin is indicated for the treatment of respiratory tract infections caused by susceptible isolates of streptococcus pneumoniae streptococcus pyogenes cephalexin is indicated for the treatment of otitis media caused by susceptible isolates of streptococcus pneumoniae haemophilus influenzae staphylococcus aureus streptococcus pyogenes moraxella catarrhalis cephalexin is indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following gram positive bacteria staphylococcus aureus streptococcus pyogenes cephalexin is indicated for the treatment of bone infections caused by susceptible isolates of staphylococcus aureus proteus mirabilis cephalexin is indicated for the treatment of genitourinary tract infections including acute prostatitis caused by susceptible isolates of escherichia coli proteus mirabilis klebsiella pneumoniae to reduce the development of drug resistant bacteria and maintain the effectiveness of cephalexin capsules cephalexin for oral suspension and cephalexin tablets and other antibacterial drugs cephalexin capsules cephalexin for oral suspension and cephalexin tablets should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information is available this information should be considered in selecting or modifying antibacterial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy" assertion.
• association label "quinapril tablets usp are indicated for the treatment of hypertension to lower blood pressure lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events primarily strokes and myocardial infarctions these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs there are no controlled trials demonstrating risk reduction with quinapril tablets usp control of high blood pressure should be part of comprehensive cardiovascular risk management including as appropriate lipid control diabetes management antithrombotic therapy smoking cessation exercise and limited sodium intake many patients will require more than one drug to achieve blood pressure goals for specific advice on goals and management see published guidelines such as those of the national high blood pressure education program s joint national committee on prevention detection evaluation and treatment of high blood pressure jnc numerous antihypertensive drugs from a variety of pharmacologic classes and with different mechanisms of action have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality and it can be concluded that it is blood pressure reduction and not some other pharmacologic property of the drugs that is largely responsible for those benefits the largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly elevated systolic or diastolic pressure causes increased cardiovascular risk and the absolute risk increase per mmhg is greater at higher blood pressures so that even modest reductions of severe hypertension can provide substantial benefit relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk so the absolute benefit is greater in patients who are at higher risk independent of their hypertension for example patients with diabetes or hyperlipidemia and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal some antihypertensive drugs have smaller blood pressure effects as monotherapy in black patients and many antihypertensive drugs have additional approved indications and effects e g on angina heart failure or diabetic kidney disease these considerations may guide selection of therapy quinapril tablets usp may be used alone or in combination with thiazide diuretics heart failure quinapril tablets usp is indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and or digitalis in using quinapril tablets usp consideration should be given to the fact that another ace inhibitor captopril has caused agranulocytosis particularly in patients with renal impairment or collagen vascular disease available data are insufficient to show that quinapril tablets usp does not have a similar risk see warnings black patients receiving ace inhibitor monotherapy have been reported to have a higher incidence of angioedema compared to non blacks it should also be noted that in controlled clinical trials ace inhibitors have an effect on blood pressure that is less in black patients than in non blacks" assertion.
• association label "sulfadiazine tablets usp are indicated in the following conditions chancroid trachoma inclusion conjunctivitis nocardiosis urinary tract infections primarily pyelonephritis pyelitis and cystitis in the absence of obstructive uropathy or foreign bodies when these infections are caused by susceptible strains of the following organisms escherichia coli klebsiella enterobacter staphylococcus aureus proteus mirabilis p vulgaris toxoplasmosis encephalitis in patients with and without acquired immunodeficiency syndrome as adjunctive therapy with pyrimethamine malaria due to chloroquine resistant strains of plasmodium falciparum prophylaxis of meningococcal meningitis when sulfonamide sensitive group a strains are known to prevail in family groups or larger closed populations the prophylactic usefulness of sulfonamides when group b or c infections are prevalent is not proved and may be harmful in closed population groups meningococcal meningitis when the organism has been demonstrated to be susceptible acute otitis media due to haemophilus influenzae prophylaxis against recurrences of rheumatic fever as an alternative to penicillin h influenzae important notes in vitro currently the increasing frequency of resistant organisms limits the usefulness of antibacterial agents including the sulfonamides especially in the treatment of recurrent and complicated urinary tract infections wide variation in blood levels may result with identical doses blood levels should be measured in patients receiving sulfonamides for serious infections free sulfonamide blood levels of 5 mg to 15 mg per 1 ml may be considered therapeutically effective for most infections and blood levels of 12 mg to 15 mg per 1 ml may be considered optimal for serious infections twenty mg per 1 ml should be the maximum total sulfonamide level since adverse reactions occur more frequently above this level" assertion.
• association label "intravenous theophylline is indicated as an adjunct to inhaled beta 2 selective agonists and systemically administered corticosteroids for the treatment of acute exacerbations of the symptoms and reversible airflow obstruction associated with asthma and other chronic lung diseases e g emphysema and chronic bronchitis" assertion.
• association label "abilify is an atypical antipsychotic indicated as oral formulations for the treatment of schizophrenia 1 1 adults efficacy was established in four 4 6 week trials and one maintenance trial in patients with schizophrenia 14 1 adolescents ages 13 17 efficacy was established in one 6 week trial in patients with schizophrenia 14 1 acute treatment of manic or mixed episodes associated with bipolar i disorder as monotherapy and as an adjunct to lithium or valproate 1 2 adults efficacy was established in four 3 week monotherapy trials and one 6 week adjunctive trial in patients with manic or mixed episodes 14 2 pediatric patients ages 1 17 efficacy was established in one 4 week monotherapy trial in patients with manic or mixed episodes 14 2 maintenance treatment of bipolar i disorder both as monotherapy and as an adjunct to lithium or valproate 1 2 adults efficacy was established in one maintenance monotherapy trial and in one maintenance adjunctive trial 14 2 adjunctive treatment of major depressive disorder mdd 1 3 adults efficacy was established in two 6 week trials in patients with mdd who had an inadequate response to antidepressant therapy during the current episode 14 3 treatment of irritability associated with autistic disorder 1 4 pediatric patients ages 6 17 years efficacy was established in two 8 week trials in patients with autistic disorder 14 4 as an injection for the acute treatment of agitation associated with schizophrenia or bipolar i disorder 1 5 adults efficacy was established in three 24 hour trials in agitated patients with schizophrenia or manic mixed episodes of bipolar i disorder 14 5 abilify is indicated for the treatment of schizophrenia the efficacy of abilify was established in four 4 6 week trials in adults and one 6 week trial in adolescents 13 to 17 years maintenance efficacy was demonstrated in one trial in adults and can be extrapolated to adolescents see clinical studies 14 1 acute treatment of manic and mixed episodes abilify is indicated for the acute treatment of manic and mixed episodes associated with bipolar i disorder both as monotherapy and as an adjunct to lithium or valproate efficacy as monotherapy was established in four 3 week monotherapy trials in adults and one 4 week monotherapy trial in pediatric patients 1 to 17 years efficacy as adjunctive therapy was established in one 6 week adjunctive trial in adults see clinical studies 14 2 maintenance treatment of bipolar i disorder abilify is indicated for the maintenance treatment of bipolar i disorder both as monotherapy and as an adjunct to either lithium or valproate maintenance efficacy was demonstrated in one monotherapy maintenance trial and in one adjunctive maintenance trial in adults see clinical studies 14 2 abilify is indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder mdd efficacy was established in two 6 week trials in adults with mdd who had an inadequate response to antidepressant therapy during the current episode see clinical studies 14 3 abilify is indicated for the treatment of irritability associated with autistic disorder efficacy was established in two 8 week trials in pediatric patients aged 6 to 17 years with irritability associated with autistic disorder including symptoms of aggression towards others deliberate self injuriousness temper tantrums and quickly changing moods see clinical studies 14 4 abilify injection is indicated for the acute treatment of agitation associated with schizophrenia or bipolar disorder manic or mixed psychomotor agitation is defined in dsm iv as excessive motor activity associated with a feeling of inner tension patients experiencing agitation often manifest behaviors that interfere with their diagnosis and care eg threatening behaviors escalating or urgently distressing behavior or self exhausting behavior leading clinicians to the use of intramuscular antipsychotic medications to achieve immediate control of the agitation efficacy was established in three short term 24 hour trials in adults see clinical studies 14 5 psychiatric disorders in children and adolescents are often serious mental disorders with variable symptom profiles that are not always congruent with adult diagnostic criteria it is recommended that psychotropic medication therapy for pediatric patients only be initiated after a thorough diagnostic evaluation has been conducted and careful consideration given to the risks associated with medication treatment medication treatment for pediatric patients with schizophrenia bipolar i disorder and irritability associated with autistic disorder is indicated as part of a total treatment program that often includes psychological educational and social interventions" assertion.
• association label "allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment atopic dermatitis bronchial asthma contact dermatitis drug hypersensitivity reactions seasonal or perennial allergic rhinitis and serum sickness collagen diseases during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus and acute rheumatic carditis dermatologic diseases bullous dermatitis herpetiformis exfoliative dermatitis mycosis fungoides pemphigus severe erythema multiforme stevens johnson syndrome severe psoriasis and severe seborrheic dermatitis edematous states to induce a diuresis or remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus endocrine disorders primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the first choice synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance congenital adrenal hyperplasia hypercalcemia associated with cancer and nonsuppurative thyroiditis gastrointestinal diseases to tide the patient over a critical period of the disease in ulcerative colitis and regional enteritis hematologic disorders idiopathic thrombocytopenic purpura in adults secondary thrombocytopenia in adults acquired autoimmune hemolytic anemia erythroblastopenia rbc anemia and congenital erythroid hypoplastic anemia miscellaneous diagnostic testing of adrenocortical hyperfunction tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy and trichinosis with neurologic or myocardial involvement neoplastic diseases for palliative management of leukemia and lymphomas in adults and acute leukemia of childhood ophthalmic diseases severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as allergic conjunctivitis keratitis allergic corneal marginal ulcers herpes zoster ophthalmicus iritis and iridocyclitis chorioretinitis anterior segment inflammation diffuse posterior uveitis and choroiditis optic neuritis and sympathetic ophthalmia respiratory diseases symptomatic sarcoidosis loeffler s syndrome not manageable by other means berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy and aspiration pneumonitis rheumatic disorders as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in psoriatic arthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy ankylosing spondylitis acute and subacute bursitis acute nonspecific tenosynovitis acute gouty arthritis post traumatic osteoarthritis synovitis of osteoarthritis and epicondylitis" assertion.
• association label "hydrocortisone butyrate cream usp 1 lipophilic is indicated for relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adults the topical treatment of mild to moderate atopic dermatitis in pediatric patients 3 months to 18 years of age hydrocortisone butyrate cream usp 1 lipophilic is a corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adults 1 the treatment of mild to moderate atopic dermatitis in patients 3 months to 18 years of age 1" assertion.
• association label "to reduce the development of drug resistant bacteria and maintain the effectiveness of penicillin g procaine and other antibacterial drugs penicillin g procaine should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antibacterial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy penicillin g procaine is indicated in the treatment of moderately severe infections in both adults and pediatric patients due to penicillin g susceptible microorganisms that are susceptible to the low and persistent serum levels common to this particular dosage form in the indications listed below therapy should be guided by bacteriological studies including susceptibility tests and by clinical response note when high sustained serum levels are required aqueous penicillin g either im or iv should be used the following infections will usually respond to adequate dosages of intramuscular penicillin g procaine moderately severe to severe infections of the upper respiratory tract skin and soft tissue infections scarlet fever and erysipelas due to susceptible streptococci group a without bacteremia note streptococci in groups a c g h l and m are very sensitive to penicillin g other groups including group d enterococcus are resistant aqueous penicillin is recommended for streptococcal infections with bacteremia moderately severe infections of the respiratory tract due to susceptible pneumococci note severe pneumonia empyema bacteremia pericarditis meningitis peritonitis and arthritis of pneumococcal etiology are better treated with aqueous penicillin g during the acute stage moderately severe infections of the skin and soft tissues due to susceptible staphylococci penicillin g susceptible note reports indicate an increasing number of strains of staphylococci resistant to penicillin g emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections indicated surgical procedures should be performed fusospirochetosis vincent s gingivitis and pharyngitis moderately severe infections of the oropharynx due to susceptible fusiform bacilli and spirochetes note necessary dental care should be accomplished in infections involving the gum tissue syphilis all stages due to susceptible treponema pallidum note this drug should not be used in the treatment of beta lactamase producing organisms which include most strains of neisseria gonorrhea yaws bejel pinta due to susceptible organisms penicillin g procaine is an adjunct to antitoxin for prevention of the carrier stage of diphtheria due to susceptible c diphtheriae anthrax due to bacillus anthracis bacillus anthracis rat bite fever due to susceptible streptobacillus moniliformis spirillum minus erysipeloid due to susceptible erysipelothrix rhusiopathia subacute bacterial endocarditis only in extremely sensitive infections due to susceptible group a streptococci" assertion.
• association label "aveed is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone primary hypogonadism congenital or acquired testicular failure due to cryptorchidism bilateral torsion orchitis vanishing testis syndrome orchiectomy klinefelter s syndrome chemotherapy or toxic damage from alcohol or heavy metals these men usually have low serum testosterone concentrations and gonadotropins follicle stimulating hormone fsh luteinizing hormone lh above the normal range hypogonadotropic hypogonadism congenital or acquired gonadotropin or luteinizing hormone releasing hormone lhrh deficiency or pituitary hypothalamic injury from tumors trauma or radiation these men have low testosterone serum concentrations but have gonadotropins in the normal or low range aveed should only be used in patients who require testosterone replacement therapy and in whom the benefits of the product outweigh the serious risks of pulmonary oil microembolism and anaphylaxis limitations of use safety and efficacy of aveed in men with age related hypogonadism also referred to as late onset hypogonadism have not been established safety and efficacy of aveed in males less than 18 years old have not been established see use in specific populations 8 4 aveed testosterone undecanoate injection is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone o primary hypogonadism congenital or acquired 1 o hypogonadotropic hypogonadism congenital or acquired 1 aveed should only be used in patients who require testosterone replacement therapy and in whom the benefits of the product outweigh the serious risks of pulmonary oil microembolism and anaphylaxis 1 limitations of use safety and efficacy of aveed in men with age related hypogonadism have not been established 1 safety and efficacy of aveed in males less than 18 years old have not been established 1 8 4" assertion.
• association label "to reduce the development of drug resistant bacteria and maintain the effectiveness of demeclocycline hydrochloride tablets and other antibacterial drugs demeclocycline hydrochloride tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antibacterial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy demeclocycline hydrochloride is indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions below rocky mountain spotted fever typhus fever and the typhus group q fever rickettsialpox and tick fevers caused by rickettsiae respiratory tract infections caused by lymphogranuloma venereum due to psittacosis ornithosis due to trachoma due to although the infectious agent is not always eliminated as judged by immunofluorescence inclusion conjunctivitis caused by nongonococcal urethritis in adults caused by or relapsing fever due to chancroid caused by plague due to tularemia due to cholera caused by campylobacter fetus infections caused by brucellosis due to species in conjunction with streptomycin bartonellosis due to granuloma inguinale caused by demeclocycline hydrochloride is indicated for treatment of infections caused by the following gram negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug species species respiratory tract infections caused by respiratory tract and urinary tract infections caused by species demeclocycline hydrochloride is indicated for treatment of infections caused by the following gram positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug upper respiratory infections caused by pneumoniae skin and skin structure infections caused by note tetracyclines including demeclocycline are not the drugs of choice in the treatment of any type of staphylococcal infection when penicillin is contraindicated tetracyclines including demeclocycline hydrochloride are alternative drugs in the treatment of the following infections uncomplicated urethritis in men due to and for the treatment of other uncomplicated gonococcal infections infections in women caused by syphilis caused by subspecies yaws caused by subspecies listeriosis due to anthrax due to vincent s infection caused by actinomycosis caused by clostridial diseases caused by species in acute intestinal amebiasis demeclocycline hydrochloride may be a useful adjunct to amebicides in severe acne demeclocycline hydrochloride may be a useful adjunctive therapy mycoplasma pneumoniae chlamydia trachomatis chlamydia psittaci chlamydia trachomatis chlamydia trachomatis ureaplasma urealyticum chlamydia trachomatis borrelia recurrentis haemophilus ducreyi yersinia pestis francisella tularensis vibrio cholerae campylobacter fetus brucella bartonella bacilliformis calymmatobacterium granulomatis escherichia coli enterobacter aerogenes shigella acinetobacter haemophilus influenzae klebsiella streptococcus staphylococcus aureus neisseria gonorrhoeae neisseria gonorrhoeae treponema pallidum pallidum treponema pallidum pertenue listeria monocytogenes bacillus anthracis fusobacterium fusiforme actinomyces israelii clostridium" assertion.
• association label "doxycycline hyclate tablets are tetracycline class drugs indicated for rickettsial infections 1 1 sexually transmitted infections 1 2 respiratory tract infections 1 3 specific bacterial infections 1 4 ophthalmic infections 1 5 anthrax including inhalational anthrax post exposure 1 6 alternative treatment for selected infections when penicillin is contraindicated 1 7 adjunctive therapy for acute intestinal amebiasis and severe acne 1 8 prophylaxis of malaria 1 9 to reduce the development of drug resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets and other antibacterial drugs doxycycline hyclate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria 1 1 doxycycline hyclate tablets are indicated for treatment of rocky mountain spotted fever typhus fever and the typhus group q fever rickettsial pox and tick fevers caused by rickettsiae doxycycline hyclate tablets are indicated for treatment of the following sexually transmitted infections uncomplicated urethral endocervical or rectal infections caused by chlamydia trachomatis nongonococcal urethritis caused by ureaplasma urealyticum lymphogranuloma venereum caused by chlamydia trachomatis granuloma inguinale caused by klebsiella granulomatis uncomplicated gonorrhea caused by neisseria gonorrhoeae chancroid caused by haemophilus ducreyi doxycycline hyclate tablets are indicated for treatment of the following respiratory tract infections respiratory tract infections caused by mycoplasma pneumoniae psittacosis ornithosis caused by chlamydophila psittaci because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline culture and susceptibility testing are recommended doxycycline is indicated for treatment of infections caused by the following microorganisms when bacteriological testing indicates appropriate susceptibility to the drug respiratory tract infections caused by haemophilus influenzae respiratory tract infections caused by klebsiella species upper respiratory infections caused by streptococcus pneumoniae doxycycline hyclate tablets are indicated for treatment of the following specific bacterial infections relapsing fever due to borrelia recurrentis plague due to yersinia pestis tularemia due to francisella tularensis cholera caused by vibrio cholerae campylobacter fetus infections caused by campylobacter fetus brucellosis due to brucella bartonellosis due to bartonella bacilliformis because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline culture and susceptibility testing are recommended doxycycline hyclate tablets are indicated for treatment of infections caused by the following gram negative microorganisms when bacteriological testing indicates appropriate susceptibility to the drug escherichia coli enterobacter aerogenes shigella acinetobacter urinary tract infections caused by klebsiella doxycycline hyclate tablets are indicated for treatment of the following ophthalmic infections trachoma caused by chlamydia trachomatis inclusion conjunctivitis caused by chlamydia trachomatis doxycycline hyclate tablets are indicated for the treatment of anthrax due to bacillus anthracis bacillus anthracis doxycycline hyclate tablets are indicted as an alternative treatment for the following selected infections when penicillin is contraindicated syphilis caused by treponema pallidum yaws caused by treponema pallidum pertenue listeriosis due to listeria monocytogenes vincent s infection caused by fusobacterium fusiforme actinomycosis caused by actinomyces israelii infections caused by clostridium in acute intestinal amebiasis doxycycline hyclate tablets may be a useful adjunct to amebicides in severe acne doxycycline hyclate tablets may be useful adjunctive therapy doxycycline hyclate tablets are indicated for the prophylaxis of malaria due to plasmodium falciparum see dosage and administration 2 4 patient counseling information 17 to reduce the development of drug resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets and other antibacterial drugs doxycycline hyclate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antibacterial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy" assertion.
• association label "neupro is a dopamine agonist indicated for the treatment of parkinson s disease 1 1 moderate to severe primary restless legs syndrome 1 2 neupro is indicated for the treatment of parkinson s disease neupro is indicated for the treatment of moderate to severe primary restless legs syndrome" assertion.
• association label "note cefuroxime axetil tablets and cefuroxime axetil for oral suspension are not bioequivalent and are not substitutable on a milligram per milligram basis see clinical pharmacology cefuroxime axetil for oral suspension is indicated for the treatment of pediatric patients 3 months to 12 years of age with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below the safety and effectiveness of cefuroxime axetil for oral suspension in the treatment of infections other than those specifically listed below have not been established either by adequate and well controlled trials or by pharmacokinetic data with which to determine an effective and safe dosing regimen pharyngitis tonsillitis note acute bacterial otitis media impetigo to reduce the development of drug resistant bacteria and maintain the effectiveness of cefuroxime axetil for oral suspension and other antibacterial drugs cefuroxime axetil for oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antibacterial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy" assertion.
• association label "prednisolone sodium phosphate oral solution 15 mg prednisolone per 5 ml is indicated in the following conditions 1 allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with seasonal or perennial allergic rhinitis asthma contact dermatitis atopic dermatitis serum sickness drug hypersensitivity reactions 2 dermatologic diseases pemphigus bullous dermatitis herpetiformis severe erythema multiforme stevens johnson syndrome exfoliative erythroderma mycosis fungoides 3 edematous states to induce diuresis or remission of proteinuria in nephrotic syndrome in adults with lupus erythematosus and in adults and pediatric populations with idiopathic nephrotic syndrome without uremia 4 endocrine disorders primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the first choice synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance congenital adrenal hyperplasia hypercalcemia associated with cancer nonsuppurative thyroiditis 5 gastrointestinal diseases to tide the patient over a critical period of the disease in ulcerative colitis regional enteritis 6 hematologic disorders idiopathic thrombocytopenic purpura in adults selected cases of secondary thrombocytopenia acquired autoimmune hemolytic anemia pure red cell aplasia diamond blackfan anemia 7 neoplastic diseases for the treatment of acute leukemia and aggressive lymphomas in adults and children 8 nervous system acute exacerbations of multiple sclerosis 9 ophthalmic diseases uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids temporal arteritis sympathetic ophthalmia 1 respiratory diseases symptomatic sarcoidosis idiopathic eosinophilic pneumonias fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy asthma as distinct from allergic asthma listed above under allergic states hypersensitivity pneumonitis idiopathic pulmonary fibrosis acute exacerbations of chronic obstructive pulmonary disease copd and pneumocystis carinii pneumonia pcp associated with hypoxemia occurring in an hiv individual who is also under treatment with appropriate anti pcp antibiotics studies support the efficacy of systemic corticosteroids for the treatment of these conditions allergic bronchopulmonary aspergillosis idiopathic bronchiolitis obliterans with organizing pneumonia 11 rheumatic disorders as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in psoriatic arthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy ankylosing spondylitis acute and subacute bursitis acute nonspecific tenosynovitis acute gouty arthritis epicondylitis for the treatment of systemic lupus erythematosus dermatomyositis polymyositis polymyalgia rheumatica sjogren s syndrome relapsing polychondritis and certain cases of vasculitis 12 miscellaneous tuberculous meningitis with subarachnoid block or impending block tuberculosis with enlarged mediastinal lymph nodes causing respiratory difficulty and tuberculosis with pleural or pericardial effusion appropriate antituberculous chemotherapy must be used concurrently when treating any tuberculosis complications trichinosis with neurologic or myocardial involvement acute or chronic solid organ rejection with or without other agents" assertion.
• association label "itraconazole oral solution is indicated for the treatment of oropharyngeal and esophageal candidiasis see clinical pharmacology special populations warnings adverse reactions post marketing experience" assertion.
• association label "meropenem for injection usp and sodium chloride injection usp is a penem antibacterial indicated for the treatment of complicated skin and skin structure infections adult patients and pediatric patients 3 months of age and older requiring the full adult dose only 1 1 complicated intra abdominal infections adult patients and pediatric patients 3 months of age and older requiring the full adult dose only 1 2 bacterial meningitis pediatric patients 3 months of age and older requiring the full adult dose only 1 3 meropenem for injection usp and sodium chloride injection usp is indicated for the treatment of complicated skin and skin structure infections csssi due to staphylococcus aureus streptococcus pyogenes streptococcus agalactiae enterococcus faecalis pseudomonas aeruginosa escherichia coli proteus mirabilis bacteroides fragilis peptostreptococcus meropenem for injection usp and sodium chloride injection usp is indicated for the treatment of complicated appendicitis and peritonitis caused by viridans group streptococci escherichia coli klebsiella pneumoniae pseudomonas aeruginosa bacteroides fragilis b thetaiotaomicron peptostreptococcus meropenem for injection usp and sodium chloride injection usp is indicated for the treatment of bacterial meningitis caused by haemophilus influenzae neisseria meningitidis streptococcus pneumoniae meropenem has been found to be effective in eliminating concurrent bacteremia in association with bacterial meningitis for information regarding use in pediatric patients 3 months of age and older see indications and usage 1 1 1 2 1 3 dosage and administration 2 3 and adverse reactions 6 1 to reduce the development of drug resistant bacteria and maintain the effectiveness of meropenem for injection usp and sodium chloride injection usp and other antibacterial drugs meropenem for injection usp and sodium chloride injection usp should only be used to treat infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antibacterial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy" assertion.
• association label "invirase in combination with ritonavir and other antiretroviral agents is indicated for the treatment of hiv infection the twice daily administration of invirase in combination with ritonavir is supported by safety data from the maxcmin 1 study see table 6 table 1 in a randomized double blind clinical study nv14256 in zidovudine experienced hiv infected patients invirase in combination with zalcitabine was shown to be superior to either invirase or zalcitabine monotherapy in decreasing the cumulative incidence of clinical disease progression to aids defining events or death furthermore in a randomized study actg229 nv14255 patients with advanced hiv infection with history of prolonged zidovudine treatment and who were given invirase 6 mg three times daily zidovudine zalcitabine experienced greater increases in cd4 cell counts as compared to those who received invirase zidovudine or zalcitabine zidovudine it should be noted that hiv treatment regimens that were used in these initial clinical studies of invirase are no longer considered standard of care saquinavir gel capsule 1 mg twice daily coadministered with ritonavir 1 mg twice daily was studied in a heterogeneous population of 148 hiv infected patients maxcmin 1 study at baseline 42 were treatment naive and 1 6 were treatment experienced of which 52 had an hiv rna level 4 copies ml at baseline results showed that 91 148 61 subjects achieved and or sustained an hiv rna level 4 copies ml at the completion of 48 weeks" assertion.
• association label "when oral therapy is not feasible and the strength dosage form and route of administration of the drug reasonably lend the preparation to the treatment of the condition the intramuscular use of methylprednisolone acetate injectable suspension is indicated as follows allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma atopic dermatitis contact dermatitis drug hypersensitivity reactions seasonal or perennial allergic rhinitis serum sickness transfusion reactions dermatologic diseases bullous dermatitis herpetiformis exfoliative erythroderma mycosis fungoides pemphigus severe erythema multiforme stevens johnson syndrome endocrine disorders primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the drug of choice synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance congenital adrenal hyperplasia hypercalcemia associated with cancer nonsuppurative thyroiditis gastrointestinal diseases to tide the patient over a critical period of the disease in regional enteritis systemic therapy and ulcerative colitis hematologic disorders acquired autoimmune hemolytic anemia congenital erythroid hypoplastic anemia diamond blackfan anemia pure red cell aplasia select cases of secondary thrombocytopenia miscellaneous trichinosis with neurologic or myocardial involvement tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy neoplastic diseases for palliative management of leukemias and lymphomas nervous system acute exacerbations of multiple sclerosis cerebral edema associated with primary or metastatic brain tumor or craniotomy ophthalmic diseases sympathetic ophthalmia temporal arteritis uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids renal diseases to induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus respiratory diseases berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy idiopathic eosinophilic pneumonias symptomatic sarcoidosis rheumatic disorders as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis acute rheumatic carditis ankylosing spondylitis psoriatic arthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy for the treatment of dermatomyositis polymyositis and systemic lupus erythematosus see warnings methylprednisolone acetate injectable suspension is indicated as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis acute and subacute bursitis acute nonspecific tenosynovitis epicondylitis rheumatoid arthritis synovitis of osteoarthritis methylprednisolone acetate injectable suspension is indicated for intralesional use in alopecia areata discoid lupus erythematosus keloids localized hypertrophic infiltrated inflammatory lesions of granuloma annulare lichen planus lichen simplex chronicus neurodermatitis and psoriatic plaques necrobiosis lipoidica diabeticorum methylprednisolone acetate injectable suspension also may be useful in cystic tumors of an aponeurosis or tendon ganglia" assertion.
• association label "to reduce the development of drug resistant bacteria and maintain the effectiveness of achromycin v tetracycline hcl capsules usp and other antibacterial drugs achromycin v tetracycline hcl capsules usp should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antibacterial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy achromycin v tetracycline hcl capsules usp is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below upper respiratory tract infections caused by streptococcus pyogenes streptococcus pneumoniae hemophilus influenzae lower respiratory tract infections caused by streptococcus pyogenes streptococcus pneumoniae mycoplasma pneumoniae klebsiella sp skin and soft tissue infections caused by streptococcus pyogenes staphylococcus aureaus infections caused by rickettsia including rocky mountain spotted fever typhus group infections q fever rickettsialpox psittacosis of ornithosis caused by chlamydia psittaci infections caused by chlamydia trachomatis granuloma inquinale caused by calymmatobacterium granulomatis relapsing fever caused by borrelia sp bartonellosis caused by bartonella bacilliformis chancroid caused by hemophilus ducreyi tularemia caused by francisella tularensis plaque caused by yersinia pestis cholera caused by vibrio cholerae brucellosis caused by brucella species infections due to campylobacter fetus as adjunctive therapy in intestinal amebiasis caused by entamoeba histolytica urinary tract infections caused by susceptible strains of escherichia coli klebsiella other infections caused by susceptible gram negative organisms such as e coli enterobacter aerogenes shigella sp acinetobacter sp klebsiella sp bacteroides sp in severe acne adjunctive therapy with achromycin v tetracycline hcl capsules usp may be useful when penicillin is contraindicated tetracyclines are alternative drugs in the treatment of the following infections syphilis and yaws caused by treponema pallidum pertenue vincent s infection caused by fusobacterium fusiforme infections caused by neisseria gonorrhoeae anthrax caused by bacillus anthracis infections due to listeria monocytogenes actinomycosis caused by actinomyces infections due to clostridium" assertion.
• association label "azathioprine tablets usp are indicated as an adjunct for the prevention of rejection in renal homotransplantation it is also indicated for the management of active rheumatoid arthritis to reduce signs and symptoms azathioprine tablets usp are indicated as an adjunct for the prevention of rejection in renal homotransplantation experience with over 16 transplants shows a 5 year patient survival of 35 to 55 but this is dependent on donor match for hla antigens anti donor or anti b cell alloantigen antibody and other variables the effect of azathioprine tablets on these variables has not been tested in controlled trials azathioprine tablets usp are indicated for the treatment of active rheumatoid arthritis ra to reduce signs and symptoms aspirin non steroidal anti inflammatory drugs and or low dose glucocorticoids may be continued during treatment with azathioprine tablets the combined use of azathioprine tablets with disease modifying anti rheumatic drugs dmards has not been studied for either added benefit or unexpected adverse effects the use of azathioprine tablets with these agents cannot be recommended" assertion.
• association label "prednisolone sodium phosphate oral solution 15 mg prednisolone per 5 ml is indicated in the following conditions 1 allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with seasonal or perennial allergic rhinitis asthma contact dermatitis atopic dermatitis serum sickness drug hypersensitivity reactions 2 dermatologic diseases pemphigus bullous dermatitis herpetiformis severe erythema multiforme stevens johnson syndrome exfoliative erythroderma mycosis fungoides 3 edematous states to induce diuresis or remission of proteinuria in nephrotic syndrome in adults with lupus erythematosus and in adults and pediatric populations with idiopathic nephrotic syndrome without uremia 4 endocrine disorders primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the first choice synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance congenital adrenal hyperplasia hypercalcemia associated with cancer nonsuppurative thyroiditis 5 gastrointestinal diseases to tide the patient over a critical period of the disease in ulcerative colitis regional enteritis 6 hematologic disorders idiopathic thrombocytopenic purpura in adults selected cases of secondary thrombocytopenia acquired autoimmune hemolytic anemia pure red cell aplasia diamond blackfan anemia 7 neoplastic diseases for the treatment of acute leukemia and aggressive lymphomas in adults and children 8 nervous system acute exacerbations of multiple sclerosis 9 ophthalmic diseases uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids temporal arteritis sympathetic ophthalmia 1 respiratory diseases symptomatic sarcoidosis idiopathic eosinophilic pneumonias fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy asthma as distinct from allergic asthma listed above under allergic states hypersensitivity pneumonitis idiopathic pulmonary fibrosis acute exacerbations of chronic obstructive pulmonary disease copd and pneumocystis carinii pneumonia pcp associated with hypoxemia occurring in an hiv individual who is also under treatment with appropriate anti pcp antibiotics studies support the efficacy of systemic corticosteroids for the treatment of these conditions allergic bronchopulmonary aspergillosis idiopathic bronchiolitis obliterans with organizing pneumonia 11 rheumatic disorders as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in psoriatic arthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy ankylosing spondylitis acute and subacute bursitis acute nonspecific tenosynovitis acute gouty arthritis epicondylitis for the treatment of systemic lupus erythematosus dermatomyositis polymyositis polymyalgia rheumatica sjogren s syndrome relapsing polychondritis and certain cases of vasculitis 12 miscellaneous tuberculous meningitis with subarachnoid block or impending block tuberculosis with enlarged mediastinal lymph nodes causing respiratory difficulty and tuberculosis with pleural or pericardial effusion appropriate antituberculous chemotherapy must be used concurrently when treating any tuberculosis complications trichinosis with neurologic or myocardial involvement acute or chronic solid organ rejection with or without other agents" assertion.
• association label "spironolactone tablets usp are indicated in the management of for primary hyperaldosteronism establishing the diagnosis of primary hyperaldosteronism by therapeutic trial short term preoperative treatment of patients with primary hyperaldosteronism long term maintenance therapy for patients with discrete aldosterone producing adrenal adenomas who are judged to be poor operative risks or who decline surgery long term maintenance therapy for patients with bilateral micro or macronodular adrenal hyperplasia idiopathic hyperaldosteronism for patients with edematous conditions for the management of edema and sodium retention when the patient is only partially responsive to or is intolerant of other therapeutic measures spironolactone tablets usp are also indicated for patients with congestive heart failure taking digitalis when other therapies are considered inappropriate congestive heart failure spironolactone levels may be exceptionally high in this condition spironolactone tablets usp are indicated for maintenance therapy together with bed rest and the restriction of fluid and sodium cirrhosis of the liver accompanied by edema and or ascites for nephrotic patients when treatment of the underlying disease restriction of fluid and sodium intake and the use of other diuretics do not provide an adequate response nephrotic syndrome spironolactone tablets usp are indicated for the treatment of hypertension to lower blood pressure lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events primarily strokes and myocardial infarctions these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes control of high blood pressure should be part of comprehensive cardiovascular risk management including as appropriate lipid control diabetes management antithrombotic therapy smoking cessation exercise and limited sodium intake many patients will require more than one drug to achieve blood pressure goals for specific advice on goals and management see published guidelines such as those of the national high blood pressure education program s joint national committee on prevention detection evaluation and treatment of high blood pressure jnc numerous antihypertensive drugs from a variety of pharmacologic classes and with different mechanisms of action have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality and it can be concluded that it is blood pressure reduction and not some other pharmacologic property of the drugs that is largely responsible for those benefits the largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly elevated systolic or diastolic pressure causes increased cardiovascular risk and the absolute risk increase per mmhg is greater at higher blood pressures so that even modest reductions of severe hypertension can provide substantial benefit relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk so the absolute benefit is greater in patients who are at higher risk independent of their hypertension for example patients with diabetes or hyperlipidemia and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal some antihypertensive drugs have smaller blood pressure effects as monotherapy in black patients and many antihypertensive drugs have additional approved indications and effects e g on angina heart failure or diabetic kidney disease these considerations may guide selection of therapy usually in combination with other drugs spironolactone tablets usp are indicated for patients who cannot be treated adequately with other agents or for whom other agents are considered inappropriate for the treatment of patients with hypokalemia when other measures are considered inappropriate or inadequate spironolactone tablets usp are also indicated for the prophylaxis of hypokalemia in patients taking digitalis when other measures are considered inadequate or inappropriate severe heart failure nyha class iii to iv to increase survival and to reduce the need for hospitalization for heart failure when used in addition to standard therapy usage in pregnancy the routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard diuretics do not prevent development of toxemia of pregnancy and there is no satisfactory evidence that they are useful in the treatment of developing toxemia edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy spironolactone tablets usp are indicated in pregnancy when edema is due to pathologic causes just as it is in the absence of pregnancy however see dependent edema in pregnancy resulting from restriction of venous return by the expanded uterus is properly treated through elevation of the lower extremities and use of support hose use of diuretics to lower intravascular volume in this case is unsupported and unnecessary precautions pregnancy there is hypervolemia during normal pregnancy which is not harmful to either the fetus or the mother in the absence of cardiovascular disease but which is associated with edema including generalized edema in the majority of pregnant women if this edema produces discomfort increased recumbency will often provide relief in rare instances this edema may cause extreme discomfort that is not relieved by rest in these cases a short course of diuretics may provide relief and may be appropriate" assertion.
• association label "to reduce the development of drug resistant bacteria and maintain the effectiveness of demeclocycline hydrochloride tablets and other antibacterial drugs demeclocycline hydrochloride tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antibacterial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy demeclocycline hydrochloride is indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions below rocky mountain spotted fever typhus fever and the typhus group q fever rickettsialpox and tick fevers caused by rickettsiae respiratory tract infections caused by lymphogranuloma venereum due to psittacosis ornithosis due to trachoma due to although the infectious agent is not always eliminated as judged by immunofluorescence inclusion conjunctivitis caused by nongonococcal urethritis in adults caused by or relapsing fever due to chancroid caused by plague due to tularemia due to cholera caused by campylobacter fetus infections caused by brucellosis due to species in conjunction with streptomycin bartonellosis due to granuloma inguinale caused by demeclocycline hydrochloride is indicated for treatment of infections caused by the following gram negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug species species respiratory tract infections caused by respiratory tract and urinary tract infections caused by species demeclocycline hydrochloride is indicated for treatment of infections caused by the following gram positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug upper respiratory infections caused by pneumoniae skin and skin structure infections caused by note tetracyclines including demeclocycline are not the drugs of choice in the treatment of any type of staphylococcal infection when penicillin is contraindicated tetracyclines including demeclocycline hydrochloride are alternative drugs in the treatment of the following infections uncomplicated urethritis in men due to and for the treatment of other uncomplicated gonococcal infections infections in women caused by syphilis caused by subspecies yaws caused by subspecies listeriosis due to anthrax due to vincent s infection caused by actinomycosis caused by clostridial diseases caused by species in acute intestinal amebiasis demeclocycline hydrochloride may be a useful adjunct to amebicides in severe acne demeclocycline hydrochloride may be a useful adjunctive therapy mycoplasma pneumoniae chlamydia trachomatis chlamydia psittaci chlamydia trachomatis chlamydia trachomatis ureaplasma urealyticum chlamydia trachomatis borrelia recurrentis haemophilus ducreyi yersinia pestis francisella tularensis vibrio cholerae campylobacter fetus brucella bartonella bacilliformis calymmatobacterium granulomatis escherichia coli enterobacter aerogenes shigella acinetobacter haemophilus influenzae klebsiella streptococcus staphylococcus aureus neisseria gonorrhoeae neisseria gonorrhoeae treponema pallidum pallidum treponema pallidum pertenue listeria monocytogenes bacillus anthracis fusobacterium fusiforme actinomyces israelii clostridium" assertion.
• association label "for the management of schizophrenia trifluoperazine hydrochloride tablets usp are effective for the short term treatment of generalized non psychotic anxiety however trifluoperazine hydrochloride tablets are not the first drug to be used in therapy for most patients with non psychotic anxiety because certain risks associated with its use are not shared by common alternative treatments i e benzodiazepines when used in the treatment of non psychotic anxiety trifluoperazine hydrochloride tablets should not be administered at doses of more than 6 mg per day or for longer than 12 weeks because the use of trifluoperazine hydrochloride tablets at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible see warnings the effectiveness of trifluoperazine hydrochloride tablets as a treatment for non psychotic anxiety was established in a 4 week clinical multicenter study of outpatients with generalized anxiety disorder dsm iii this evidence does not predict that trifluoperazine hydrochloride tablets will be useful in patients with other non psychotic conditions in which anxiety or signs that mimic anxiety are found i e physical illness organic mental conditions agitated depression character pathologies etc trifluoperazine hydrochloride tablets have not been shown effective in the management of behavioral complications in patients with mental retardation" assertion.
• association label "rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old information related to usage of rizatriptan benzoate in pediatric patients 6 to 17 years old is approved for merck co inc s rizatriptan benzoate tablets however due to merck co inc s marketing exclusivity rights this drug product is not labeled with that pediatric patient 6 to 17 years old usage information limitations of use rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established if a patient has no response for the first migraine attack treated with rizatriptan benzoate tablets the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets is administered to treat any subsequent attacks rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine see contraindications 4 rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache rizatriptan benzoate tablets are a serotonin 5 ht 1b 1d receptor agonist triptan indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age 1 limitations of use use only after clear diagnosis of migraine has been established 1 not indicated for the prophylactic therapy of migraine 1 not indicated for the treatment of cluster headache 1" assertion.
• association label "doxycycline hyclate tablets are tetracycline class drugs indicated for rickettsial infections 1 1 sexually transmitted infections 1 2 respiratory tract infections 1 3 specific bacterial infections 1 4 ophthalmic infections 1 5 anthrax including inhalational anthrax post exposure 1 6 alternative treatment for selected infections when penicillin is contraindicated 1 7 adjunctive therapy for acute intestinal amebiasis and severe acne 1 8 prophylaxis of malaria 1 9 to reduce the development of drug resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets and other antibacterial drugs doxycycline hyclate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria 1 1 doxycycline hyclate tablets are indicated for treatment of rocky mountain spotted fever typhus fever and the typhus group q fever rickettsial pox and tick fevers caused by rickettsiae doxycycline hyclate tablets are indicated for treatment of the following sexually transmitted infections uncomplicated urethral endocervical or rectal infections caused by chlamydia trachomatis nongonococcal urethritis caused by ureaplasma urealyticum lymphogranuloma venereum caused by chlamydia trachomatis granuloma inguinale caused by klebsiella granulomatis uncomplicated gonorrhea caused by neisseria gonorrhoeae chancroid caused by haemophilus ducreyi doxycycline hyclate tablets are indicated for treatment of the following respiratory tract infections respiratory tract infections caused by mycoplasma pneumoniae psittacosis ornithosis caused by chlamydophila psittaci because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline culture and susceptibility testing are recommended doxycycline is indicated for treatment of infections caused by the following microorganisms when bacteriological testing indicates appropriate susceptibility to the drug respiratory tract infections caused by haemophilus influenzae respiratory tract infections caused by klebsiella species upper respiratory infections caused by streptococcus pneumoniae doxycycline hyclate tablets are indicated for treatment of the following specific bacterial infections relapsing fever due to borrelia recurrentis plague due to yersinia pestis tularemia due to francisella tularensis cholera caused by vibrio cholerae campylobacter fetus infections caused by campylobacter fetus brucellosis due to brucella bartonellosis due to bartonella bacilliformis because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline culture and susceptibility testing are recommended doxycycline hyclate tablets are indicated for treatment of infections caused by the following gram negative microorganisms when bacteriological testing indicates appropriate susceptibility to the drug escherichia coli enterobacter aerogenes shigella acinetobacter urinary tract infections caused by klebsiella doxycycline hyclate tablets are indicated for treatment of the following ophthalmic infections trachoma caused by chlamydia trachomatis inclusion conjunctivitis caused by chlamydia trachomatis doxycycline hyclate tablets are indicated for the treatment of anthrax due to bacillus anthracis bacillus anthracis doxycycline hyclate tablets are indicted as an alternative treatment for the following selected infections when penicillin is contraindicated syphilis caused by treponema pallidum yaws caused by treponema pallidum pertenue listeriosis due to listeria monocytogenes vincent s infection caused by fusobacterium fusiforme actinomycosis caused by actinomyces israelii infections caused by clostridium in acute intestinal amebiasis doxycycline hyclate tablets may be a useful adjunct to amebicides in severe acne doxycycline hyclate tablets may be useful adjunctive therapy doxycycline hyclate tablets are indicated for the prophylaxis of malaria due to plasmodium falciparum see dosage and administration 2 4 patient counseling information 17 to reduce the development of drug resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets and other antibacterial drugs doxycycline hyclate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antibacterial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy" assertion.
• association label "fluvoxamine maleate extended release capsules are a selective serotonin reuptake inhibitor ssri indicated for the treatment of obsessive compulsive disorder ocd 1 one 12 week study with fluvoxamine maleate extended release capsules in adults 14 1 two 1 week studies with immediate release ir fluvoxamine tablets in adults and one 1 week study with ir fluvoxamine tablets in children and adolescents 14 1 14 3 one maintenance study with ir fluvoxamine tablets 14 2 fluvoxamine maleate extended release capsules are indicated for the treatment of obsessive compulsive disorder ocd as defined in the dsm iv obsessive compulsive disorder is characterized by recurrent and persistent ideas thoughts impulses or images obsessions that are ego dystonic and or repetitive purposeful and intentional behaviors compulsions that are recognized by the person as excessive or unreasonable the obsessions or compulsions cause marked distress are time consuming or significantly interfere with social or occupational functioning the efficacy of fluvoxamine maleate extended release capsules was demonstrated in one 12 week trial in adults with fluvoxamine maleate extended release capsules as well as in two 1 week trials in adults and in one 1 week trial in children and adolescents ages 8 to 17 years with immediate release fluvoxamine tablets in outpatients with the diagnosis of ocd as defined in dsm iv or dsm iii r see clinical studies 14 1 14 3 the efficacy of fluvoxamine for long term use was established in one maintenance study in adults with immediate release fluvoxamine tablets see clinical studies 14 2 see dosage and administration 2 4" assertion.
• association label "when oral therapy is not feasible and the strength dosage form and route of administration of the drug reasonably lend the preparation to the treatment of the condition the intramuscular use of methylprednisolone acetate injectable suspension usp is indicated as follows control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma atopic dermatitis contact dermatitis drug hypersensitivity reactions seasonal or perennial allergic rhinitis serum sickness transfusion reactions bullous dermatitis herpetiformis exfoliative erythroderma mycosis fungoides pemphigus severe erythema multiforme stevens johnson syndrome primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the drug of choice synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance congenital adrenal hyperplasia hypercalcemia associated with cancer nonsuppurative thyroiditis to tide the patient over a critical period of the disease in regional enteritis systemic therapy ulcerative colitis acquired autoimmune hemolytic anemia congenital erythroid hypoplastic anemia diamond blackfan anemia pure red cell aplasia select cases of secondary thrombocytopenia trichinosis with neurologic or myocardial involvement tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy for palliative management of leukemias and lymphomas acute exacerbations of multiple sclerosis cerebral edema associated with primary or metastatic brain tumor or craniotomy sympathetic ophthalmia temporal arteritis uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids to induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus berylliosis symptomatic sarcoidosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy idiopathic eosinophilic pneumonias symptomatic sarcoidosis as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis acute rheumatic carditis ankylosing spondylitis psoriatic arthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy for the treatment of dermatomyositis polymyositis and systemic lupus erythematosus see warnings methylprednisolone acetate injectable suspension usp is indicated as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis acute and subacute bursitis acute nonspecific tenosynovitis epicondylitis rheumatoid arthritis synovitis of osteoarthritis methylprednisolone acetate injectable suspension usp is indicated for intralesional use in alopecia areata discoid lupus erythematosus keloids localized hypertrophic infiltrated inflammatory lesions of granuloma annulare lichen planus lichen simplex chronicus neurodermatitis and psoriatic plaques necrobiosis lipoidica diabeticorum methylprednisolone acetate injectable suspension usp also may be useful in cystic tumors of an aponeurosis or tendon ganglia" assertion.
• association label "venlafaxine hydrochloride extended release capsules usp are indicated for the treatment of major depressive disorder the efficacy of venlafaxine hydrochloride extended release capsules usp in the treatment of major depressive disorder was established in 8 and 12 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the dsm iii r or dsm iv category of major depressive disorder see clinical trials a major depressive episode dsm iv implies a prominent and relatively persistent nearly every day for at least 2 weeks depressed mood or the loss of interest or pleasure in nearly all activities representing a change from previous functioning and includes the presence of at least five of the following nine symptoms during the same two week period depressed mood markedly diminished interest or pleasure in usual activities significant change in weight and or appetite insomnia or hypersomnia psychomotor agitation or retardation increased fatigue feelings of guilt or worthlessness slowed thinking or impaired concentration a suicide attempt or suicidal ideation the efficacy of venlafaxine hydrochloride tablets in the treatment of major depressive disorder in adult inpatients meeting diagnostic criteria for major depressive disorder with melancholia was established in a 4 week controlled trial see the safety and efficacy of venlafaxine hydrochloride extended release capsules usp in hospitalized depressed patients have not been adequately studied clinical trials the efficacy of venlafaxine hydrochloride extended release capsules usp in maintaining a response in major depressive disorder for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo controlled trial the efficacy of venlafaxine hydrochloride tablets in maintaining a response in patients with recurrent major depressive disorder who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo controlled trial see nevertheless the physician who elects to use venlafaxine hydrochloride tablets venlafaxine hydrochloride extended release capsules usp for extended periods should periodically re evaluate the long term usefulness of the drug for the individual patient see clinical trials dosage and administration social anxiety disorder venlafaxine hydrochloride extended release capsules usp are indicated for the treatment of social anxiety disorder also known as social phobia as defined in dsm iv 3 23 social anxiety disorder dsm iv is characterized by a marked and persistent fear of 1 or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others exposure to the feared situation almost invariably provokes anxiety which may approach the intensity of a panic attack the feared situations are avoided or endured with intense anxiety or distress the avoidance anxious anticipation or distress in the feared situation s interferes significantly with the person s normal routine occupational or academic functioning or social activities or relationships or there is a marked distress about having the phobias lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment the efficacy of venlafaxine hydrochloride extended release capsules usp in the treatment of social anxiety disorder was established in four 12 week and one 6 month placebocontrolled trials in adult outpatients with social anxiety disorder dsm iv see clinical trials although the effectiveness of venlafaxine hydrochloride extended release capsules usp has been demonstrated in a 6 month clinical trial in patients with social anxiety disorder the physician who elects to use venlafaxine hydrochloride extended release capsules usp for extended periods should periodically re evaluate the long term usefulness of the drug for the individual patient see dosage and administration panic disorder venlafaxine hydrochloride extended release capsules usp are indicated for the treatment of panic disorder with or without agoraphobia as defined in dsm iv panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks worry about the implications or consequences of the attacks and or a significant change in behavior related to the attacks panic disorder dsm iv is characterized by recurrent unexpected panic attacks ie a discrete period of intense fear or discomfort in which four or more of the following symptoms develop abruptly and reach a peak within 1 minutes 1 palpitations pounding heart or accelerated heart rate 2 sweating 3 trembling or shaking 4 sensations of shortness of breath or smothering 5 feeling of choking 6 chest pain or discomfort 7 nausea or abdominal distress 8 feeling dizzy unsteady lightheaded or faint 9 derealization feelings of unreality or depersonalization being detached from oneself 1 fear of losing control 11 fear of dying 12 paresthesias numbness or tingling sensations 13 chills or hot flushes the efficacy of venlafaxine hydrochloride extended release capsules usp in the treatment of panic disorder was established in two 12 week placebo controlled trials in adult outpatients with panic disorder dsm iv the efficacy of venlafaxine hydrochloride extended release capsules usp in prolonging time to relapse in panic disorder among responders following 12 weeks of open label acute treatment was demonstrated in a placebo controlled study see clinical pharmacology clinical trials nevertheless the physician who elects to use venlafaxine hydrochloride extended release capsules usp for extended periods should periodically re evaluate the long term usefulness of the drug for the individual patient see dosage and administration" assertion.
• association label "to reduce the development of drug resistant bacteria and maintain the effectiveness of penicillin g procaine and other antibacterial drugs penicillin g procaine should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antibacterial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy penicillin g procaine is indicated in the treatment of moderately severe infections in both adults and pediatric patients due to penicillin g susceptible microorganisms that are susceptible to the low and persistent serum levels common to this particular dosage form in the indications listed below therapy should be guided by bacteriological studies including susceptibility tests and by clinical response note when high sustained serum levels are required aqueous penicillin g either im or iv should be used the following infections will usually respond to adequate dosages of intramuscular penicillin g procaine moderately severe to severe infections of the upper respiratory tract skin and soft tissue infections scarlet fever and erysipelas due to susceptible streptococci group a without bacteremia note streptococci in groups a c g h l and m are very sensitive to penicillin g other groups including group d enterococcus are resistant aqueous penicillin is recommended for streptococcal infections with bacteremia moderately severe infections of the respiratory tract due to susceptible pneumococci note severe pneumonia empyema bacteremia pericarditis meningitis peritonitis and arthritis of pneumococcal etiology are better treated with aqueous penicillin g during the acute stage moderately severe infections of the skin and soft tissues due to susceptible staphylococci penicillin g susceptible note reports indicate an increasing number of strains of staphylococci resistant to penicillin g emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections indicated surgical procedures should be performed fusospirochetosis vincent s gingivitis and pharyngitis moderately severe infections of the oropharynx due to susceptible fusiform bacilli and spirochetes note necessary dental care should be accomplished in infections involving the gum tissue syphilis all stages due to susceptible treponema pallidum note this drug should not be used in the treatment of beta lactamase producing organisms which include most strains of neisseria gonorrhea yaws bejel pinta due to susceptible organisms penicillin g procaine is an adjunct to antitoxin for prevention of the carrier stage of diphtheria due to susceptible c diphtheriae anthrax due to bacillus anthracis bacillus anthracis rat bite fever due to susceptible streptobacillus moniliformis spirillum minus erysipeloid due to susceptible erysipelothrix rhusiopathia subacute bacterial endocarditis only in extremely sensitive infections due to susceptible group a streptococci" assertion.
• association label "saphris is indicated for schizophrenia in adults see clinical studies 14 1 bipolar i disorder see clinical studies 14 2 acute monotherapy of manic or mixed episodes in adults and pediatric patients 1 to 17 years of age adjunctive treatment to lithium or valproate in adults maintenance monotherapy treatment in adults saphris is an atypical antipsychotic indicated for 1 schizophrenia in adults bipolar i disorder acute monotherapy treatment of manic or mixed episodes in adults and pediatric patients 1 to 17 years of age adjunctive treatment to lithium or valproate in adults maintenance monotherapy treatment in adults" assertion.
• out1 label "out1" assertion.
• img label "img" assertion.
• step label "Add two numbers together" assertion.
• out1 label "out1" assertion.
• a label "a" assertion.
• b label "b" assertion.
• LinguisticSystem label "python" assertion.
• b label "b" assertion.
• a label "a" assertion.
• LinguisticSystem label "python" assertion.
• out1 label "out1" assertion.
• step label "Multiply two numbers together" assertion.
• out1 label "out1" assertion.
• img label "img" assertion.
• step label "Convert the image" assertion.
• LinguisticSystem label "python" assertion.
• out1 label "out1" assertion.
• img label "img" assertion.
• img label "img" assertion.
• out1 label "out1" assertion.
• image label "image" assertion.
• LinguisticSystem label "python" assertion.

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