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• withStatus label "has the status" assertion.
• withStatus label "has the status" assertion.
• withStatus label "has the status" assertion.
• submitted label "submitted" assertion.
• submitted label "submitted" assertion.
• submitted label "submitted" assertion.
• association label "famotidine is indicated in most adult patients heal within 4 weeks there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks studies have not assessed the safety of famotidine in uncomplicated active duodenal ulcer for periods of more than eight weeks short term treatment of active duodenal ulcer controlled studies in adults have not extended beyond one year maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer most adult patients heal within 6 weeks studies have not assessed the safety or efficacy of famotidine in uncomplicated active benign gastric ulcer for periods of more than 8 weeks short term treatment of active benign gastric ulcer famotidine is indicated for short term treatment of patients with symptoms of gerd see famotidine is also indicated for the short term treatment of esophagitis due to gerd including erosive or ulcerative disease diagnosed by endoscopy see short term treatment of gastroesophageal reflux disease gerd clinical pharmacology in adults clinical studies clinical pharmacology in adults clinical studies treatment of pathological hypersecretory conditions e g zollinger ellison syndrome multiple endocrine adenomas see clinical pharmacology in adults clinical studies" 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 "mebendazole tablets are indicated for the treatment of enterobius vermicularis trichuris trichiura ascaris lumbricoides ancylostoma duodenale necator americanus efficacy varies as a function of such factors as preexisting diarrhea and gastrointestinal transit time degree of infection and helminth strains efficacy rates derived from various studies are shown in the table below pinworm enterobiasis whipworm trichuriasis common roundworm ascariasis hookworm cure rates 95 68 98 96 egg reduction 93 99 99" assertion.
• association label "vexol r 1 rimexolone ophthalmic suspension is indicated for the treatment of postoperative inflammation following ocular surgery and in the treatment of anterior uveitis" assertion.
• association label "pamidronate disodium for injection usp in conjunction with adequate hydration is indicated for the treatment of moderate or severe hypercalcemia associated with malignancy with or without bone metastases patients who have either epidermoid or non epidermoid tumors respond to treatment with pamidronate disodium for injection usp vigorous saline hydration an integral part of hypercalcemia therapy should be initiated promptly and an attempt should be made to restore the urine output to about 2 l day throughout treatment mild or asymptomatic hypercalcemia may be treated with conservative measures i e saline hydration with or without loop diuretics patients should be hydrated adequately throughout the treatment but overhydration especially in those patients who have cardiac failure must be avoided diuretic therapy should not be employed prior to correction of hypovolemia the safety and efficacy of pamidronate disodium for injection usp in the treatment of hypercalcemia associated with hyperparathyroidism or with other non tumor related conditions has not been established pamidronate disodium for injection usp is indicated for the treatment of patients with moderate to severe paget s disease of bone the effectiveness of pamidronate disodium for injection usp was demonstrated primarily in patients with serum alkaline phosphatase 3 times the upper limit of normal pamidronate disodium for injection usp therapy in patients with paget s disease has been effective in reducing serum alkaline phosphatase and urinary hydroxyproline levels by 5 in at least 5 of patients and by 3 in at least 8 of patients pamidronate disodium for injection usp therapy has also been effective in reducing these biochemical markers in patients with paget s disease who failed to respond or no longer responded to other treatments pamidronate disodium for injection usp is indicated in conjunction with standard antineoplastic therapy for the treatment of osteolytic bone metastases of breast cancer and osteolytic lesions of multiple myeloma the pamidronate disodium for injection usp treatment effect appeared to be smaller in the study of breast cancer patients receiving hormonal therapy than in the study of those receiving chemotherapy however overall evidence of clinical benefit has been demonstrated see clinical pharmacology osteolytic bone metastases of breast cancer and osteolytic lesions of multiple myeloma clinical trials" 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 "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 "desmopressin acetate injection is indicated for patients with hemophilia a with factor viii coagulant activity levels greater than 5 desmopressin acetate injection will often maintain hemostasis in patients with hemophilia a during surgical procedures and postoperatively when administered 3 minutes prior to scheduled procedure desmopressin acetate injection will also stop bleeding in hemophilia a patients with episodes of spontaneous or trauma induced injuries such as hemarthroses intramuscular hematomas or mucosal bleeding desmopressin acetate injection is not indicated for the treatment of hemophilia a with factor viii coagulant activity levels equal to or less than 5 or for the treatment of hemophilia b or in patients who have factor viii antibodies in certain clinical situations it may be justified to try desmopressin acetate injection in patients with factor viii levels between 2 to 5 however these patients should be carefully monitored desmopressin acetate injection is indicated for patients with mild to moderate classic von willebrand s disease type i with factor viii levels greater than 5 desmopressin acetate injection will often maintain hemostasis in patients with mild to moderate von willebrand s disease during surgical procedures and postoperatively when administered 3 minutes prior to the scheduled procedure desmopressin acetate injection will usually stop bleeding in mild to moderate von willebrand s patients with episodes of spontaneous or trauma induced injuries such as hemarthroses intramuscular hematomas or mucosal bleeding those von willebrand s disease patients who are least likely to respond are those with severe homozygous von willebrand s disease with factor viii coagulant activity and factor viii von willebrand factor antigen levels less than 1 other patients may respond in a variable fashion depending on the type of molecular defect they have bleeding time and factor viii coagulant activity ristocetin cofactor activity and von willebrand factor antigen should be checked during administration of desmopressin acetate injection to ensure that adequate levels are being achieved desmopressin acetate injection is not indicated for the treatment of severe classic von willebrand s disease type i and when there is evidence of an abnormal molecular form of factor viii antigen see warnings desmopressin acetate injection 4 mcg per ml is indicated as antidiuretic replacement therapy in the management of central cranial diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region desmopressin acetate injection is ineffective for the treatment of nephrogenic diabetes insipidus acetate injection is also available as an intranasal preparation however this means of delivery can be compromised by a variety of factors that can make nasal insufflation ineffective or inappropriate these include poor intranasal absorption nasal congestion and blockage nasal discharge atrophy of nasal mucosa and severe atrophic rhinitis intranasal delivery may be inappropriate where there is an impaired level of consciousness in addition cranial surgical procedures such as transsphenoidal hypophysectomy create situations where an alternative route of administration is needed as in cases of nasal packing or recovery from surgery" assertion.
• association label "paliperidone is an atypical antipsychotic agent indicated for treatment of schizophrenia 1 1 adults efficacy was established in three 6 week trials and one maintenance trial 14 1 adolescents ages 12 to 17 efficacy was established in one 6 week trial 14 1 treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and or antidepressants 1 2 efficacy was established in two 6 week trials in adult patients 14 2 paliperidone extended release tablets are indicated for the treatment of schizophrenia see clinical studies 14 1 the efficacy of paliperidone in schizophrenia was established in three 6 week trials in adults and one 6 week trial in adolescents as well as one maintenance trial in adults paliperidone extended release tablets are indicated for the treatment of schizoaffective disorder as monotherapy and an adjunct to mood stabilizers and or antidepressant therapy see clinical studies 14 2 the efficacy of paliperidone in schizoaffective disorder was established in two 6 week trials in adults" 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 "vinblastine sulfate injection is indicated in the palliative treatment of the following i frequently responsive malignancies generalized hodgkin s disease stages iii and iv ann arbor modification of rye staging system lymphocytic lymphoma nodular and diffuse poorly and well differentiated histiocytic lymphoma mycosis fungoides advanced stages advanced carcinoma of the testis kaposi s sarcoma letterer siwe disease histiocytosis x ii less frequently responsive malignancies choriocarcinoma resistant to other chemotherapeutic agents carcinoma of the breast unresponsive to appropriate endocrine surgery and hormonal therapy current principles of chemotherapy for many types of cancer include the concurrent administration of several antineoplastic agents for enhanced therapeutic effect without additive toxicity agents with different dose limiting clinical toxicities and different mechanisms of action are generally selected therefore although vinblastine sulfate is effective as a single agent in the aforementioned indications it is usually administered in combination with other antineoplastic drugs such combination therapy produces a greater percentage of response than does a single agent regimen these principles have been applied for example in the chemotherapy of hodgkin s disease vinblastine sulfate has been shown to be one of the most effective single agents for the treatment of hodgkin s disease advanced hodgkin s disease has also been successfully treated with several multiple drug regimens that included vinblastine sulfate patients who had relapses after treatment with the mopp program mechlorethamine hydrochloride nitrogen mustard vincristine sulfate prednisone and procarbazine have likewise responded to combination drug therapy that included vinblastine sulfate a protocol using cyclophosphamide in place of nitrogen mustard and vinblastine sulfate instead of vincristine sulfate is an alternative therapy for previously untreated patients with advanced hodgkin s disease advanced testicular germinal cell cancers embryonal carcinoma teratocarcinoma and choriocarcinoma are sensitive to vinblastine sulfate alone but better clinical results are achieved when vinblastine sulfate is administered concomitantly with other antineoplastic agents the effect of bleomycin is significantly enhanced if vinblastine sulfate is administered six to eight hours prior to the administration of bleomycin this schedule permits more cells to be arrested during metaphase the stage of the cell cycle in which bleomycin is active" assertion.
• association label "to reduce the development of drug resistant bacteria and maintain the effectiveness of neomycin sulfate tablets and other antibacterial drugs neomycin sulfate 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 suppression of intestinal bacteria neomycin sulfate tablets are indicated as adjunctive therapy as part of a regimen for the suppression of the normal bacterial flora of the bowel e g preoperative preparation of the bowel it is given concomitantly with erythromycin enteric coated base see dosage and administration hepatic coma portal systemic encephalopathy neomycin sulfate has been shown to be effective adjunctive therapy in hepatic coma by reduction of the ammonia forming bacteria in the intestinal tract the subsequent reduction in blood ammonia has resulted in neurologic improvement" assertion.
• association label "benazepril hydrochloride 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 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 it may be used alone or in combination with thiazide diuretics benazepril hydrochloride tablets usp are an angiotensin converting enzyme ace inhibitor 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" assertion.
• association label "itraconazole capsules are indicated for the treatment of the following fungal infections in immunocompromised and non immunocompromised patients 1 blastomycosis pulmonary and extrapulmonary 2 histoplasmosis including chronic cavitary pulmonary disease and disseminated non meningeal histoplasmosis and 3 aspergillosis pulmonary and extrapulmonary in patients who are intolerant of or who are refractory to amphotericin b therapy specimens for fungal cultures and other relevant laboratory studies wet mount histopathology serology should be obtained before therapy to isolate and identify causative organisms therapy may be instituted before the results of the cultures and other laboratory studies are known however once these results become available antiinfective therapy should be adjusted accordingly itraconazole capsules are also indicated for the treatment of the following fungal infections in non immunocompromised patients 1 onychomycosis of the toenail with or without fingernail involvement due to dermatophytes tinea unguium and 2 onychomycosis of the fingernail due to dermatophytes tinea unguium prior to initiating treatment appropriate nail specimens for laboratory testing koh preparation fungal culture or nail biopsy should be obtained to confirm the diagnosis of onychomycosis see clinical pharmacology special populations contraindications warnings adverse reactions post marketing experience description of clinical studies blastomycosis analyses were conducted on data from two open label non concurrently controlled studies n 73 combined in patients with normal or abnormal immune status the median dose was 2 mg day a response for most signs and symptoms was observed within the first 2 weeks and all signs and symptoms cleared between 3 and 6 months results of these two studies demonstrated substantial evidence of the effectiveness of itraconazole for the treatment of blastomycosis compared with the natural history of untreated cases histoplasmosis analyses were conducted on data from two open label non concurrently controlled studies n 34 combined in patients with normal or abnormal immune status not including hiv infected patients the median dose was 2 mg day a response for most signs and symptoms was observed within the first 2 weeks and all signs and symptoms cleared between 3 and 12 months results of these two studies demonstrated substantial evidence of the effectiveness of itraconazole for the treatment of histoplasmosis compared with the natural history of untreated cases histoplasmosis in hiv infected patients data from a small number of hiv infected patients suggested that the response rate of histoplasmosis in hiv infected patients is similar to that of non hiv infected patients the clinical course of histoplasmosis in hiv infected patients is more severe and usually requires maintenance therapy to prevent relapse aspergillosis analyses were conducted on data from an open label single patient use protocol designed to make itraconazole available in the u s for patients who either failed or were intolerant of amphotericin b therapy n 19 the findings were corroborated by two smaller open label studies n 31 combined in the same patient population most adult patients were treated with a daily dose of 2 to 4 mg with a median duration of 3 months results of these studies demonstrated substantial evidence of effectiveness of itraconazole as a second line therapy for the treatment of aspergillosis compared with the natural history of the disease in patients who either failed or were intolerant of amphotericin b therapy onychomycosis of the toenail analyses were conducted on data from three double blind placebo controlled studies n 214 total 11 given itraconazole capsules in which patients with onychomycosis of the toenails received 2 mg of itraconazole capsules once daily for 12 consecutive weeks results of these studies demonstrated mycologic cure defined as simultaneous occurrence of negative koh plus negative culture in 54 of patients thirty five percent 35 of patients were considered an overall success mycologic cure plus clear or minimal nail involvement with significantly decreased signs and 14 of patients demonstrated mycologic cure plus clinical cure clearance of all signs with or without residual nail deformity the mean time to overall success was approximately 1 months twenty one percent 21 of the overall success group had a relapse worsening of the global score or conversion of koh or culture from negative to positive onychomycosis of the fingernail analyses were conducted on data from a double blind placebo controlled study n 73 total 37 given itraconazole capsules in which patients with onychomycosis of the fingernails received a 1 week course of 2 mg of itraconazole capsules b i d followed by a 3 week period without itraconazole which was followed by a second 1 week course of 2 mg of itraconazole capsules b i d results demonstrated mycologic cure in 61 of patients fifty six percent 56 of patients were considered an overall success and 47 of patients demonstrated mycologic cure plus clinical cure the mean time to overall success was approximately 5 months none of the patients who achieved overall success relapsed" assertion.
• association label "nuvigil is indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea osa narcolepsy or shift work disorder swd in osa nuvigil is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction if continuous positive airway pressure cpap is the treatment of choice for a patient a maximal effort to treat with cpap for an adequate period of time should be made prior to initiating nuvigil for excessive sleepiness if nuvigil is used adjunctively with cpap the encouragement of and periodic assessment of cpap compliance is necessary in all cases careful attention to the diagnosis and treatment of the underlying sleep disorder s is of utmost importance prescribers should be aware that some patients may have more than one sleep disorder contributing to their excessive sleepiness the effectiveness of nuvigil in long term use greater than 12 weeks has not been systematically evaluated in placebo controlled trials the physician who elects to prescribe nuvigil for an extended time in patients should periodically re evaluate long term usefulness for the individual patient nuvigil is indicated to improve wakefulness in adult patients with excessive sleepiness associated with treated obstructive sleep apnea osa narcolepsy or shift work disorder swd 1" assertion.
• association label "buspirone hydrochloride tablets are indicated for the management of anxiety disorders or 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 the efficacy of buspirone hydrochloride tablets have been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to generalized anxiety disorder gad many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms the patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study with an average symptom duration of 6 months generalized anxiety disorder 3 2 is described in the american psychiatric association s diagnostic and statistical manual iii1 as follows generalized persistent anxiety of at least 1 month continual duration manifested by symptoms from three of the four following categories 1 motor tension shakiness jitteriness jumpiness trembling tension muscle aches fatigability inability to relax eyelid twitch furrowed brow strained face fidgeting restlessness easy startle 2 autonomic hyperactivity sweating heart pounding or racing cold clammy hands dry mouth dizziness lightheadedness paresthesias tingling in hands or feet upset stomach hot or cold spells frequent urination diarrhea discomfort in the pit of the stomach lump in the throat flushing pallor high resting pulse and respiration rate 3 apprehensive expectation anxiety worry fear rumination and anticipation of misfortune to self or others 4 vigilance and scanning hyperattentiveness resulting in distractibility difficulty in concentrating insomnia feeling on edge irritability impatience the above symptoms would not be due to another mental disorder such as a depressive disorder or schizophrenia however mild depressive symptoms are common in gad the effectiveness of buspirone hydrochloride tablets in long term use that is for more than 3 to 4 weeks has not been demonstrated in controlled trials there is no body of evidence available that systematically addresses the appropriate duration of treatment for gad however in a study of long term use 264 patients were treated with buspirone hydrochloride tablets for 1 year without ill effect therefore the physician who elects to use buspirone hydrochloride tablets for extended periods should periodically reassess the usefulness of the drug for the individual patient" assertion.
• association label "prednisolone syrup prednisolone oral solution usp is 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 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 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 miscellaneous tuberculous meningitis with subarachnoid block or impending block used concurrently with appropriate antituberculous chemotherapy trichinosis with neurologic or myocardial involvement in addition to the above indications prednisolone syrup prednisolone oral solution usp is indicated for systemic dermatomyositis polymyositis" assertion.
• association label "gentamicin sulfate ophthalmic solution is indicated in the topical treatment of ocular bacterial infections including conjunctivitis keratitis keratoconjunctivitis corneal ulcers blepharitis blepharoconjunctivitis acute meibomianitis and dacryocystitis caused by susceptible strains of the following microorganisms staphylococcus aureus staphylococcus epidermidis streptococcus pyogenes streptococcus pneumoniae enterobacter aerogenes escherichia coli haemophilus influenzae klebsiella pneumoniae neisseria gonorrhoeae pseudomonas aeruginosa and serratia marcescens" 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 "nadolol tablets usp are indicated for the long term management of patients with angina pectoris nadolol 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 nadolol 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 nadolol tablets usp may be used alone or in combination with other antihypertensive agents especially thiazide type diuretics" assertion.
• integrin-clustering label "integrin clustering" assertion.
• spi label "Increased glycocalyx bulk mechanically drives integrin clustering" assertion.
• spi label "Glycocalyx bulk mechanically drives integrin clustering in cancer cells engaged with the extracellular matrix" assertion.
• association label "tirosint is l thyroxine t4 indicated for adults and pediatric patients 6 years and older with hypothyroidism as replacement therapy in primary thyroidal secondary pituitary and tertiary hypothalamic congenital or acquired hypothyroidism 1 pituitary thyrotropin thyroid stimulating hormone tsh suppression as an adjunct to surgery and radioiodine therapy in the management of thyrotropin dependent well differentiated thyroid cancer 1 limitations of use not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine sufficient patients 1 not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis 1 hypothyroidism tirosint is indicated as a replacement therapy in adults and pediatric patients 6 years and older with primary thyroidal secondary pituitary and tertiary hypothalamic congenital or acquired hypothyroidism pituitary thyrotropin thyroid stimulating hormone tsh suppression tirosint is indicated as an adjunct to surgery and radioiodine therapy in the management of adults and pediatric patients 6 years and older with thyrotropin dependent well differentiated thyroid cancer limitations of use tirosint is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine sufficient patients as there are no clinical benefits and overtreatment with tirosint may induce hyperthyroidism see warnings and precautions 5 4 tirosint is not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis" 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 "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 "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 "afinitor is a kinase inhibitor indicated for the treatment of postmenopausal women with advanced hormone receptor positive her2 negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole 1 1 adults with progressive neuroendocrine tumors of pancreatic origin pnet and adults with progressive well differentiated non functional neuroendocrine tumors net of gastrointestinal gi or lung origin that are unresectable locally advanced or metastatic limitation of use 1 2 adults with advanced renal cell carcinoma rcc after failure of treatment with sunitinib or sorafenib 1 3 adults with renal angiomyolipoma and tuberous sclerosis complex tsc not requiring immediate surgery 1 4 afinitor and afinitor disperz are kinase inhibitors indicated for the treatment of adult and pediatric patients aged 1 year and older with tsc who have subependymal giant cell astrocytoma sega that requires therapeutic intervention but cannot be curatively resected 1 5 afinitor disperz is a kinase inhibitor indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with tsc associated partial onset seizures 1 6 afinitor r afinitor is indicated for the treatment of adult patients with progressive neuroendocrine tumors of pancreatic origin pnet with unresectable locally advanced or metastatic disease afinitor is indicated for the treatment of adult patients with progressive well differentiated non functional net of gastrointestinal gi or lung origin with unresectable locally advanced or metastatic disease limitation of use see clinical studies 14 2 afinitor is indicated for the treatment of adult patients with advanced rcc after failure of treatment with sunitinib or sorafenib afinitor is indicated for the treatment of adult patients with renal angiomyolipoma and tsc not requiring immediate surgery afinitor and afinitor disperz r afinitor disperz is indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with tsc associated partial onset seizures" assertion.
• association label "thiothixene capsules are effective in the management of schizophrenia thiothixene capsules have not been evaluated in the management of behavioral complications in patients with mental retardation" 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 "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 "indications and usage thyroid hormone drugs are indicated as replacement or supplemental therapy in patients with hypothyroidism of any etiology except transient hypothyroidism during the recovery phase of subacute thyroiditis this category includes cretinism myxedema and ordinary hypothyroidism in patients of any age pediatric patients adults the elderly or state including pregnancy primary hypothyroidism resulting from functional deficiency primary atrophy partial or total absence of thyroid gland or the effects of surgery radiation or drugs with or without the presence of goiter and secondary pituitary or tertiary hypothalamic hypothyroidism see warnings as pituitary thyroid stimulating hormone tsh suppressants in the treatment or prevention of various types of euthyroid goiters including thyroid nodules subacute or chronic lymphocytic thyroiditis hashimoto s and multinodular goiter as diagnostic agents in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy liothyronine sodium tablets usp can be used in patients allergic to desiccated thyroid or thyroid extract derived from pork or beef" assertion.
• association label "votrient r votrient is indicated for the treatment of patients with advanced soft tissue sarcoma sts who have received prior chemotherapy limitation s of use votrient is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma 1 advanced soft tissue sarcoma who have received prior chemotherapy 1 limitation s of use" 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 "benzphetamine hydrochloride tablets are indicated in the management of exogenous obesity as a short term a few weeks adjunct in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index bmi of 3 kg m2 or higher who have not responded to appropriate weight reducing regimen diet and or exercise alone below is a chart of body mass index bmi based on various heights and weights bmi is calculated by taking the patient s weight in kilograms kg divided by the patient s height in meters m squared metric conversions are as follows pounds 2 2 kg inches x 254 meters the limited usefulness of agents of this class see clinical pharmacology body mass index bmi kg m 2 weight pounds height feet inches 5 5 3 5 6 5 9 6 6 3 14 27 25 23 21 19 18 15 29 27 24 22 2 19 16 31 28 26 24 22 2 17 33 3 28 25 23 21 18 35 32 29 27 25 23 19 37 34 31 28 26 24 2 39 36 32 3 27 25 21 41 37 34 31 29 26 22 43 39 36 33 3 28 23 45 41 37 34 31 29 24 47 43 39 36 33 3 25 49 44 4 37 34 31 benzphetamine hydrochloride tablets are indicated for use as monotherapy only" 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 "azasite r haemophilus influenzae staphylococcus aureus streptococcus mitis streptococcus pneumoniae efficacy for this organism was studied in fewer than 1 infections azasite is a macrolide antibiotic indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following microorganisms cdc coryneform group g haemophilus influenzae staphylococcus aureus streptococcus mitis streptococcus pneumoniae 1" assertion.
• association label "adult patients 1 1 cold sores herpes labialis genital herpes treatment in immunocompetent patients initial or recurrent episode suppression in immunocompetent or hiv infected patients reduction of transmission herpes zoster pediatric patients 1 2 cold sores herpes labialis limitations of use 1 3 the efficacy and safety of valacyclovir hydrochloride tablets have not been established in immunocompromised patients other than for the suppression of genital herpes in hiv infected patients cold sores herpes labialis valacyclovir hydrochloride tablets are indicated for treatment of cold sores herpes labialis the efficacy of valacyclovir hydrochloride tablets initiated after the development of clinical signs of a cold sore e g papule vesicle or ulcer has not been established genital herpes initial episode valacyclovir hydrochloride tablets are indicated for treatment of the initial episode of genital herpes in immunocompetent adults the efficacy of treatment with valacyclovir hydrochloride tablets when initiated more than 72 hours after the onset of signs and symptoms has not been established valacyclovir hydrochloride tablets are indicated for treatment of recurrent episodes of genital herpes in immunocompetent adults the efficacy of treatment with valacyclovir hydrochloride tablets when initiated more than 24 hours after the onset of signs and symptoms has not been established valacyclovir hydrochloride tablets are indicated for chronic suppressive therapy of recurrent episodes of genital herpes in immunocompetent and in hiv infected adults the efficacy and safety of valacyclovir hydrochloride tablets for the suppression of genital herpes beyond 1 year in immunocompetent patients and beyond 6 months in hiv infected patients have not been established valacyclovir hydrochloride tablets are indicated for the reduction of transmission of genital herpes in immunocompetent adults the efficacy of valacyclovir hydrochloride tablets for the reduction of transmission of genital herpes beyond 8 months in discordant couples has not been established the efficacy of valacyclovir hydrochloride tablets for the reduction of transmission of genital herpes in individuals with multiple partners and non heterosexual couples has not been established safer sex practices should be used with suppressive therapy see current centers for disease control and prevention cdc sexually transmitted diseases treatment guidelines herpes zoster valacyclovir hydrochloride tablets are indicated for the treatment of herpes zoster shingles in immunocompetent adults the efficacy of valacyclovir hydrochloride tablets when initiated more than 72 hours after the onset of rash and the efficacy and safety of valacyclovir hydrochloride tablets for treatment of disseminated herpes zoster have not been established cold sores herpes labialis valacyclovir hydrochloride tablets are indicated for the treatment of cold sores herpes labialis in pediatric patients 12 years of age the efficacy of valacyclovir hydrochloride tablets initiated after the development of clinical signs of a cold sore e g papule vesicle or ulcer has not been established labeling describing use of valacyclovir hydrochloride tablets in pediatric patients with chickenpox ages 2 to 18 years is approved for glaxosmithkline s valtrex r caplets however due to glaxosmithkline s marketing exclusivity rights a description of that pediatric use is not approved for this valacyclovir hydrochloride tablet product the efficacy and safety of valacyclovir hydrochloride tablets have not been established in immunocompromised patients other than for the suppression of genital herpes in hiv infected patients with a cd4 cell count 1 cells mm 3 patients 12 years of age with cold sores herpes labialis patients 18 years of age with genital herpes patients 18 years of age with herpes zoster neonates and infants as suppressive therapy following neonatal herpes simplex virus hsv infection labeling describing use of valacyclovir hydrochloride tablets in pediatric patients with chickenpox ages of 2 to 18 years is approved for glaxosmithkline s valtrex r" 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 "carmustine for injection usp is indicated as palliative therapy as a single agent or in established combination therapy in the following brain tumors glioblastoma brainstem glioma medulloblastoma astrocytoma ependymoma and metastatic brain tumors multiple myeloma in combination with prednisone relapsed or refractory hodgkin s lymphoma in combination with other approved drugs relapsed or refractory non hodgkin s lymphomas in combination with other approved drugs carmustine for injection usp is a nitrosourea indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following brain tumors glioblastoma brainstem glioma medulloblastoma astrocytoma ependymoma and metastatic brain tumors 1 multiple myeloma in combination with prednisone 1 relapsed or refractory hodgkin s lymphoma in combination with other approved drugs 1 relapsed or refractory non hodgkin s lymphomas in combination with other approved drugs 1" assertion.
• association label "perphenazine tablets are indicated for use in the treatment of schizophrenia and for the control of severe nausea and vomiting in adults perphenazine tablets have not been shown effective for the management of behavioral complications in patients with mental retardation" assertion.
• association label "mirapex r pramipexole dihydrochloride tablets are indicated for the treatment of the signs and symptoms of idiopathic parkinson s disease the effectiveness of mirapex tablets was demonstrated in randomized controlled trials in patients with early parkinson s disease who were not receiving concomitant levodopa therapy as well as in patients with advanced disease on concomitant levodopa see clinical studies mirapex tablets are indicated for the treatment of moderate to severe primary restless legs syndrome rls key diagnostic criteria for rls are an urge to move the legs usually accompanied or caused by uncomfortable and unpleasant leg sensations symptoms begin or worsen during periods of rest or inactivity such as lying or sitting symptoms are partially or totally relieved by movement such as walking or stretching at least as long as the activity continues and symptoms are worse or occur only in the evening or night difficulty falling asleep may frequently be associated with symptoms of rls" assertion.
• association label "methylprednisolone 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 rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy ankylosing spondylitis acute and subacute bursitis synovitis of osteoarthritis acute nonspecific tenosynovitis post traumatic osteoarthritis psoriatic arthritis epicondylitis acute gouty arthritis 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 bullous dermatitis herpetiformis severe erythema multiforme stevens johnson syndrome severe seborrheic dermatitis exfoliative dermatitis mycosis fungoides pemphigus severe psoriasis 5 allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment seasonal or perennial allergic rhinitis drug hypersensitivity reactions serum sickness contact dermatitis bronchial asthma atopic dermatitis 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 keratitis optic neuritis allergic conjunctivitis chorioretinitis iritis and iridocyclitis 7 respiratory diseases symptomatic sarcoidosis berylliosis loeffler s syndrome not manageable by other means 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.
• expression-of-genes-IRX3-AND-IRX5 label "expression of genes IRX3 AND IRX5" assertion.
• Q26972 label "gene expression" assertion.
• Q26972 label "gene expression" assertion.
• spi label "A regulatory element within the first intron of FTO affects IRX3 and IRX5 expression during early adipogenesis" assertion.
• social-group-size label "Social group size" assertion.
• spi label "The cortex size of humans does not relate to their social group size" assertion.
• usage-of-linked-data-scopes label "Usage of the Linked Data Scopes ontology" assertion.
• property label "the property on which the restriction is applied" assertion.
• name label "the name of the class" assertion.
• description label "description of the class" assertion.
• restrictiontype label "select type of restriction" assertion.
• newclass label "short ID of new class" assertion.
• class label "URI of existing class" assertion.
• assertion label "Defining a new class by a property restriction" assertion.
• creator label "ORCID of creator" assertion.
• assertion label "Additional nanopublication creators" assertion.
• spi label "Sonic hedgehog signalling pathway is an essential regulator of astrocytes development." assertion.
• spi label "Sonic hedgehog signalling directs patterned cell remodeling during neural tube closure." assertion.
• dysregulation-sonic-hedgehog-signaling label "dysregulation sonic hedgehog signaling" assertion.
• doublecortin-pseudo-repeats label "doublecortin pseudo-repeats" assertion.
• adherenceToTheFAIRGuidingPrinciples label "adherence to the FAIR Guiding Principles" assertion.
• spi label "Every thing of type adherence to FAIR Guiding Principles that is in the context of a thing of type dataset can have a relation of type enables to a thing of type automated discovery that is in the same context (i.e. the same dataset)." 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 "losartan potassium tablet usp is an angiotensin ii receptor blocker arb indicated for treatment of hypertension to lower blood pressure in adults and children greater than 6 years old lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events primarily strokes and myocardial infarctions 1 1 reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy there is evidence that this benefit does not apply to black patients 1 2 treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension 1 3 losartan potassium tablets usp are indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older to lower blood pressure lowering blood pressure lowers the risk of fatal and nonfatal 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 losartan 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 losartan potassium tablets usp may be administered with other antihypertensive agents losartan potassium tablets usp are indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy but there is evidence that this benefit does not apply to black patients see use in specific populations 8 6 and clinical pharmacology 12 3 losartan potassium tablets usp are indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria urinary albumin to creatinine ratio 3 mg g in patients with type 2 diabetes and a history of hypertension in this population losartan potassium 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 3" assertion.
• association label "duloxetine delayed release capsules are serotonin and norepinephrine reuptake inhibitor snri indicated for major depressive disorder mdd 1 1 generalized anxiety disorder gad 1 2 diabetic peripheral neuropathic pain dpnp 1 3 chronic musculoskeletal pain 1 5 duloxetine delayed release capsules are indicated for the treatment of major depressive disorder mdd the efficacy of duloxetine was established in four short term and one maintenance trial in adults 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 5 of the following 9 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 or a suicide attempt or suicidal ideation duloxetine delayed release capsules are indicated for the treatment of generalized anxiety disorder gad the efficacy of duloxetine was established in three short term trials and one maintenance trial in adults see duloxetine delayed release capsules are indicated for the treatment of generalized anxiety disorder gad the efficacy of duloxetine was established in three short term trials and one maintenance trial in adults see clinical studies 14 2 generalized anxiety disorder is defined by the dsm iv as excessive anxiety and worry present more days than not for at least 6 months the excessive anxiety and worry must be difficult to control and must cause significant distress or impairment in normal functioning it must be associated with at least 3 of the following 6 symptoms restlessness or feeling keyed up or on edge being easily fatigued difficulty concentrating or mind going blank irritability muscle tension and or sleep disturbance generalized anxiety disorder is defined by the dsm iv as excessive anxiety and worry present more days than not for at least 6 months the excessive anxiety and worry must be difficult to control and must cause significant distress or impairment in normal functioning it must be associated with at least 3 of the following 6 symptoms restlessness or feeling keyed up or on edge being easily fatigued difficulty concentrating or mind going blank irritability muscle tension and or sleep disturbance duloxetine delayed release capsules are indicated for the management of neuropathic pain dpnp associated with diabetic peripheral neuropathy see clinical studies 14 3 duloxetine delayed release capsules are indicated for the management of chronic musculoskeletal pain this has been established in studies in patients with chronic low back pain clbp and chronic pain due to osteoarthritis see clinical studies 14 5" assertion.
• association label "prexxartan is an angiotensin ii receptor blocker arb indicated for hypertension in adults and children six years and older to lower blood pressure lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events primarily strokes and myocardial infarctions 1 1 heart failure nyha class ii iv prexxartan significantly reduces hospitalization for heart failure in patients who are unable to swallow valsartan tablets 1 2 stable left ventricular failure or left ventricular dysfunction following myocardial infarction prexxartan reduces cardiovascular mortality in patients who are unable to swallow valsartan tablets 1 3 prexxartan is indicated for the treatment of hypertension in adults and children six years and older 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 valsartan principally belongs there are no controlled trials in hypertensive patients demonstrating risk reduction with valsartan 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 e g 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 prexxartan may be used alone or in combination with other antihypertensive agents prexxartan is indicated for the treatment of heart failure nyha class ii iv to reduce the risk of hospitalization for heart failure in patients who are unable to swallow valsartan tablets there is no evidence that valsartan provides added benefits when it is used with an adequate dose of an ace inhibitor see warnings and precautions 5 2 clinical pharmacology 12 3 clinical studies 14 2 prexxartan is indicated to reduce the risk of cardiovascular death in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction who are unable to swallow valsartan tablets see warnings and precautions 5 2 clinical pharmacology 12 3 clinical studies 14 3" 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 "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 "a intravenous or intramuscular administration 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 those products labeled for intravenous or intramuscular use are indicated as follows 1 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 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 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 post traumatic osteoarthritis synovitis of osteoarthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy acute and subacute bursitis epicondylitis acute nonspecific tenosynovitis acute gouty arthritis psoriatic arthritis ankylosing spondylitis 3 collagen diseases during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus acute rheumatic carditis 4 dermatologic diseases pemphigus severe erythema multiforme stevens johnson syndrome exfoliative dermatitis bullous dermatitis herpetiformis severe seborrheic dermatitis severe psoriasis mycosis fungoides 5 allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in bronchial asthma contact dermatitis atopic dermatitis serum sickness seasonal or perennial allergic rhinitis drug hypersensitivity reactions urticarial transfusion reactions acute noninfectious laryngeal edema epinephrine is the drug of first choice 6 ophthalmic diseases severe acute and chronic allergic and inflammatory processes involving the eye such as herpes zoster ophthalmicus iritis iridocyclitis chorioretinitis diffuse posterior uveitis and choroiditis optic neuritis sympathetic ophthalmia anterior segment inflammation allergic conjunctivitis allergic corneal marginal ulcers keratitis 7 gastrointestinal diseases to tide the patient over a critical period of the disease in ulcerative colitis systemic therapy regional enteritis systemic therapy 8 respiratory diseases symptomatic sarcoidosis berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate anti tuberculosis chemotherapy loeffler s syndrome not manageable by other means aspiration pneumonitis 9 hematologic disorders acquired autoimmune hemolytic anemia idiopathic thrombocytopenic purpura in adults i v only i m administration is contraindicated secondary thrombocytopenia in adults erythroblastopenia rbc anemia congenital erythroid hypoplastic anemia 1 neoplastic diseases for palliative management of leukemias and lymphomas in adults acute leukemic of childhood 11 edematous states to induce diuresis or remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus 12 nervous system acute exacerbations of multiple sclerosis 13 miscellaneous tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate anti tuberculosis chemotherapy trichinosis with neurologic or myocardial involvement diagnostic testing of adrenocortical hyperfunction cerebral edema of diverse etiologies in conjunction with adequate neurological evaluation and management b intra articular or soft tissue administration when the strength and dosage form of the drug lend the preparation to the treatment of the condition those products labeled for intra articular or soft tissue administration are indicated as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in synovitis of osteoarthritis rheumatoid arthritis acute and subacute bursitis acute gouty arthritis epicondylitis acute nonspecific tenosynovitis post traumatic osteoarthritis c intralesional administration when the strength and dosage form of the drug lend the preparation to the treatment of the condition those products labeled for intralesional administration are indicated for keloids localized hypertrophic infiltrated inflammatory lesions of lichen planus psoriatic plaques granuloma annulare and lichen simplex chronicus neurodermatitis discoid lupus erythematosus necrobiosis lipoidica diabeticorum alopecia areata they also may be useful in cystic tumors of an aponeurosis tendon ganglia" assertion.
• association label "maintenance of normal sinus rhythm delay in af afl recurrence dofetilide capsules are indicated for the maintenance of normal sinus rhythm delay in time to recurrence of atrial fibrillation atrial flutter af afl in patients with atrial fibrillation atrial flutter of greater than one week duration who have been converted to normal sinus rhythm because dofetilide can cause life threatening ventricular arrhythmias it should be reserved for patients in whom atrial fibrillation atrial flutter is highly symptomatic in general antiarrhythmic therapy for atrial fibrillation atrial flutter aims to prolong the time in normal sinus rhythm recurrence is expected in some patients see clinical studies conversion of atrial fibrillation flutter dofetilide capsules are indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm dofetilide capsules have not been shown to be effective in patients with paroxysmal atrial fibrillation" assertion.
• association label "paclitaxel injection usp is indicated as first line and subsequent therapy for the treatment of advanced carcinoma of the ovary as first line therapy paclitaxel injection usp is indicated in combination with cisplatin paclitaxel injection usp is indicated for the adjuvant treatment of node positive breast cancer administered sequentially to standard doxorubicin containing combination chemotherapy in the clinical trial there was an overall favorable effect on disease free and overall survival in the total population of patients with receptor positive and receptor negative tumors but the benefit has been specifically demonstrated by available data median follow up 3 months only in the patients with estrogen and progesterone receptor negative tumors see clinical studies breast carcinoma paclitaxel injection usp is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy prior therapy should have included an anthracycline unless clinically contraindicated paclitaxel injection usp in combination with cisplatin is indicated for the first line treatment of non small cell lung cancer in patients who are not candidates for potentially curative surgery and or radiation therapy paclitaxel injection usp is indicated for the second line treatment of aids related kaposi s sarcoma" assertion.
• association label "donepezil hydrochloride orally disintegrating tablets usp are an acetylcholinesterase inhibitor indicated for the treatment of dementia of the alzheimer s type efficacy has been demonstrated in patients with mild moderate and severe alzheimer s disease 1 donepezil hydrochloride orally disintegrating tablets usp are indicated for the treatment of dementia of the alzheimer s type efficacy has been demonstrated in patients with mild moderate and severe alzheimer s disease" assertion.
• association label "pantoprazole sodium delayed release tablets are indicated for pantoprazole sodium delayed release tablet is a proton pump inhibitor indicated for the following short term treatment of erosive esophagitis associated with gastroesophageal reflux disease gerd 1 1 maintenance of healing of erosive esophagitis 1 2 pathological hypersecretory conditions including zollinger ellison syndrome 1 3 pantoprazole sodium delayed release tablets are indicated in adults for the short term treatment up to 8 weeks in the healing and symptomatic relief of erosive esophagitis for those adult patients who have not healed after 8 weeks of treatment an additional 8 week course of pantoprazole sodium delayed release tablets may be considered safety of treatment beyond 8 weeks in pediatric patients has not been established pediatric indication and usage information in pediatric patients ages five years and older with erosive esophagitis associated with gerd is approved for wyeth pharmaceuticals inc s pantoprazole sodium delayed release tablets however due to wyeth pharmaceuticals inc s marketing exclusivity rights this drug product is not labeled with that pediatric information pantoprazole sodium delayed release tablets are indicated for maintenance of healing of erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with gerd controlled studies did not extend beyond 12 months pantoprazole sodium delayed release tablets are indicated for the long term treatment of pathological hypersecretory conditions including zollinger ellison syndrome" assertion.
• association label "tinidazole is a nitroimidazole antimicrobial indicated for 1 1 1 2 1 3 1 4 8 1 to reduce the development of drug resistant bacteria and maintain the effectiveness of tinidazole and other antibacterial drugs tinidazole should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria 1 5 tinidazole is indicated for the treatment of trichomoniasis caused by trichomonas vaginalis see clinical studies 14 1 tinidazole is indicated for the treatment of giardiasis caused by giardia duodenalis g lamblia see clinical studies 14 2 tinidazole is indicated for the treatment of intestinal amebiasis and amebic liver abscess caused by entamoeba histolytica see clinical studies 14 3 14 4 tinidazole is indicated for the treatment of bacterial vaginosis formerly referred to as haemophilus gardnerella adult women see use in specific populations 8 1 14 5 other pathogens commonly associated with vulvovaginitis such as trichomonas vaginalis chlamydia trachomatis neisseria gonorrhoeae candida albicans herpes simplex to reduce the development of drug resistant bacteria and maintain the effectiveness of tinidazole and other antibacterial drugs tinidazole 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 "phentermine hydrochloride orally disintegrating tablets are sympathomimetic amine anorectic indicated as a short term adjunct a few weeks in a regimen of weight reduction based on exercise behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index greater than or equal to 3 kg m 2 2 1 the limited usefulness of agents of this class including phentermine hydrochloride should be measured against possible risk factors inherent in their use 1 phentermine hydrochloride orally disintegrating tablets are indicated as a short term a few weeks adjunct in a regimen of weight reduction based on exercise behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index greater than or equal to 3 kg m 2 2 below is a chart of body mass index bmi based on various heights and weights bmi is calculated by taking the patient s weight in kilograms kg divided by the patient s height in meters m squared metric conversions are as follows pounds 2 2 kg inches x 254 meters body mass index bmi kg m 2 header weight 5 5 3 5 6 5 9 6 6 3 14 27 25 23 21 19 18 15 29 27 24 22 2 19 16 31 28 26 24 22 2 17 33 3 28 25 23 21 18 35 32 29 27 25 23 19 37 34 31 28 26 24 2 39 36 32 3 27 25 21 41 37 34 31 29 26 22 43 39 36 33 3 28 23 45 41 37 34 31 29 24 47 43 39 36 33 3 25 49 44 4 37 34 31 the limited usefulness of agents of this class including phentermine hydrochloride see clinical pharmacology 12 1 12 2" assertion.
• association label "miacalcin synthetic injection is a calcitonin indicated for the following conditions 1 1 1 2 1 3 limitations of use 1 4 5 3 miacalcin injection is indicated for the treatment of symptomatic paget s disease of bone in patients with moderate to severe disease characterized by polyostotic involvement with elevated serum alkaline phosphatase and urinary hydroxyproline excretion there is no evidence that the prophylactic use of calcitonin salmon is beneficial in asymptomatic patients miacalcin injection should be used only in patients who do not respond to alternative treatments or for whom such treatments are not suitable e g patients for whom other therapies are contraindicated or for patients who are intolerant or unwilling to use other therapies miacalcin injection is indicated for the early treatment of hypercalcemic emergencies along with other appropriate agents when a rapid decrease in serum calcium is required until more specific treatment of the underlying disease can be accomplished it may also be added to existing therapeutic regimens for hypercalcemia such as intravenous fluids and furosemide oral phosphate or corticosteroids or other agents miacalcin injection is indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause the evidence of efficacy for calcitonin salmon injection is based on increases in total body calcium observed in clinical trials fracture reduction efficacy has not been demonstrated miacalcin injection should be reserved for patients for whom alternative treatments are not suitable e g patients for whom other therapies are contraindicated or for patients who are intolerant or unwilling to use other therapies due to the possible association between malignancy and calcitonin salmon use the need for continued therapy should be re evaluated on a periodic basis see warnings and precautions 5 3" assertion.
• association label "methamphetamine hydrochloride tablets are indicated as an integral part of a total treatment program which typically includes other remedial measures psychological educational social for a stabilizing effect in children over 6 years of age with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms moderate to severe distractibility short attention span hyperactivity emotional lability and impulsivity the diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin nonlocalizing soft neurological signs learning disability and abnormal eeg may or may not be present and a diagnosis of central nervous system dysfunction may or may not be warranted as a short term i e a few weeks adjunct in a regimen of weight reduction based on caloric restriction for patients in whom obesity is refractory to alternative therapy e g repeated diets group programs and other drugs the limited usefulness of methamphetamine hydrochloride tablets see clinical pharmacology" assertion.
• association label "a intravenous or intramuscular administration 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 those products labeled for intravenous or intramuscular use are indicated as follows 1 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 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 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 post traumatic osteoarthritis synovitis of osteoarthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy acute and subacute bursitis epicondylitis acute nonspecific tenosynovitis acute gouty arthritis psoriatic arthritis ankylosing spondylitis 3 collagen diseases during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus acute rheumatic carditis 4 dermatologic diseases pemphigus severe erythema multiforme stevens johnson syndrome exfoliative dermatitis bullous dermatitis herpetiformis severe seborrheic dermatitis severe psoriasis mycosis fungoides 5 allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in bronchial asthma contact dermatitis atopic dermatitis serum sickness seasonal or perennial allergic rhinitis drug hypersensitivity reactions urticarial transfusion reactions acute noninfectious laryngeal edema epinephrine is the drug of first choice 6 ophthalmic diseases severe acute and chronic allergic and inflammatory processes involving the eye such as herpes zoster ophthalmicus iritis iridocyclitis chorioretinitis diffuse posterior uveitis and choroiditis optic neuritis sympathetic ophthalmia anterior segment inflammation allergic conjunctivitis allergic corneal marginal ulcers keratitis 7 gastrointestinal diseases to tide the patient over a critical period of the disease in ulcerative colitis systemic therapy regional enteritis systemic therapy 8 respiratory diseases symptomatic sarcoidosis berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate anti tuberculosis chemotherapy loeffler s syndrome not manageable by other means aspiration pneumonitis 9 hematologic disorders acquired autoimmune hemolytic anemia idiopathic thrombocytopenic purpura in adults i v only i m administration is contraindicated secondary thrombocytopenia in adults erythroblastopenia rbc anemia congenital erythroid hypoplastic anemia 1 neoplastic diseases for palliative management of leukemias and lymphomas in adults acute leukemic of childhood 11 edematous states to induce diuresis or remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus 12 nervous system acute exacerbations of multiple sclerosis 13 miscellaneous tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate anti tuberculosis chemotherapy trichinosis with neurologic or myocardial involvement diagnostic testing of adrenocortical hyperfunction cerebral edema of diverse etiologies in conjunction with adequate neurological evaluation and management b intra articular or soft tissue administration when the strength and dosage form of the drug lend the preparation to the treatment of the condition those products labeled for intra articular or soft tissue administration are indicated as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in synovitis of osteoarthritis rheumatoid arthritis acute and subacute bursitis acute gouty arthritis epicondylitis acute nonspecific tenosynovitis post traumatic osteoarthritis c intralesional administration when the strength and dosage form of the drug lend the preparation to the treatment of the condition those products labeled for intralesional administration are indicated for keloids localized hypertrophic infiltrated inflammatory lesions of lichen planus psoriatic plaques granuloma annulare and lichen simplex chronicus neurodermatitis discoid lupus erythematosus necrobiosis lipoidica diabeticorum alopecia areata they also may be useful in cystic tumors of an aponeurosis tendon ganglia" assertion.
• association label "esomeprazole magnesium delayed release capsules usp are a proton pump inhibitor indicated for the following treatment of gastroesophageal reflux disease gerd 1 1 risk reduction of nsaid associated gastric ulcer 1 2 eradication to reduce the risk of duodenal ulcer recurrence h pylori 1 3 pathological hypersecretory conditions including zollinger ellison syndrome 1 4 healing of erosive esophagitis esomeprazole magnesium delayed release capsules usp are indicated for the short term treatment 4 to 8 weeks in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis for those patients who have not healed after 4 to 8 weeks of treatment an additional 4 to 8 week course of esomeprazole magnesium delayed release capsules usp may be considered maintenance of healing of erosive esophagitis esomeprazole magnesium delayed release capsules usp are indicated to maintain symptom resolution and healing of erosive esophagitis controlled studies do not extend beyond 6 months symptomatic gastroesophageal reflux disease esomeprazole magnesium delayed release capsules usp are indicated for short term treatment 4 to 8 weeks of heartburn and other symptoms associated with gerd in adults and children 1 year or older esomeprazole magnesium delayed release capsules usp are indicated for the reduction in the occurrence of gastric ulcers associated with continuous nsaid therapy in patients at risk for developing gastric ulcers patients are considered to be at risk due to their age 6 and or documented history of gastric ulcers controlled studies do not extend beyond 6 months triple therapy esomeprazole magnesium delayed release capsules usp plus amoxicillin and clarithromycin esomeprazole magnesium delayed release capsules usp in combination with amoxicillin and clarithromycin is indicated for the treatment of patients with infection and duodenal ulcer disease active or history of within the past 5 years to eradicate eradication of has been shown to reduce the risk of duodenal ulcer recurrence h pylori h pylori h pylori see dosage and administration and clinical studies 2 14 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 and the prescribing information for clarithromycin 12 4 esomeprazole magnesium delayed release capsules usp are indicated for the long term treatment of pathological hypersecretory conditions including zollinger ellison syndrome" assertion.
• association label "glyburide tablets usp micronized are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus" assertion.
• association label "vinorelbine injection usp is indicated in combination with cisplatin for first line treatment of patients with locally advanced or metastatic non small cell lung cancer nsclc as a single agent for the treatment of patients with metastatic nsclc vinorelbine injection usp is a vinca alkaloid indicated in combination with cisplatin for first line treatment of patients with locally advanced or metastatic non small cell lung cancer nsclc 1 as a single agent for first line treatment of patients with metastatic nsclc 1" 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 "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 "amiloride hcl tablets are indicated as adjunctive treatment with thiazide diuretics or other kaliureticdiuretic agents in congestive heart failure or hypertension to a help restore normal serum potassium levels in patients who develop hypokalemia on the kaliuretic diuretic b prevent development of hypokalemia in patients who would be exposed to particular risk if hypokalemia were to develop e g digitalized patients or patients with significant cardiac arrhythmias the use of potassium conserving agents is often unnecessary in patients receiving diuretics for uncomplicated essential hypertension when such patients have a normal diet amiloride hcl tablets have little additive diuretic or antihypertensive effect when added to a thiazide diuretic amiloride hcl tablets should rarely be used alone it has weak compared with thiazides diuretic and antihypertensive effects used as single agents potassium sparing diuretics including amiloride hcl tablets result in an increased risk of hyperkalemia approximately 1 with amiloride amiloride hcl tablets should be used alone only when persistent hypokalemia has been documented and only with careful titration of the dose and close monitoring of serum electrolytes" assertion.
• association label "carefully consider the potential benefits and risks of naprosyn ec naprosyn anaprox anaprox ds or naprosyn suspension and other treatment options before deciding to use naprosyn ec naprosyn anaprox anaprox ds or naprosyn suspension use the lowest effective dose for the shortest duration consistent with individual patient treatment goals see warnings naproxen as naprosyn ec naprosyn anaprox anaprox ds or naprosyn suspension is indicated for the relief of the signs and symptoms of rheumatoid arthritis for the relief of the signs and symptoms of osteoarthritis for the relief of the signs and symptoms of ankylosing spondylitis for the relief of the signs and symptoms of juvenile arthritis naproxen as naprosyn suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient s weight naproxen as naprosyn anaprox anaprox ds and naprosyn suspension is also indicated for relief of the signs and symptoms of tendonitis for relief of the signs and symptoms of bursitis for relief of the signs and symptoms of acute gout for the management of pain for the management of primary dysmenorrhea ec naprosyn is not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen containing products see clinical pharmacology dosage and administration" assertion.
• association label "bromocriptine mesylate tablets are indicated for the treatment of dysfunctions associated with hyperprolactinemia amenorrhea galactorrhea infertility or hypogonadism prolactin secreting adenomas reduction tumor size bromocriptine mesylate tablets therapy is indicated in the treatment of acromegaly bromocriptine mesylate tablets therapy alone or as adjunctive therapy with pituitary irradiation or surgery reduces serum growth hormone by 5 or more in approximately 1 2 of patients treated although not usually to normal levels since the effects of external pituitary radiation may not become maximal for several years adjunctive therapy with bromocriptine mesylate tablets offers potential benefit before the effects of irradiation are manifested bromocriptine mesylate tablets are indicated in the treatment of the signs and symptoms of idiopathic or postencephalitic parkinson s disease as adjunctive treatment to levodopa alone or with a peripheral decarboxylase inhibitor bromocriptine mesylate tablets therapy may provide additional therapeutic benefits in those patients who are currently maintained on optimal dosages of levodopa those who are beginning to deteriorate develop tolerance to levodopa therapy and those who are experiencing end of dose failure on levodopa therapy bromocriptine mesylate tablets therapy may permit a reduction of the maintenance dose of levodopa and thus may ameliorate the occurrence and or severity of adverse reactions associated with long term levodopa therapy such as abnormal involuntary movements e g dyskinesias and the marked swings in motor function on off phenomenon continued efficacy of bromocriptine mesylate tablets therapy during treatment of more than 2 years has not been established data are insufficient to evaluate potential benefit from treating newly diagnosed parkinson s disease with bromocriptine mesylate tablets studies have shown however significantly more adverse reactions notably nausea hallucinations confusion and hypotension in bromocriptine mesylate treated patients than in levodopa carbidopa treated patients patients unresponsive to levodopa are poor candidates for bromocriptine mesylate tablets therapy" assertion.
• association label "vancomycin hydrochloride for injection usp is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin resistant b lactam resistant staphylococci it is indicated for penicillin allergic patients for patients who cannot receive or who have failed to respond to other drugs including the penicillins or cephalosporins and for infections caused by vancomycin susceptible organisms that are resistant to other antimicrobial drugs vancomycin hydrochloride for injection usp is indicated for initial therapy when methicillin resistant staphylococci are suspected but after susceptibility data are available therapy should be adjusted accordingly vancomycin hydrochloride for injection usp is effective in the treatment of staphylococcal endocarditis its effectiveness has been documented in other infections due to staphylococci including septicemia bone infections lower respiratory tract infections skin and skin structure infections when staphylococcal infections are localized and purulent antibiotics are used as adjuncts to appropriate surgical measures vancomycin hydrochloride for injection usp has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by s viridans or s bovis for endocarditis caused by enterococci e g e faecalis vancomycin hydrochloride has been reported to be effective only in combination with an aminoglycoside vancomycin hydrochloride for injection usp has been reported to be effective for the treatment of diphtheroid endocarditis vancomycin hydrochloride for injection usp has been used successfully in combination with either rifampin an aminoglycoside or both in early onset prosthetic valve endocarditis caused by s epidermidis or diphtheroids specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin to reduce the development of drug resistant bacteria and maintain the effectiveness of vancomycin hydrochloride for injection usp and other antibacterial drugs vancomycin hydrochloride for injection 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 the parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic associated pseudomembranous colitis produced by c difficile and for staphylococcal enterocolitis parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications vancomycin is not effective by the oral route for other types of infection" assertion.
• association label "paroxetine capsules are indicated for the treatment of moderate to severe vasomotor symptoms vms associated with menopause limitation of use paroxetine capsules are not indicated for the treatment of any psychiatric condition paroxetine capsules contain a lower dose of paroxetine than that used to treat depression obsessive compulsive disorder panic disorder generalized anxiety disorder social anxiety disorder and post traumatic stress disorder the safety and efficacy of this lower dose of paroxetine in paroxetine capsules have not been established for any psychiatric condition patients who require paroxetine for treatment of a psychiatric condition should discontinue paroxetine capsules and initiate a paroxetine containing medication that is indicated for such use paroxetine is a selective serotonin reuptake inhibitor ssri indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause vms 1 limitation of use 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 "when oral therapy is not feasible the intramuscular use r r control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma atopic dermatitis contact dermatitis drug hypersensitivity reactions perennial or seasonal allergic rhinitis serum sickness transfusion reactions bullous dermatitis herpetiformis exfoliative erythroderma mycosis fungoides pemphigus severe erythema multiforme stevens johnson syndrome congenital adrenal hyperplasia hypercalcemia associated with cancer nonsuppurative thyroiditis hydrocortisone or cortisone is the drug of choice in primary or secondary adrenocortical insufficiency synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance to tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis acquired autoimmune hemolytic anemia diamond blackfan anemia pure red cell aplasia selected cases of secondary thrombocytopenia trichinosis with neurologic or myocardial involvement tuberculous meningitis with subarachnoid block or impending block when used 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 fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy idiopathic eosinophilic pneumonias symptomatic sarcoidosis rheumatic disorders the intra articular or soft tissue administration the intralesional administration celestone soluspan injectable suspension may also be useful in cystic tumors of an aponeurosis or tendon ganglia" assertion.
• association label "horizant is indicated for treatment of moderate to severe primary restless legs syndrome rls in adults 1 1 management of postherpetic neuralgia phn in adults 1 2 horizant a r horizant is not recommended for patients who are required to sleep during the daytime and remain awake at night horizant gabapentin enacarbil extended release tablets are indicated for the management of postherpetic neuralgia phn in adults" assertion.

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