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Matches in Nanopublications for { ?s <http://www.w3.org/2000/01/rdf-schema#label> ?o ?g. }

• association label "nizatidineoral solution is indicated for up to 8 weeks for the treatment of active duodenal ulcer in most patients the ulcer will heal within 4 weeks nizatidineoral solution is indicated for maintenance therapy for duodenal ulcer patients at a reduced dosage of 15 mg h s after healing of an active duodenal ulcer the consequences of continuous therapy with nizatidine for longer than 1 year are not known nizatidine oral solution is indicated for up to 12 weeks for the treatment of endoscopically diagnosed esophagitis including erosive and ulcerative esophagitis and associated heartburn due to gerd nizatidine oral solution is indicated for up to 8 weeks for the treatment of active benign gastric ulcer before initiating therapy care should be taken to exclude the possibility of malignant gastric ulceration in pediatric patients nizatidine oral solution is indicated for ages 12 years and older nizatidine oral solution is indicated for up to 8 weeks for the treatment of endoscopically diagnosed esophagitis including erosive and ulcerative esophagitis and associated heartburn due to gerd" assertion.
• association label "griseofulvin tablets usp are indicated for the treatment of dermatophyte infections of the skin not adequately treated by topical therapy hair and nails namely tinea corporis tinea pedis tinea cruris tinea barbae tinea capitis tinea unguium when caused by one or more of the following species of fungi epidermophyton floccosum microsporum audouinii microsporum canis microsporum gypseum trichophyton crateriform trichophyton gallinae trichophyton interdigitalis trichophyton megnini trichophyton mentagrophytes trichophyton rubrum trichophyton schoenleini trichophyton sulphureum trichophyton tonsurans trichophyton verrucosum note prior to initiating treatment appropriate specimens for laboratory testing koh preparation fungal culture or nail biopsy should be obtained to confirm the diagnosis griseofulvin tablets usp are not bacterial infections candidiasis moniliasis histoplasmosis actinomycosis sporotrichosis chromoblastomycosis coccidioidomycosis north american blastomycosis cryptococcosis torulosis tinea versicolor nocardiosis the use of this drug is not justified in minor or trivial dermatophyte infections which will respond to topical agents alone" assertion.
• association label "geodon is indicated for the treatment of schizophrenia as monotherapy for the acute treatment of bipolar manic or mixed episodes and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder geodon intramuscular is indicated for acute agitation in schizophrenic patients when deciding among the alternative treatments available for the condition needing treatment the prescriber should consider the finding of ziprasidone s greater capacity to prolong the qt qtc interval compared to several other an tipsychotic drugs prolongation of the qtc interval is associated in some other drugs with the ability to cause torsade de pointes type arrhythmia a potentially fatal polymorphic ventricular tachycardia and sudden death in many cases this would lead to the conclusion that other drugs should be tried first whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known see warnings and precautions 5 2 see warnings and precautions 5 2 geodon is an atypical antipsychotic in choosing among treatments prescribers should be aware of the capacity of geodon to prolong the qt interval and may consider the use of other drugs first 5 2 geodon is indicated as an oral formulation for the treatment of schizophrenia 1 1 adults efficacy was established in four 4 6 week trials and one maintenance trial in adult patients with schizophrenia 14 1 acute treatment as monotherapy of manic or mixed episodes associated with bipolar i disorder 1 2 adults efficacy was established in two 3 week trials in adult patients with manic or mixed episodes 14 2 maintenance treatment of bipolar i disorder as an adjunct to lithium or valproate 1 2 adults efficacy was established in one maintenance trial in adult patients 14 2 geodon as an intramuscular injection is indicated for the acute treatment of agitation in schizophrenic patients 1 3 adults efficacy was established in two short term trials in agitated patients with schizophrenia 1 3 geodon is indicated for the treatment of schizophrenia the efficacy of oral ziprasidone was established in four short term 4 and 6 week controlled trials of adult schizophrenic inpatients and in one maintenance trial of stable adult schizophrenic inpatients see clinical studies 14 1 geodon is indicated as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar i disorder efficacy was established in two 3 week monotherapy studies in adult patients see clinical studies 14 2 geodon is indicated as an adjunct to lithium or valproate for the maintenance treatment of bipolar i disorder efficacy was established in a maintenance trial in adult patients the efficacy of geodon as monotherapy for the maintenance treatment of bipolar i disorder has not been systematically evaluated in controlled clinical trials see clinical studies 14 2 geodon intramuscular is indicated for the treatment of acute agitation in schizophrenic patients for whom treatment with ziprasidone is appropriate and who need intramuscular antipsychotic medication for rapid control of agitation the efficacy of intramuscular ziprasidone for acute agitation in schizophrenia was established in single day controlled trials of agitated schizophrenic inpatients see clinical trials 14 1 psychomotor agitation is defined in dsm iv as excessive motor activity associated with a feeling of inner tension schizophrenic patients experiencing agitation often manifest behaviors that interfere with their diagnosis and care e g 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 since there is no experience regarding the safety of administering ziprasidone intramuscular to schizophrenic patients already taking oral ziprasidone the practice of co administration is not recommended ziprasidone intramuscular is intended for intramuscular use only and should not be administered intravenously" assertion.
• association label "doxorubicin hydrochloride hcl for injection is an anthracycline topoisomerase ii inhibitor indicated as a component of multiagent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer 1 1 for the treatment of acute lymphoblastic leukemia acute myeloblastic leukemia hodgkin lymphoma non hodgkin lymphoma metastatic breast cancer metastatic wilms tumor metastatic neuroblastoma metastatic soft tissue sarcoma metastatic bone sarcomas metastatic ovarian carcinoma metastatic transitional cell bladder carcinoma metastatic thyroid carcinoma metastatic gastric carcinoma metastatic bronchogenic carcinoma 1 2 doxorubicin hcl for injection is indicated as a component of multi agent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer see clinical studies 14 doxorubicin hcl for injection is indicated for the treatment of acute lymphoblastic leukemia acute myeloblastic leukemia hodgkin lymphoma non hodgkin lymphoma nhl metastatic breast cancer metastatic wilms tumor metastatic neuroblastoma metastatic soft tissue sarcoma metastatic bone sarcoma metastatic ovarian carcinoma metastatic transitional cell bladder carcinoma metastatic thyroid carcinoma metastatic gastric carcinoma metastatic bronchogenic carcinoma" assertion.
• association label "sertraline hydrochloride oral solution is indicated for the treatment of the following see clinical studies 14 major depressive disorder mdd obsessive compulsive disorder ocd panic disorder pd posttraumatic stress disorder ptsd social anxiety disorder sad premenstrual dysphoric disorder pmdd sertraline hydrochloride oral solution is a selective serotonin reuptake inhibitor ssri indicated for the treatment of 1 major depressive disorder mdd obsessive compulsive disorder ocd panic disorder pd post traumatic stress disorder ptsd social anxiety disorder sad premenstrual dysphoric disorder pmdd" assertion.
• association label "scopolamine transdermal system is an anticholinergic agent indicated in adults for the prevention of nausea and vomiting associated with scopolamine transdermal system is indicated in adults for prevention of nausea and vomiting associated with motion sickness see clinical studies 14 1 scopolamine transdermal system is indicated in adults for prevention of nausea and vomiting associated with recovery from anesthesia and or opiate analgesia and surgery see clinical studies 14 2" assertion.
• association label "metronidazole gel usp 1 is indicated for the topical treatment of inflammatory lesions of rosacea metronidazole gel usp 1 is a nitroimidazole indicated for the topical treatment of inflammatory lesions of rosacea 1" assertion.
• association label "amphotericin b for injection usp should be administered primarily to patients with progressive potentially life threatening fungal infections this potent drug should not be used to treat noninvasive fungal infections such as oral thrush vaginal candidiasis and esophageal candidiasis in patients with normal neutrophil counts amphotericin b for injection usp is specifically intended to treat potentially life threatening fungal infections aspergillosis cryptococcosis torulosis north american blastomycosis systemic candidiasis coccidioido mycosis histoplasmosis zygomycosis including mucormycosis due to susceptible species of the genera absidia mucor rhizopus conidiobolus basidiobolus amphotericin b may be useful in the treatment of american mucocutaneous leishmaniasis but it is not the drug of choice as primary therapy" assertion.
• association label "epaned is an angiotensin converting enzyme inhibitor indicated for 1 1 1 2 1 3 epaned is indicated for the treatment of hypertension to lower blood pressure in adults and children older than one month see pediatric use 8 4 14 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 this drug control of high blood pressure should be part of comprehensive cardiovascular risk management including as appropriate lipid control diabetes management antithrombotic therapy smoking cessation exercise and limited sodium intake many patients will require more than 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 epaned is effective alone or in combination with other antihypertensive agents especially thiazide type diuretics the blood pressure lowering effects of epaned and thiazides are approximately additive epaned is indicated for the treatment of symptomatic heart failure usually in combination with diuretics and digitalis in these patients epaned increases survival and decreases the frequency of hospitalization in clinically stable asymptomatic patients with left ventricular dysfunction ejection fraction 35 percent epaned decreases the rate of development of overt heart failure and decreases the incidence of hospitalization for heart failure" assertion.
• association label "when oral therapy is not feasible the intramuscular use 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 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 the intra articular or soft tissue administration the intralesional administration betamethasone sodium phosphate and betamethasone acetate injectable suspension may also be useful in cystic tumors of an aponeurosis or tendon ganglia" assertion.
• association label "indications wilson s disease two types of patients require treatment for wilson s disease 1 the symptomatic and 2 the asymptomatic in whom it can be assumed the disease will develop in the future if the patient is not treated diagnosis suspected on the basis of family or individual history physical examination or a low serum concentration of ceruloplasmin is confirmed by the demonstration of kayser fleischer rings or particularly in the asymptomatic patient by the quantitative demonstration in a liver biopsy specimen of a concentration of copper in excess of 25 mcg g dry weight treatment has two objectives 1 to minimize dietary intake and absorption of copper 2 to promote excretion of copper deposited in tissues the first objective is attained by a daily diet that contains no more than one or two milligrams of copper such a diet should exclude most importantly chocolate nuts shellfish mushrooms liver molasses broccoli and cereals enriched with copper and be composed to as great an extent as possible of foods with a low copper content distilled or demineralized water should be used if the patient s drinking water contains more than 1 mg of copper per liter for the second objective a copper chelating agent is used in symptomatic patients this treatment usually produces marked neurologic improvement fading of kayser fleischer rings and gradual amelioration of hepatic dysfunction and psychic disturbances clinical experience to date suggests that life is prolonged with the above regimen noticeable improvement may not occur for one to three months occasionally neurologic symptoms become worse during initiation of therapy with depen despite this the drug should not be discontinued permanently although temporary interruption may result in clinical improvement of the neurological symptoms it carries an increased risk of developing a sensitivity reaction upon resumption of therapy see warnings for quantitative test for serum ceruloplasmin see morell a g windsor j sternlieb i scheinberg i h measurement of the concentration of ceruloplasmin in serum by determination of its oxidase activity in laboratory diagnosis of liver disease f w sunderman f w sunderman jr eds st louis warren h green inc 1968 pp 193 195 treatment of asymptomatic patients has been carried out for over ten years symptoms and signs of the disease appear to be prevented indefinitely if daily treatment with depen can be continued cystinuria arginine lysine ornithine and cysteine are soluble substances readily excreted there is no apparent pathology connected with their excretion in excessive quantities cystine however is so slightly soluble at the usual range of urinary ph that it is not excreted readily and so crystallizes and forms stones in the urinary tract stone formation is the only known pathology in cystinuria normal daily output of cystine is 4 to 8 mg in cystinuria output is greatly increased and may exceed 1 g day at 5 to 6 mg day stone formation is almost certain when it is more than 3 mg day treatment is indicated conventional treatment is directed at keeping urinary cystine diluted enough to prevent stone formation keeping the urine alkaline enough to dissolve as much cystine as possible and minimizing cystine production by a diet low in methionine the major dietary precursor of cystine patients must drink enough fluid to keep urine specific gravity below 1 1 take enough alkali to keep urinary ph at 7 5 to 8 and maintain a diet low in methionine this diet is not recommended in growing children and probably is contraindicated in pregnancy because of its low protein content see precautions when these measures are inadequate to control recurrent stone formation depen may be used as additional therapy when patients refuse to adhere to conventional treatment depen may be a useful substitute it is capable of keeping cystine excretion to near normal values thereby hindering stone formation and the serious consequences of pyelonephritis and impaired renal function that develop in some patients bartter and colleagues depict the process by which penicillamine interacts with cystine to form penicillamine cysteine mixed disulfide as in this process it is assumed that the deprotonated form of penicillamine ps is the active factor in bringing about the disulfide interchange rheumatoid arthritis precautions" assertion.
• association label "carefully consider the potential benefits and risks of celebrex and other treatment options before deciding to use celebrex use the lowest effective dose for the shortest duration consistent with individual patient treatment goals see warnings and precautions 5 celebrex is a nonsteroidal anti inflammatory drug indicated for osteoarthritis oa 1 1 rheumatoid arthritis ra 1 2 juvenile rheumatoid arthritis jra in patients 2 years and older 1 3 ankylosing spondylitis as 1 4 acute pain ap 1 5 primary dysmenorrhea pd 1 6 familial adenomatous polyposis fap adjunct to usual care 1 7 celebrex is indicated for relief of the signs and symptoms of oa see clinical studies 14 1 celebrex is indicated for relief of the signs and symptoms of ra see clinical studies 14 2 celebrex is indicated for relief of the signs and symptoms of jra in patients 2 years and older see clinical studies 14 3 celebrex is indicated for the relief of signs and symptoms of as see clinical studies 14 4 celebrex is indicated for the management of ap in adults see clinical studies 14 5 celebrex is indicated for the treatment of pd see clinical studies 14 5 celebrex is indicated to reduce the number of adenomatous colorectal polyps in fap as an adjunct to usual care e g endoscopic surveillance surgery it is not known whether there is a clinical benefit from a reduction in the number of colorectal polyps in fap patients it is also not known whether the effects of celebrex treatment will persist after celebrex is discontinued the efficacy and safety of celebrex treatment in patients with fap beyond six months have not been studied see warnings and precautions 5 15 clinical studies 14 6" 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.
• LinguisticSystem label "python" assertion.
• out1 label "out1" assertion.
• img1 label "img1" assertion.
• img2 label "img2" assertion.
• step label "Convert the RGB color image to grayscale" assertion.
• out1 label "out1" assertion.
• LinguisticSystem label "python" assertion.
• img label "img" assertion.
• step label "Add blur to image" assertion.
• LinguisticSystem label "python" assertion.
• plan label "YAIB: Yet Another Image Blender (licence:cc0,author:rsiebes, date:06-05-2021 )" assertion.
• association label "terbutaline sulfate injection usp is indicated for the prevention and reversal of bronchospasm in patients 12 years of age and older with asthma and reversible bronchospasm associated with bronchitis and emphysema" 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 "1 1 mania divalproex sodium delayed release tablets are a valproate and are indicated for the treatment of the manic episodes associated with bipolar disorder a manic episode is a distinct period of abnormally and persistently elevated expansive or irritable mood typical symptoms of mania include pressure of speech motor hyperactivity reduced need for sleep flight of ideas grandiosity poor judgment aggressiveness and possible hostility the efficacy of divalproex sodium delayed release tablets were established in 3 week trials with patients meeting dsm iii r criteria for bipolar disorder who were hospitalized for acute mania see clinical studies 14 1 the safety and effectiveness of divalproex sodium delayed release tablets for long term use in mania i e more than 3 weeks has not been demonstrated in controlled clinical trials therefore healthcare providers who elect to use divalproex sodium delayed release tablets for extended periods should continually reevaluate the long term usefulness of the drug for the individual patient 1 2 epilepsy divalproex sodium delayed release tablets are indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures divalproex sodium delayed release tablets are also indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures and adjunctively in patients with multiple seizure types that include absence seizures simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs complex absence is the term used when other signs are also present 1 3 migraine divalproex sodium delayed release tablets are indicated for prophylaxis of migraine headaches there is no evidence that divalproex sodium delayed release tablets are useful in the acute treatment of migraine headaches 1 4 important limitations because of the risk to the fetus of decreased iq neural tube defects and other major congenital malformations which may occur very early in pregnancy valproate should not be administered to a woman of childbearing potential unless the drug is essential to the management of her medical condition see warnings and precautions 5 2 5 3 5 4 8 1 17 3 divalproex sodium delayed release tablets are contraindicated for prophylaxis of migraine headaches in women who are pregnant" 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 "bendamustine hydrochloride injection is an alkylating drug indicated for treatment of patients with chronic lymphocytic leukemia cll efficacy relative to first line therapies other than chlorambucil has not been established 1 1 indolent b cell non hodgkin lymphoma nhl that has progressed during or within six months of treatment with rituximab or a rituximab containing regimen 1 2 bendamustine hydrochloride injection is indicated for the treatment of patients with chronic lymphocytic leukemia efficacy relative to first line therapies other than chlorambucil has not been established bendamustine hydrochloride injection is indicated for the treatment of patients with indolent b cell non hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab containing regimen" assertion.
• association label "valacyclovir hydrochloride is a nucleoside analogue dna polymerase inhibitor indicated for 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 chickenpox limitations of use 1 3 the efficacy and safety of valacyclovir 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 tablets are indicated for treatment of cold sores herpes labialis the efficacy of valacyclovir 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 tablets are indicated for treatment of the initial episode of genital herpes in immunocompetent adults the efficacy of treatment with valacyclovir tablets when initiated more than 72 hours after the onset of signs and symptoms has not been established recurrent episodes valacyclovir tablets are indicated for treatment of recurrent episodes of genital herpes in immunocompetent adults the efficacy of treatment with valacyclovir tablets when initiated more than 24 hours after the onset of signs and symptoms has not been established suppressive therapy valacyclovir 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 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 reduction of transmission valacyclovir tablets are indicated for the reduction of transmission of genital herpes in immunocompetent adults the efficacy of valacyclovir tablets for the reduction of transmission of genital herpes beyond 8 months in discordant couples has not been established the efficacy of valacyclovir 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 tablets are indicated for the treatment of herpes zoster shingles in immunocompetent adults the efficacy of valacyclovir tablets when initiated more than 72 hours after the onset of rash and the efficacy and safety of valacyclovir tablets for treatment of disseminated herpes zoster have not been established cold sores herpes labialis valacyclovir tablets are indicated for the treatment of cold sores herpes labialis in pediatric patients 12 years of age the efficacy of valacyclovir tablets initiated after the development of clinical signs of a cold sore e g papule vesicle or ulcer has not been established chickenpox valacyclovir tablets are indicated for the treatment of chickenpox in immunocompetent pediatric patients 2 to 18 years of age based on efficacy data from clinical studies with oral acyclovir treatment with valacyclovir tablets should be initiated within 24 hours after the onset of rash see clinical studies 14 4 the efficacy and safety of valacyclovir 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 12years of age with cold sores herpes labialis patients 2 years of age or 18 years of age with chickenpox patients 18years of age with genital herpes patients 18years of age with herpes zoster neonates and infants as suppressive therapy following neonatal herpes simplex virus hsv infection" assertion.
• association label "moxifloxacin ophthalmic solution usp 5 is a topical fluoroquinolone anti infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms corynebacterium species micrococcus luteus staphylococcus aureus staphylococcus epidermidis staphylococcus haemolyticus staphylococcus hominis staphylococcus warneri streptococcus pneumoniae streptococcus viridans group acinetobacter lwoffii haemophilus influenzae haemophilus parainfluenzae chlamydia trachomatis efficacy for this organism was studied in fewer than 1 infections 1 moxifloxacin ophthalmic solution usp 5 is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms corynebacterium species micrococcus luteus staphylococcus aureus staphylococcus epidermidis staphylococcus haemolyticus staphylococcus hominis staphylococcus warneri streptococcus pneumoniae streptococcus viridans group acinetobacter lwoffii haemophilus influenzae haemophilus parainfluenzae chlamydia trachomatis efficacy for this organism was studied in fewer than 1 infections" assertion.
• association label "cimetidine tablets are indicated in most patients heal within 4 weeks and there is rarely reason to use cimetidine tablets at full dosage for longer than 6 to 8 weeks see concomitant antacids should be given as needed for relief of pain however simultaneous administration of cimetidine tablets and antacids is not recommended since antacids have been reported to interfere with the absorption of cimetidine 1 short term treatment of active duodenal ulcer dosage and administration duodenal ulcer patients have been maintained on continued treatment with cimetidine tablets 4 mg at bedtime for periods of up to 5 years 2 maintenance therapy for duodenal ulcer patients at reduced dosage after healing of active ulcer there is no information concerning usefulness of treatment periods of longer than 8 weeks 3 short term treatment of active benign gastric ulcer erosive esophagitis diagnosed by endoscopy treatment is indicated for 12 weeks for healing of lesions and control of symptoms the use of cimetidine tablets beyond 12 weeks has not been established see 4 erosive gastroesophageal reflux gerd dosage and administration gerd i e zollinger ellison syndrome systemic mastocytosis multiple endocrine adenomas 5 the treatment of pathological hypersecretory conditions" assertion.
• association label "for adjunctive treatment of edema due to congestive heart failure drug induced edema centrencephalic epilepsies petit mal unlocalized seizures chronic simple open angle glaucoma secondary glaucoma and preoperatively in acute angle closure glaucoma where delay of surgery is desired in order to lower intraocular pressure acetazolamide tablets are also indicated for the prevention or amelioration of symptoms associated with acute mountain sickness in climbers attempting rapid ascent and in those who are very susceptible to acute mountain sickness despite gradual ascent" assertion.
• association label "allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment atopic dermatitis bronchial asthma contact dermatitis drug hypersensitivity reactions seasonal or perennial allergic rhinitis and serum sickness collagen diseases during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus and acute rheumatic carditis dermatologic diseases bullous dermatitis herpetiformis exfoliative dermatitis mycosis fungoides pemphigus severe erythema multiforme stevens johnson syndrome severe psoriasis and severe seborrheic dermatitis edematous states to induce a diuresis or remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus endocrine disorders primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the first choice synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance congenital adrenal hyperplasia hypercalcemia associated with cancer and nonsuppurative thyroiditis gastrointestinal diseases to tide the patient over a critical period of the disease in ulcerative colitis and regional enteritis hematologic disorders idiopathic thrombocytopenic purpura in adults secondary thrombocytopenia in adults acquired autoimmune hemolytic anemia erythroblastopenia rbc anemia and congenital erythroid hypoplastic anemia miscellaneous diagnostic testing of adrenocortical hyperfunction tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy and trichinosis with neurologic or myocardial involvement neoplastic diseases for palliative management of leukemia and lymphomas in adults and acute leukemia of childhood ophthalmic diseases severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as allergic conjunctivitis keratitis allergic corneal marginal ulcers herpes zoster ophthalmicus iritis and iridocyclitis chorioretinitis anterior segment inflammation diffuse posterior uveitis and choroiditis optic neuritis and sympathetic ophthalmia respiratory diseases symptomatic sarcoidosis loeffler s syndrome not manageable by other means berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy and aspiration pneumonitis rheumatic disorders as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in psoriatic arthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy ankylosing spondylitis acute and subacute bursitis acute nonspecific tenosynovitis acute gouty arthritis post traumatic osteoarthritis synovitis of osteoarthritis and epicondylitis" assertion.
• association label "liothyronine sodium is an l triiodothyronine t3 indicated for hypothyroidism as replacement in primary thyroidal secondary pituitary and tertiary hypothalamic congenital or acquired hypothyroidism 1 1 pituitary thyroid stimulating hormone tsh suppression as an adjunct to surgery and radioiodine therapy in the management of well differentiated thyroid cancer 1 2 thyroid suppression test as a diagnostic agent in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy 1 3 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 hypothyroidism during the recovery phase of subacute thyroiditis 1 liothyronine sodium is indicated as a replacement therapy in primary thyroidal secondary pituitary and tertiary hypothalamic congenital or acquired hypothyroidism liothyronine sodium is indicated as an adjunct to surgery and radioiodine therapy in the management of well differentiated thyroid cancer liothyronine sodium is indicated as a diagnostic agent in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy limitations of use liothyronine sodium 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 liothyronine sodium may induce hyperthyroidism see warnings and precautions 5 4 liothyronine sodium is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis" assertion.
• association label "the efficacy of paroxetine the effects of paroxetine in hospitalized depressed patients have not been adequately studied the efficacy of paroxetine in maintaining a response in major depressive disorder for up to 1 year was demonstrated in a placebo controlled trial see clinical pharmacology clinical trials nevertheless the physician who elects to use paroxetine for extended periods should periodically re evaluate the long term usefulness of the drug for the individual patient the efficacy of paroxetine was established in two 12 week trials with obsessive compulsive outpatients whose diagnoses corresponded most closely to the dsm iiir category of obsessive compulsive disorder see clinical pharmacology clinical trials obsessive compulsive disorder is characterized by recurrent and persistent ideas thoughts impulses or images obsessions that are ego dystonic and or repetitive purposeful and intentional behaviors compulsions that are recognized by the person as excessive or unreasonable long term maintenance of efficacy was demonstrated in a 6 month relapse prevention trial in this trial patients assigned to paroxetine showed a lower relapse rate compared to patients on placebo see clinical pharmacology clinical trials nevertheless the physician who elects to use paroxetine the efficacy of paroxetine was established in three 1 to 12 week trials in panic disorder patients whose diagnoses corresponded to the dsm iiir category of panic disorder see clinical pharmacology clinical trials panic disorder dsm iv is characterized by recurrent unexpected panic attacks i e a discrete period of intense fear or discomfort in which 4 or more of the following symptoms develop abruptly and reach a peak within 1 minutes 1 palpitations pounding heart or accelerated heart rate 2 sweating 3 trembling or shaking 4 sensations of shortness of breath or smothering 5 feeling of choking 6 chest pain or discomfort 7 nausea or abdominal distress 8 feeling dizzy unsteady lightheaded or faint 9 derealization feelings of unreality or depersonalization being detached from oneself 1 fear of losing control 11 fear of dying 12 paresthesias numbness or tingling sensations 13 chills or hot flushes long term maintenance of efficacy was demonstrated in a 3 month relapse prevention trial in this trial patients with panic disorder assigned to paroxetine demonstrated a lower relapse rate compared to patients on placebo see clinical pharmacology clinical trials nevertheless the physician who prescribes paroxetine for extended periods should periodically re evaluate the long term usefulness of the drug for the individual patient the efficacy of paroxetine was established in three 12 week trials in adult patients with social anxiety disorder dsm iv paroxetine has not been studied in children or adolescents with social phobia see clinical pharmacology clinical trials the effectiveness of paroxetine in long term treatment of social anxiety disorder i e for more than 12 weeks has not been systematically evaluated in adequate and well controlled trials therefore the physician who elects to prescribe paroxetine for extended periods should periodically re evaluate the long term usefulness of the drug for the individual patient see dosage and administration the efficacy of paroxetine in the treatment of gad was established in two 8 week placebo controlled trials in adults with gad paroxetine has not been studied in children or adolescents with generalized anxiety disorder see clinical pharmacology clinical trials generalized anxiety disorder dsm iv is characterized by excessive anxiety and worry apprehensive expectation that is persistent for at least 6 months and which the person finds difficult to control it must be associated with at least 3 of the following 6 symptoms restlessness or feeling keyed up or on edge being easily fatigued difficulty concentrating or mind going blank irritability muscle tension sleep disturbance the efficacy of paroxetine in maintaining a response in patients with generalized anxiety disorder who responded during an 8 week acute treatment phase while taking paroxetine and were then observed for relapse during a period of up to 24 weeks was demonstrated in a placebo controlled trial see clinical pharmacology clinical trials nevertheless the physician who elects to use paroxetine for extended periods should periodically re evaluate the long term usefulness of the drug for the individual patient see dosage and administration" assertion.
• association label "allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment atopic dermatitis bronchial asthma contact dermatitis drug hypersensitivity reactions seasonal or perennial allergic rhinitis and serum sickness collagen diseases during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus and acute rheumatic carditis dermatologic diseases bullous dermatitis herpetiformis exfoliative dermatitis mycosis fungoides pemphigus severe erythema multiforme stevens johnson syndrome severe psoriasis and severe seborrheic dermatitis edematous states to induce a diuresis or remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus endocrine disorders primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the first choice synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance congenital adrenal hyperplasia hypercalcemia associated with cancer and nonsuppurative thyroiditis gastrointestinal diseases to tide the patient over a critical period of the disease in ulcerative colitis and regional enteritis hematologic disorders idiopathic thrombocytopenic purpura in adults secondary thrombocytopenia in adults acquired autoimmune hemolytic anemia erythroblastopenia rbc anemia and congenital erythroid hypoplastic anemia miscellaneous diagnostic testing of adrenocortical hyperfunction tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy and trichinosis with neurologic or myocardial involvement neoplastic diseases for palliative management of leukemia and lymphomas in adults and acute leukemia of childhood ophthalmic diseases severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as allergic conjunctivitis keratitis allergic corneal marginal ulcers herpes zoster ophthalmicus iritis and iridocyclitis chorioretinitis anterior segment inflammation diffuse posterior uveitis and choroiditis optic neuritis and sympathetic ophthalmia respiratory diseases symptomatic sarcoidosis loeffler s syndrome not manageable by other means berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy and aspiration pneumonitis rheumatic disorders as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in psoriatic arthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy ankylosing spondylitis acute and subacute bursitis acute nonspecific tenosynovitis acute gouty arthritis post traumatic osteoarthritis synovitis of osteoarthritis and epicondylitis" assertion.
• association label "ramipril is an angiotension 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 it may be used alone or in combination with thiazide diuretics 1 1 in patients 55 years or older at high risk of developing a major cardiovascular event ramipril is indicated to reduce the risk of myocardial infarction stroke or death from cardiovascular causes 1 2 ramipril is indicated in stable patients who have demonstrated clinical signs of congestive heart failure post myocardial infarction 1 3 ramipril is indicated for the treatment of hypertension to lower blood pressure lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events primarily strokes and myocardial infarctions these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug control of high blood pressure should be part of comprehensive cardiovascular risk management including as appropriate lipid control diabetes management antithrombotic therapy smoking cessation exercise and limited sodium intake many patients will require more than 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 ramipril may be used alone or in combination with thiazide diuretics ramipril is indicated in patients 55 years or older at high risk of developing a major cardiovascular event because of a history of coronary artery disease stroke peripheral vascular disease or diabetes that is accompanied by at least one other cardiovascular risk factor hypertension elevated total cholesterol levels low hdl levels cigarette smoking or documented microalbuminuria to reduce the risk of myocardial infarction stroke or death from cardiovascular causes ramipril can be used in addition to other needed treatment such as antihypertensive antiplatelet or lipid lowering therapy see clinical studies 14 2 ramipril is indicated in stable patients who have demonstrated clinical signs of congestive heart failure within the first few days after sustaining acute myocardial infarction administration of ramipril to such patients has been shown to decrease the risk of death principally cardiovascular death and to decrease the risks of failure related hospitalization and progression to severe resistant heart failure see clinical studies 14 3" assertion.
• source label "URI of the source used by this formalization activity" assertion.
• quote label "a source quote" assertion.
• creator label "ORCID identifier of the person who performed the formalization" assertion.
• activity label "an activity" assertion.
• assertion label "Generated by a formalization activity" assertion.
• mystatement label "All cats are gray" assertion.
• association label "zoledronic acid injection is a bisphosphonate indicated for zoledronic acid injection is indicated for treatment of osteoporosis in postmenopausal women in postmenopausal women with osteoporosis diagnosed by bone mineral density bmd or prevalent vertebral fracture zoledronic acid injection reduces the incidence of fractures hip vertebral and non vertebral osteoporosis related fractures in patients at high risk of fracture defined as a recent low trauma hip fracture zoledronic acid injection reduces the incidence of new clinical fractures see clinical studies 14 1 zoledronic acid injection is indicated for prevention of osteoporosis in postmenopausal women see clinical studies 14 2 zoledronic acid injection is indicated for treatment to increase bone mass in men with osteoporosis see clinical studies 14 3 zoledronic acid injection is indicated for the treatment and prevention of glucocorticoid induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7 5 mg or greater of prednisone and who are expected to remain on glucocorticoids for at least 12 months see clinical studies 14 4 zoledronic acid injection is indicated for treatment of paget s disease of bone in men and women treatment is indicated in patients with paget s disease of bone with elevations in serum alkaline phosphatase of two times or higher than the upper limit of the age specific normal reference range or those who are symptomatic or those at risk for complications from their disease see clinical studies 14 5 the safety and effectiveness of zoledronic acid injection for the treatment of osteoporosis is based on clinical data of three years duration the optimal duration of use has not been determined all patients on bisphosphonate therapy should have the need for continued therapy re evaluated on a periodic basis patients at low risk for fracture should be considered for drug discontinuation after 3 to 5 years of use patients who discontinue therapy should have their risk for fracture re evaluated periodically" assertion.
• association label "carefully consider the potential benefits and risks of sulindac and other treatment options before deciding to use sulindac use the lowest effective dose for the shortest duration consistent with individual patient treatment goals see warnings sulindac tablets usp are indicated for acute or long term use in the relief of signs and symptoms of the following osteoarthritis rheumatoid arthritis ankylosing spondylitis acute painful shoulder acute subacromial bursitis supraspinatus tendinitis acute gouty arthritis the safety and effectiveness of sulindac have not been established in rheumatoid arthritis patients who are designated in the american rheumatism association classification as functional class iv incapacitated largely or wholly bedridden or confined to wheelchair little or no self care" assertion.
• association label "sotalol hydrochloride tablets usp are indicated for the treatment of documented ventricular arrhythmias such as sustained ventricular tachycardia that in the judgment of the physician are life threatening because of the proarrhythmic effects of sotalol hydrochloride tablets see warnings initiation of sotalol hydrochloride tablet usp treatment or increasing doses as with other antiarrhythmic agents used to treat life threatening arrhythmias should be carried out in the hospital the response to treatment should then be evaluated by a suitable method e g pes or holter monitoring prior to continuing the patient on chronic therapy various approaches have been used to determine the response to antiarrhythmic therapy including sotalol hydrochloride tablets usp in the esvem trial response by holter monitoring was tentatively defined as 1 suppression of ventricular tachycardia 9 suppression of non sustained vt 8 suppression of paired vpcs and 75 suppression of total vpcs in patients who had at least 1 vpcs hour at baseline this tentative response was confirmed if vt lasting 5 or more beats was not observed during treadmill exercise testing using a standard bruce protocol the pes protocol utilized a maximum of three extrastimuli at three pacing cycle lengths and two right ventricular pacing sites response by pes was defined as prevention of induction of the following 1 monomorphic vt lasting over 15 seconds 2 non sustained polymorphic vt containing more than 15 beats of monomorphic vt in patients with a history of monomorphic vt 3 polymorphic vt or vf greater than 15 beats in patients with vf or a history of aborted sudden death without monomorphic vt and 4 two episodes of polymorphic vt or vf of greater than 15 beats in a patient presenting with monomorphic vt sustained vt or nsvt producing hypotension during the final treadmill test was considered a drug failure in a multicenter open label long term study of sotalol hydrochloride tablets usp in patients with life threatening ventricular arrhythmias which had proven refractory to other antiarrhythmic medications response by holter monitoring was defined as in esvem response by pes was defined as non inducibility of sustained vt by at least double extrastimuli delivered at a pacing cycle length of 4 msec overall survival and arrhythmia recurrence rates in this study were similar to those seen in esvem although there was no comparative group to allow a definitive assessment of outcome antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias sotalol is also indicated for the maintenance of normal sinus rhythm delay in time to recurrence of atrial fibrillation atrial flutter afib afl in patients with symptomatic afib afl who are currently in sinus rhythm and is marketed under the brand name betapace af sotalol hydrochloride tablets usp are not approved for the afib afl indication and should not be substituted for betapace af because only betapace af is distributed with a patient package insert that is appropriate for patients with afib afl" assertion.
• association label "carefully consider the potential benefits and risks of celebrex and other treatment options before deciding to use celebrex use the lowest effective dose for the shortest duration consistent with individual patient treatment goals see warnings and precautions 5 celebrex is a nonsteroidal anti inflammatory drug indicated for osteoarthritis oa 1 1 rheumatoid arthritis ra 1 2 juvenile rheumatoid arthritis jra in patients 2 years and older 1 3 ankylosing spondylitis as 1 4 acute pain ap 1 5 primary dysmenorrhea pd 1 6 familial adenomatous polyposis fap adjunct to usual care 1 7 celebrex is indicated for relief of the signs and symptoms of oa see clinical studies 14 1 celebrex is indicated for relief of the signs and symptoms of ra see clinical studies 14 2 celebrex is indicated for relief of the signs and symptoms of jra in patients 2 years and older see clinical studies 14 3 celebrex is indicated for the relief of signs and symptoms of as see clinical studies 14 4 celebrex is indicated for the management of ap in adults see clinical studies 14 5 celebrex is indicated for the treatment of pd see clinical studies 14 5 celebrex is indicated to reduce the number of adenomatous colorectal polyps in fap as an adjunct to usual care e g endoscopic surveillance surgery it is not known whether there is a clinical benefit from a reduction in the number of colorectal polyps in fap patients it is also not known whether the effects of celebrex treatment will persist after celebrex is discontinued the efficacy and safety of celebrex treatment in patients with fap beyond six months have not been studied see warnings and precautions 5 15 clinical studies 14 6" assertion.
• association label "fanapt r see clinical studies 14 when deciding among the alternative treatments available for this condition the prescriber should consider the finding that fanapt see warnings and precaution s 5 2 patients must be titrated to an effective dose of fanapt s ee dosage and administration 2 1 and clinical studies 14 the effectiveness of fanapt in long term use that is for more than 6 weeks has not been systematically evaluated in controlled trials therefore the physician who elects to use fanapt for extended periods should periodically re evaluate the long term usefulness of the drug for the individual patient s ee dosage and administration 2 3 fanapt is an atypical antipsychotic agent indicated for the treatment of schizophrenia in adults 1 14" assertion.
• association label "sutent is a kinase inhibitor indicated for the treatment of gastrointestinal stromal tumor gist after disease progression on or intolerance to imatinib mesylate 1 1 the treatment of advanced renal cell carcinoma rcc 1 2 the adjuvant treatment of adult patients at high risk of recurrent rcc following nephrectomy 1 3 the treatment of progressive well differentiated pancreatic neuroendocrine tumors pnet in patients with unresectable locally advanced or metastatic disease 1 4 sutent is indicated for the treatment of gastrointestinal stromal tumor after disease progression on or intolerance to imatinib mesylate sutent is indicated for the treatment of advanced renal cell carcinoma sutent is indicated for the adjuvant treatment of adult patients at high risk of recurrent rcc following nephrectomy sutent is indicated for the treatment of progressive well differentiated pancreatic neuroendocrine tumors in patients with unresectable locally advanced or metastatic disease" assertion.
• association label "indications and usage for the treatment of the following conditions 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 or thermal burns or penetration of foreign bodies steroid responsive inflammatory conditions of the external auditory meatus such as allergic otitis externa selected purulent and nonpurulent infective otitis externa when the hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation" assertion.
• association label "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 perennial or seasonal allergic rhinitis and serum sickness dermatologic diseases bullous dermatitis herpetiformis exfoliative erythroderma mycosis fungoides pemphigus and severe erythema multiforme stevens johnson syndrome endocrine disorders primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the drug of choice may be used in conjunction with synthetic mineralocorticoid analogs where applicable in infancy mineralocorticoid supplementation is of particular importance congenital adrenal hyperplasia hypercalcemia associated with cancer and nonsuppurative thyroiditis gastrointestinal diseases to tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis hematologic disorders acquired autoimmune hemolytic anemia congenital erythroid hypoplastic anemia diamond blackfan anemia idiopathic thrombocytopenic purpura in adults pure red cell aplasia and selected cases of secondary thrombocytopenia miscellaneous diagnostic testing of adrenocortical hyperfunction trichinosis with neurologic or myocardial involvement tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy neoplastic diseases for the palliative management of leukemias and lymphomas nervous system acute exacerbations of multiple sclerosis cerebral edema associated with primary or metastatic brain tumor craniotomy or head injury ophthalmic diseases sympathetic ophthalmia temporal arteritis uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids renal diseases to induce a 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" 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 "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 "cefpodoxime proxetil is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below recommended dosages durations of therapy and applicable patient populations vary among these infections please see dosage and administration acute otitis media streptococcus pneumoniae streptococcus pyogenes haemophilus influenzae moraxella branhamella catarrhalis pharyngitis and or tonsillitis streptococcus pyogenes note community acquired pneumonia s pneumoniae h influenzae acute bacterial exacerbation of chronic bronchitis s pneumoniae h influenzae m catarrhalis h influenzae acute uncomplicated urethral and cervical gonorrhea neisseria gonorrhoeae acute uncomplicated ano rectal infections in women neisseria gonorrhoeae note n gonorrhoeae n gonorrhoeae uncomplicated skin and skin structure infections staphylococcus aureus streptococcus pyogenes note dosage and administration acute maxillary sinusitis haemophilus influenzae streptococcus pneumoniae moraxella catarrhalis uncomplicated urinary tract infections cystitis escherichia coli klebsiella pneumoniae proteus mirabilis staphylococcus saprophyticus note clinical studies appropriate specimens for bacteriological examination should be obtained in order to isolate and identify causative organisms and to determine their susceptibility to cefpodoxime therapy may be instituted while awaiting the results of these studies once these results become available antimicrobial therapy should be adjusted accordingly to reduce the development of drug resistant bacteria and maintain the effectiveness of cefpodoxime proxetil tablets usp and other antibacterial drugs cefpodoxime proxetil tablets 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" assertion.
• association label "nizatidineoral solution is indicated for up to 8 weeks for the treatment of active duodenal ulcer in most patients the ulcer will heal within 4 weeks nizatidineoral solution is indicated for maintenance therapy for duodenal ulcer patients at a reduced dosage of 15 mg h s after healing of an active duodenal ulcer the consequences of continuous therapy with nizatidine for longer than 1 year are not known nizatidine oral solution is indicated for up to 12 weeks for the treatment of endoscopically diagnosed esophagitis including erosive and ulcerative esophagitis and associated heartburn due to gerd nizatidine oral solution is indicated for up to 8 weeks for the treatment of active benign gastric ulcer before initiating therapy care should be taken to exclude the possibility of malignant gastric ulceration in pediatric patients nizatidine oral solution is indicated for ages 12 years and older nizatidine oral solution is indicated for up to 8 weeks for the treatment of endoscopically diagnosed esophagitis including erosive and ulcerative esophagitis and associated heartburn due to gerd" assertion.
• association label "alprazolam tablets are indicated for the management of anxiety disorder a condition corresponding most closely to the apa diagnostic and statistical manual dsm iii r diagnosis of generalized anxiety disorder or the short term relief of symptoms of anxiety anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic generalized anxiety disorder is characterized by unrealistic or excessive anxiety and worry apprehensive expectation about two or more life circumstances for a period of six months or longer during which the person has been bothered more days than not by these concerns at least 6 of the following 18 symptoms are often present in these patients trembling twitching or feeling shaky muscle tension aches or soreness restlessness easy fatigability shortness of breath or smothering sensations palpitations or accelerated heart rate sweating or cold clammy hands dry mouth dizziness or light headedness nausea diarrhea or other abdominal distress flushes or chills frequent urination trouble swallowing or lump in throat feeling keyed up or on edge exaggerated startle response difficulty concentrating or mind going blank because of anxiety trouble falling or staying asleep irritability these symptoms must not be secondary to another psychiatric disorder or caused by some organic factor motor tension autonomic hyperactivity vigilance and scanning anxiety associated with depression is responsive to alprazolam alprazolam tablets are also indicated for the treatment of panic disorder with or without agoraphobia studies supporting this claim were conducted in patients whose diagnoses corresponded closely to the dsm iii r criteria for panic disorder see clinical studies panic disorder is an illness characterized by recurrent panic attacks the panic attacks at least initially are unexpected later in the course of this disturbance certain situations eg driving a car or being in a crowded place may become associated with having a panic attack these panic attacks are not triggered by situations in which the person is the focus of others attention as in social phobia the diagnosis requires four such attacks within a four week period or one or more attacks followed by at least a month of persistent fear of having another attack the panic attacks must be characterized by at least four of the following symptoms dyspnea or smothering sensations dizziness unsteady feelings or faintness palpitations or tachycardia trembling or shaking sweating choking nausea or abdominal distress depersonalization or derealization paresthesias hot flashes or chills chest pain or discomfort fear of dying fear of going crazy or of doing something uncontrolled at least some of the panic attack symptoms must develop suddenly and the panic attack symptoms must not be attributed to some know organic factors panic disorder is frequently associated with some symptoms of agoraphobia demonstrations of the effectiveness of alprazolam by systematic clinical study are limited to four months duration for anxiety disorder and four to ten weeks duration for panic disorder however patients with panic disorder have been treated on an open basis for up to eight months without apparent loss of benefit the physician should periodically reassess the usefulness of the drug for the individual patient" assertion.
• association label "cleocin vaginal ovules are indicated for 3 day treatment of bacterial vaginosis in non pregnant women there are no adequate and well controlled studies of cleocin vaginal ovules in pregnant women note lactobacillus gardnerella other pathogens commonly associated with vulvovaginitis eg trichomonas vaginalis chlamydia trachomatis neisseria gonorrhoeae candida albicans" assertion.
• association label "predialysis patients calcitriol oral solution is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure ccr 15 to 55 ml min not yet on dialysis in children the creatinine clearance value must be corrected for a surface area of 1 73 square meters a serum ipth level of 1 pg ml is strongly suggestive of secondary hyperparathyroidism dialysis patients calcitriol oral solution is indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis in these patients calcitriol oral solution administration enhances calcium absorption reduces serum alkaline phosphatase levels and may reduce elevated parathyroid hormone levels and the histological manifestations of osteitis fibrosa cystica and defective mineralization hypoparathyroidism patients calcitriol oral solution is also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism idiopathic hypoparathyroidism and pseudohypoparathyroidism" 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 "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 "for the treatment of severe hypoglycemia glucagon is indicated as a treatment for severe hypoglycemia low blood sugar which may occur in patients with diabetes mellitus because patients with type 1 diabetes may have less of an increase in blood glucose levels compared with a stable type 2 patient supplementary carbohydrate should be given as soon as possible especially to a pediatric patient for use as a diagnostic aid glucagon is indicated as a diagnostic aid in the radiologic examination of the stomach duodenum small bowel and colon when diminished intestinal motility would be advantageous glucagon is as effective for this examination as are the anticholinergic drugs however as use of glucagon in combination with anticholinergic drugs may result in increased side effects the use of glucagon in combination with anticholinergic drugs is not recommended" assertion.
• association label "prednisone tablets are indicated in the following conditions 1 endocrine disorders primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the first choice synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance congenital adrenal hyperplasia nonsuppurative thyroiditis hypercalcemia associated with cancer 2 rheumatic disorders as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in psoriatic arthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy ankylosing spondylitis acute and subacute bursitis acute nonspecific tenosynovitis acute gouty arthritis post traumatic osteoarthritis synovitis of osteoarthritis epicondylitis 3 collagen diseases during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus systemic dermatomyositis polymyositis acute rheumatic carditis 4 dermatologic diseases pemphigus bullous dermatitis herpetiformis severe erythema multiforme stevens johnson syndrome exfoliative dermatitis mycosis fungoides severe psoriasis severe seborrheic dermatitis 5 allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment seasonal or perennial allergic rhinitis bronchial asthma contact dermatitis atopic dermatitis serum sickness drug hypersensitivity reactions 6 ophthalmic diseases severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as allergic corneal marginal ulcers herpes zoster ophthalmicus anterior segment inflammation diffuse posterior uveitis and choroiditis sympathetic ophthalmia allergic conjunctivitis keratitis chorioretinitis optic neuritis iritis and iridocyclitis 7 respiratory diseases symptomatic sarcoidosis loeffler s syndrome not manageable by other means berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy aspiration pneumonitis 8 hematologic disorders idiopathic thrombocytopenic purpura in adults secondary thrombocytopenia in adults acquired autoimmune hemolytic anemia erythroblastopenia rbc anemia congenital erythroid hypoplastic anemia 9 neoplastic diseases for palliative management of leukemias and lymphomas in adults acute leukemia of childhood 1 edematous states to induce a diuresis or remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus 11 gastrointestinal diseases to tide the patient over a critical period of the disease in ulcerative colitis regional enteritis 12 nervous system acute exacerbations of multiple sclerosis 13 miscellaneous tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy trichinosis with neurologic or myocardial involvement" assertion.
• association label "lansoprazole delayed release orally disintegrating tablets are a proton pump inhibitor ppi indicated for the treatment of active duodenal ulcer in adults 1 1 eradication of h pylori 1 2 maintenance of healed duodenal ulcers in adults 1 3 treatment of active benign gastric ulcer in adults 1 4 healing of non steroidal anti inflammatory drugs nsaid associated gastric ulcer in adults 1 5 risk reduction of nsaid associated gastric ulcer in adults 1 6 treatment of symptomatic gastroesophageal reflux disease gerd in adults and pediatric patients 1 year of age and older 1 7 treatment of erosive esophagitis ee in adults and pediatric patients 1 year of age and older 1 8 maintenance of healing of ee in adults 1 9 pathological hypersecretory conditions including zollinger ellison syndrome zes in adults 1 1 lansoprazole delayed release orally disintegrating tablets are indicated in adults for short term treatment for four weeks for healing and symptom relief of active duodenal ulcer see clinical studies 14 1 triple therapy lansoprazole delayed release orally disintegrating tablets amoxicillin clarithromycin lansoprazole delayed release orally disintegrating tablets in combination with amoxicillin plus clarithromycin as triple therapy is indicated in adults for the treatment of patients with h pylori h pylori h pylori see clinical studies 14 2 please refer to the full prescribing information for amoxicillin and clarithromycin dual therapy lansoprazole delayed release orally disintegrating tablets amoxicillin lansoprazole delayed release orally disintegrating tablets in combination with amoxicillin as dual therapy is indicated in adults for the treatment of patients with h pylori who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected microbiology h pylori see clinical studies 14 2 please refer to the full prescribing information for amoxicillin lansoprazole delayed release orally disintegrating tablets are indicated in adults to maintain healing of duodenal ulcers controlled studies do not extend beyond 12 months see clinical studies 14 3 lansoprazole delayed release orally disintegrating tablets are indicated in adults for short term treatment up to eight weeks for healing and symptom relief of active benign gastric ulcer see clinical studies 14 4 lansoprazole delayed release orally disintegrating tablets are indicated in adults for the treatment of nsaid associated gastric ulcer in patients who continue nsaid use controlled studies did not extend beyond eight weeks see clinical studies 14 5 lansoprazole delayed release orally disintegrating tablets are indicated in adults for reducing the risk of nsaid associated gastric ulcers in patients with a history of a documented gastric ulcer who require the use of an nsaid controlled studies did not extend beyond 12 weeks see clinical studies 14 6 lansoprazole delayed release orally disintegrating tablets are indicated for short term treatment in adults and pediatric patients 12 to 17 years of age up to eight weeks and pediatric patients one to 11 years of age up to 12 weeks for the treatment of heartburn and other symptoms associated with gerd see clinical studies 14 7 lansoprazole delayed release orally disintegrating tablets are indicated for short term treatment in adults and pediatric patients 12 to 17 years of age up to eight weeks and pediatric patients one to 11 years of age up to 12 weeks for healing and symptom relief of all grades of ee for adults who do not heal with lansoprazole delayed release orally disintegrating tablets for eight weeks 5 to 1 it may be helpful to give an additional eight weeks of treatment if there is a recurrence of erosive esophagitis an additional eight week course of lansoprazole delayed release orally disintegrating tablets may be considered see clinical studies 14 8 lansoprazole delayed release orally disintegrating tablets are indicated in adults to maintain healing of ee controlled studies did not extend beyond 12 months see clinical studies 14 9 lansoprazole delayed release orally disintegrating tablets are indicated in adults for the long term treatment of pathological hypersecretory conditions including zollinger ellison syndrome see clinical studies 14 1" assertion.
• association label "ranitidine tablets are indicated in 1 short term treatment of active duodenal ulcer most patients heal within 4 weeks studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks 2 maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers no placebo controlled comparative studies have been carried out for periods of longer than 1 year 3 the treatment of pathological hypersecretory conditions e g zollinger ellison syndrome and systemic mastocytosis 4 short term treatment of active benign gastric ulcer most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated studies available to date have not assessed the safety of ranitidine in uncomplicated benign gastric ulcer for periods of more than 6 weeks 5 maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers placebo controlled studies have been carried out for 1 year 6 treatment of gerd symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine tablets 15 mg twice daily 7 treatment of endoscopically diagnosed erosive esophagitis symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine tablets 15 mg 4 times daily 8 maintenance of healing of erosive esophagitis placebo controlled trials have been carried out for 48 weeks concomitant antacids should be given as needed for pain relief to patients with active duodenal ulcer active benign gastric ulcer hypersecretory states gerd and erosive esophagitis" assertion.
• association label "adasuve 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 care e g threatening behaviors escalating or urgently distressing behavior self exhausting behavior leading clinicians to the use of rapidly absorbed antipsychotic medications to achieve immediate control of the agitation see clinical studies 14 the efficacy of adasuve was established in one study of acute agitation in patients with schizophrenia and one study of acute agitation in patients with bipolar i disorder see clinical studies 14 limitations of use as part of the adasuve rems program to mitigate the risk of bronchospasm adasuve must be administered only in an enrolled healthcare facility see warnings and precautions 5 2 adasuve is a typical antipsychotic indicated for the acute treatment of agitation associated with schizophrenia or bipolar i disorder in adults efficacy was demonstrated in 2 trials in acute agitation one in schizophrenia and one in bipolar i disorder 1 14 limitations of use adasuve must be administered only in an enrolled healthcare facility 1" assertion.
• association label "hypertension lisinopril tablets usp are indicated for the treatment of hypertension to lower blood pressure lowering blood pressure lowers the risk of fatal and non fatal cardiovascular events primarily strokes and myocardial infarctions these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including lisinopril control of high blood pressure should be part of comprehensive cardiovascular risk management including as appropriate lipid control diabetes management antithrombotic therapy smoking cessation exercise and limited sodium intake many patients will require more than 1 drug to achieve blood pressure goals for specific advice on goals and management see published guidelines such as those of the national high blood pressure education program s joint national committee on prevention detection evaluation and treatment of high blood pressure jnc numerous antihypertensive drugs from a variety of pharmacologic classes and with different mechanisms of action have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality and it can be concluded that it is blood pressure reduction and not some other pharmacologic property of the drugs that is largely responsible for those benefits the largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly elevated systolic or diastolic pressure causes increased cardiovascular risk and the absolute risk increase per mmhg is greater at higher blood pressures so that even modest reductions of severe hypertension can provide substantial benefit relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk so the absolute benefit is greater in patients who are at higher risk independent of their hypertension for example patients with diabetes or hyperlipidemia and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal some antihypertensive drugs have smaller blood pressure effects as monotherapy in black patients and many antihypertensive drugs have additional approved indications and effects eg on angina heart failure or diabetic kidney disease these considerations may guide selection of therapy lisinopril tablets usp may be administered alone or with other antihypertensive agents heart failure lisinopril tablets usp are indicated as adjunctive therapy in the management of heart failure in patients who are not responding adequately to diuretics and digitalis acute myocardial infarction lisinopril tablets usp are indicated for the treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction to improve survival patients should receive as appropriate the standard recommended treatments such as thrombolytics aspirin and beta blockers in using lisinopril tablets usp consideration should be given to the fact that another angiotensin converting enzyme inhibitor captopril has caused agranulocytosis particularly in patients with renal impairment or collagen vascular disease and that available data are insufficient to show that lisinopril tablets usp does not have a similar risk see warnings in considering the use of lisinopril tablets usp it should be noted that in controlled clinical trials ace inhibitors have an effect on blood pressure that is less in black patients than in non blacks in addition ace inhibitors have been associated with a higher rate of angioedema in black than in non black patients see warnings anaphylactoid and possibly related reactions" assertion.
• association label "allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment atopic dermatitis bronchial asthma contact dermatitis drug hypersensitivity reactions seasonal or perennial allergic rhinitis and serum sickness collagen diseases during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus and acute rheumatic carditis dermatologic diseases bullous dermatitis herpetiformis exfoliative dermatitis mycosis fungoides pemphigus severe erythema multiforme stevens johnson syndrome severe psoriasis and severe seborrheic dermatitis edematous states to induce a diuresis or remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus endocrine disorders primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the first choice synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance congenital adrenal hyperplasia hypercalcemia associated with cancer and nonsuppurative thyroiditis gastrointestinal diseases to tide the patient over a critical period of the disease in ulcerative colitis and regional enteritis hematologic disorders idiopathic thrombocytopenic purpura in adults secondary thrombocytopenia in adults acquired autoimmune hemolytic anemia erythroblastopenia rbc anemia and congenital erythroid hypoplastic anemia miscellaneous diagnostic testing of adrenocortical hyperfunction tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy and trichinosis with neurologic or myocardial involvement neoplastic diseases for palliative management of leukemia and lymphomas in adults and acute leukemia of childhood ophthalmic diseases severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as allergic conjunctivitis keratitis allergic corneal marginal ulcers herpes zoster ophthalmicus iritis and iridocyclitis chorioretinitis anterior segment inflammation diffuse posterior uveitis and choroiditis optic neuritis and sympathetic ophthalmia respiratory diseases symptomatic sarcoidosis loeffler s syndrome not manageable by other means berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy and aspiration pneumonitis rheumatic disorders as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in psoriatic arthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy ankylosing spondylitis acute and subacute bursitis acute nonspecific tenosynovitis acute gouty arthritis post traumatic osteoarthritis synovitis of osteoarthritis and epicondylitis" assertion.
• association label "revlimid is a thalidomide analogue indicated for the treatment of patients with multiple myeloma mm in combination with dexamethasone 1 1 mm as maintenance following autologous hematopoietic stem cell transplantation auto hsct 1 1 transfusion dependent anemia due to low or intermediate 1 risk myelodysplastic syndromes mds associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities 1 2 mantle cell lymphoma mcl whose disease has relapsed or progressed after two prior therapies one of which included bortezomib 1 3 limitations of use revlimid is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia cll outside of controlled clinical trials 1 4 revlimid in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma mm revlimid is indicated as maintenance therapy in patients with mm following autologous hematopoietic stem cell transplantation auto hsct revlimid is indicated for the treatment of patients with transfusion dependent anemia due to low or intermediate 1 risk myelodysplastic syndromes mds associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities revlimid is indicated for the treatment of patients with mantle cell lymphoma mcl whose disease has relapsed or progressed after two prior therapies one of which included bortezomib revlimid is not indicated and is not recommended for the treatment of patients with cll outside of controlled clinical trials see warnings and precautions 5 5" assertion.
• association label "i vasospastic angina nifedipine extended release tablets are indicated for the management of vasospastic angina confirmed by any of the following criteria 1 classical pattern of angina at rest accompanied by st segment elevation 2 angina or coronary artery spasm provoked by ergonovine or 3 angiographically demonstrated coronary artery spasm in those patients who have had angiography the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina provided that the above criteria are satisfied nifedipine extended release tablets may also be used where the clinical presentation suggests a possible vasospastic component but where vasospasm has not been confirmed e g where pain has a variable threshold on exertion or in unstable angina where electrocardiographic findings are compatible with intermittent vasospasm or when angina is refractory to nitrates and or adequate doses of beta blockers ii chronic stable angina classical effort associated angina nifedipine extended release tablets are indicated for the management of chronic stable angina effort associated angina without evidence of vasospasm in patients who remain symptomatic despite adequate doses of beta blockers and or organic nitrates or who cannot tolerate those agents in chronic stable angina effort associated angina nifedipine has been effective in controlled trials of up to eight weeks duration in reducing angina frequency and increasing exercise tolerance but confirmation of sustained effectiveness and evaluation of long term safety in these patients is incomplete controlled studies in small numbers of patients suggest concomitant use of nifedipine and beta blocking agents may be beneficial in patients with chronic stable angina but available information is not sufficient to predict with confidence the effects of concurrent treatment especially in patients with compromised left ventricular function or cardiac conduction abnormalities when introducing such concomitant therapy care must be taken to monitor blood pressure closely since severe hypotension can occur from the combined effects of the drugs see warnings iii hypertension nifedipine extended release tablets 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 nifedipine extended release tablets 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 nifedipine extended release tablets may be used alone or in combination with other antihypertensive agents" assertion.
• association label "omeprazole delayed release capsules are a proton pump inhibitor ppi indicated for the treatment of active duodenal ulcer in adults 1 1 eradication of helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults 1 2 treatment of active benign gastric ulcer in adults 1 3 treatment of symptomatic gastroesophageal reflux disease gerd in patients 2 years of age and older 1 4 maintenance of healing of ee due to acid mediated gerd in patients 2 years of age and older 1 6 pathologic hypersecretory conditions in adults 1 7 omeprazole delayed release capsules are a proton pump inhibitor ppi indicated for the treatment of active duodenal ulcer in adults 1 1 eradication of helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults 1 2 treatment of active benign gastric ulcer in adults 1 3 treatment of symptomatic gastroesophageal reflux disease gerd in patients 2 years of age and older 1 4 maintenance of healing of ee due to acid mediated gerd in patients 2 years of age and older 1 6 pathologic hypersecretory conditions in adults 1 7 omeprazole delayed release capsules are indicated for short term treatment of active duodenal ulcer in adults most patients heal within four weeks some patients may require an additional four weeks of therapy eradication of h pylori has been shown to reduce the risk of duodenal ulcer recurrence triple therapy omeprazole delayed release capsules in combination with clarithromycin and amoxicillin is indicated for treatment of patients with h pylori infection and duodenal ulcer disease active or up to 1 year history to eradicate h pylori in adults dual therapy omeprazole delayed release capsules in combination with clarithromycin are indicated for treatment of patients with h pylori infection and duodenal ulcer disease to eradicate h pylori in adults among patients who fail therapy omeprazole delayed release capsules with clarithromycin is more likely to be associated with the development of clarithromycin resistance as compared with triple therapy in patients who fail therapy susceptibility testing should be done if resistance to clarithromycin is demonstrated or susceptibility testing is not possible alternative antimicrobial therapy should be instituted see clinical pharmacology 12 4 and the clarithromycin prescribing information microbiology sectio n omeprazole delayed release capsules are indicated for short term treatment 4 to 8 weeks of active benign gastric ulcer in adults omeprazole delayed release capsules are indicated for the treatment of heartburn and other symptoms associated with gerd for up to 4 weeks in patients 2 years of age and older pediatric patients 2 years of age to adults omeprazole delayed release capsules are indicated for the short term treatment 4 to 8 weeks of ee due to acid mediated gerd that has been diagnosed by endoscopy in patients 2 years of age and older the efficacy of omeprazole delayed release capsules used for longer than 8 weeks in patients with ee has not been established if a patient does not respond to 8 weeks of treatment an additional 4 weeks of treatment may be given if there is recurrence of ee or gerd symptoms e g heartburn additional 4 to 8 week courses of omeprazole delayed release capsules may be considered omeprazole delayed release capsules are indicated for the maintenance healing of ee due to acid mediated gerd in patients 2 years of age and older controlled studies do not extend beyond 12 months omeprazole delayed release capsules are indicated for the long term treatment of pathological hypersecretory conditions e g zollinger ellison syndrome multiple endocrine adenomas and systemic mastocytosis in adults" 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 "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 perennial or seasonal allergic rhinitis and serum sickness dermatologic diseases bullous dermatitis herpetiformis exfoliative erythroderma mycosis fungoides pemphigus and severe erythema multiforme stevens johnson syndrome endocrine disorders primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the drug of choice may be used in conjunction with synthetic mineralocorticoid analogs where applicable in infancy mineralocorticoid supplementation is of particular importance congenital adrenal hyperplasia hypercalcemia associated with cancer and nonsuppurative thyroiditis gastrointestinal diseases to tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis hematologic disorders acquired autoimmune hemolytic anemia congenital erythroid hypoplastic anemia diamond blackfan anemia idiopathic thrombocytopenic purpura in adults pure red cell aplasia and selected cases of secondary thrombocytopenia miscellaneous diagnostic testing of adrenocortical hyperfunction trichinosis with neurologic or myocardial involvement tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy neoplastic diseases for the palliative management of leukemias and lymphomas nervous system acute exacerbations of multiple sclerosis cerebral edema associated with primary or metastatic brain tumor craniotomy or head injury ophthalmic diseases sympathetic ophthalmia temporal arteritis uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids renal diseases to induce a 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" assertion.
• association label "oxiconazole nitrate cream is indicated for the topical treatment of the following dermal infections tinea pedis tinea cruris and tinea corporis due to trichophyton rubrum trichophyton mentagrophytes epidermophyton floccosum malassezia furfur dosage and administration clinical studies oxiconazole nitrate cream may be used in pediatric patients for tinea corporis tinea cruris tinea pedis and tinea pityriasis versicolor however these indications for which oxiconazole nitrate cream has been shown to be effective rarely occur in children below the age of 12" assertion.
• association label "indications based on a review of this drug by the national academy of sciences national research council and or other information fda has classified the indications as follows effective management of nausea and vomiting and dizziness associated with motion sickness possibly effective management of vertigo associated with diseases affecting the vestibular system final classification of the less than effective indications required further investigation" 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 "xenical is indicated for obesity management including weight loss and weight maintenance when used in conjunction with a reduced calorie diet xenical is also indicated to reduce the risk for weight regain after prior weight loss xenical is indicated for obese patients with an initial body mass index bmi 3 kg m 2 2 table 1 table 1 body mass index bmi kg m 2 conversion factors weight in lbs 2 2 weight in kilograms kg height in inches x 254 height in meters m 1 foot 12 inches xenical is a reversible inhibitor of gastrointestinal lipases indicated for obesity management including weight loss and weight maintenance when used in conjunction with a reduced calorie diet 1 xenical is also indicated to reduce the risk for weight regain after prior weight loss 1" assertion.
• association label "equetro is a mood stabilizer indicated for the treatment of acute manic or mixed episodes associated with bipolar i disorder 1 1 indicated for the treatment of the pain associated with trigeminal neuralgia 1 2 an anti epileptic drug aed indicated for the treatment of partial seizures with complex symptomatology generalized tonic clonic seizures and mixed seizures 1 3 equetro is indicated for treatment of patients with acute manic or mixed episodes associated with bipolar i disorder see clinical studies 14 1 equetro is indicated in the treatment of the pain associated with trigeminal neuralgia beneficial results have also been reported in glossopharyngeal neuralgia this drug is not a simple analgesic and should not be used for the relief of trivial aches or pains equetro is indicated for the treatment of partial seizures with complex symptomatology e g psychomotor temporal lobe generalized tonic clonic seizures grand mal and mixed seizure patterns which include the seizure types listed here or other partial or generalized seizures limitations of usage equetro is not indicated for the treatment of absence seizures petit mal carbamazepine has been associated with increased frequency of generalized convulsions in these patients" assertion.
• association label "cefixime is a cephalosporin antibacterial drug indicated in the treatment of adults and pediatric patients six months and older with the following infections uncomplicated urinary tract infections 1 1 otitis media 1 2 pharyngitis and tonsillitis 1 3 acute exacerbations of chronic bronchitis 1 4 uncomplicated gonorrhea cervical urethral 1 5 to reduce the development of drug resistant bacteria and maintain the effectiveness of cefixime and other antibacterial drugs cefixime for oral suspension and cefixime capsules should be used only to treat infections that are proven or strongly suspected to be caused by bacteria 1 6 cefixime for oral suspension and cefixime capsule is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated urinary tract infections caused by susceptible isolates of escherichia coli proteus mirabilis cefixime for oral suspension and cefixime capsule is indicated in the treatment of adults and pediatric patients six months of age or older with otitis media caused by susceptible isolates of haemophilus influenzae moraxella catarrhalis streptococcus pyogenes streptococcus pyogenes note for patients with otitis media caused by streptococcus pneumoniae see clinical studies 14 cefixime for oral suspension and cefixime capsule is indicated in the treatment of adults and pediatric patients six months of age or older with pharyngitis and tonsillitis caused by susceptible isolates of streptococcus pyogenes note penicillin is the usual drug of choice in the treatment of streptococcus pyogenes infections cefixime for oral suspension and cefixime capsule is generally effective in the eradication of streptococcus pyogenes from the nasopharynx however data establishing the efficacy of cefixime for oral suspension and cefixime capsule in the subsequent prevention of rheumatic fever is not available cefixime for oral suspension and cefixime capsule is indicated in the treatment of adults and pediatric patients six months of age or older with acute exacerbations of chronic bronchitis caused by susceptible isolates of streptococcus pneumoniae haemophilus influenzae cefixime for oral suspension and cefixime capsule is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated gonorrhea cervical urethral caused by susceptible isolates of neisseria gonorrhoeae to reduce the development of drug resistant bacteria and maintain the effectiveness of cefixime and other antibacterial drugs cefixime for oral suspension and cefixime capsule should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antimicrobial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy" assertion.
• association label "travoprost ophthalmic solution usp 4 is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension travoprost ophthalmic solution usp 4 is a prostaglandin analog indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension 1" 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 "penicillin g sodium for injection usp is indicated in the treatment of serious infections caused by susceptible strains of the designated microorganisms in the conditions listed below appropriate culture and susceptibility tests should be done before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to penicillin g therapy with penicillin g sodium for injection usp may be initiated before results of such tests are known when there is reason to believe the infection may involve any of the organisms listed below however once these results become available appropriate therapy should be continued clinical indication infecting organism septicemia empyema pneumonia pericarditis endocarditis meningitis streptococcus pyogenes group a b hemolytic streptococcus other b hemolytic streptococci including groups c h g l and m streptococcus pneumoniae staphylococcus penicillinase producing strains anthrax bacillus anthracis actinomycosis cervico facial disease and thoracic and abdominal disease actinomyces israelil botulism adjunctive therapy to antitoxin gas gangrene and tetanus adjunctive therapy to human tetanus immune globulin clostridium species diphtheria adjunctive therapy to antitoxin and prevention of the carrier state corynebacterium diphtheriae erysipelothrix endocarditis erysipelothrix rhusiopthiae fusospirochetosis severe infections of the oropharynx vincent s lower respiratory tract and genital area fusobacterium species and spirochetes listeria infections including meningitis and endocarditis listeria monocytogenes pasteurella infections including bacteremia and meningitis pasteurella multocida haverhill fever streptobacillus moniliformis rat bite fever spirillum minus or streptobacillus moniliformis disseminated gonococcal infections neisseria gonorrhoeae penicillin susceptible syphilis congenital and neurosyphilis treponema pallidum meningococcal meningitis and or septicemia neisseria meningitidis gram negative bacillary infections bacteremias escherichia coli enterobacter aerogenes alcaligenes faecalis salmonella shigella proteus mirabilis is not the drug of choice in the treatment of gram negative bacillary infections to reduce the development of drug resistant bacteria and maintain the effectiveness of penicillin g sodium and other antibacterial drugs penicillin g sodium 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 "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 "spironolactone tablets usp are indicated in the management of for primary hyperaldosteronism establishing the diagnosis of primary hyperaldosteronism by therapeutic trial short term preoperative treatment of patients with primary hyperaldosteronism long term maintenance therapy for patients with discrete aldosterone producing adrenal adenomas who are judged to be poor operative risks or who decline surgery long term maintenance therapy for patients with bilateral micro or macronodular adrenal hyperplasia idiopathic hyperaldosteronism for patients with edematous conditions for the management of edema and sodium retention when the patient is only partially responsive to or is intolerant of other therapeutic measures spironolactone tablets usp are also indicated for patients with congestive heart failure taking digitalis when other therapies are considered inappropriate congestive heart failure spironolactone levels may be exceptionally high in this condition spironolactone tablets usp are indicated for maintenance therapy together with bed rest and the restriction of fluid and sodium cirrhosis of the liver accompanied by edema and or ascites for nephrotic patients when treatment of the underlying disease restriction of fluid and sodium intake and the use of other diuretics do not provide an adequate response nephrotic syndrome spironolactone tablets usp are indicated for the treatment of hypertension to lower blood pressure lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events primarily strokes and myocardial infarctions these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes control of high blood pressure should be part of comprehensive cardiovascular risk management including as appropriate lipid control diabetes management antithrombotic therapy smoking cessation exercise and limited sodium intake many patients will require more than one drug to achieve blood pressure goals for specific advice on goals and management see published guidelines such as those of the national high blood pressure education program s joint national committee on prevention detection evaluation and treatment of high blood pressure jnc numerous antihypertensive drugs from a variety of pharmacologic classes and with different mechanisms of action have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality and it can be concluded that it is blood pressure reduction and not some other pharmacologic property of the drugs that is largely responsible for those benefits the largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly elevated systolic or diastolic pressure causes increased cardiovascular risk and the absolute risk increase per mmhg is greater at higher blood pressures so that even modest reductions of severe hypertension can provide substantial benefit relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk so the absolute benefit is greater in patients who are at higher risk independent of their hypertension for example patients with diabetes or hyperlipidemia and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal some antihypertensive drugs have smaller blood pressure effects as monotherapy in black patients and many antihypertensive drugs have additional approved indications and effects e g on angina heart failure or diabetic kidney disease these considerations may guide selection of therapy usually in combination with other drugs spironolactone tablets usp are indicated for patients who cannot be treated adequately with other agents or for whom other agents are considered inappropriate for the treatment of patients with hypokalemia when other measures are considered inappropriate or inadequate spironolactone tablets usp are also indicated for the prophylaxis of hypokalemia in patients taking digitalis when other measures are considered inadequate or inappropriate severe heart failure nyha class iii to iv to increase survival and to reduce the need for hospitalization for heart failure when used in addition to standard therapy usage in pregnancy the routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard diuretics do not prevent development of toxemia of pregnancy and there is no satisfactory evidence that they are useful in the treatment of developing toxemia edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy spironolactone tablets usp are indicated in pregnancy when edema is due to pathologic causes just as it is in the absence of pregnancy however see dependent edema in pregnancy resulting from restriction of venous return by the expanded uterus is properly treated through elevation of the lower extremities and use of support hose use of diuretics to lower intravascular volume in this case is unsupported and unnecessary precautions pregnancy there is hypervolemia during normal pregnancy which is not harmful to either the fetus or the mother in the absence of cardiovascular disease but which is associated with edema including generalized edema in the majority of pregnant women if this edema produces discomfort increased recumbency will often provide relief in rare instances this edema may cause extreme discomfort that is not relieved by rest in these cases a short course of diuretics may provide relief and may be appropriate" assertion.
• association label "venlafaxine hydrochloride extended release capsules usp are indicated for the treatment of major depressive disorder the efficacy of venlafaxine hydrochloride extended release capsules usp in the treatment of major depressive disorder was established in 8 and 12 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the dsm iii r or dsm iv category of major depressive disorder see clinical trials a major depressive episode dsm iv implies a prominent and relatively persistent nearly every day for at least 2 weeks depressed mood or the loss of interest or pleasure in nearly all activities representing a change from previous functioning and includes the presence of at least five of the following nine symptoms during the same two week period depressed mood markedly diminished interest or pleasure in usual activities significant change in weight and or appetite insomnia or hypersomnia psychomotor agitation or retardation increased fatigue feelings of guilt or worthlessness slowed thinking or impaired concentration a suicide attempt or suicidal ideation the efficacy of venlafaxine hydrochloride tablets in the treatment of major depressive disorder in adult inpatients meeting diagnostic criteria for major depressive disorder with melancholia was established in a 4 week controlled trial see the safety and efficacy of venlafaxine hydrochloride extended release capsules usp in hospitalized depressed patients have not been adequately studied clinical trials the efficacy of venlafaxine hydrochloride extended release capsules usp in maintaining a response in major depressive disorder for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo controlled trial the efficacy of venlafaxine hydrochloride tablets in maintaining a response in patients with recurrent major depressive disorder who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo controlled trial see nevertheless the physician who elects to use venlafaxine hydrochloride tablets venlafaxine hydrochloride extended release capsules usp for extended periods should periodically re evaluate the long term usefulness of the drug for the individual patient see clinical trials dosage and administration social anxiety disorder venlafaxine hydrochloride extended release capsules usp are indicated for the treatment of social anxiety disorder also known as social phobia as defined in dsm iv 3 23 social anxiety disorder dsm iv is characterized by a marked and persistent fear of 1 or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others exposure to the feared situation almost invariably provokes anxiety which may approach the intensity of a panic attack the feared situations are avoided or endured with intense anxiety or distress the avoidance anxious anticipation or distress in the feared situation s interferes significantly with the person s normal routine occupational or academic functioning or social activities or relationships or there is a marked distress about having the phobias lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment the efficacy of venlafaxine hydrochloride extended release capsules usp in the treatment of social anxiety disorder was established in four 12 week and one 6 month placebocontrolled trials in adult outpatients with social anxiety disorder dsm iv see clinical trials although the effectiveness of venlafaxine hydrochloride extended release capsules usp has been demonstrated in a 6 month clinical trial in patients with social anxiety disorder the physician who elects to use venlafaxine hydrochloride extended release capsules usp for extended periods should periodically re evaluate the long term usefulness of the drug for the individual patient see dosage and administration panic disorder venlafaxine hydrochloride extended release capsules usp are indicated for the treatment of panic disorder with or without agoraphobia as defined in dsm iv panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks worry about the implications or consequences of the attacks and or a significant change in behavior related to the attacks panic disorder dsm iv is characterized by recurrent unexpected panic attacks ie a discrete period of intense fear or discomfort in which four or more of the following symptoms develop abruptly and reach a peak within 1 minutes 1 palpitations pounding heart or accelerated heart rate 2 sweating 3 trembling or shaking 4 sensations of shortness of breath or smothering 5 feeling of choking 6 chest pain or discomfort 7 nausea or abdominal distress 8 feeling dizzy unsteady lightheaded or faint 9 derealization feelings of unreality or depersonalization being detached from oneself 1 fear of losing control 11 fear of dying 12 paresthesias numbness or tingling sensations 13 chills or hot flushes the efficacy of venlafaxine hydrochloride extended release capsules usp in the treatment of panic disorder was established in two 12 week placebo controlled trials in adult outpatients with panic disorder dsm iv the efficacy of venlafaxine hydrochloride extended release capsules usp in prolonging time to relapse in panic disorder among responders following 12 weeks of open label acute treatment was demonstrated in a placebo controlled study see clinical pharmacology clinical trials nevertheless the physician who elects to use venlafaxine hydrochloride extended release capsules usp for extended periods should periodically re evaluate the long term usefulness of the drug for the individual patient see dosage and administration" assertion.
• association label "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 "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 "latanoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension latanoprost ophthalmic solution is a prostaglandin f2a analogue indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension 1" assertion.
• association label "xeljanz xeljanz xr is a janus kinase jak inhibitor rheumatoid arthritis limitations of use 1 psoriatic arthritis limitations of use 1 ulcerative colitis limitations of use 1 rheumatoid arthritis xeljanz xeljanz xr is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate it may be used as monotherapy or in combination with methotrexate or other nonbiologic disease modifying antirheumatic drugs dmards limitations of use use of xeljanz xeljanz xr in combination with biologic dmards or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended psoriatic arthritis xeljanz xeljanz xr is indicated for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other disease modifying antirheumatic drugs dmards limitations of use use of xeljanz xeljanz xr in combination with biologic dmards or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended ulcerative colitis xeljanz is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis uc limitations of use use of xeljanz in combination with biological therapies for uc or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended" assertion.
• association label "iclusig ponatinib is a kinase inhibitor indicated for the treatment of adult patients with chronic phase accelerated phase or blast phase chronic myeloid leukemia cml or ph all for whom no other tyrosine kinase inhibitor tki therapy is indicated treatment of adult patients with t315i positive cml chronic phase accelerated phase or blast phase or t315i positive philadelphia chromosome positive acute lymphoblastic leukemia ph all iclusig is a kinase inhibitor indicated for the treatment of adult patients with chronic phase accelerated phase or blast phase chronic myeloid leukemia cml or ph all for whom no other tyrosine kinase inhibitor tki therapy is indicated treatment of adult patients with t315i positive cml chronic phase accelerated phase or blast phase or t315i positive philadelphia chromosome positive acute lymphoblastic leukemia ph all 1 limitations of use iclusig is not indicated and is not recommended for the treatment of patients with newly diagnosed chronic phase cml 5 7 limitations of use iclusig is not indicated and is not recommended for the treatment of patients with newly diagnosed chronic phase cml see warnings and precautions 5 7" assertion.
• association label "tudorza r pressair r aclidinium bromide inhalation powder is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease copd tudorza pressair is an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease copd 1" assertion.
• association label "adlyxin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus adlyxin is a glucagon like peptide 1 glp 1 receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus 1 limitations of use 1 has not been studied in patients with chronic pancreatitis or a history of unexplained pancreatitis consider other antidiabetic therapies in patients with a history of pancreatitis not for treatment of type 1 diabetes or diabetic ketoacidosis has not been studied in combination with short acting insulin has not been studied in patients with gastroparesis and is not recommended in patients with gastroparesis limitations of use adlyxin has not been studied in patients with chronic pancreatitis or a history of unexplained pancreatitis consider other antidiabetic therapies in patients with a history of pancreatitis see warnings and precautions 5 2 adlyxin is not a substitute for insulin adlyxin is not indicated for use in patients with type 1 diabetes mellitus or for treatment of diabetic ketoacidosis the concurrent use of adlyxin with short acting insulin has not been studied and is not recommended adlyxin has not been studied in patients with gastroparesis and is not recommended in patients with gastroparesis" assertion.
• association label "imbruvica is a kinase inhibitor indicated for the treatment of adult patients with mantle cell lymphoma mcl who have received at least one prior therapy 1 1 chronic lymphocytic leukemia cll small lymphocytic lymphoma sll 1 2 chronic lymphocytic leukemia cll small lymphocytic lymphoma sll with 17p deletion 1 3 waldenstrom s macroglobulinemia wm 1 4 marginal zone lymphoma mzl who require systemic therapy and have received at least one prior anti cd2 based therapy 1 5 chronic graft versus host disease cgvhd after failure of one or more lines of systemic therapy 1 6 imbruvica is indicated for the treatment of adult patients with mantle cell lymphoma mcl who have received at least one prior therapy accelerated approval was granted for this indication based on overall response rate continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial see clinical studies 14 1 imbruvica is indicated for the treatment of adult patients with chronic lymphocytic leukemia cll small lymphocytic lymphoma sll imbruvica is indicated for the treatment of adult patients with chronic lymphocytic leukemia cll small lymphocytic lymphoma sll with 17p deletion imbruvica is indicated for the treatment of adult patients with waldenstrom s macroglobulinemia wm imbruvica is indicated for the treatment of adult patients with marginal zone lymphoma mzl who require systemic therapy and have received at least one prior anti cd2 based therapy accelerated approval was granted for this indication based on overall response rate see clinical studies 14 4 imbruvica is indicated for the treatment of adult patients with chronic graft versus host disease cgvhd after failure of one or more lines of systemic therapy" assertion.
• association label "cyramza r as a single agent or in combination with paclitaxel for treatment of advanced or metastatic gastric or gastro esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine or platinum containing chemotherapy 1 1 in combination with docetaxel for treatment of metastatic non small cell lung cancer with disease progression on or after platinum based chemotherapy patients with egfr or alk genomic tumor aberrations should have disease progression on fda approved therapy for these aberrations prior to receiving cyramza 1 2 in combination with folfiri for the treatment of metastatic colorectal cancer with disease progression on or after prior therapy with bevacizumab oxaliplatin and a fluoropyrimidine 1 3 as a single agent for the treatment of hepatocellular carcinoma in patients who have an alpha fetoprotein of 4 ng ml and have been treated with sorafenib 1 4 cyramza r cyramza in combination with docetaxel is indicated for the treatment of patients with metastatic non small cell lung cancer nsclc with disease progression on or after platinum based chemotherapy patients with epidermal growth factor receptor egfr or anaplastic lymphoma kinase alk genomic tumor aberrations should have disease progression on fda approved therapy for these aberrations prior to receiving cyramza cyramza in combination with folfiri irinotecan folinic acid and fluorouracil is indicated for the treatment of patients with metastatic colorectal cancer mcrc with disease progression on or after prior therapy with bevacizumab oxaliplatin and a fluoropyrimidine" assertion.
• association label "tanzeum is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus see clinical studies 14 limitations of use see warnings and precautions 5 1 see warnings and precautions 5 2 see adverse reactions 6 1 tanzeum is a glp 1 receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus 1 limitations of use 1 5 1 1 5 2 1 1 1" assertion.
• association label "actemra r rheumatoid arthritis ra 1 1 adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease modifying anti rheumatic drugs dmards giant cell arteritis gca 1 2 adult patients with giant cell arteritis polyarticular juvenile idiopathic arthritis pjia 1 3 patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis systemic juvenile idiopathic arthritis sjia 1 4 patients 2 years of age and older with active systemic juvenile idiopathic arthritis cytokine release syndrome crs 1 5 adults and pediatric patients 2 years of age and older with chimeric antigen receptor car t cell induced severe or life threatening cytokine release syndrome actemra r actemra r actemra r actemra r actemra r" assertion.
• association label "imbruvica is a kinase inhibitor indicated for the treatment of adult patients with mantle cell lymphoma mcl who have received at least one prior therapy 1 1 chronic lymphocytic leukemia cll small lymphocytic lymphoma sll 1 2 chronic lymphocytic leukemia cll small lymphocytic lymphoma sll with 17p deletion 1 3 waldenstrom s macroglobulinemia wm 1 4 marginal zone lymphoma mzl who require systemic therapy and have received at least one prior anti cd2 based therapy 1 5 chronic graft versus host disease cgvhd after failure of one or more lines of systemic therapy 1 6 imbruvica is indicated for the treatment of adult patients with mantle cell lymphoma mcl who have received at least one prior therapy accelerated approval was granted for this indication based on overall response rate continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial see clinical studies 14 1 imbruvica is indicated for the treatment of adult patients with chronic lymphocytic leukemia cll small lymphocytic lymphoma sll imbruvica is indicated for the treatment of adult patients with chronic lymphocytic leukemia cll small lymphocytic lymphoma sll with 17p deletion imbruvica is indicated for the treatment of adult patients with waldenstrom s macroglobulinemia wm imbruvica is indicated for the treatment of adult patients with marginal zone lymphoma mzl who require systemic therapy and have received at least one prior anti cd2 based therapy accelerated approval was granted for this indication based on overall response rate see clinical studies 14 4 imbruvica is indicated for the treatment of adult patients with chronic graft versus host disease cgvhd after failure of one or more lines of systemic therapy" assertion.
• association label "benlysta belimumab is indicated for the treatment of patients aged 5 years and older with active autoantibody positive systemic lupus erythematosus sle who are receiving standard therapy limitations of use the efficacy of benlysta has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus benlysta has not been studied in combination with other biologics or intravenous cyclophosphamide use of benlysta is not recommended in these situations benlysta is a b lymphocyte stimulator blys specific inhibitor indicated for the treatment of patients aged 5 years and older with active autoantibody positive systemic lupus erythematosus who are receiving standard therapy 1 limitations of use the efficacy of benlysta has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus benlysta has not been studied in combination with other biologics or intravenous cyclophosphamide use of benlysta is not recommended in these situations 1" assertion.
• association label "chronic lymphocytic leukemia cll arzerra ofatumumab is indicated in combination with chlorambucil for the treatment of previously untreated patients with cll for whom fludarabine based therapy is considered inappropriate see clinical studies 14 1 in combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed cll see clinical studies 14 2 for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive cll see clinical studies 14 3 for the treatment of patients with cll refractory to fludarabine and alemtuzumab see clinical studies 14 4 arzerra ofatumumab is a cd2 directed cytolytic monoclonal antibody indicated for the treatment of chronic lymphocytic leukemia cll 1 in combination with chlorambucil for the treatment of previously untreated patients with cll for whom fludarabine based therapy is considered inappropriate in combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed cll for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive cll for the treatment of patients with cll refractory to fludarabine and alemtuzumab" assertion.
• association label "adcetris is a cd3 directed antibody drug conjugate indicated for treatment of adult patients with previously untreated stage iii or iv classical hodgkin lymphoma chl in combination with doxorubicin vinblastine and dacarbazine 1 1 classical hodgkin lymphoma chl at high risk of relapse or progression as post autologous hematopoietic stem cell transplantation auto hsct consolidation 1 2 classical hodgkin lymphoma chl after failure of auto hsct or after failure of at least two prior multi agent chemotherapy regimens in patients who are not auto hsct candidates 1 3 previously untreated systemic anaplastic large cell lymphoma salcl or other cd3 expressing peripheral t cell lymphomas ptcl including angioimmunoblastic t cell lymphoma and ptcl not otherwise specified in combination with cyclophosphamide doxorubicin and prednisone 1 4 systemic anaplastic large cell lymphoma salcl after failure of at least one prior multi agent chemotherapy regimen 1 5 primary cutaneous anaplastic large cell lymphoma pcalcl or cd3 expressing mycosis fungoides mf who have received prior systemic therapy 1 6 adcetris is indicated for the treatment of adult patients with previously untreated stage iii or iv chl in combination with doxorubicin vinblastine and dacarbazine adcetris is indicated for the treatment of adult patients with chl at high risk of relapse or progression as post autologous hematopoietic stem cell transplantation auto hsct consolidation adcetris is indicated for the treatment of adult patients with chl after failure of auto hsct or after failure of at least two prior multi agent chemotherapy regimens in patients who are not auto hsct candidates adcetris is indicated for the treatment of adult patients with previously untreated salcl or other cd3 expressing ptcl including angioimmunoblastic t cell lymphoma and ptcl not otherwise specified in combination with cyclophosphamide doxorubicin and prednisone adcetris is indicated for the treatment of adult patients with salcl after failure of at least one prior multi agent chemotherapy regimen adcetris is indicated for the treatment of adult patients with pcalcl or cd3 expressing mf who have received prior systemic therapy" assertion.

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