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• 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 "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 "hypertension propranolol hydrochloride tablets usp are indicated in the management of hypertension it may be used alone or used in combination with other antihypertensive agents particularly a thiazide diuretic propranolol hydrochloride tablets usp are not indicated in the management of hypertensive emergencies angina pectoris due to coronary atherosclerosis propranolol hydrochloride tablets usp are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris atrial fibrillation propranolol hydrochloride tablets usp are indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response myocardial infarction propranolol hydrochloride tablets usp are indicated to reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable migraine propranolol hydrochloride tablets usp are indicated for the prophylaxis of common migraine headache the efficacy of propranolol in the treatment of a migraine attack that has started has not been established and propranolol is not indicated for such use essential tremor propranolol hydrochloride tablets usp are indicated in the management of familial or hereditary essential tremor familial or essential tremor consists of involuntary rhythmic oscillatory movements usually limited to the upper limbs it is absent at rest but occurs when the limb is held in a fixed posture or position against gravity and during active movement propranolol hydrochloride tablets usp cause a reduction in the tremor amplitude but not in the tremor frequency propranolol hydrochloride tablets usp are not indicated for the treatment of tremor associated with parkinsonism hypertrophic subaortic stenosis propranolol hydrochloride tablets usp improve nyha functional class in symptomatic patients with hypertrophic subaortic stenosis pheochromocytoma propranolol hydrochloride tablets usp are indicated as an adjunct to alpha adrenergic blockade to control blood pressure and reduce symptoms of catecholamine secreting tumors" 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 "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 "latuda is indicated for latuda is indicated for treatment of adult and adolescent patients 13 to 17 years with schizophrenia see clinical studies 14 1 monotherapy treatment of adult and pediatric patients 1 to 17 years with major depressive episode associated with bipolar i disorder bipolar depression see clinical studies 14 2 14 2 adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar i disorder bipolar depression see clinical studies 14 2 latuda is an atypical antipsychotic indicated for the treatment of schizophrenia in adults and adolescents 13 to 17 years 1 14 1 depressive episode associated with bipolar i disorder bipolar depression in adults and pediatric patients 1 to 17 years as monotherapy 1 14 2 depressive episode associated with bipolar i disorder bipolar depression in adults as adjunctive therapy with lithium or valproate 1 14 2" assertion.
• association label "hydrocortisone acetate suppositories are indicated for use in inflamed hemorrhoids post irradiation factitial proctitis as an adjunct in the treatment of chronic ulcerative colitis cryptitis and other inflammatory conditions of anorectum and pruritus ani" assertion.
• association label "prednisone tablets usp 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 2 rheumatic disorders as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in psoriatic arthritis 3 collagen diseases during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus 4 dermatologic diseases pemphigus 5 allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment seasonal or perennial allergic rhinitis 6 ophthalmic diseases severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as allergic corneal marginal ulcers 7 respiratory diseases symptomatic sarcoidosis 8 hematologic disorders idiopathic thrombocytopenic purpura in adults 9 neoplastic diseases for palliative management of leukemias and lymphomas in adults 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 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" 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 "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 "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 "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 "diazepam is indicated for the management of anxiety disorders or for the short term relief of the symptoms of anxiety anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic in acute alcohol withdrawal diazepam may be useful in the symptomatic relief of acute agitation tremor impending or acute delirium tremens and hallucinosis as an adjunct prior to endoscopic procedures if apprehension anxiety or acute stress reactions are present and to diminish the patient s recall of the procedures see warnings diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology such as inflammation of the muscles or joints or secondary to trauma spasticity caused by upper motor neuron disorders such as cerebral palsy and paraplegia athetosis stiff man syndrome and tetanus injectable diazepam is a useful adjunct in status epilepticus and severe recurrent convulsive seizures diazepam is a useful premedication the intramuscular route is preferred for relief of anxiety and tension in patients who are to undergo surgical procedures intravenously prior to cardioversion for the relief of anxiety and tension and to diminish the patient s recall of the procedure" assertion.
• association label "diltiazem hydrochloride injection is indicated for the following atrial fibrillation or atrial flutter temporary control of rapid ventricular rate in atrial fibrillation or atrial flutter it should not be used in patients with atrial fibrillation or atrial flutter associated with an accessory bypass tract such as in wolff parkinson white wpw syndrome or short pr syndrome paroxysmal supraventricular tachycardia rapid conversion of paroxysmal supraventricular tachycardias psvt to sinus rhythm this includes av nodal reentrant tachycardias and reciprocating tachycardias associated with an extranodal accessory pathway such as the wpw syndrome or short pr syndrome unless otherwise contraindicated appropriate vagal maneuvers should be attempted prior to administration of diltiazem hydrochloride injection the use of diltiazem hydrochloride injection should be undertaken with caution when the patient is compromised hemodynamically or is taking other drugs that decrease any or all of the following peripheral resistance myocardial filling myocardial contractility or electrical impulse propagation in the myocardium for either indication and particularly when employing continuous intravenous infusion the setting should include continuous monitoring of the ecg and frequent measurement of blood pressure a defibrillator and emergency equipment should be readily available in domestic controlled trials in patients with atrial fibrillation or atrial flutter bolus administration of diltiazem hydrochloride injection was effective in reducing heart rate by at least 2 in 95 of patients diltiazem hydrochloride injection rarely converts atrial fibrillation or atrial flutter to normal sinus rhythm following administration of one or two intravenous bolus doses of diltiazem injection response usually occurs within 3 minutes and maximal heart rate reduction generally occurs in 2 to 7 minutes heart rate reduction may last from 1 to 3 hours if hypotension occurs it is generally short lived but may last from 1 to 3 hours a 24 hour continuous infusion of diltiazem injection in the treatment of atrial fibrillation or atrial flutter maintained at least a 2 heart rate reduction during the infusion in 83 of patients upon discontinuation of infusion heart rate reduction may last from 5 hours to more than 1 hours median duration 7 hours hypotension if it occurs may be similarly persistent in the controlled clinical trials 3 2 of patients required some form of intervention typically use of intravenous fluids or the trendelenburg position for blood pressure support following diltiazem hydrochloride injection in domestic controlled trials bolus administration of diltiazem hydrochloride injection was effective in converting psvt to normal sinus rhythm in 88 of patients within 3 minutes of the first or second bolus dose symptoms associated with the arrhythmia were improved in conjunction with decreased heart rate or conversion to normal sinus rhythm following administration of diltiazem hydrochloride injection" assertion.
• association label "parkinson s disease ropinirole hydrochloride tablets are indicated for the treatment of the signs and symptoms of idiopathic parkinson s disease the effectiveness of ropinirole hydrochloride tablets were demonstrated in randomized controlled trials in patients with early parkinson s disease who were not receiving concomitant l dopa therapy as well as in patients with advanced disease on concomitant l dopa see clinical pharmacology clinical trials restless legs syndrome ropinirole hydrochloride tablets are indicated for the treatment of moderate to severe primary restless legs syndrome rls key diagnostic criteria for rls are an urge to move the legs usually accompanied or caused by uncomfortable and unpleasant leg sensations symptoms begin or worsen during periods of rest or inactivity such as lying or sitting symptoms are partially or totally relieved by movement such as walking or stretching at least as long as the activity continues and symptoms are worse or occur only in the evening or night difficulty falling asleep may frequently be associated with moderate to severe rls" assertion.
• association label "zyprexa r as oral formulation for the treatment of schizophrenia 1 1 adults efficacy was established in three clinical trials in patients with schizophrenia two 6 week trials and one maintenance trial 14 1 adolescents ages 13 17 efficacy was established in one 6 week trial in patients with schizophrenia 14 1 1 1 acute treatment of manic or mixed episodes associated with bipolar i disorder and maintenance treatment of bipolar i disorder 1 2 adults efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar i disorder two 3 to 4 week trials and one maintenance trial 14 2 adolescents ages 13 17 efficacy was established in one 3 week trial in patients with manic or mixed episodes associated with bipolar i disorder 14 2 1 2 medication therapy for pediatric patients with schizophrenia or bipolar i disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks 1 3 adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar i disorder 1 2 efficacy was established in two 6 week clinical trials in adults 14 2 as zyprexa intramuscular for the treatment of acute agitation associated with schizophrenia and bipolar i mania 1 4 efficacy was established in three 1 day trials in adults 14 3 as zyprexa and fluoxetine in combination for the treatment of depressive episodes associated with bipolar i disorder 1 5 efficacy was established with symbyax olanzapine and fluoxetine in combination in adults refer to the product label for symbyax treatment of treatment resistant depression major depressive disorder in patients who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode 1 6 efficacy was established with symbyax olanzapine and fluoxetine in combination in adults refer to the product label for symbyax oral zyprexa is indicated for the treatment of schizophrenia efficacy was established in three clinical trials in adult patients with schizophrenia two 6 week trials and one maintenance trial in adolescent patients with schizophrenia ages 13 17 efficacy was established in one 6 week trial see clinical studies 14 1 when deciding among the alternative treatments available for adolescents clinicians should consider the increased potential in adolescents as compared with adults for weight gain and hyperlipidemia clinicians should consider the potential long term risks when prescribing to adolescents and in many cases this may lead them to consider prescribing other drugs first in adolescents see warnings and precautions 5 5 5 6 monotherapy see clinical studies 14 2 when deciding among the alternative treatments available for adolescents clinicians should consider the increased potential in adolescents as compared with adults for weight gain and hyperlipidemia clinicians should consider the potential long term risks when prescribing to adolescents and in many cases this may lead them to consider prescribing other drugs first in adolescents see warnings and precautions 5 5 5 6 adjunctive therapy to lithium or valproate see clinical studies 14 2 pediatric schizophrenia and bipolar i disorder are serious mental disorders however diagnosis can be challenging for pediatric schizophrenia symptom profiles can be variable and for bipolar i disorder pediatric patients may have variable patterns of periodicity of manic or mixed symptoms it is recommended that medication therapy for pediatric schizophrenia and bipolar i disorder be initiated only after a thorough diagnostic evaluation has been performed and careful consideration given to the risks associated with medication treatment medication treatment for both pediatric schizophrenia and bipolar i disorder should be part of a total treatment program that often includes psychological educational and social interventions zyprexa intramuscular is indicated for the treatment of acute agitation associated with schizophrenia and bipolar i mania efficacy was demonstrated in 3 short term 24 hours of im treatment placebo controlled trials in agitated adult inpatients with schizophrenia or bipolar i disorder manic or mixed episodes see clinical studies 14 3 psychomotor agitation is defined in dsm iv as excessive motor activity associated with a feeling of inner tension patients experiencing agitation often manifest behaviors that interfere with their diagnosis and care 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 oral zyprexa and fluoxetine in combination is indicated for the treatment of depressive episodes associated with bipolar i disorder based on clinical studies in adult patients when using zyprexa and fluoxetine in combination refer to the clinical studies section of the package insert for symbyax zyprexa monotherapy is not indicated for the treatment of depressive episodes associated with bipolar i disorder oral zyprexa and fluoxetine in combination is indicated for the treatment of treatment resistant depression major depressive disorder in patients who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode based on clinical studies in adult patients when using zyprexa and fluoxetine in combination refer to the clinical studies section of the package insert for symbyax zyprexa monotherapy is not indicated for the treatment of treatment resistant depression" assertion.
• association label "tinidazole is a nitroimidazole antimicrobial indicated for 1 1 1 2 1 3 1 4 8 1 to reduce the development of drug resistant bacteria and maintain the effectiveness of tinidazole and other antibacterial drugs tinidazole should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria 1 5 tinidazole is indicated for the treatment of trichomoniasis caused by trichomonas vaginalis see clinical studies 14 1 tinidazole is indicated for the treatment of giardiasis caused by giardia duodenalis g lamblia see clinical studies 14 2 tinidazole is indicated for the treatment of intestinal amebiasis and amebic liver abscess caused by entamoeba histolytica see clinical studies 14 3 14 4 tinidazole is indicated for the treatment of bacterial vaginosis formerly referred to as haemophilus gardnerella adult women see use in specific populations 8 1 14 5 other pathogens commonly associated with vulvovaginitis such as trichomonas vaginalis chlamydia trachomatis neisseria gonorrhoeae candida albicans herpes simplex to reduce the development of drug resistant bacteria and maintain the effectiveness of tinidazole and other antibacterial drugs tinidazole should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antibacterial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy" assertion.
• association label "dactinomycin for injection is an actinomycin indicated for the treatment of 1 1 1 2 1 3 1 4 1 5 1 6 dactinomycin for injection is indicated for the treatment of adult and pediatric patients with wilms tumor as part of a multi phase combination chemotherapy regimen dactinomycin for injection is indicated for the treatment of adult and pediatric patients with rhabdomyosarcoma as part of a multi phase combination chemotherapy regimen dactinomycin for injection is indicated for the treatment of adult and pediatric patients with ewing sarcoma as part of a multi phase combination chemotherapy regimen dactinomycin for injection is indicated for the treatment of adult and pediatric patients with metastatic nonseminomatous testicular cancer as part of a multi phase combination chemotherapy regimen dactinomycin for injection is indicated for the treatment of post menarchal patients with gestational trophoblastic neoplasia as a single agent or as part of a combination chemotherapy regimen dactinomycin for injection is indicated for the treatment of adult patients with locally recurrent or locoregional solid malignancies as a component of palliative or adjunctive regional perfusion" assertion.
• association label "to reduce the development of drug resistant bacteria and maintain the effectiveness of ery tab and other antibacterial drugs ery tab 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 r r ery tab tablets are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the diseases listed below r upper respiratory tract infections of mild to moderate degree caused by when used concomitantly with adequate doses of sulfonamides since many strains of are not susceptible to the erythromycin concentrations ordinarily achieved see appropriate sulfonamide labeling for prescribing information streptococcus pyogenes streptococcus pneumoniae haemophilus influenzae h influenzae lower respiratory tract infections of mild to moderate severity caused by or streptococcus pyogenes streptococcus pneumoniae listeriosis caused by listeria monocytogenes respiratory tract infections due to mycoplasma pneumoniae skin and skin structure infections of mild to moderate severity caused by or resistant staphylococci may emerge during treatment streptococcus pyogenes staphylococcus aureus pertussis whooping cough caused by erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals bordetella pertussis diphtheria infections due to as an adjunct to antitoxin to prevent establishment of carriers and to eradicate the organism in carriers corynebacterium diphtheriae erythrasma in the treatment of infections due to corynebacterium minutissimum intestinal amebiasis caused by oral erythromycins only extraenteric amebiasis requires treatment with other agents entamoeba histolytica acute pelvic inflammatory disease caused by erythrocin lactobionate i v erythromycin lactobionate for injection usp followed by erythromycin base orally as an alternative drug in treatment of acute pelvic inflammatory disease caused by in female patients with a history of sensitivity to penicillin patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow up serologic test for syphilis after 3 months neisseria gonorrhoeae r n gonorrhoeae erythromycins are indicated for treatment of the following infections caused by conjunctivitis of the newborn pneumonia of infancy and urogenital infections during pregnancy when tetracyclines are contraindicated or not tolerated erythromycin is indicated for the treatment of uncomplicated urethral endocervical or rectal infections in adults due to chlamydia trachomatis chlamydia trachomatis when tetracyclines are contraindicated or not tolerated erythromycin is indicated for the treatment of nongonococcal urethritis caused by ureaplasma urealyticum primary syphilis caused by erythromycin oral forms only is an alternative choice of treatment for primary syphilis in patients allergic to the penicillins in treatment of primary syphilis spinal fluid should be examined before treatment and as part of the follow up after therapy treponema pallidum legionnaires disease caused by although no controlled clinical efficacy studies have been conducted and limited preliminary clinical data suggest that erythromycin may be effective in treating legionnaires disease legionella pneumophila in vitro penicillin is considered by the american heart association to be the drug of choice in the prevention of initial attacks of rheumatic fever treatment of streptococcus pyogenes infections of the upper respiratory tract e g tonsillitis or pharyngitis erythromycin is indicated for the treatment of penicillin allergic patients the therapeutic dose should be administered for ten days 4 penicillin or sulfonamides are considered by the american heart association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever in patients who are allergic to penicillin and sulfonamides oral erythromycin is recommended by the american heart association in the long term prophylaxis of streptococcal pharyngitis for the prevention of recurrent attacks of rheumatic fever 4" assertion.
• association label "azilect rasagiline tablets is indicated for the treatment of the signs and symptoms of idiopathic parkinson s disease as initial monotherapy and as adjunct therapy to levodopa the effectiveness of azilect was demonstrated in patients with early parkinson s disease who were receiving azilect as monotherapy and who were not receiving any concomitant dopaminergic therapy the effectiveness of azilect as adjunct therapy was demonstrated in patients with parkinson s disease who were treated with levodopa azilect is indicated for the treatment of the signs and symptoms of idiopathic parkinson s disease as initial monotherapy and as adjunct therapy to levodopa 1" 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 "zavesca is a glucosylceramide synthase inhibitor indicated as monotherapy for treatment of adult patients with mild moderate type 1 gaucher disease for whom enzyme replacement therapy is not a therapeutic option 1 1 zavesca is a glucosylceramide synthase inhibitor indicated as monotherapy for the treatment of adult patients with mild to moderate type 1 gaucher disease for whom enzyme replacement therapy is not a therapeutic option e g due to allergy hypersensitivity or poor venous access" assertion.
• association label "bromocriptine mesylate tablets usp are indicated for the treatment of dysfunctions associated with hyperprolactinemia amenorrhea galactorrhea infertility or hypogonadism prolactin secreting adenomas reduction tumor size bromocriptine mesylate tablets usp are indicated in the treatment of acromegaly bromocriptine mesylate tablets usp therapy alone or as adjunctive therapy with pituitary irradiation or surgery reduces serum growth hormone by 5 or more in approximately one half 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 usp offers potential benefit before the effects of irradiation are manifested bromocriptine mesylate tablets usp 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 usp 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 usp 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 usp therapy during treatment of more than two years has not been established data are insufficient to evaluate potential benefit from treating newly diagnosed parkinson s disease with bromocriptine mesylate tablets usp studies have shown however significantly more adverse reactions notably nausea hallucinations confusion and hypotension in bromocriptine mesylate tablets usp treated patients than in levodopa carbidopa treated patients patients unresponsive to levodopa are poor candidates for bromocriptine mesylate tablets usp therapy" assertion.
• association label "probenecid tablets are indicated for the treatment of the hyperuricemia associated with gout and gouty arthritis as an adjuvant to therapy with penicillin or with ampicillin methicillin oxacillin cloxacillin or nafcillin for elevation and prolongation of plasma levels by whatever route the antibiotic is given" assertion.
• association label "riluzole tablets usp is indicated for the treatment of amyotrophic lateral sclerosis als riluzole tablets usp is indicated for the treatment of amyotrophic lateral sclerosis als 1" assertion.
• association label "topotecan hydrochloride for injection is a topoisomerase inhibitor indicated for treatment of patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy as a single agent 1 1 patients with small cell lung cancer slsc platinum sensitive disease who progressed at least 6 days after initiation of first line chemotherapy as a single agent 1 2 patients with stage iv b recurrent or persistent cervical cancer which is not amenable to curative treatment in combination with cisplatin 1 3 topotecan hydrochloride for injection as a single agent is indicated for the treatment of patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy topotecan hydrochloride for injection as a single agent is indicated for the treatment of patients with small cell lung cancer sclc with platinum sensitive disease who progressed at least 6 days after initiation of first line chemotherapy topotecan hydrochloride for injection in combination with cisplatin is indicated for the treatment of patients with stage iv b recurrent or persistent cervical cancer of the cervix not amenable to curative treatment" assertion.
• association label "to reduce the development of drug resistant bacteria and maintain the effectiveness of penicillin v potassium tablets penicillin v potassium for oral solution and other antibacterial drugs penicillin v potassium tablets and penicillin v potassium for oral solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antimicrobial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy penicillin v potassium tablets usp and penicillin v potassium for oral solution usp are indicated in the treatment of mild to moderately severe infections due to penicillin g sensitive microorganisms therapy should be guided by bacteriological studies including sensitivity tests and by clinical response note severe pneumonia empyema bacteremia pericarditis meningitis and arthritis should not be treated with penicillin v during the acute stage indicated surgical procedures should be performed the following infections will usually respond to adequate dosage of penicillin v streptococcal infections without bacteremia mild to moderate infections of the upper respiratory tract scarlet fever and mild erysipelas note streptococci in groups a c g h l and m are very sensitive to penicillin other groups including group d enterococcus are resistant pneumococcal infections mild to moderately severe infections of the respiratory tract staphylococcal infections penicillin g sensitive mild infections of the skin and soft tissues note reports indicate an increasing number of strains of staphylococci resistant to penicillin g emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections fusospirochetosis vincent s gingivitis and pharyngitis mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin note necessary dental care should be accomplished in infections involving the gum tissue medical conditions in which oral penicillin therapy is indicated as prophylaxis for the prevention of recurrence following rheumatic fever and or chorea prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions although no controlled clinical efficacy studies have been conducted penicillin v has been suggested by the american heart association and the american dental association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients with congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract 1 oral penicillin should not be used in those patients at particularly high risk for endocarditis e g those with prosthetic heart valves or surgically constructed systemic pulmonary shunts penicillin v should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery lower intestinal tract surgery sigmoidoscopy and childbirth since it may happen that alpha haemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever prophylactic agents other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen note when selecting antibiotics for the prevention of bacterial endocarditis the physician or dentist should read the full joint statement of the american heart association and the american dental association the manufacturer s complete drug information can be viewed on the fda site here" assertion.
• association label "itraconazole capsules are indicated for the treatment of the following fungal infections in immunocompromised and non immunocompromised patients 1 blastomycosis pulmonary and extrapulmonary 2 histoplasmosis including chronic cavitary pulmonary disease and disseminated non meningeal histoplasmosis and 3 aspergillosis pulmonary and extrapulmonary in patients who are intolerant of or who are refractory to amphotericin b therapy specimens for fungal cultures and other relevant laboratory studies wet mount histopathology serology should be obtained before therapy to isolate and identify causative organisms therapy may be instituted before the results of the cultures and other laboratory studies are known however once these results become available antiinfective therapy should be adjusted accordingly itraconazole capsules are also indicated for the treatment of the following fungal infections in non immunocompromised patients 1 onychomycosis of the toenail with or without fingernail involvement due to dermatophytes tinea unguium and 2 onychomycosis of the fingernail due to dermatophytes tinea unguium prior to initiating treatment appropriate nail specimens for laboratory testing koh preparation fungal culture or nail biopsy should be obtained to confirm the diagnosis of onychomycosis see clinical pharmacology special populations contraindications warnings adverse reactions post marketing experience description of clinical studies blastomycosis analyses were conducted on data from two open label non concurrently controlled studies n 73 combined in patients with normal or abnormal immune status the median dose was 2 mg day a response for most signs and symptoms was observed within the first 2 weeks and all signs and symptoms cleared between 3 and 6 months results of these two studies demonstrated substantial evidence of the effectiveness of itraconazole for the treatment of blastomycosis compared with the natural history of untreated cases histoplasmosis analyses were conducted on data from two open label non concurrently controlled studies n 34 combined in patients with normal or abnormal immune status not including hiv infected patients the median dose was 2 mg day a response for most signs and symptoms was observed within the first 2 weeks and all signs and symptoms cleared between 3 and 12 months results of these two studies demonstrated substantial evidence of the effectiveness of itraconazole for the treatment of histoplasmosis compared with the natural history of untreated cases histoplasmosis in hiv infected patients data from a small number of hiv infected patients suggested that the response rate of histoplasmosis in hiv infected patients is similar to that of non hiv infected patients the clinical course of histoplasmosis in hiv infected patients is more severe and usually requires maintenance therapy to prevent relapse aspergillosis analyses were conducted on data from an open label single patient use protocol designed to make itraconazole available in the u s for patients who either failed or were intolerant of amphotericin b therapy n 19 the findings were corroborated by two smaller open label studies n 31 combined in the same patient population most adult patients were treated with a daily dose of 2 to 4 mg with a median duration of 3 months results of these studies demonstrated substantial evidence of effectiveness of itraconazole as a second line therapy for the treatment of aspergillosis compared with the natural history of the disease in patients who either failed or were intolerant of amphotericin b therapy onychomycosis of the toenail analyses were conducted on data from three double blind placebo controlled studies n 214 total 11 given itraconazole capsules in which patients with onychomycosis of the toenails received 2 mg of itraconazole capsules once daily for 12 consecutive weeks results of these studies demonstrated mycologic cure defined as simultaneous occurrence of negative koh plus negative culture in 54 of patients thirty five percent 35 of patients were considered an overall success mycologic cure plus clear or minimal nail involvement with significantly decreased signs and 14 of patients demonstrated mycologic cure plus clinical cure clearance of all signs with or without residual nail deformity the mean time to overall success was approximately 1 months twenty one percent 21 of the overall success group had a relapse worsening of the global score or conversion of koh or culture from negative to positive onychomycosis of the fingernail analyses were conducted on data from a double blind placebo controlled study n 73 total 37 given itraconazole capsules in which patients with onychomycosis of the fingernails received a 1 week course of 2 mg of itraconazole capsules b i d followed by a 3 week period without itraconazole which was followed by a second 1 week course of 2 mg of itraconazole capsules b i d results demonstrated mycologic cure in 61 of patients fifty six percent 56 of patients were considered an overall success and 47 of patients demonstrated mycologic cure plus clinical cure the mean time to overall success was approximately 5 months none of the patients who achieved overall success relapsed" assertion.
• association label "topotecan hydrochloride for injection is a topoisomerase inhibitor indicated for treatment of patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy as a single agent 1 1 patients with small cell lung cancer slsc platinum sensitive disease who progressed at least 6 days after initiation of first line chemotherapy as a single agent 1 2 patients with stage iv b recurrent or persistent cervical cancer which is not amenable to curative treatment in combination with cisplatin 1 3 topotecan hydrochloride for injection as a single agent is indicated for the treatment of patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy topotecan hydrochloride for injection as a single agent is indicated for the treatment of patients with small cell lung cancer sclc with platinum sensitive disease who progressed at least 6 days after initiation of first line chemotherapy topotecan hydrochloride for injection in combination with cisplatin is indicated for the treatment of patients with stage iv b recurrent or persistent cervical cancer of the cervix not amenable to curative treatment" assertion.
• association label "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 "gleevec is a kinase inhibitor indicated for the treatment of newly diagnosed adult and pediatric patients with philadelphia chromosome positive chronic myeloid leukemia ph cml in chronic phase 1 1 patients with philadelphia chromosome positive chronic myeloid leukemia ph cml in blast crisis bc accelerated phase ap or in chronic phase cp after failure of interferon alpha therapy 1 2 adult patients with relapsed or refractory philadelphia chromosome positive acute lymphoblastic leukemia ph all 1 3 pediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukemia ph all in combination with chemotherapy 1 4 adult patients with myelodysplastic myeloproliferative diseases mds mpd associated with pdgfr platelet derived growth factor receptor gene re arrangements as determined with an fda approved test 1 5 adult patients with aggressive systemic mastocytosis asm without the d816v c kit mutation as determined with an fda approved test or with c kit mutational status unknown 1 6 adult patients with hypereosinophilic syndrome hes and or chronic eosinophilic leukemia cel who have the fip1l1 pdgfri fusion kinase mutational analysis or fish demonstration of chic2 allele deletion and for patients with hes and or cel who are fip1l1 pdgfri fusion kinase negative or unknown 1 7 adult patients with unresectable recurrent and or metastatic dermatofibrosarcoma protuberans dfsp 1 8 patients with kit cd117 positive unresectable and or metastatic malignant gastrointestinal stromal tumors gist 1 9 adjuvant treatment of adult patients following resection of kit cd117 positive gist 1 1 newly diagnosed adult and pediatric patients with philadelphia chromosome positive chronic myeloid leukemia ph cml in chronic phase patients with philadelphia chromosome positive chronic myeloid leukemia in blast crisis accelerated phase or in chronic phase after failure of interferon alpha therapy adult patients with relapsed or refractory philadelphia chromosome positive acute lymphoblastic leukemia ph all pediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukemia ph all in combination with chemotherapy adult patients with myelodysplastic myeloproliferative diseases associated with pdgfr platelet derived growth factor receptor gene re arrangements as determined with an fda approved test see dosage and administration 2 6 adult patients with aggressive systemic mastocytosis without the d816v c kit mutation as determined with an fda approved test see dosage and administration 2 7 adult patients with hypereosinophilic syndrome and or chronic eosinophilic leukemia who have the fip1l1 pdgfri fusion kinase mutational analysis or fish demonstration of chic2 allele deletion and for patients with hes and or cel who are fip1l1 pdgfri fusion kinase negative or unknown adult patients with unresectable recurrent and or metastatic dermatofibrosarcoma protuberans patients with kit cd117 positive unresectable and or metastatic malignant gastrointestinal stromal tumors adjuvant treatment of adult patients following complete gross resection of kit cd117 positive gist" assertion.
• association label "symptomatic trichomoniasis metronidazole tablets usp are indicated for the treatment of t vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures wet smears and or cultures asymptomatic trichomoniasis metronidazole tablets usp are indicated in the treatment of asymptomatic t vaginalis infection in females when the organism is associated with endocervicitis cervicitis or cervical erosion since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears additional smears should be performed after eradication of the parasite treatment of asymptomatic sexual partners t vaginalis infection is a venereal disease therefore asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present in order to prevent reinfection of the partner the decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one in making this decision it should be noted that there is evidence that a woman may become reinfected if her sexual partner is not treated also since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier negative smears and cultures cannot be relied upon in this regard in any event the sexual partner should be treated with metronidazole tablets usp in cases of reinfection amebiasis metronidazole tablets usp are indicated in the treatment of acute intestinal amebiasis amebic dysentery and amebic liver abscess in amebic liver abscess metronidazole tablet therapy does not obviate the need for aspiration or drainage of pus anaerobic bacterial infections metronidazole tablets usp are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria indicated surgical procedures should be performed in conjunction with metronidazole tablet therapy in a mixed aerobic and anaerobic infection antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to metronidazole tablets usp intra abdominal infections including peritonitis intra abdominal abscess and liver abscess caused by bacteroides species including the b fragilis group b fragilis b distasonis b ovatus b thetaiotaomicron b vulgatus clostridium species eubacterium species peptococcus species and peptostreptococcus species skin and skin structure infections caused by bacteroides species including the b fragilis group clostridium species peptococcus species peptostreptococcus species and fusobacterium species gynecologic infections including endometritis endomyometritis tubo ovarian abscess and postsurgical vaginal cuff infection caused by bacteroides species including the b fragilis group clostridium species peptococcus species peptostreptococcus species and fusobacterium species bacterial septicemia caused by bacteroides species including the b fragilis group and clostridium species bone and joint infections as adjunctive therapy caused by bacteroides species including the b fragilis group central nervous system cns infections including meningitis and brain abscess caused by bacteroides species including the b fragilis group lower respiratory tract infections including pneumonia empyema and lung abscess caused by bacteroides species including the b fragilis group endocarditis caused by bacteroides species including the b fragilis group to reduce the development of drug resistant bacteria and maintain the effectiveness of metronidazole tablets usp and other antibacterial drugs metronidazole 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 "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 "carbidopa tablets are indicated for use with carbidopa levodopa or with levodopa in the treatment of the symptoms of idiopathic parkinson s disease paralysis agitans postencephalitic parkinsonism and symptomatic parkinsonism which may follow injury to the nervous system by carbon monoxide intoxication and or manganese intoxication carbidopa is for use with carbidopa levodopa in patients for whom the dosage of carbidopa levodopa provides less than adequate daily dosage usually 7 mg daily of carbidopa carbidopa is for use with levodopa in the occasional patient whose dosage requirement of carbidopa and levodopa necessitates separate titration of each medication carbidopa is used with carbidopa levodopa or with levodopa to permit the administration of lower doses of levodopa with reduced nausea and vomiting more rapid dosage titration and with a somewhat smoother response however patients with markedly irregular on off responses to levodopa have not been shown to benefit from the addition of carbidopa since carbidopa prevents the reversal of levodopa effects caused by pyridoxine supplemental pyridoxine vitamin b6 can be given to patients when they are receiving carbidopa and levodopa concomitantly or as carbidopa levodopa although the administration of carbidopa permits control of parkinsonism and parkinson s disease with much lower doses of levodopa there is no conclusive evidence at present that this is beneficial other than in reducing nausea and vomiting permitting more rapid titration and providing a somewhat smoother response to levodopa certain patients who responded poorly to levodopa alone have improved when carbidopa and levodopa were given concurrently this was most likely due to decreased peripheral decarboxylation of levodopa rather than to a primary effect of carbidopa on the peripheral nervous system carbidopa has not been shown to enhance the intrinsic efficacy of levodopa in deciding whether to give carbidopa with carbidopa levodopa or with levodopa to patients who have nausea and or vomiting the physician should be aware that while many patients may be expected to improve some may not since one cannot predict which patients are likely to improve this can only be determined by a trial of therapy it should be further noted that in controlled trials comparing carbidopa and levodopa with levodopa alone about half the patients with nausea and or vomiting on levodopa alone improved spontaneously despite being retained on the same dose of levodopa during the controlled portion of the trial" assertion.
• association label "erivedge is indicated for the treatment of adults with metastatic basal cell carcinoma or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery and who are not candidates for radiation erivedge r 1" assertion.
• association label "sirturo is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in the treatment of adults 18 years and older with pulmonary multi drug resistant tuberculosis mdr tb reserve sirturo for use when an effective treatment regimen cannot otherwise be provided administer sirturo by directly observed therapy dot this indication is approved under accelerated approval based on time to sputum culture conversion see clinical studies 14 sirturo is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in adults 18 years and older with pulmonary multi drug resistant tuberculosis mdr tb reserve sirturo for use when an effective treatment regimen cannot otherwise be provided administer sirturo by directly observed therapy dot 1 2 1 this indication is approved under accelerated approval based on time to sputum culture conversion continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials 1 14 limitations of use 1 14 limitations of use do not use sirturo for the treatment of latent infection due to mycobacterium tuberculosis drug sensitive tuberculosis extra pulmonary tuberculosis infections caused by non tuberculous mycobacteria the safety and efficacy of sirturo in the treatment of hiv infected patients with mdr tb have not been established as clinical data are limited see clinical studies 14" assertion.
• association label "luzu luliconazole cream 1 is indicated for the topical treatment of interdigital tinea pedis tinea cruris and tinea corporis caused by the organisms trichophyton rubrum epidermophyton floccosum luzu luliconazole cream 1 is an azole antifungal indicated for the topical treatment of interdigital tinea pedis tinea cruris and tinea corporis caused by the organisms trichophyton rubrum epidermophyton floccosum 1" assertion.
• association label "incruse ellipta is indicated for the long term once daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease copd including chronic bronchitis and or emphysema incruse ellipta is an anticholinergic indicated for the long term once daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease copd 1" assertion.
• association label "rapivab is an influenza virus neuraminidase inhibitor indicated for the treatment of acute uncomplicated influenza in patients 2 years and older who have been symptomatic for no more than two days 1 limitations of use efficacy based on clinical trials in which the predominant influenza virus type was influenza a a limited number of subjects infected with influenza b virus were enrolled 1 consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use 1 efficacy could not be established in patients with serious influenza requiring hospitalization 1 limitations of use efficacy of rapivab is based on clinical trials of naturally occurring influenza in which the predominant influenza infections were influenza a virus a limited number of subjects infected with influenza b virus were enrolled influenza viruses change over time emergence of resistance substitutions could decrease drug effectiveness other factors for example changes in viral virulence might also diminish clinical benefit of antiviral drugs prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use rapivab see microbiology 12 4 the efficacy of rapivab could not be established in patients with serious influenza requiring hospitalization see clinical studies 14 3" assertion.
• association label "savaysa is a factor xa inhibitor indicated to reduce the risk of stroke and systemic embolism se in patients with nonvalvular atrial fibrillation nvaf 1 1 limitation of use for nvaf savaysa should not be used in patients with creatinine clearance crcl 95 ml min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied 6 mg 1 1 savaysa is indicated for the treatment of deep vein thrombosis dvt and pulmonary embolism pe following 5 to 1 days of initial therapy with a parenteral anticoagulant 1 2 savaysa is indicated to reduce the risk of stroke and systemic embolism se in patients with nonvalvular atrial fibrillation nvaf limitation of use for nvaf savaysa should not be used in patients with crcl 95 ml min because of an increased risk of ischemic stroke compared to warfarin see dosage and administr ation 2 1 warnings and precautions 5 1 clinical studies 14 1 savaysa is indicated for the treatment of deep vein thrombosis dvt and pulmonary embolism pe following 5 to 1 days of initial therapy with a parenteral anticoagulant" assertion.
• association label "acthar gel is indicated as monotherapy for the treatment of infantile spasms in infants and children under 2 years of age 1 1 acthar gel is indicated for the treatment of exacerbations of multiple sclerosis in adults 1 2 acthar gel may be used for the following disorders and diseases rheumatic collagen dermatologic allergic states ophthalmic respiratory and edematous state 1 3 1 9 acthar gel repository corticotropin injection is indicated as monotherapy for the treatment of infantile spasms in infants and children under 2 years of age acthar gel repository corticotropin injection is indicated for the treatment of acute exacerbations of multiple sclerosis in adults controlled clinical trials have shown acthar gel to be effective in speeding the resolution of acute exacerbations of multiple sclerosis however there is no evidence that it affects the ultimate outcome or natural history of the disease 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 during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus systemic dermatomyositis polymyositis severe erythema multiforme stevens johnson syndrome serum sickness severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as keratitis iritis iridocyclitis diffuse posterior uveitis and choroiditis optic neuritis chorioretinitis anterior segment inflammation symptomatic sarcoidosis to induce a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus" assertion.
• association label "natpara is a parathyroid hormone indicated as an adjunct to calcium and vitamin d to control hypocalcemia in patients with hypoparathyroidism limitations of use because of the potential risk of osteosarcoma natpara is recommended only for patients who cannot be well controlled on calcium supplements and active forms of vitamin d alone see warnings and precautions 5 1 natpara was not studied in patients with hypoparathyroidism caused by calcium sensing receptor mutations natpara was not studied in patients with acute post surgical hypoparathyroidism natpara is a parathyroid hormone indicated as an adjunct to calcium and vitamin d to control hypocalcemia in patients with hypoparathyroidism 1 limitations of use because of the potential risk of osteosarcoma natpara is recommended only for patients who cannot be well controlled on calcium supplements and active forms of vitamin d alone 5 1 natpara was not studied in patients with hypoparathyroidism caused by calcium sensing receptor mutations natpara was not studied in patients with acute post surgical hypoparathyroidism" assertion.
• association label "alecensa is indicated for the treatment of patients with anaplastic lymphoma kinase alk positive metastatic non small cell lung cancer nsclc as detected by an fda approved test alecensa is a kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase alk positive metastatic non small cell lung cancer nsclc as detected by an fda approved test 1" assertion.
• association label "unituxin dinutuximab is indicated in combination with granulocyte macrophage colony stimulating factor gm csf interleukin 2 il 2 and 13 cis retinoic acid ra for the treatment of pediatric patients with high risk neuroblastoma who achieve at least a partial response to prior first line multiagent multimodality therapy see clinical studies 14 unituxin is a gd2 binding monoclonal antibody indicated in combination with granulocyte macrophage colony stimulating factor gm csf interleukin 2 il 2 and 13 cis retinoic acid ra for the treatment of pediatric patients with high risk neuroblastoma who achieve at least a partial response to prior first line multiagent multimodality therapy 1" assertion.
• association label "afinitor is a kinase inhibitor indicated for the treatment of postmenopausal women with advanced hormone receptor positive her2 negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole 1 1 adults with progressive neuroendocrine tumors of pancreatic origin pnet and adults with progressive well differentiated non functional neuroendocrine tumors net of gastrointestinal gi or lung origin that are unresectable locally advanced or metastatic limitation of use 1 2 adults with advanced renal cell carcinoma rcc after failure of treatment with sunitinib or sorafenib 1 3 adults with renal angiomyolipoma and tuberous sclerosis complex tsc not requiring immediate surgery 1 4 afinitor and afinitor disperz are kinase inhibitors indicated for the treatment of adult and pediatric patients aged 1 year and older with tsc who have subependymal giant cell astrocytoma sega that requires therapeutic intervention but cannot be curatively resected 1 5 afinitor disperz is a kinase inhibitor indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with tsc associated partial onset seizures 1 6 afinitor r afinitor is indicated for the treatment of adult patients with progressive neuroendocrine tumors of pancreatic origin pnet with unresectable locally advanced or metastatic disease afinitor is indicated for the treatment of adult patients with progressive well differentiated non functional net of gastrointestinal gi or lung origin with unresectable locally advanced or metastatic disease limitation of use see clinical studies 14 2 afinitor is indicated for the treatment of adult patients with advanced rcc after failure of treatment with sunitinib or sorafenib afinitor is indicated for the treatment of adult patients with renal angiomyolipoma and tsc not requiring immediate surgery afinitor and afinitor disperz r afinitor disperz is indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with tsc associated partial onset seizures" assertion.
• association label "prolia is a rank ligand rankl inhibitor indicated for treatment of postmenopausal women with osteoporosis at high risk for fracture 1 1 treatment to increase bone mass in men with osteoporosis at high risk for fracture 1 2 treatment of glucocorticoid induced osteoporosis in men and women at high risk for fracture 1 3 treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer 1 4 treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer 1 5 prolia is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as a history of osteoporotic fracture or multiple risk factors for fracture or patients who have failed or are intolerant to other available osteoporosis therapy in postmenopausal women with osteoporosis prolia reduces the incidence of vertebral nonvertebral and hip fractures see clinical studies 14 1 prolia is indicated for treatment to increase bone mass in men with osteoporosis at high risk for fracture defined as a history of osteoporotic fracture or multiple risk factors for fracture or patients who have failed or are intolerant to other available osteoporosis therapy see clinical studies 14 2 prolia is indicated for the treatment of glucocorticoid induced osteoporosis in men and women at high risk of fracture who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7 5 mg or greater of prednisone and expected to remain on glucocorticoids for at least 6 months high risk of fracture is defined as a history of osteoporotic fracture multiple risk factors for fracture or patients who have failed or are intolerant to other available osteoporosis therapy see clinical studies 14 3 prolia is indicated as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer in these patients prolia also reduced the incidence of vertebral fractures see clinical studies 14 4 prolia is indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer see clinical studies 14 5" assertion.
• association label "stelara r adult patients with moderate to severe plaque psoriasis ps 1 1 active psoriatic arthritis psa 1 2 moderately to severely active crohn s disease cd failed or were intolerant to treatment with immunomodulators or corticosteroids but never failed a tumor necrosis factor tnf blocker or failed or were intolerant to treatment with one or more tnf blockers 1 3 adolescent patients 12 years or older with moderate to severe plaque psoriasis 1 1 stelara r stelara r r stelara r failed or were intolerant to treatment with immunomodulators or corticosteroids but never failed treatment with a tumor necrosis factor tnf blocker or failed or were intolerant to treatment with one or more tnf blockers" assertion.
• association label "simponi is a tumor necrosis factor tnf blocker indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis ra in combination with methotrexate 1 1 active psoriatic arthritis psa alone or in combination with methotrexate 1 2 active ankylosing spondylitis as 1 3 moderate to severe ulcerative colitis uc with an inadequate response or intolerant to prior treatment or requiring continuous steroid therapy 1 4 inducing and maintaining clinical response improving endoscopic appearance of the mucosa during induction inducing clinical remission achieving and sustaining clinical remission in induction responders simponi in combination with methotrexate is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis simponi alone or in combination with methotrexate is indicated for the treatment of adult patients with active psoriatic arthritis simponi is indicated for the treatment of adult patients with active ankylosing spondylitis simponi is indicated in adult patients with moderately to severely active ulcerative colitis who have demonstrated corticosteroid dependence or who have had an inadequate response to or failed to tolerate oral aminosalicylates oral corticosteroids azathioprine or 6 mercaptopurine for inducing and maintaining clinical response improving endoscopic appearance of the mucosa during induction inducing clinical remission achieving and sustaining clinical remission in induction responders see clinical studies 14 4" assertion.
• association label "cimzia is a tumor necrosis factor tnf blocker indicated for reducing signs and symptoms of crohn s disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy 1 1 treatment of adults with moderately to severely active rheumatoid arthritis 1 2 treatment of adult patients with active psoriatic arthritis 1 3 treatment of adults with active ankylosing spondylitis 1 4 treatment of adults with active non radiographic axial spondyloarthritis with objective signs of inflammation 1 5 treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy 1 6 cimzia is indicated for reducing signs and symptoms of crohn s disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy cimzia is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis ra cimzia is indicated for the treatment of adult patients with active psoriatic arthritis psa cimzia is indicated for the treatment of adults with active ankylosing spondylitis as see clinical studies 14 4 cimzia is indicated for the treatment of adults with active non radiographic axial spondyloarthritis nr axspa with objective signs of inflammation see clinical studies 14 5 cimzia is indicated for the treatment of adults with moderate to severe plaque psoriasis pso who are candidates for systemic therapy or phototherapy see clinical studies 14 6" assertion.
• association label "cimzia is a tumor necrosis factor tnf blocker indicated for reducing signs and symptoms of crohn s disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy 1 1 treatment of adults with moderately to severely active rheumatoid arthritis 1 2 treatment of adult patients with active psoriatic arthritis 1 3 treatment of adults with active ankylosing spondylitis 1 4 treatment of adults with active non radiographic axial spondyloarthritis with objective signs of inflammation 1 5 treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy 1 6 cimzia is indicated for reducing signs and symptoms of crohn s disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy cimzia is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis ra cimzia is indicated for the treatment of adult patients with active psoriatic arthritis psa cimzia is indicated for the treatment of adults with active ankylosing spondylitis as see clinical studies 14 4 cimzia is indicated for the treatment of adults with active non radiographic axial spondyloarthritis nr axspa with objective signs of inflammation see clinical studies 14 5 cimzia is indicated for the treatment of adults with moderate to severe plaque psoriasis pso who are candidates for systemic therapy or phototherapy see clinical studies 14 6" assertion.
• association label "lucentis is indicated for the treatment of patients with lucentis a vascular endothelial growth factor vegf inhibitor is indicated for the treatment of patients with neovascular wet age related macular degeneration amd 1 1 macular edema following retinal vein occlusion rvo 1 2 diabetic macular edema dme 1 3 diabetic retinopathy dr 1 4 myopic choroidal neovascularization mcnv 1 5" assertion.
• association label "renflexis is a tumor necrosis factor tnf blocker indicated for crohn s disease reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy 1 1 reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing disease 1 1 pediatric crohn s disease reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients with moderately to severely active disease who have had an inadequate response to conventional therapy 1 2 ulcerative colitis reducing signs and symptoms inducing and maintaining clinical remission and mucosal healing and eliminating corticosteroid use in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy 1 3 pediatric ulcerative colitis reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients with moderately to severely active disease who have had an inadequate response to conventional therapy 1 4 rheumatoid arthritis in combination with methotrexate reducing signs and symptoms inhibiting the progression of structural damage and improving physical function in patients with moderately to severely active disease 1 5 ankylosing spondylitis reducing signs and symptoms in patients with active disease 1 6 psoriatic arthritis reducing signs and symptoms of active arthritis inhibiting the progression of structural damage and improving physical function 1 7 plaque psoriasis treatment of adult patients with chronic severe i e extensive and or disabling plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate 1 8 renflexis is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active crohn s disease who have had an inadequate response to conventional therapy renflexis is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing crohn s disease renflexis is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active crohn s disease who have had an inadequate response to conventional therapy renflexis is indicated for reducing signs and symptoms inducing and maintaining clinical remission and mucosal healing and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy renflexis is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy renflexis in combination with methotrexate is indicated for reducing signs and symptoms inhibiting the progression of structural damage and improving physical function in patients with moderately to severely active rheumatoid arthritis renflexis is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis renflexis is indicated for reducing signs and symptoms of active arthritis inhibiting the progression of structural damage and improving physical function in patients with psoriatic arthritis renflexis is indicated for the treatment of adult patients with chronic severe i e extensive and or disabling plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate renflexis should only be administered to patients who will be closely monitored and have regular follow up visits with a physician see boxed warnings warnings and precautions 5" assertion.
• association label "renflexis is a tumor necrosis factor tnf blocker indicated for crohn s disease reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy 1 1 reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing disease 1 1 pediatric crohn s disease reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients with moderately to severely active disease who have had an inadequate response to conventional therapy 1 2 ulcerative colitis reducing signs and symptoms inducing and maintaining clinical remission and mucosal healing and eliminating corticosteroid use in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy 1 3 pediatric ulcerative colitis reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients with moderately to severely active disease who have had an inadequate response to conventional therapy 1 4 rheumatoid arthritis in combination with methotrexate reducing signs and symptoms inhibiting the progression of structural damage and improving physical function in patients with moderately to severely active disease 1 5 ankylosing spondylitis reducing signs and symptoms in patients with active disease 1 6 psoriatic arthritis reducing signs and symptoms of active arthritis inhibiting the progression of structural damage and improving physical function 1 7 plaque psoriasis treatment of adult patients with chronic severe i e extensive and or disabling plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate 1 8 renflexis is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active crohn s disease who have had an inadequate response to conventional therapy renflexis is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing crohn s disease renflexis is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active crohn s disease who have had an inadequate response to conventional therapy renflexis is indicated for reducing signs and symptoms inducing and maintaining clinical remission and mucosal healing and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy renflexis is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy renflexis in combination with methotrexate is indicated for reducing signs and symptoms inhibiting the progression of structural damage and improving physical function in patients with moderately to severely active rheumatoid arthritis renflexis is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis renflexis is indicated for reducing signs and symptoms of active arthritis inhibiting the progression of structural damage and improving physical function in patients with psoriatic arthritis renflexis is indicated for the treatment of adult patients with chronic severe i e extensive and or disabling plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate renflexis should only be administered to patients who will be closely monitored and have regular follow up visits with a physician see boxed warnings warnings and precautions 5" assertion.
• association label "renflexis is a tumor necrosis factor tnf blocker indicated for crohn s disease reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy 1 1 reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing disease 1 1 pediatric crohn s disease reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients with moderately to severely active disease who have had an inadequate response to conventional therapy 1 2 ulcerative colitis reducing signs and symptoms inducing and maintaining clinical remission and mucosal healing and eliminating corticosteroid use in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy 1 3 pediatric ulcerative colitis reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients with moderately to severely active disease who have had an inadequate response to conventional therapy 1 4 rheumatoid arthritis in combination with methotrexate reducing signs and symptoms inhibiting the progression of structural damage and improving physical function in patients with moderately to severely active disease 1 5 ankylosing spondylitis reducing signs and symptoms in patients with active disease 1 6 psoriatic arthritis reducing signs and symptoms of active arthritis inhibiting the progression of structural damage and improving physical function 1 7 plaque psoriasis treatment of adult patients with chronic severe i e extensive and or disabling plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate 1 8 renflexis is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active crohn s disease who have had an inadequate response to conventional therapy renflexis is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing crohn s disease renflexis is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active crohn s disease who have had an inadequate response to conventional therapy renflexis is indicated for reducing signs and symptoms inducing and maintaining clinical remission and mucosal healing and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy renflexis is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy renflexis in combination with methotrexate is indicated for reducing signs and symptoms inhibiting the progression of structural damage and improving physical function in patients with moderately to severely active rheumatoid arthritis renflexis is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis renflexis is indicated for reducing signs and symptoms of active arthritis inhibiting the progression of structural damage and improving physical function in patients with psoriatic arthritis renflexis is indicated for the treatment of adult patients with chronic severe i e extensive and or disabling plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate renflexis should only be administered to patients who will be closely monitored and have regular follow up visits with a physician see boxed warnings warnings and precautions 5" assertion.
• association label "rituxan rituximab is a cd2 directed cytolytic antibody indicated for the treatment of adult patients with non hodgkin s lymphoma nhl 1 1 relapsed or refractory low grade or follicular cd2 positive b cell nhl as a single agent previously untreated follicular cd2 positive b cell nhl in combination with first line chemotherapy and in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy as single agent maintenance therapy non progressing including stable disease low grade cd2 positive b cell nhl as a single agent after first line cyclophosphamide vincristine and prednisone cvp chemotherapy previously untreated diffuse large b cell cd2 positive nhl in combination with cyclophosphamide doxorubicin vincristine and prednisone chop or other anthracycline based chemotherapy regimens chronic lymphocytic leukemia cll 1 2 previously untreated and previously treated cd2 positive cll in combination with fludarabine and cyclophosphamide fc rheumatoid arthritis ra in combination with methotrexate in adult patients with moderately to severely active ra who have inadequate response to one or more tnf antagonist therapies 1 3 granulomatosis with polyangiitis gpa wegener s granulomatosis and microscopic polyangiitis mpa in adult patients in combination with glucocorticoids 1 4 moderate to severe pemphigus vulgaris pv in adult patients 1 5 rituxan rituximab is indicated for the treatment of adult patients with relapsed or refractory low grade or follicular cd2 positive b cell nhl as a single agent previously untreated follicular cd2 positive b cell nhl in combination with first line chemotherapy and in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy as single agent maintenance therapy non progressing including stable disease low grade cd2 positive b cell nhl as a single agent after first line cyclophosphamide vincristine and prednisone cvp chemotherapy previously untreated diffuse large b cell cd2 positive nhl in combination with cyclophosphamide doxorubicin vincristine prednisone chop or other anthracycline based chemotherapy regimens rituxan is indicated in combination with fludarabine and cyclophosphamide fc for the treatment of adult patients with previously untreated and previously treated cd2 positive cll rituxan in combination with methotrexate is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tnf antagonist therapies rituxan in combination with glucocorticoids is indicated for the treatment of adult patients with granulomatosis with polyangiitis gpa wegener s granulomatosis and microscopic polyangiitis mpa rituxan is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris" assertion.
• association label "entyvio is an integrin receptor antagonist indicated for adult ulcerative colitis uc 1 1 adult patients with moderately to severely active uc who have had an inadequate response with lost response to or were intolerant to a tumor necrosis factor tnf blocker or immunomodulator or had an inadequate response with were intolerant to or demonstrated dependence on corticosteroids inducing and maintaining clinical response inducing and maintaining clinical remission improving endoscopic appearance of the mucosa achieving corticosteroid free remission adult crohn s disease cd 1 2 adult patients with moderately to severely active cd who have had an inadequate response with lost response to or were intolerant to a tnf blocker or immunomodulator or had an inadequate response with were intolerant to or demonstrated dependence on corticosteroids achieving clinical response achieving clinical remission achieving corticosteroid free remission entyvio vedolizumab is indicated for inducing and maintaining clinical response inducing and maintaining clinical remission improving the endoscopic appearance of the mucosa and achieving corticosteroid free remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with lost response to or were intolerant to a tumor necrosis factor tnf blocker or immunomodulator or had an inadequate response with were intolerant to or demonstrated dependence on corticosteroids entyvio vedolizumab is indicated for achieving clinical response achieving clinical remission and achieving corticosteroid free remission in adult patients with moderately to severely active crohn s disease who have had an inadequate response with lost response to or were intolerant to a tumor necrosis factor tnf blocker or immunomodulator or had an inadequate response with were intolerant to or demonstrated dependence on corticosteroids" assertion.
• association label "levemir is indicated to improve glycemic control in adults and children with diabetes mellitus important limitations of use levemir is not recommended for the treatment of diabetic ketoacidosis intravenous rapid acting or short acting insulin is the preferred treatment for this condition levemir is a long acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus 1 important limitations of use not recommended for treating diabetic ketoacidosis use intravenous rapid acting or short acting insulin instead" assertion.
• association label "odomzo sonidegib is indicated for the treatment of adult patients with locally advanced basal cell carcinoma bcc that has recurred following surgery or radiation therapy or those who are not candidates for surgery or radiation therapy odomzo is a hedgehog pathway inhibitor indicated for the treatment of adult patients with locally advanced basal cell carcinoma bcc that has recurred following surgery or radiation therapy or those who are not candidates for surgery or radiation therapy 1" assertion.
• association label "opdivo is a programmed death receptor 1 pd 1 blocking antibody indicated for the treatment of 1 1 1 2 1 3 a 1 4 1 5 1 5 a 1 6 1 7 a 1 8 a 1 9 a 1 1 a opdivo as a single agent or in combination with ipilimumab is indicated for the treatment of patients with unresectable or metastatic melanoma opdivo is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection opdivo is indicated for the treatment of patients with metastatic non small cell lung cancer nsclc with 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 opdivo opdivo is indicated for the treatment of patients with metastatic small cell lung cancer sclc with progression after platinum based chemotherapy and at least one other line of therapy this indication is approved under accelerated approval based on overall response rate and duration of response see clinical studies 14 4 opdivo in combination with ipilimumab is indicated for the treatment of patients with intermediate or poor risk previously untreated advanced rcc opdivo is indicated for the treatment of adult patients with classical hodgkin lymphoma chl that has relapsed or progressed after autologous hematopoietic stem cell transplantation hsct and brentuximab vedotin or 3 or more lines of systemic therapy that includes autologous hsct this indication is approved under accelerated approval based on overall response rate see clinical studies 14 6 opdivo is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck scchn with disease progression on or after platinum based therapy opdivo is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who this indication is approved under accelerated approval based on tumor response rate and duration of response see clinical studies 14 8 opdivo as a single agent or in combination with ipilimumab is indicated for the treatment of adult and pediatric patients 12 years and older with microsatellite instability high msi h or mismatch repair deficient dmmr metastatic colorectal cancer crc that has progressed following treatment with a fluoropyrimidine oxaliplatin and irinotecan this indication is approved under accelerated approval based on overall response rate and duration of response see clinical studies 14 9 opdivo is indicated for the treatment of patients with hepatocellular carcinoma hcc who have been previously treated with sorafenib this indication is approved under accelerated approval based on tumor response rate and durability of response see clinical studies 14 1" assertion.
• association label "apidra is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus apidra is a rapid acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus 1" assertion.
• association label "naglazyme galsulfase is indicated for patients with mucopolysaccharidosis vi mps vi maroteaux lamy syndrome naglazyme has been shown to improve walking and stair climbing capacity naglazyme is a hydrolytic lysosomal glycosaminoglycan gag specific enzyme indicated for patients with mucopolysaccharidosis vi mps vi maroteaux lamy syndrome naglazyme has been shown to improve walking and stair climbing capacity 1" assertion.
• association label "ixinity coagulation factor ix recombinant is a human blood coagulation factor indicated in adults and children 12 years of age with hemophilia b for control and prevention of bleeding episodes perioperative management ixinity is not indicated for induction of immune tolerance in patients with hemophilia b ixinity coagulation factor ix recombinant is a human blood coagulation factor indicated in adults and children 12 years of age with hemophilia b for control and prevention of bleeding episodes perioperative management 1 ixinity is not indicated for induction of immune tolerance in patients with hemophilia b" assertion.
• association label "cyclophosphamide for injection is an alkylating drug indicated for treatment of malignant diseases 1 1 minimal change nephrotic syndrome in pediatric patients 1 2 limitations of use the safety and effectiveness for the treatment of nephrotic syndrome in adults or other renal disease has not been established cyclophosphamide for injection is indicated for the treatment of malignant lymphomas stages iii and iv of the ann arbor staging system hodgkin s disease lymphocytic lymphoma nodular or diffuse mixed cell type lymphoma histiocytic lymphoma burkitt s lymphoma multiple myeloma leukemias chronic lymphocytic leukemia chronic granulocytic leukemia it is usually ineffective in acute blastic crisis acute myelogenous and monocytic leukemia acute lymphoblastic stem cell leukemia cyclophosphamide for injection given during remission is effective in prolonging its duration mycosis fungoides advanced disease neuroblastoma disseminated disease adenocarcinoma of the ovary retinoblastoma carcinoma of the breast cyclophosphamide for injection although effective alone in susceptible malignancies is more frequently used concurrently or sequentially with other antineoplastic drugs cyclophosphamide for injection is indicated for the treatment of biopsy proven minimal change nephrotic syndrome in pediatrics patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy limitations of use the safety and effectiveness for the treatment of nephrotic syndrome in adults or other renal disease has not been established" assertion.
• association label "cyclophosphamide for injection is an alkylating drug indicated for treatment of malignant diseases 1 1 minimal change nephrotic syndrome in pediatric patients 1 2 limitations of use the safety and effectiveness for the treatment of nephrotic syndrome in adults or other renal disease has not been established cyclophosphamide for injection is indicated for the treatment of malignant lymphomas stages iii and iv of the ann arbor staging system hodgkin s disease lymphocytic lymphoma nodular or diffuse mixed cell type lymphoma histiocytic lymphoma burkitt s lymphoma multiple myeloma leukemias chronic lymphocytic leukemia chronic granulocytic leukemia it is usually ineffective in acute blastic crisis acute myelogenous and monocytic leukemia acute lymphoblastic stem cell leukemia cyclophosphamide for injection given during remission is effective in prolonging its duration mycosis fungoides advanced disease neuroblastoma disseminated disease adenocarcinoma of the ovary retinoblastoma carcinoma of the breast cyclophosphamide for injection although effective alone in susceptible malignancies is more frequently used concurrently or sequentially with other antineoplastic drugs cyclophosphamide for injection is indicated for the treatment of biopsy proven minimal change nephrotic syndrome in pediatrics patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy limitations of use the safety and effectiveness for the treatment of nephrotic syndrome in adults or other renal disease has not been established" assertion.
• association label "noxafil is an azole antifungal agent indicated for injection delayed release tablets and oral suspension prophylaxis of invasive aspergillus candida 1 1 oral suspension treatment of oropharyngeal candidiasis opc including opc refractory ropc to itraconazole and or fluconazole 1 2 noxafil r aspergillus candida noxafil injection is indicated in patients 18 years of age and older noxafil delayed release tablets and oral suspension are indicated in patients 13 years of age and older noxafil oral suspension is indicated for the treatment of oropharyngeal candidiasis including oropharyngeal candidiasis refractory to itraconazole and or fluconazole" assertion.
• association label "enalapril maleate is indicated for the treatment of hypertension enalapril maleate is effective alone or in combination with other antihypertensive agents especially thiazide type diuretics the blood pressure lowering effects of enalapril maleate and thiazides are approximately additive enalapril maleate is indicated for the treatment of symptomatic congestive heart failure usually in combination with diuretics and digitalis in these patients enalapril maleate improves symptoms increases survival and decreases the frequency of hospitalization see clinical pharmacology heart failure mortality trials for details and limitations of survival trials in clinically stable asymptomatic patients with left ventricular dysfunction ejection fraction 35 percent enalapril maleate decreases the rate of development of overt heart failure and decreases the incidence of hospitalization for heart failure see clinical pharmacology heart failure mortality trials for details and limitations of survival trials in using enalapril maleate 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 enalapril maleate does not have a similar risk see warnings in considering use of enalapril maleate 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 it should be noted that black patients receiving ace inhibitors have been reported to have a higher incidence of angioedema compared to non blacks see warnings head and neck angioedema" assertion.
• association label "ilaris is an interleukin 1b blocker indicated for the treatment of periodic fever syndromes cryopyrin associated periodi c syndromes caps familial cold autoinflammatory syndrome fcas 1 1 muckle wells syndrome mws 1 1 tumor necrosis factor receptor associated periodic syndrome traps 1 1 hyperimmunoglobulin d syndrome hids mevalonate kinase deficiency mkd 1 1 familial mediterranean fever fmf 1 1 active systemic juvenile idiopathic arthritis sjia 1 2 ilaris r cryopyrin associated periodic syndromes caps ilaris is indicated for the treatment of cryopyrin associated periodic syndromes caps in adults and children 4 years of age and older including familial cold autoinflammatory syndrome fcas muckle wells syndrome mws tumor necrosis factor receptor tnf associated periodic syndrome traps ilaris is indicated for the treatment of tumor necrosis factor tnf receptor associated periodic syndrome traps in adult and pediatric patients hyperimmunoglobulin d syndrome hids mevalonate kinase deficiency mkd ilaris is indicated for the treatment of hyperimmunoglobulin d hyper igd syndrome hids mevalonate kinase deficiency mkd in adult and pediatric patients familial mediterranean fever fmf ilaris is indicated for the treatment of familial mediterranean fever fmf in adult and pediatric patients ilaris is indicated for the treatment of active systemic juvenile idiopathic arthritis sjia in patients aged 2 years and older" assertion.
• patient_undergoing_PCI label "patient undergoing PCI" assertion.
• cost-effective_treatment label "cost-effective treatment" assertion.
• association label "this association" assertion.
• readableassertion label "describe the assertion concisely (e.g. tylenol treats pain in adults patients)" assertion.
• subject label "search for the indicated drug" assertion.
• cohortAgeLabel label "describe the life stage or age of the cohort (e.g. Adults)" assertion.
• cohortAgeMax label "describe the maximum age of the cohort (e.g. 80)" assertion.
• objectNarrower label "optionally provide a narrower concepts for the disease" assertion.
• publication label "add the URL of a publication supporting this association (doi, PubMed...)" assertion.
• associationRelation label "provide the type of drug indication" assertion.
• object label "search for the disease it treats" assertion.
• cohortAgeMin label "describe the minimum age of the cohort (e.g. 7)" assertion.
• cohort label "the study cohort" assertion.
• hasPhenotype label "provide additional phenotypes for the cohort" assertion.
• assertion label "Defining a drug indication with its context (BioLink model)" assertion.
• narrow_match label "has more specific concept" assertion.
• narrow_match label "narrow match - a list of terms from different schemas or terminology systems that have a narrower, more specific meaning. Narrower terms are typically shown as children in a hierarchy or tree." assertion.
• narrow_match label "narrow match - a list of terms from different schemas or terminology systems that have a narrower, more specific meaning. Narrower terms are typically shown as children in a hierarchy or tree." assertion.
• openbiodiv-knowledge-graph label "OpenBiodiv knowledge graph" assertion.
• semantic-triples-extracted-from-biodiversity-literature label "semantic triple extracted from biodiversity literature" assertion.
• biodiversity-data-reuse label "biodiversity data reuse" assertion.
• spi label "The OpenBiodiv knowledge graph contains semantic triples extracted from biodiversity literature" assertion.
• obesity-wih-metabolic-abnormality label "obesity with metabolic abnormality" assertion.
• obesity-wih-metabolic-abnormality label "obesity wih metabolic abnormality" assertion.
• object label "search for the disease it treats" assertion.
• readableassertion label "describe the assertion concisely (e.g. tylenol treats pain in adults patients)" assertion.
• cohortAgeMax label "describe the maximum age of the cohort (e.g. 80)" assertion.
• cohort label "the study cohort" assertion.
• subject label "search for the indicated drug" assertion.
• association label "this association" assertion.
• hasPhenotype label "provide additional phenotypes for the cohort" assertion.
• cohortAgeLabel label "describe the life stage or age of the cohort (e.g. Adults)" assertion.
• publication label "add the URL of a publication supporting this association (doi, PubMed...)" assertion.

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