United States - English - NLM (National Library of Medicine)

proficient rx lp - mirtazapine (unii: a051q2099q) (mirtazapine - unii:a051q2099q) - mirtazapine 30 mg - mirtazapine tablets usp are indicated for the treatment of major depressive disorder. the efficacy of mirtazapine tablets usp in the treatment of major depressive disorder was established in 6 week controlled trials of outpatients whose diagnoses corresponded most closely to the diagnostic and statistical manual of mental disorders – 3rd edition (dsm-iii) category of major depressive disorder (see clinical pharmacology ). a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation. the effectiveness of mirtazapine tablets usp

United States - English - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - mirtazapine (unii: a051q2099q) (mirtazapine - unii:a051q2099q) - mirtazapine 15 mg - mirtazapine tablets are indicated for the treatment of major depressive disorder. the efficacy of mirtazapine tablets in the treatment of major depressive disorder was established in 6 week controlled trials of outpatients whose diagnoses corresponded most closely to the diagnostic and statistical manual of mental disorders – 3rd edition (dsm-iii) category of major depressive disorder (see clinical pharmacology ). a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation. the effectiveness of mirtazapine tablets in hospitali

United States - English - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - mirtazapine (unii: a051q2099q) (mirtazapine - unii:a051q2099q) - mirtazapine 15 mg - mirtazapine tablets are indicated for the treatment of major depressive disorder. the efficacy of mirtazapine tablets in the treatment of major depressive disorder was established in 6 week controlled trials of outpatients whose diagnoses corresponded most closely to the diagnostic and statistical manual of mental disorders – 3rd edition (dsm-iii) category of major depressive disorder (see clinical pharmacology ). a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation. the effectiveness of mirtazapine tablets in hospitali

United States - English - NLM (National Library of Medicine)

major pharmaceuticals - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine 25 mg - quetiapine fumarate tablets are indicated for the treatment of schizophrenia. the efficacy of quetiapine in schizophrenia was established in three 6 week trials in adults. the effectiveness of quetiapine for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials. [see clinical studies (14.1)].    pediatric use information in patients (13 to 17 years of age) with schizophrenia is approved for astrazeneca pharmaceuticals lp’s quetiapine fumarate drug product labeling. however, due to astrazeneca pharmaceuticals lp’s marketing exclusivity rights; this drug product is not labeled for such use in those adolescent patients. quetiapine fumarate tablets are indicated for the acute treatment of manic episodes associated with bipolar i disorder, both as monotherapy and as an adjunct to lithium or divalproex. efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, [see clinical studies (14.2) ]. quetiapine fum

United States - English - NLM (National Library of Medicine)

cardinal health - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine 25 mg - quetiapine fumarate tablets are indicated for the treatment of schizophrenia. the efficacy of quetiapine in schizophrenia was established in three 6 week trials in adults. the effectiveness of quetiapine for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials. [see clinical studies (14.1)].    pediatric use information in patients (13 to 17 years of age) with schizophrenia is approved for astrazeneca pharmaceuticals lp’s quetiapine fumarate drug product labeling. however, due to astrazeneca pharmaceuticals lp’s marketing exclusivity rights; this drug product is not labeled for such use in those adolescent patients. quetiapine fumarate tablets are indicated for the acute treatment of manic episodes associated with bipolar i disorder, both as monotherapy and as an adjunct to lithium or divalproex. efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, [see clinical studies (14.2) ]. quetiapine fum

United States - English - NLM (National Library of Medicine)

physicians total care, inc. - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine 50 mg - quetiapine fumarate tablets are indicated for the treatment of schizophrenia. the efficacyof quetiapine in schizophrenia was established in three 6 week trials in adults. the effectiveness of quetiapine for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials. [see clinical studies (14.1) ].    pediatric use information in patients (13 to 17 years of age) with schizophrenia is approved for astrazeneca pharmaceuticals lp’s quetiapine fumarate drug product labeling. however, due to astrazeneca pharmaceuticals lp’s marketing exclusivity rights; this drug product is not labeled for such use in those adolescent patients. quetiapine fumarate tablets are indicated for the acute treatment of manic episodes associated with bipolar i disorder, both as monotherapy and as an adjunct to lithium or divalproex. efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, [see clinical studies (14.2) ]. quetiapine f

United States - English - NLM (National Library of Medicine)

state of florida doh central pharmacy - nevirapine (unii: 99dk7fvk1h) (nevirapine - unii:99dk7fvk1h) - nevirapine 200 mg - nevirapine tablets are indicated for use in combination with other antiretroviral agents for the treatment of hiv-1 infection. this indication is based on one principal clinical trial (bi 1090) that demonstrated prolonged suppression of hiv-1 rna and two smaller supportive trials, one of which (bi 1046) is described below. additional important information regarding the use of nevirapine tablets for the treatment of hiv-1 infection: - based on serious and life threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine tablets should not be initiated in adult females with cd4+ cell counts greater than 250 cells/mm3 or in adult males with cd4+ cell counts greater than 400 cells/mm3 unless the benefit outweighs the risk [see boxed warning and warnings and precautions (5.1) ]. - the 14-day lead-in period with nevirapine tablets 200 mg daily dosing must be strictly followed; it has been demonstrated to reduce the frequency of rash [see dosage and administration (2.4) and warnings and

United States - English - NLM (National Library of Medicine)

aurobindo pharma limited - nevirapine (unii: 99dk7fvk1h) (nevirapine - unii:99dk7fvk1h) - nevirapine 200 mg - nevirapine tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv-1) infection in adults and pediatric patients 15 days and older [see clinical studies (14.1, 14.2)] . limitations of use: based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine tablets is not recommended to be initiated, unless the benefit outweighs the risk, in:  - adult females with cd4+ cell counts greater than 250 cells/mm3 or  - adult males with cd4+ cell counts greater than 400 cells/mm3 [see warnings and precautions (5.1)]. nevirapine tablets are contraindicated: - in patients with moderate or severe (child-pugh class b or c, respectively) hepatic impairment [see warnings and precautions (5.1)  and use in specific populations (8.7) ] . - for use as part of occupational and non-occupational post-exposure prophylaxis (pep) regimens [see warnings and precautions (5.1)]. pregnancy exposure registry there is a p

United States - English - NLM (National Library of Medicine)

micro labs limited - nevirapine (unii: 99dk7fvk1h) (nevirapine - unii:99dk7fvk1h) - nevirapine 200 mg - nevirapine tablet is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv-1) infection in adults and pediatric patients 15 days and older [see clinical studies (14.1, 14.2)] . limitations of use: based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine tablet is not recommended to be initiated, unless the benefit outweighs the risk, in: - adult females with cd4 + cell counts greater than 250 cells/mm 3 or - adult males with cd4 + cell counts greater than 400 cells/mm 3 [see warnings and precautions (5.1)] . nevirapine is contraindicated: - in patients with moderate or severe (child-pugh class b or c, respectively) hepatic impairment [see  warnings and precautions (5.1) and use in specific po

United States - English - NLM (National Library of Medicine)

breckenridge pharmaceutical, inc. - nevirapine (unii: 99dk7fvk1h) (nevirapine - unii:99dk7fvk1h) - nevirapine 200 mg - nevirapine is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv-1) infection in adults and pediatric patients 15 days and older. [see clinical studies (14.1, 14.2)] limitations of use: based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine is not recommended to be initiated, unless the benefit outweighs the risk, in: nevirapine is contraindicated: pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to nevirapine during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary available data from the apr show no difference in the risk of overall major birth defects for nevirapine compared with the background rate for major birth defects of 2.7% in the u.s. reference population of the metropolitan atlanta congenital defects program (m