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

preferred pharmaceuticals,inc. - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride 100 mg - bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder (mdd), as defined by the diagnostic and statistical manual (dsm) . the efficacy of bupropion hydrochloride tablets in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with mdd [see clinical studies (14)] . risk summary data from epidemiological studies of pregnant women exposed to bupropion in the first trimester indicate no increased risk of congenital malformations overall. all pregnancies, regardless of drug exposure, have a background rate of 2% to 4% for major malformations, and 15% to 20% for pregnancy loss. no clear evidence of teratogenic activity was found in reproductive developmental studies conducted in rats and rabbits; however, in rabbits, slightly increased incidences of fetal malformations and skeletal variations were observed at doses approximately equal to the maximum recommended human do

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

proficient rx lp - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride 75 mg - bupropion hydrochloride tablets, usp are indicated for the treatment of major depressive disorder (mdd), as defined by the diagnostic and statistical manual (dsm) . the efficacy of bupropion hydrochloride tablets, usp in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with mdd [see clinical studies (14)] . risk summary: data from epidemiological studies of pregnant women exposed to bupropion in the first trimester indicate no increased risk of congenital malformations overall. all pregnancies, regardless of drug exposure, have a background rate of 2% to 4% for major malformations, and 15% to 20% for pregnancy loss. no clear evidence of teratogenic activity was found in reproductive developmental studies conducted in rats and rabbits; however, in rabbits, slightly increased incidences of fetal malformations and skeletal variations were observed at doses approximately equal to the maximum recommen

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

sandoz inc - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride 75 mg - bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder (mdd), as defined by the diagnostic and statistical manual (dsm) . the efficacy of bupropion hydrochloride tablets in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with mdd [see clinical studies ( 14 )] . risk summary data from epidemiological studies of pregnant women exposed to bupropion in the first trimester indicate no increased risk of congenital malformations overall. all pregnancies, regardless of drug exposure, have a background rate of 2% to 4% for major malformations, and 15% to 20% for pregnancy loss. no clear evidence of teratogenic activity was found in reproductive developmental studies conducted in rats and rabbits; however, in rabbits, slightly increased incidences of fetal malformations and skeletal variations were observed at doses approximately equal to the maximum recommended human

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

mylan institutional inc. - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride 75 mg - bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder (mdd), as defined by the diagnostic and statistical manual (dsm). the efficacy of bupropion hydrochloride tablets in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with mdd [see clinical studies (14)] . - bupropion hydrochloride tablets are contraindicated in patients with a seizure disorder. - bupropion hydrochloride tablets are contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa as a higher incidence of seizures was observed in such patients treated with bupropion hydrochloride tablets [see warnings and precautions (5.3)]

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

nucare pharmaceuticals,inc. - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride 75 mg - bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder (mdd), as defined by the diagnostic and statistical manual (dsm). the efficacy of bupropion hydrochloride tablets in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with mdd [see clinical studies ( 14)]. - bupropion hydrochloride tablets are contraindicated in patients with a seizure disorder. - bupropion hydrochloride tablets are contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa as a higher incidence of seizures was observed in such patients treated with bupropion hydrochloride tablets [see warnings and precautions ( 5.3)]. - bupropion hydrochloride tablets are contraindicated in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs

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

preferred pharmaceuticals inc. - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride extended-release tablets, (xl) are indicated for the treatment of major depressive disorder (mdd), as defined by the diagnostic and statistical manual (dsm). the efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with mdd. the efficacy of the sustained-release formulation of bupropion in the maintenance treatment of mdd was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment [see clinical studies (14.1) ]. bupropion hydrochloride extended-release tablets, (xl) are indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (sad). the efficacy of bupropion hydrochloride extended-release tablets, (xl) in the prevention of seasonal major depressive episodes was established in 3 placebo-controlled t

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

clinical solutions wholesale, llc - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride extended-release tablets, (sr) are indicated for the treatment of major depressive disorder (mdd), as defined by the diagnostic and statistical manual (dsm). the efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with mdd [see clinical studies ( 14)] . the efficacy of bupropion hydrochloride extended-release tablet (sr) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see clinical studies ( 14)] . - bupropion hydrochloride extended-release tablets (sr) are contraindicated in patients with a seizure disorder. - bupropion hydrochloride extended-release tablets (sr) are contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa as a higher incidence of seizures was observed in such patients treated with the immediate-releas

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

remedyrepack inc. - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride extended-release tablets (sr) are indicated for the treatment of major depressive disorder (mdd), as defined by the diagnostic and statistical manual (dsm ) . the efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with mdd [see clinical studies ( 14)] . the efficacy of bupropion in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see clinical studies ( 14)] . - bupropion hydrochloride extended-release tablets (sr) are contraindicated in patients with a seizure disorder. - bupropion hydrochloride extended-release tablets (sr) are contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa as a higher incidence of seizures was observed

Israel - English - Ministry of Health

abic marketing ltd, israel - prasugrel as hydrobromide - film coated tablets - prasugrel as hydrobromide 10 mg - prasugrel - prasugrel teva, co-administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in patients with acute coronary syndrome ( i.e. unstable angina, non-st segment elevation myocardial infarction [ua/nstemi] or st segment elevation myocardial infarction [stemi] undergoing primary or delayed percutaneous coronary intervention (pci). the increased efficacy should be balanced with the increased risk in patients with bleeding tendencyin those who had tia/cva in the past and in those above the age of 75 or weight below 60 kg.

Israel - English - Ministry of Health

abic marketing ltd, israel - prasugrel as hydrobromide - film coated tablets - prasugrel as hydrobromide 5 mg - prasugrel - prasugrel teva, co-administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in patients with acute coronary syndrome ( i.e. unstable angina, non-st segment elevation myocardial infarction [ua/nstemi] or st segment elevation myocardial infarction [stemi] undergoing primary or delayed percutaneous coronary intervention (pci). the increased efficacy should be balanced with the increased risk in patients with bleeding tendencyin those who had tia/cva in the past and in those above the age of 75 or weight below 60 kg.