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

aidarex pharmaceuticals llc - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride 150 mg - bupropion hydrochloride extended-release tablets (sr) are indicated for the treatment of major depressive disorder. the efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled trials of depressed inpatients and in one 6-week controlled trial of depressed outpatients whose diagnoses corresponded most closely to the major depression category of the apa diagnostic and statistical manual (dsm) (see clinical pharmacology). a major depressive episode (dsm-iv) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least 5 of the following symptoms have been present during the same 2-week period and represent a change from previous functioning: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a

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

aidarex pharmaceuticals llc - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride 150 mg - 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 in the prevention of seasonal major depressive episodes was established in 3 placebo-controlled trials in ad

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

cardinal health, inc. - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride 150 mg - 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 tablets (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)] . 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

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

h.j. harkins company, inc. - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride 100 mg - bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder. a physician considering bupropion for the management of a patient’s first episode of depression should be aware that the drug may cause generalized seizures in a dose dependent manner with an approximate incidence of 0.4% (4/1,000). this incidence of seizures may exceed that of other marketed antidepressants by as much as 4-fold. this relative risk is only an approximate estimate because no direct comparative studies have been conducted (see warnings). the efficacy of bupropion has been established in three placebo-controlled trials, including two of approximately 3 weeks’ duration in depressed inpatients and one of approximately 6 weeks’ duration in depressed outpatients. the depressive disorder of the patients studied corresponds most closely to the major depression category of the apa diagnostic and statistical manual iii. major depression implies a prominent and relatively persistent depressed or dysphoric mood t

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

wockhardt limited - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride 100 mg - bupropion hydrochloride extended-release tablets (sr) are indicated for the treatment of major depressive disorder. the efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled trials of depressed inpatients and in one 6-week controlled trial of depressed outpatients whose diagnoses corresponded most closely to the major depression category of the apa diagnostic and statistical manual (dsm) (see clinical pharmacology). a major depressive episode (dsm-iv) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least 5 of the following symptoms have been present during the same 2-week period and represent a change from previous functioning: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a

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

cardinal health - 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 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)] . 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 recommend

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

sandoz inc - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride 150 mg - bupropion hydrochloride extended-release tablets (sr) are indicated as an aid to smoking cessation treatment. pregnancy category c 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 2 times the maximum recommended human dose (mrhd) and greater and decreased fetal weights were seen at doses three times the mrhd and greater. bupropion hydrochloride extended-release tablets (sr) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. clinical consideratio

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

proficient rx lp - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride 100 mg - bupropion hydrochloride extended-release tablets (sr) are indicated for the treatment of major depressive disorder. the efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled trials of depressed inpatients and in one 6-week controlled trial of depressed outpatients whose diagnoses corresponded most closely to the major depression category of the apa diagnostic and statistical manual (dsm) (see clinical pharmacology). a major depressive episode (dsm-iv) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least 5 of the following symptoms have been present during the same 2-week period and represent a change from previous functioning: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentr

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

rebel distributors corp - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride 100 mg - bupropion hydrochloride extended-release tablets (sr) are indicated for the treatment of major depressive disorder. the efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled trials of depressed inpatients and in one 6-week controlled trial of depressed outpatients whose diagnoses corresponded most closely to the major depression category of the apa diagnostic and statistical manual (dsm) (see clinical pharmacology). a major depressive episode (dsm-iv) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least 5 of the following symptoms have been present during the same 2-week period and represent a change from previous functioning: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a

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

dispensing solutions, inc. - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride 100 mg - bupropion hydrochloride extended-release tablets (sr) are indicated for the treatment of major depressive disorder. the efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled trials of depressed inpatients and in one 6-week controlled trial of depressed outpatients whose diagnoses corresponded most closely to the major depression category of the apa diagnostic and statistical manual (dsm) (see clinical pharmacology). a major depressive episode (dsm-iv) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least 5 of the following symptoms have been present during the same 2-week period and represent a change from previous functioning: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentr