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

direct rx - sertraline hydrochloride (unii: uti8907y6x) (sertraline - unii:quc7nx6wmb) - sertraline 50 mg - major depressive disorder – sertraline hydrochloride is indicated for the treatment of major depressive disorder in adults. the efficacy of sertraline hydrochloride in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the dsm-iii category of major depressive disorder (see clinical trials under clinical pharmacology). a major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. the antidepressant action of sertraline hydrochloride in hos

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

watson laboratories, inc. - sertraline hydrochloride (unii: uti8907y6x) (sertraline - unii:quc7nx6wmb) - tablet - 25 mg - major depressive disorder –sertraline hydrochloride tablets are indicated for the treatment of major depressive disorder in adults. the efficacy of sertraline hydrochloride tablets in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the dsm-iii category of major depressive disorder (seeclinical trials under clinical pharmacology ). a major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. the antidepressant action of sertraline hydr

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

bryant ranch prepack - sertraline hydrochloride (unii: uti8907y6x) (sertraline - unii:quc7nx6wmb) - sertraline 50 mg - sertraline hydrochloride tablets are 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 tablets are contraindicated in patients: - taking, or within 14 days of stopping, maois, (including the maois linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see warnings and precautions (5.2), drug interactions (7.1)] . - taking pimozide [see drug interactions (7.1)] . - with known hypersensitivity to sertr

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

rpk pharmaceuticals, inc. - sertraline hydrochloride (unii: uti8907y6x) (sertraline - unii:quc7nx6wmb) - sertraline 50 mg - sertraline tablets are 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 is contraindicated in patients: - taking, or within 14 days of stopping, maois, (including the maois linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see warnings and precautions (5.2), drug interactions (7.1)] . - taking pimozide [see drug interactions (7.1)] . - with known hypersensitivity to sertraline (e.g., anaphylaxis, angioedema) [see adverse reactions (6.1, 6.2)]. risk summary overall, available published epidemiologic studies of pregnant women exposed to sertraline in the first trimester suggest no difference in major birth defect risk compared to the background rate for major birth defects in comparator populations. some studies have reported in

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

bryant ranch prepack - sertraline hydrochloride (unii: uti8907y6x) (sertraline - unii:quc7nx6wmb) - sertraline 25 mg - sertraline tablets are 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 is contraindicated in patients: - taking, or within 14 days of stopping, maois, (including the maois linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see warnings and precautions (5.2), drug interactions (7.1)] . - taking pimozide [see drug interactions (7.1)] . - with known hypersensitivity to sertraline (e.g., anaphylaxis, angioedema) [see adverse reactions (6.1, 6.2)]. risk summary overall, available published epidemiologic studies of pregnant women exposed to sertraline in the first trimester suggest no difference in major birth defect risk compared to the background rate for major birth defects in comparator populations. some studies have reported in

Israel - English - Ministry of Health

teva israel ltd - sertraline as hydrochloride - film coated tablets - sertraline as hydrochloride 50 mg - sertraline - sertraline - for the treatment of symptoms of depression in patients with or without a history of mania. following satisfactory response, continuation with sertaline therapy is effective in preventing relapse of the initial episode of depression or recurrence of further depressive episodes.

Israel - English - Ministry of Health

teva israel ltd - sertraline as hydrochloride - film coated tablets - sertraline as hydrochloride 100 mg - sertraline - sertraline - for the treatment of symptoms of depression in patients with or without a history of mania. following satisfactory response, continuation with sertaline therapy is effective in preventing relapse of the initial episode of depression or recurrence of further depressive episodes.

Australia - English - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - sertraline hydrochloride, quantity: 111.8 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; methylcellulose; magnesium stearate; hypromellose; hyprolose; titanium dioxide; iron oxide yellow; colloidal anhydrous silica; macrogol 8000 - sertraline is indicated in adults for the treatment of 1) major depression; 2) premenstrual dysphoric disorder (pmdd) as defined by dsm-iv criteria.

Australia - English - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - sertraline hydrochloride, quantity: 55.9 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; methylcellulose; magnesium stearate; hypromellose; hyprolose; titanium dioxide; indigo carmine; colloidal anhydrous silica; macrogol 8000 - sertraline is indicated in adults for the treatment of 1) major depression; 2) premenstrual dysphoric disorder (pmdd) as defined by dsm-iv criteria.

Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - sertraline hydrochloride, quantity: 111.9 mg (equivalent: sertraline, qty 100 mg) - tablet, film coated - excipient ingredients: hyprolose; sodium starch glycollate type a; titanium dioxide; polysorbate 80; microcrystalline cellulose; calcium hydrogen phosphate; macrogol 400; hypromellose; magnesium stearate - children and adolescents sertraline hydrochloride is indicated for the treatment of children (aged 6 years of age and older) and adolescents with ocd.,adults sertraline hydrochloride is indicated for the treatment of: ? major depression, obsessive compulsive disorder (ocd) and panic disorder ? social phobia (social anxiety disorder) and the prevention of its relapse ? pre-menstrual dysphoric disorder (pmdd) as defined by dsm-iv criteria