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

remedyrepack inc. - duloxetine hydrochloride (unii: 9044sc542w) (duloxetine - unii:o5tnm5n07u) - duloxetine delayed-release capsules, usp are indicated for the treatment of: - major depressive disorder [see clinical studies 14.1] - generalized anxiety disorder [see clinical studies 14.2] - diabetic peripheral neuropathy [see clinical studies 14.3] - chronic musculoskeletal pain [see clinical studies 14.5] monoamine oxidase inhibitors (maois) — the use of maois intended to treat psychiatric disorders with duloxetine delayed-release capsules or within 5 days of stopping treatment with duloxetine delayed-release capsules is contraindicated because of an increased risk of serotonin syndrome. the use of duloxetine delayed-release capsules within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated [see dosage and administration (2.8) and warnings and precautions (5.4)]. starting duloxetine delayed-release capsules in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin

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

remedyrepack inc. - duloxetine hydrochloride (unii: 9044sc542w) (duloxetine - unii:o5tnm5n07u) - duloxetine delayed-release capsules, usp are indicated for the treatment of: - major depressive disorder [see clinical studies 14.1] - generalized anxiety disorder [see clinical studies 14.2] - diabetic peripheral neuropathy [see clinical studies 14.3] - chronic musculoskeletal pain [see clinical studies 14.5] monoamine oxidase inhibitors (maois) — the use of maois intended to treat psychiatric disorders with duloxetine delayed-release capsules or within 5 days of stopping treatment with duloxetine delayed-release capsules is contraindicated because of an increased risk of serotonin syndrome. the use of duloxetine delayed-release capsules within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated [see dosage and administration (2.8) and warnings and precautions (5.4)]. starting duloxetine delayed-release capsules in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin

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

ncs healthcare of ky, llc dba vangard labs - duloxetine hydrochloride (unii: 9044sc542w) (duloxetine - unii:o5tnm5n07u) - duloxetine delayed-release capsules, usp are indicated for the treatment of: - major depressive disorder[see clinical studies 14.1] - generalized anxiety disorder[see clinical studies 14.2] - diabetic peripheral neuropathy[see clinical studies 14.3] - chronic musculoskeletal pain[see clinical studies 14.5] monoamine oxidase inhibitors (maois) — the use of maois intended to treat psychiatric disorders with duloxetine delayed-release capsules or within 5 days of stopping treatment with duloxetine delayed-release capsules is contraindicated because of an increased risk of serotonin syndrome. the use of duloxetine delayed-release capsules within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated [see dosage and administration (2.8) and warnings and precautions (5.4)]. starting duloxetine delayed-release capsules in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin synd

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

tya pharmaceuticals - duloxetine hydrochloride (unii: 9044sc542w) (duloxetine - unii:o5tnm5n07u) - duloxetine 30 mg - duloxetine delayed-release capsules, usp are indicated for the treatment of major depressive disorder (mdd). the efficacy of duloxetine delayed-release capsules, usp was established in four short-term and one maintenance trial in adults . [see clinical studies (14.1)] 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, or a suicide attempt or suicidal ideation. duloxetine delayed-release capsules, usp are indicated for the treatment of generalized anxiety disorder (gad). the efficacy of duloxetine delayed-release capsules,

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

remedyrepack inc. - duloxetine hydrochloride (unii: 9044sc542w) (duloxetine - unii:o5tnm5n07u) - duloxetine delayed-release capsules usp are indicated for the treatment of:  - major depressive disorder [see clinical studies ( 14.1)]  - generalized anxiety disorder [see clinical studies ( 14.2)]  - diabetic peripheral neuropathy [see clinical studies ( 14.3)]  - chronic musculoskeletal pain [see clinical studies ( 14.5)] monoamine oxidase inhibitors (maois) — the use of maois intended to treat psychiatric disorders with duloxetine or within 5 days of stopping treatment with duloxetine is contraindicated because of an increased risk of serotonin syndrome. the use of duloxetine within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated [see dosage and administration ( 2.8) and warnings and precautions ( 5.4)]. starting duloxetine in a patient who is being treated with m

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

preferred pharmaceuticals inc. - duloxetine hydrochloride (unii: 9044sc542w) (duloxetine - unii:o5tnm5n07u) - duloxetine delayed-release capsules are indicated for the treatment of: starting duloxetine delayed-release capsules in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see dosage and administration (2.9) and warnings and precautions (5.4)] . pregnancy category c risk summary — there are no adequate and well-controlled studies of duloxetine administration in pregnant women. in animal studies with duloxetine, fetal weights were decreased but there was no evidence of teratogenicity in pregnant rats and rabbits at oral doses administered during the period of organogenesis up to 4 and 7 times the maximum recommended human dose (mrhd) of 120 mg/day, respectively. when duloxetine was administered orally to pregnant rats throughout gestation and lactation, pup weights at birth and pup survival to 1 day postpartum were decreased at a dose 2 times the mrhd. at this dose, pup behaviors consistent with i

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

lupin australia pty limited - duloxetine hydrochloride, quantity: 67.36 mg - capsule, enteric - excipient ingredients: croscarmellose sodium; purified talc; pregelatinised maize starch; lactose monohydrate; hypromellose; triethyl citrate; polysorbate 80; isopropyl alcohol; hypromellose phthalate; magnesium stearate; dichloromethane; methanol; titanium dioxide; propylene glycol; butan-1-ol; purified water; shellac; ethanol absolute; ammonia; potassium hydroxide; iron oxide yellow; gelatin; acetic acid; silicon dioxide; sodium lauryl sulfate; citric acid; indigo carmine aluminium lake; ethanol; strong ammonia solution; iron oxide black - duloxetine hydrochloride is indicated for the following:,-treatment of major depressive disorder (mdd). ,-treatment of generalised anxiety disorder (gad).

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

lupin australia pty limited - duloxetine hydrochloride, quantity: 33.68 mg - capsule, enteric - excipient ingredients: hypromellose phthalate; triethyl citrate; lactose monohydrate; croscarmellose sodium; dichloromethane; polysorbate 80; hypromellose; pregelatinised maize starch; magnesium stearate; methanol; purified talc; isopropyl alcohol; titanium dioxide; propylene glycol; butan-1-ol; purified water; shellac; ethanol absolute; ammonia; potassium hydroxide; ethanol; strong ammonia solution; iron oxide black; indigo carmine; gelatin; acetic acid; silicon dioxide; sodium lauryl sulfate; citric acid - duloxetine hydrochloride is indicated for the following:,-treatment of major depressive disorder (mdd). ,-treatment of generalised anxiety disorder (gad).

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

remedyrepack inc. - duloxetine hydrochloride (unii: 9044sc542w) (duloxetine - unii:o5tnm5n07u) - duloxetine delayed-release capsules are indicated for the treatment of: - major depressive disorder [see clinical studies (14.1)] - generalized anxiety disorder [see clinical studies (14.2)] - diabetic peripheral neuropathy [see clinical studies (14.3)] - chronic musculoskeletal pain [see clinical studies (14.5)] monoamine oxidase inhibitors (maois) — the use of maois intended to treat psychiatric disorders with duloxetine delayed-release capsules or within 5 days of stopping treatment with duloxetine delayed-release capsules is contraindicated because of an increased risk of serotonin syndrome. the use of duloxetine delayed-release capsules within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated [see  dosage and administration (2.8) and warnings and precautions (5.4)] . starting duloxetine delayed-release capsules in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of ser

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

remedyrepack inc. - duloxetine hydrochloride (unii: 9044sc542w) (duloxetine - unii:o5tnm5n07u) - duloxetine delayed-release capsules are indicated for the treatment of: - major depressive disorder [see clinical studies (14.1)] - generalized anxiety disorder [see clinical studies (14.2)] - diabetic peripheral neuropathy [see clinical studies (14.3)] - fibromyalgia [see clinical studies (14.4)] - chronic musculoskeletal pain [see clinical studies (14.5)] monoamine oxidase inhibitors (maois) - the use of maois intended to treat psychiatric disorders with duloxetine delayed-release capsules or within 5 days of stopping treatment with duloxetine delayed-release capsules are contraindicated because of an increased risk of serotonin syndrome. the use of duloxetine delayed-release capsules within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated [see dosage and administration (2.8) and warnings and precautions (5.4)] .  starting duloxetine delayed-release capsules in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contra