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

encube ethicals private limited - adapalene (unii: 1l4806j2qf) (adapalene - unii:1l4806j2qf) - adapalene gel, 0.3% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. adapalene gel, 0.3% is contraindicated in patients who have known hypersensitivity to adapalene or any excipient of adapalene gel, 0.3% [see warnings and precautions (5.1) ]. risk summary available data from clinical trials with adapalene gel, use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. in animal reproduction studies, oral administration of adapalene to pregnant rats and rabbits_ during organogenesis at dose exposures 40 and 81 times, respectively, the human exposure at the maximum recommended human dose (mrhd) of 2 g resulted in fetal skeletal and visceral malformations ( see data). the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defects

Canada - English - Health Canada

taro pharmaceuticals inc - adapalene; benzoyl peroxide - gel - 0.1%; 2.5% - adapalene 0.1%; benzoyl peroxide 2.5% - keratolytic agents

Canada - English - Health Canada

taro pharmaceuticals inc - adapalene; benzoyl peroxide - gel - 0.3%; 2.5% - adapalene 0.3%; benzoyl peroxide 2.5% - keratolytic agents

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

padagis israel pharmaceuticals ltd - adapalene (unii: 1l4806j2qf) (adapalene - unii:1l4806j2qf), benzoyl peroxide (unii: w9wzn9a0gm) (benzoyl peroxide - unii:w9wzn9a0gm) - adapalene and benzoyl peroxide topical gel, 0.3%/2.5% is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. adapalene and benzoyl peroxide topical gel, 0.3%/2.5% is contraindicated in patients with a history of hypersensitivity reactions to benzoyl peroxide or any components of the formulation in adapalene and benzoyl peroxide topical gel, 0.3%/2.5%. risk summary available pharmacovigilance data with adapalene and benzoyl peroxide topical gel, 0.3%/2.5% use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. animal reproduction studies have not been conducted with the combination gel. adapalene gel, 0.3% available data from clinical trials with adapalene gel 0.3% use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. in animal reproduction studies, or

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

physicians total care, inc. - adapalene (unii: 1l4806j2qf) (adapalene - unii:1l4806j2qf), benzoyl peroxide (unii: w9wzn9a0gm) (benzoyl peroxide - unii:w9wzn9a0gm) - adapalene 1 mg in 1 g - epiduo gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. none pregnancy category c. there are no well-controlled trials in pregnant women treated with epiduo gel. animal reproduction studies have not been conducted with the combination gel or benzoyl peroxide. furthermore, such studies are not always predictive of human response; therefore, epiduo gel should be used during pregnancy only if the potential benefit justifies the risk to the fetus. no teratogenic effects were observed in rats treated with oral doses of 0.15 to 5.0 mg adapalene/kg/day, up to 25 times (mg/m2 /day) the maximum recommended human dose (mrhd) of 2 grams of epiduo gel. however, teratogenic changes were observed in rats and rabbits when treated with oral doses of ≥ 25 mg adapalene/kg/day representing 123 and 246 times mrhd, respectively. findings included cleft palate, microphthalmia, encephalocele and skeletal abnormalities in rats; and umbilical hernia, exophthalmos and kidney and skelet

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

galderma laboratories, l.p. - adapalene (unii: 1l4806j2qf) (adapalene - unii:1l4806j2qf), benzoyl peroxide (unii: w9wzn9a0gm) (benzoyl peroxide - unii:w9wzn9a0gm) - adapalene 1 mg in 1 g - epiduo gel is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. none pregnancy category c. there are no well-controlled trials in pregnant women treated with epiduo gel. animal reproduction studies have not been conducted with the combination gel or benzoyl peroxide. furthermore, such studies are not always predictive of human response; therefore, epiduo gel should be used during pregnancy only if the potential benefit justifies the risk to the fetus. no teratogenic effects were observed in rats treated with oral doses of 0.15 to 5.0 mg adapalene/kg/day, up to 25 times (mg/m2 /day) the maximum recommended human dose (mrhd) of 2 grams of epiduo gel. however, teratogenic changes were observed in rats and rabbits when treated with oral doses of ≥ 25 mg adapalene/kg/day representing 123 and 246 times mrhd, respectively. findings included cleft palate, microphthalmia, encephalocele and skeletal abnormalities in rats; and umbilical hernia, exophthalmos and kidney and skeleta

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

physicians total care, inc. - adapalene (unii: 1l4806j2qf) (adapalene - unii:1l4806j2qf) - adapalene 1 mg in 1 g - differin lotion is indicated for the topical treatment of acne vulgaris in patients 12 years and older. none. pregnancy category c. there are no well-controlled trials in pregnant women treated with differin lotion. therefore, differin lotion should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. animal reproduction studies have not been conducted with differin lotion. furthermore, such studies are not always predictive of human response. human data in clinical trials involving differin lotion, 0.1% in the treatment of acne vulgaris, women of childbearing potential initiated treatment only after a negative pregnancy test. two women became pregnant while using differin lotion, 0.1%. one patient delivered a healthy full term baby and the other patient electively terminated her pregnancy. animal data no teratogenic effects were observed in rats treated with oral doses of 0.15 to 5.0 mg adapalene/kg/day, up to 25 times (mg/m2/day) the maximum recommended human dos

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

galderma laboratories, l.p. - adapalene (unii: 1l4806j2qf) (adapalene - unii:1l4806j2qf), benzoyl peroxide (unii: w9wzn9a0gm) (benzoyl peroxide - unii:w9wzn9a0gm) - adapalene 3 mg in 1 g - epiduo forte is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. epiduo forte is contraindicated in patients with a history of hypersensitivity reactions to benzoyl peroxide or any components of the formulation in epiduo forte. risk summary available pharmacovigilance data with epiduo forte use in pregnant women are insufficient to establish a drug associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. animal reproduction studies have not been conducted with the combination gel. adapalene gel, 0.3% available data from clinical trials with adapalene gel 0.3% use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. in animal reproduction studies, oral administration of adapalene to pregnant rats and rabbits during organogenesis at dose exposures 41 and 81 times, respectively, the human exposure at the ma

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

galderma laboratories, l.p - adapalene (unii: 1l4806j2qf) (adapalene - unii:1l4806j2qf) - adapalene 1 mg in 1 g - differin® cream is indicated for the topical treatment of acne vulgaris. differin® cream should not be administered to individuals who are hypersensitive to adapalene or any of the components in the cream vehicle.

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

galderma laboratories, l.p. - adapalene (unii: 1l4806j2qf) (adapalene - unii:1l4806j2qf) - adapalene 0.1 g in 100 ml - differin lotion is indicated for the topical treatment of acne vulgaris in patients 12 years and older. differin lotion is contraindicated in patients who have known hypersensitivity to adapalene or any excipient of differin lotion [see warnings and precautions (5.1) ] risk summary available data from clinical trials with differin lotion use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. in animal reproduction studies, oral administration of adapalene to pregnant rats and rabbits during organogenesis at dose exposures 122 and 243 times, respectively, the human exposure at the maximum recommended human dose (mrhd) of 2 g resulted in fetal skeletal and visceral malformations (see data ). the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defects, loss, or other adverse outcomes. in the u.s. general popula