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

sandoz inc. - adapalene (unii: 1l4806j2qf) (adapalene - unii:1l4806j2qf) - adapalene 3 mg in 1 g - 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% should not be administered to individuals who are hypersensitive to adapalene or any of the components in the gel vehicle. teratogenic effects. pregnancy category c. retinoids may cause fetal harm, when administered to pregnant women.  adapalene has been shown to be teratogenic in rats and rabbits when administered orally (see animal data below).  there are no adequate and well-controlled studies in pregnant women.  adapalene gel, 0.3% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.  the safety and efficacy of adapalene gel, 0.3% in pregnancy has not been established. human data in clinical trials involving adapalene gel, 0.3% in the treatment of acne vulgaris, women of child-bearing potential initiated treatment only after having had a negative pregnancy test and used effective birth control measures during therapy.  ho

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

biomes pharmaceuticals - adapalene (unii: 1l4806j2qf) (adapalene - unii:1l4806j2qf), benzoyl peroxide (unii: w9wzn9a0gm) (benzoyl peroxide - unii:w9wzn9a0gm) - adapalene and benzoyl peroxide swab 0.1% / 2.5% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. none teratogenic effects: pregnancy category c there are no well-controlled trials in pregnant women treated with adapalene and benzoyl peroxide. animal reproduction studies have not been conducted with the combination or benzoyl peroxide. furthermore, such studies are not always predictive of human response; therefore, adapalene and benzoyl peroxide 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 mg  adapalene/kg/day, up to 25 times  (mg/m2/day) the  maximum recommended human dose (mrhd) of 2 grams  of adapalene and benzoyl peroxide. however, teratogenic changes were observed in rats and rabbits when treated with oral doses of greater than or equal to 25 mg adapalene/kg/day representing 123 and 246 times mrhd, respectively. findings included

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

call inc. (dba rochester pharmaceuticals) - adapalene (unii: 1l4806j2qf) (adapalene - unii:1l4806j2qf) - adapalene 1 mg in 1 ml - adapalene topical solution, 0.1% is indicated for the topical treatment of acne vulgaris. adapalene topical solution, 0.1% should not be administered to individuals who are hypersensitive to adapalene or any of the components in the vehicle solution.

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

alembic pharmaceuticals inc. - 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 is contraindicated in patients who have known hypersensitivity to adapalene or any excipient of adapalene gel [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, loss, or other adverse outcomes. in the u.s. general population

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

aleor dermaceuticals 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% should not be administered to individuals who are hypersensitive to adapalene or any of the components in the gel vehicle. teratogenic effects. pregnancy category c. retinoids may cause fetal harm, when administered to pregnant women. adapalene has been shown to be teratogenic in rats and rabbits when administered orally (see animal data below). there are no adequate and well-controlled studies in pregnant women. adapalene gel, 0.3% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. the safety and efficacy of adapalene gel, 0.3% in pregnancy has not been established. human data in clinical trials involving adapalene gel, 0.3% in the treatment of acne vulgaris, women of child-bearing potential initiated treatment only after having had a negative pregnancy test and used effective birth control measures during therapy. however

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

sandoz inc. - adapalene (unii: 1l4806j2qf) (adapalene - unii:1l4806j2qf), benzoyl peroxide (unii: w9wzn9a0gm) (benzoyl peroxide - unii:w9wzn9a0gm) - adapalene and benzoyl peroxide gel 0.1% / 2.5% 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 adapalene and benzoyl peroxide gel 0.1% / 2.5%. 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, adapalene and benzoyl peroxide gel 0.1% / 2.5% 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 adapalene and benzoyl peroxide gel 0.1% / 2.5%. 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 in

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

padagis israel pharmaceuticals ltd - adapalene (unii: 1l4806j2qf) (adapalene - unii:1l4806j2qf) - adapalene 0.1 g in 100 g - adapalene cream, 0.1% is indicated for the topical treatment of acne vulgaris. adapalene cream, 0.1% 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), 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)

actavis pharma, inc. - adapalene (unii: 1l4806j2qf) (adapalene - unii:1l4806j2qf) - adapalene 3 mg in 1 g - adapalene gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. adapalene gel is contraindicated in patients who have known hypersensitivity to adapalene or any excipient of adapalene gel [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, loss, or other adverse outcomes. in the u.s. general population th

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

actavis pharma, inc. - adapalene (unii: 1l4806j2qf) (adapalene - unii:1l4806j2qf), benzoyl peroxide (unii: w9wzn9a0gm) (benzoyl peroxide - unii:w9wzn9a0gm) - adapalene 1 mg in 1 g - adapalene and benzoyl peroxide gel 0.1% / 2.5% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. none teratogenic effects: pregnancy category c there are no well-controlled trials in pregnant women treated with adapalene and benzoyl peroxide 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, adapalene and benzoyl peroxide 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 mg adapalene/kg/day, up to 25 times (mg/m2 /day) the maximum recommended human dose (mrhd) of 2 grams of adapalene and benzoyl peroxide gel. however, teratogenic changes were observed in rats and rabbits when treated with oral doses of greater than or equal to 25 mg adapalene/kg/day representing 123 and 246 times mrhd, respectively. findin