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

taro pharmaceuticals u.s.a., inc. - adapalene (unii: 1l4806j2qf) (adapalene - unii:1l4806j2qf) - adapalene gel is indicated for the topical treatment of acne vulgaris. adapalene gel should not be administered to individuals who are hypersensitive to adapalene or any of the components in the vehicle gel.

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)

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)

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

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

bryant ranch prepack - adapalene (unii: 1l4806j2qf) (adapalene - unii:1l4806j2qf) - adapalene cream is indicated for the topical treatment of acne vulgaris. adapalene 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)

mayne pharma inc. - adapalene (unii: 1l4806j2qf) (adapalene - unii:1l4806j2qf) - adapalene cream is indicated for the topical treatment of acne vulgaris. adapalene 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)

marnel pharmaceuticals, inc. - adapalene (unii: 1l4806j2qf) (adapalene - unii:1l4806j2qf) - indications and usage:   plixda (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)

gabar health sciences corp. - 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, loss, or other adverse outcomes. in the u.s. general population the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 15 to 20%, respectively.   data  animal data no malformations were observed in rats treated with oral adapalene doses of 0.15 to 5.0 mg/kg/day, up to 8 times the mrhd based on a mg/m 2 comparison. however, malformations were observed in rats and rabbits when treated with oral doses of ≥25 mg/kg/day adapalene (40 and 81 times the mrhd, respectively, based on a mg/m 2 comparison). findings included cleft palate, microphthalmia, encephalocele, and skeletal abnormalities in rats and umbilical hernia, exophthalmos, and kidney and skeletal abnormalities in rabbits. dermal adapalene embryofetal development studies in rats and rabbits at doses up to 6.0 mg/kg/day (9.7 and 19.5 times the mrhd, respectively, based on a mg/m 2 comparison) exhibited no fetotoxicity and only minimal increases in skeletal variations (supernumerary ribs in both species and delayed ossification in rabbits). risk summary there are no data on the presence of topical adapalene gel or its metabolite in human milk, the effects on the breastfed infant, or the effects on milk production. in animal studies, adapalene is present in rat milk with oral administration of the drug. when a drug is present in animal milk, it is likely that the drug will be present in human milk. it is possible that topical administration of large amounts of adapalene could result in sufficient systemic absorption to produce detectable quantities in human milk ( see clinical considerations ). the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for adapalene gel, 0.3% and any potential adverse effects on the breastfed child from adapalene gel, 0.3% or from the underlying maternal condition.   clinical considerations  to minimize potential exposure to the breastfed infant via breastmilk, use adapalene gel, 0.3% on the smallest area of skin and for the shortest duration possible while breastfeeding. avoid application of adapalene gel, 0.3% to areas with increased risk for potential ingestion by or ocular exposure to the breastfeeding child. safety and effectiveness have not been established in pediatric patients below the age of 12. clinical studies of adapalene gel, 0.3% did not include subjects 65 years of age and older to determine whether they respond differently than younger subjects. safety and effectiveness in geriatric patients age 65 and above have not been established.

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 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 included cleft palate, microphthalmia, encephalocele and skeletal abnormalities in rats; and umbilical hernia, exophthalmos and kidney and skeletal abnormalities in rabbits. dermal teratology studies conducted in rats and rabbits at doses of 0.6-6.0 mg adapalene/kg/day [25-59 times (mg/m2 ) the mrhd] exhibited no fetotoxicity and only minimal increases in supernumerary ribs in both species and delayed ossification in rabbits. it is not known whether adapalene or benzoyl peroxide is excreted in human milk following use of adapalene and benzoyl peroxide gel, 0.1%/2.5%. because many drugs are excreted in human milk, caution should be exercised when adapalene and benzoyl peroxide gel, 0.1%/2.5% is administered to a nursing woman. safety and effectiveness of adapalene and benzoyl peroxide gel, 0.1%/2.5% in pediatric patients under the age of 9 have not been established. clinical studies of adapalene and benzoyl peroxide gel, 0.1%/2.5% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.