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

owen laboratories, inc. - adapalene (unii: 1l4806j2qf) (adapalene - unii:1l4806j2qf) - adapalene .1 g in 100 ml - adapalene 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 adapalene lotion. therefore, adapalene 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 adapalene lotion. furthermore, such studies are not always predictive of human response. human data in clinical trials involving adapalene 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 adapalene 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 hu

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

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

owen laboratories, 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. however

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

call inc (d.b.a 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)

taro pharmaceuticals u.s.a., 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% 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, 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 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 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 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)

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)

prugen, inc. - adapalene (unii: 1l4806j2qf) (adapalene - unii:1l4806j2qf) - adapalene 45 g in 1 g - adapalene gel, 0.1% 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.

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

prasco laboratories - 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 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. 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 5.0 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. 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, encephaloc

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

prasco laboratories - 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. however,

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