Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

bryant ranch prepack - 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.

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

encube ethicals private limited - 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 inc

Iisrael - inglise - Ministry of Health

a.m.i. medical technologies limited, israel - adapalene - cream - adapalene 0.1 %w/w - adapalene - adapalene - for the cutaneous treatment of acne vulgaris, where comedones, papules and postules predominate. acne of the face, chest or back is appropriate for treatment. the treatment is limited up to six months in adolescents over 12 years.

Ameerika Ühendriigid - inglise - 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.

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

l’oreal usa products inc - adapalene (unii: 1l4806j2qf) (adapalene - unii:1l4806j2qf) - acne treatment for the treatment of acne

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

glenmark therapeutics inc., usa - adapalene (unii: 1l4806j2qf) (adapalene - unii:1l4806j2qf) - acne treatment

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

bryant ranch prepack - 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, oral administration of adapalene to pregnant rats and rabbits during organogenesis at dose exposures 41 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) . benzoyl peroxide gel, 2.5% the systemic exposure of benzoyl peroxide is unknown. based on published literature, benzoyl peroxide is rapidly metabolized to benzoic acid (an endogenous substance), which is eliminated in the urine. hence, maternal use is not expected to result in fetal exposure of the drug. the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 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 of 2 grams of adapalene and benzoyl peroxide topical gel, 0.3%/2.5% based on a mg/m2 comparison. however, malformations were observed in rats and rabbits when treated with oral doses of ≥ 25 mg/kg/day adapalene (41 and 81 times the mrhd, respectively, based on a mg/m2 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/m2 comparison) exhibited no fetotoxicity and only minimal increases in skeletal variations (supernumerary ribs in both species and delayed ossification in rabbits). risk summary adapalene gel, 0.3% there are no data on the presence of adapalene topical 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) . benzoyl peroxide gel, 2.5% the systemic exposure of benzoyl peroxide is unknown. based on the published literature, benzoyl peroxide is rapidly metabolized to benzoic acid (an endogenous substance), which is eliminated in the urine. any amount of benzoyl peroxide excreted into human milk by a nursing mother would be expected to be rapidly metabolized by tissue and stomach esterases. there are no data on the presence of benzoyl peroxide in human milk, its effects on the breastfed infant or its effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for adapalene and benzoyl peroxide topical gel, 0.3%/2.5% and any potential adverse effects on the breastfed child from adapalene and benzoyl peroxide topical gel, 0.3%/2.5% or from the underlying maternal condition. clinical considerations to minimize potential exposure to the breastfed infant via breastmilk, use adapalene and benzoyl peroxide topical gel, 0.3%/2.5% on the smallest area of skin and for the shortest duration possible while breastfeeding. advise breastfeeding women not to apply adapalene and benzoyl peroxide topical gel, 0.3%/2.5% directly to the nipple and areola to avoid direct infant exposure. safety and effectiveness of adapalene and benzoyl peroxide topical gel, 0.3%/2.5% in pediatric patients under the age of 12 have not been established. clinical studies of adapalene and benzoyl peroxide topical gel, 0.3%/2.5% did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects.

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

dolgencorp, inc. (dollar general & rexall) - adapalene (unii: 1l4806j2qf) (adapalene - unii:1l4806j2qf) - acne treatment - for the treatment of acne

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

cardinal health (leader) 70000 - adapalene (unii: 1l4806j2qf) (adapalene - unii:1l4806j2qf) - acne treatment - for the treatment of acne

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

top care (topco associates llc) - adapalene (unii: 1l4806j2qf) (adapalene - unii:1l4806j2qf) - acne treatment - for the treatment of acne