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

zydus pharmaceuticals (usa) inc. - fondaparinux sodium (unii: x0q6n9usoz) (fondaparinux - unii:j177fow5jl) - fondaparinux sodium injection is indicated for the prophylaxis of deep vein thrombosis (dvt), which may lead to pulmonary embolism (pe): - in patients undergoing hip fracture surgery, including extended prophylaxis; - in patients undergoing hip replacement surgery; - in patients undergoing knee replacement surgery; - in patients undergoing abdominal surgery who are at risk for thromboembolic complications. fondaparinux sodium injection is indicated for the treatment of acute deep vein thrombosis when administered in conjunction with warfarin sodium. fondaparinux sodium injection is indicated for the treatment of acute pulmonary embolism when administered in conjunction with warfarin sodium when initial therapy is administered in the hospital. fondaparinux sodium injection is contraindicated in the following conditions:(4) - severe renal impairment (creatinine clearance [crcl] <30 ml/min). [see warnings and precautions (5.3) and use in specific populations (8.6).] - active major bleeding. - bacterial endocardi

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.

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

glenmark pharmaceuticals inc., usa - adapalene (unii: 1l4806j2qf) (adapalene - unii:1l4806j2qf), benzoyl peroxide (unii: w9wzn9a0gm) (benzoyl peroxide - unii:w9wzn9a0gm) - 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 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, encephalocele

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

taro pharmaceuticals u.s.a., inc. - adapalene (unii: 1l4806j2qf) (adapalene - unii:1l4806j2qf), benzoyl peroxide (unii: w9wzn9a0gm) (benzoyl peroxide - unii:w9wzn9a0gm) - adapalene and benzoyl peroxide topical gel 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 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. risk summary available pharmacovigilance data with adapalene and benzoyl peroxide topical 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. 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 r

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)

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)

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 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/m 2 /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,

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)

teva pharmaceuticals usa, inc - adapalene (unii: 1l4806j2qf) (adapalene - unii:1l4806j2qf), benzoyl peroxide (unii: w9wzn9a0gm) (benzoyl peroxide - unii:w9wzn9a0gm) - adapalene and benzoyl peroxide gel is indicated for the topical treatment of acne vulgaris. 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. 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 8 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 41 and 81 times mrhd, respectively. findings included cleft palate, microphthalmia, encephalocele, and skeletal abnormalities in rats; and umbilical h

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

mayne pharma inc. - adapalene (unii: 1l4806j2qf) (adapalene - unii:1l4806j2qf), benzoyl peroxide (unii: w9wzn9a0gm) (benzoyl peroxide - unii:w9wzn9a0gm) - adapalene and benzoyl peroxide gel is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. adapalene and benzoyl peroxide gel is contraindicated in patients with a history of hypersensitivity reactions to benzoyl peroxide or any components of the formulation in adapalene and benzoyl peroxide gel. risk summary available pharmacovigilance data with adapalene and benzoyl peroxide 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. 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 or