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

oceanside pharmaceuticals - tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - tretinoin gel is indicated for topical treatment of acne vulgaris. none. pregnancy category c there are no well-controlled trials in pregnant women treated with tretinoin gel. tretinoin gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. tretinoin gel at doses of 0.1, 0.3 and 1 g/kg/day was tested for maternal and developmental toxicity in pregnant sprague-dawley rats by dermal application. the dose of 1 g/kg/day was approximately 4 times the clinical dose assuming 100% absorption and based on body surface area comparison. possible tretinoin-associated teratogenic effects (craniofacial abnormalities (hydrocephaly), asymmetrical thyroids, variations in ossification, and increased supernumerary ribs) were noted in the fetuses of tretinoin gel treated animals. these findings were not observed in control animals. other maternal and reproductive parameters in the tretinoin gel treated animals were not different from control. for purposes of comparison of the

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

mylan pharmaceuticals inc. - tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - tretinoin gel is indicated for topical treatment of acne vulgaris. none. there are no well-controlled studies in pregnant women treated with tretinoin gel. tretinoin gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. tretinoin gel at doses of 0.1, 0.3 and 1 g/kg/day was tested for maternal and developmental toxicity in pregnant sprague-dawley rats by dermal application. the dose of 1 g/kg/day was approximately 4 times the clinical dose assuming 100% absorption and based on body surface area comparison. possible tretinoin-associated teratogenic effects (craniofacial abnormalities (hydrocephaly), asymmetrical thyroids, variations in ossification, and increased supernumerary ribs) were noted in the fetuses of tretinoin gel treated animals. these findings were not observed in control animals. other maternal and reproductive parameters in the tretinoin gel treated animals were not different from control. for purposes of comparison of the animal exposure to

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

mylan pharmaceuticals inc. - tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - tretinoin gel microsphere is a retinoid indicated for topical application in the treatment of acne vulgaris. none. there are no adequate and well-controlled studies in pregnant women. tretinoin gel microsphere should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. thirty human cases of temporally associated congenital malformations have been reported during two decades of clinical use of tretinoin products. although no definite pattern of teratogenicity and no causal association has been established from these cases, five of the reports describe the rare birth defect category holoprosencephaly (defects associated with incomplete midline development of the forebrain). the significance of these spontaneous reports in terms of risk to the fetus is not known. for purposes of comparison of the animal exposure to systemic human exposure, the mrhd applied topically is defined as 1 gram of tretinoin gel microsphere , 0.1%, applied daily to a 60 kg person (0.017 mg t

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

taro pharmaceuticals u.s.a., inc. - tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - tretinoin cream is indicated for topical application in the treatment of acne vulgaris. the safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established. use of the product should be discontinued if hypersensitivity to any of the ingredients is noted.

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

taro pharmaceuticals u.s.a., inc. - tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - tretinoin cream is indicated for topical application in the treatment of acne vulgaris. the safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established. use of the product should be discontinued if hypersensitivity to any of the ingredients is noted.

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

major pharmaceuticals - tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - tretinoin capsules are indicated for the induction of remission in patients with acute promyelocytic leukemia (apl), french-american-british (fab) classification m3 (including the m3 variant), characterized by the presence of the t(15;17) translocation and/or the presence of the pml/rarα gene who are refractory to, or who have relapsed from, anthracycline chemotherapy, or for whom anthracycline-based chemotherapy is contraindicated. tretinoin capsules are for the induction of remission only. the optimal consolidation or maintenance regimens have not been defined, but all patients should receive an accepted form of remission consolidation and/or maintenance therapy for apl after completion of induction therapy with tretinoin capsules. tretinoin capsules are contraindicated in patients with a known hypersensitivity to tretinoin capsules, any of its components, or other retinoids. tretinoin capsules should not be given to patients who are sensitive to parabens, which are used as preservatives in the gelatin caps

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

bryant ranch prepack - tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - tretinoin capsules are indicated for the induction of remission in patients with acute promyelocytic leukemia (apl), french-american-british (fab) classification m3 (including the m3 variant), characterized by the presence of the t(15;17) translocation and/or the presence of the pml/rarα gene who are refractory to, or who have relapsed from, anthracycline chemotherapy, or for whom anthracycline-based chemotherapy is contraindicated. tretinoin capsules are for the induction of remission only. the optimal consolidation or maintenance regimens have not been defined, but all patients should receive an accepted form of remission consolidation and/or maintenance therapy for apl after completion of induction therapy with tretinoin capsules. tretinoin capsules are contraindicated in patients with a known hypersensitivity to tretinoin capsules, any of its components, or other retinoids. tretinoin capsules should not be given to patients who are sensitive to parabens, which are used as preservatives in the gelatin capsule.

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

bryant ranch prepack - tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - tretinoin capsules are indicated for the induction of remission in patients with acute promyelocytic leukemia (apl), french-american-british (fab) classification m3 (including the m3 variant), characterized by the presence of the t(15;17) translocation and/or the presence of the pml/rarα gene who are refractory to, or who have relapsed from, anthracycline chemotherapy, or for whom anthracycline based chemotherapy is contraindicated. tretinoin is for the induction of remission only. the optimal consolidation or maintenance regimens have not been defined, but all patients should receive an accepted form of remission consolidation and/or maintenance therapy for apl after completion of induction therapy with tretinoin. tretinoin is contraindicated in patients with a known hypersensitivity to tretinoin, any of its components, or other retinoids.

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

remedyrepack inc. - tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - tretinoin cream is indicated for topical application in the treatment of acne vulgaris. the safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established. use of the product should be discontinued if hypersensitivity to any of the ingredients is noted.

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

avkare - tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - tretinoin capsules are indicated for the induction of remission in patients with acute promyelocytic leukemia (apl), french-american-british (fab) classification m3 (including the m3 variant), characterized by the presence of the t(15;17) translocation and/or the presence of the pml/rarα gene who are refractory to, or who have relapsed from, anthracycline chemotherapy, or for whom anthracycline-based chemotherapy is contraindicated. tretinoin is for the induction of remission only. the optimal consolidation or maintenance regimens have not been defined, but all patients should receive an accepted form of remission consolidation and/or maintenance therapy for apl after completion of induction therapy with tretinoin. tretinoin is contraindicated in patients with a known hypersensitivity to tretinoin, any of its components, or other retinoids.