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rebel distributors corp - tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - tretinoin 0.1 mg in 1 g - tretinoin gel and cream are 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)

triax pharmaceuticals, llc - tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - tretinoin 0.25 mg in 1 g - tretinoin gel and cream are 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. safety and effectiveness in pediatric patients below the age of 12 have not been established. safety and effectiveness in a geriatric population have not been established. clinical studies of tretinoin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger patients.

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

amneal pharmaceuticals ny llc - isotretinoin (unii: eh28up18if) (isotretinoin - unii:eh28up18if) - isotretinoin 10 mg - severe recalcitrant nodular acne isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne. nodules are inflammatory lesions with a diameter of 5 mm or greater. the nodules may become suppurative or hemorrhagic. “severe,” by definition,2 means “many” as opposed to “few or several” nodules. because of significant adverse effects associated with its use, isotretinoin capsules should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics . in addition, isotretinoin capsulesare indicated only for those patients who are not pregnant, because isotretinoin capsules can cause life-threatening birth defects (see boxed contraindications and warnings ). a single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients.1,3,4 if a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off isotretinoin capsules. the optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see warnings, skeletal, bone mineral density, hyperostosis, premature epiphyseal closure ). pregnancy: category x. see boxed contraindications and warnings . allergic reactions isotretinoin capsules are contraindicated in patients who are hypersensitive to this medication or to any of its components (see precautions, hypersensitivity ).

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

actavis pharma, inc. - tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - tretinoin 0.25 mg in 1 g - tretinoin cream, usp is indicated for topical application in the treatment of acne vulgaris. the safety and efficacy of this product in the treatment of other disorders have not been established. the product should not be used if there is hypersensitivity to any of the ingredients.

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

padagis us llc - tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - tretinoin 0.25 mg in 1 g - tretinoin gel and cream are 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)

spear dermatology products inc - tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - tretinoin 0.25 mg in 1 g - tretinoin 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)

preferred pharmaceuticals inc. - tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - tretinoin 0.5 mg in 1 g - tretinoin gel and cream are 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)

glenmark pharmaceuticals inc., usa - tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - tretinoin 10 mg - tretinoin capsules are indicated for the induction of remission in adults and pediatric patients 1 year of age and older with acute promyelocytic leukemia (apl) characterized by the presence of the t(15;17) translocation or pml/rarα gene expression, and who are refractory to or who have relapsed from anthracycline chemotherapy or for whom anthracycline-based chemotherapy is contraindicated. tretinoin is contraindicated in patients with a known hypersensitivity to tretinoin, any of its components, or other retinoids. reactions have included rash, pruritus, face edema, and dyspnea. [see adverse reactions (6.1)]. click here to enter use in specific populations risk summary based on findings in animals and its mechanism of action [see clinical pharmacology (12.1)], tretinoin can cause embryo-fetal loss and malformations when administered to a pregnant woman. tretinoin is a retinoid and there is an increased risk of major congenital malformations, spontaneous abortions and premature births following exposure to r

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

oceanside pharmaceuticals - tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - tretinoin 1 mg in 1 g - tretinoin gel microsphere is a retinoid indicated for topical application in the treatment of acne vulgaris. none. pregnancy category c 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 tretinoin/kg body weight). pregnant rats were treated with tretinoin gel microsphere, 0.1%, at daily dermal doses of 0.5 to 1.0 mg/kg/day tretinoin on gestation days 6-15. alterations were seen in vertebrae and ribs of offspring at 5 to 10 times the mrhd based on the body surface area (bsa) comparison. pregnant new zealand white rabbits were treated with tretinoin gel microsphere, 0.1%, at daily dermal doses of 0.2, 0.5, and 1.0 mg/kg/day tretinoin on gestation days 7-19. doses were administered topically for 24 hours a day while wearing elizabethan collars to prevent ingestion of the drug. increased incidences of certain alterations, including domed head and hydrocephaly, typical of retinoid-induced fetal malformations in this species, were observed at 0.5 and 1.0 mg/kg/day. similar malformations were not observed at 0.2 mg/kg/day, 4 times the mrhd based on bsa comparison. other pregnant rabbits exposed topically for six hours per day to 0.5 or 1.0 mg/kg/day tretinoin while restrained in stocks to prevent ingestion, did not show any malformations at doses up to 19 times (1.0 mg/kg/day) the mrhd based on bsa comparison, but fetal resorptions were increased at 0.5 mg/kg (10 times the mrhd based on bsa comparison). oral tretinoin has been shown to cause malformations in rats, mice, rabbits, hamsters, and nonhuman primates. tretinoin induced fetal malformations in wistar rats when given orally at doses greater than 1 mg/kg/day (10 times the mrhd based on bsa comparison). in the cynomolgus monkey, fetal malformations were reported for doses of 10 mg/kg/day but none were observed at 5 mg/kg/day (95 times the mrhd based on bsa comparison), although increased skeletal variations were observed at all doses. dose-related increases in embryolethality and abortion also were reported. similar results have also been reported in pigtail macaques. in oral peri- and postnatal development studies in rats with tretinoin, decreased survival of neonates and growth retardation were observed at doses in excess of 2 mg/kg/day (19 times the mrhd based on bsa comparison). nonteratogenic effects on fetus oral tretinoin has been shown to be fetotoxic in rats when administered at doses 24 times the mrhd based on bsa comparison. topical tretinoin has been shown to be fetotoxic in rabbits when administered at doses 10 times the mrhd based on bsa comparison. it is not known whether tretinoin and/or its metabolites are excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when tretinoin gel microsphere is administered to a nursing woman. safety and effectiveness in children below the age of 12 have not been established. safety and effectiveness in a geriatric population have not been established. clinical trials of tretinoin gel microsphere, 0.1%, 0.08% and 0.04%, did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger subjects.

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

american health packaging - tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - tretinoin 10 mg - 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