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)

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

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

avkare - 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

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

spear dermatology products inc - tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - tretinoin 1 mg in 1 g - tretinoin gel microsphere , 0.1% and 0.04%, 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 gel microsphere , 0.1% and 0.04%. 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 maximum recommended human dose (mrhd) applied topically is defined as 1 gram of tre

Australia - English - Department of Health (Therapeutic Goods Administration)

southern cross pharma pty ltd - isotretinoin, quantity: 20 mg - capsule, soft - excipient ingredients: soya oil; yellow beeswax; hydrogenated soya oil; partially hydrogenated soya oil; gelatin; glycerol; titanium dioxide; iron oxide red; iron oxide yellow; propylene glycol; brilliant blue fcf; ethanol; purified water; shellac; strong ammonia solution - treatment of severe cystic acne. a single course of therapy has been shown to result in complete and prolonged remission of disease in many patients. if a second course of therapy is needed, it should not be initiated until at least eight weeks after completion of the first course, since experience has shown that patients may continue to improve while off the drug. because of significant adverse effects associated with its use, isotretinoin should be reserved for patients with severe cystic acne who are unresponsive to conventional therapy, including systemic antibiotics.

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)

obagi cosmeceuticals llc - tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - tretinoin 0.05 g in 100 g - 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)

dispensing solutions, inc. - tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - tretinoin 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. 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

amneal pharma australia pty ltd - isotretinoin -

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

rebel distributors corp - tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - 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.