ABD - İngilizce - NLM (National Library of Medicine)

a-s medication solutions - 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.

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

southern cross pharma pty ltd - isotretinoin, quantity: 10 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.

ABD - İngilizce - NLM (National Library of Medicine)

remedyrepack inc. - 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.

ABD - İngilizce - NLM (National Library of Medicine)

oceanside pharmaceuticals - tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - tretinoin 0.5 mg in 1 g

ABD - İngilizce - NLM (National Library of Medicine)

avera mckennan hospital - tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - tretinoin 10 mg

ABD - İngilizce - NLM (National Library of Medicine)

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

ABD - İngilizce - NLM (National Library of Medicine)

preferred pharmaceuticals, inc. - tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - 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.

ABD - İngilizce - NLM (National Library of Medicine)

oceanside pharmaceuticals - tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - tretinoin gel is indicated for topical treatment of acne vulgaris. none. 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 four 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 human exposure, the clinical dose is defined as 2 g of tretinoin gel applied daily to a 50 kg person. oral tretinoin has been shown to be teratogenic in rats, mice, rabbits, hamsters and nonhuman primates. tretinoin was teratogenic in wistar rats when given orally in doses greater than 1 mg/kg/day (approximately eight times the clinical dose based on body surface area 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 (approximately 80 times the clinical dose based on body surface area 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. topical tretinoin in a different formulation has generated equivocal results in animal teratogenicity tests. there is evidence for teratogenicity (shortened or kinked tail) of topical tretinoin in wistar rats at doses greater than 1 mg/kg/day (approximately eight times the clinical dose assuming 100% absorption and based on body surface area comparison). anomalies (humerus: short 13%, bent 6%, os parietal incompletely ossified 14%) have also been reported when 10 mg/kg/day (approximately 160 times the clinical dose assuming 100% absorption and based on body surface area comparison) was topically applied. supernumerary ribs have been a consistent finding in rats when dams were treated topically or orally with retinoids. with widespread use of any drug, a small number of birth defect reports associated temporally with the administration of the drug would be expected by chance alone. cases of temporally associated congenital malformations have been reported with use of other topical tretinoin products. the significance of these spontaneous reports in terms of risk to the fetus is not known. nonteratogenic effects on fetuses: oral tretinoin has been shown to be fetotoxic in rats when administered in doses 20 times the clinical dose based on body surface area comparison. topical tretinoin has been shown to be fetotoxic in rabbits when administered in doses eight times the clinical dose based on body surface area comparison. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when tretinoin gel is administered to a nursing woman. safety and effectiveness in children below the age of 10 have not been established. a total of 381 pediatric subjects (aged 10 to 16 years) treated with tretinoin gel were enrolled into the two clinical studies. across these two studies, comparable safety and efficacy were observed between pediatric and adult subjects. safety and effectiveness in a geriatric population have not been established. clinical studies of tretinoin gel did not include any subjects over age 65 to determine whether they respond differently from younger subjects.

ABD - İngilizce - 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

ABD - İngilizce - 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.