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

oceanside pharmaceuticals - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c), tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - clindamycin phosphate 1.2% and tretinoin 0.025% gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older. clindamycin phosphate 1.2% and tretinoin 0.025% gel is contraindicated in patients with regional enteritis, ulcerative colitis, or history of antibiotic-associated colitis. pregnancy category c. there are no well-controlled trials in pregnant women treated with clindamycin phosphate 1.2% and tretinoin 0.025% gel. clindamycin phosphate 1.2% and tretinoin 0.025% gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. clindamycin phosphate 1.2% and tretinoin 0.025% gel was tested for maternal and developmental toxicity in new zealand white rabbits with topical doses of 60, 180 and 600 mg/kg/day. clindamycin phosphate 1.2% and tretinoin 0.025% gel at 600 mg/kg/day (approximately 12 times the recommended clinical dose assuming 100% absorption and based on body surface area comparison) was considered to be the no-observed-adve

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

actavis pharma, inc. - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c), tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - clindamycin 12 mg in 1 g - clindamycin phosphate and tretinoin gel 1.2% / 0.025% is indicated for the topical treatment of acne vulgaris in patients 12 years or older. clindamycin phosphate and tretinoin gel is contraindicated in patients with regional enteritis, ulcerative colitis, or history of antibiotic-associated colitis. pregnancy category c. there are no well-controlled trials in pregnant women treated with clindamycin phosphate and tretinoin gel. clindamycin phosphate and tretinoin gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. clindamycin phosphate and tretinoin gel was tested for maternal and developmental toxicity in new zealand white rabbits with topical doses of 60, 180 and 600 mg/kg/day. clindamycin phosphate and tretinoin gel at 600 mg/kg/day (approximately 12 times the recommended clinical dose assuming 100% absorption and based on body surface area comparison) was considered to be the no-observed-adverse-effect level (noael) for maternal and developmental toxicity following dermal administration of clindamycin phosphate and tretinoin gel for two weeks prior to artificial insemination and continuing until gestation day 18, inclusive. for purposes of comparisons of the animal exposure to human exposure, the recommended clinical dose is defined as 1 g of clindamycin phosphate and tretinoin gel applied daily to a 60 kg person. clindamycin teratology (segment ii) studies using clindamycin were performed orally in rats (up to 600 mg/kg/day) and mice (up to 100 mg/kg/day) (583 and 49 times amount of clindamycin in the recommended clinical dose based on a body surface area comparison, respectively) or with subcutaneous doses of clindamycin up to 180 mg/kg/day (175 and 88 times the amount of clindamycin in the recommended clinical dose based on a body surface area comparison, respectively) revealed no evidence of teratogenicity. tretinoin in oral segment iii studies in rats with tretinoin, decreased survival of neonates and growth retardation were observed at doses in excess of 2 mg/kg/day (~ 78 times the recommended clinical dose assuming 100% absorption and based on body surface area comparison). 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. thirty cases of temporally associated congenital malformations have been reported during two decades of clinical use of another formulation of topical tretinoin. although no definite pattern of teratogenicity and no causal association have been established from these cases, 5 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. dermal tretinoin has been shown to be fetotoxic in rabbits when administered in doses 40 times the recommended human clinical dose based on a body surface area comparison. oral tretinoin has been shown to be fetotoxic in rats when administered in doses 78 times the recommended clinical dose based on a body surface area comparison. it is not known whether clindamycin is excreted in human milk following use of clindamycin phosphate and tretinoin gel. however, orally and parenterally administered clindamycin has been reported to appear in breast milk. because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. it is not known whether tretinoin is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when clindamycin phosphate and tretinoin gel is administered to a nursing woman. safety and effectiveness of clindamycin phosphate and tretinoin gel in pediatric patients under the age of 12 have not been established. clinical trials of clindamycin phosphate and tretinoin gel included patients 12 to 17 years of age. [see clinical studies (14)] clinical studies of clindamycin phosphate and tretinoin gel did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

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

viatris pty ltd - tretinoin, quantity: 0.25 mg; clindamycin phosphate, quantity: 12 mg (equivalent: clindamycin, qty 10 mg) - gel - excipient ingredients: purified water; disodium edetate; methyl hydroxybenzoate; carbomer 981; butylated hydroxytoluene; polysorbate 80; citric acid; glycerol; propyl hydroxybenzoate; trometamol - acnatac is indicated for the topical treatment of acne vulgaris when comedones, papules and pustules are present in patients 12 years or older. consideration should be given to official guidance on the appropriate use of antibacterial agents and acne treatment.

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

prasco laboratories - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c), tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - clindamycin phosphate and tretinoin gel, 1.2%/0.025% is indicated for the topical treatment of acne vulgaris in patients 12 years and older. clindamycin phosphate and tretinoin gel is contraindicated in patients with regional enteritis, ulcerative colitis, or history of antibiotic-associated colitis. pregnancy category c. there are no well-controlled studies in pregnant women treated with clindamycin phosphate and tretinoin gel. clindamycin phosphate and tretinoin gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. a limit teratology study performed in sprague dawley rats treated topically with clindamycin phosphate and tretinoin gel or 0.025% tretinoin gel at a dose

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

solaris pharma corporation - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c), tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - clindamycin phosphate and tretinoin gel is indicated for the topical treatment of acne vulgaris in patients 12 years and older. clindamycin phosphate and tretinoin gel is contraindicated in patients with regional enteritis, ulcerative colitis, or history of antibiotic-associated colitis. pregnancy category c. there are no well-controlled studies in pregnant women treated with clindamycin phosphate and tretinoin gel. clindamycin phosphate and tretinoin gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. a limit teratology study performed in sprague dawley rats treated topically with clindamycin phosphate and tretinoin gel or 0.025% tretinoin gel at a dose of 2 ml/kg during gestation days 6 to 15 did not result in teratogenic effects. although no systemic levels of tretinoin were detected, craniofacial and heart abnormalities were described in drug-treated groups. these abnormalities are consistent with retinoid effects and occurred at 16 times the recomm

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

bausch health us, llc - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c), tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - clindamycin 12 mg in 1 g - ziana gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older. ziana gel is contraindicated in patients with regional enteritis, ulcerative colitis, or history of antibiotic-associated colitis. pregnancy category c. there are no well-controlled trials in pregnant women treated with ziana gel. ziana gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. ziana gel was tested for maternal and developmental toxicity in new zealand white rabbits with topical doses of 60, 180 and 600 mg/kg/day. ziana gel at 600 mg/kg/day (approximately 12 times the recommended clinical dose assuming 100% absorption and based on body surface area comparison) was considered to be the no-observed-adverse-effect level (noael) for maternal and developmental toxicity following dermal administration of ziana gel for 2 weeks prior to artificial insemination and continuing until gestation day 18, inclusive. for purposes of comparisons of the animal expos

Ireland - English - HPRA (Health Products Regulatory Authority)

european regulatory affairs t/a ivowen - clindamycin phosphate; benzoyl peroxide, hydrous - gel - 10 + 50 milligram(s)/gram - clindamycin, combinations

Ireland - English - HPRA (Health Products Regulatory Authority)

morningside healthcare (malta) limited - clindamycin phosphate; benzoyl peroxide, hydrous - gel - clindamycin, combinations

Malta - English - Medicines Authority

meda pharmaceuticals limited - clindamycin phosphate; tretinoin - gel - clindamycin phosphate 10 mg/g; tretinoin 0.25 mg/g - anti-acne preparations

Malta - English - Medicines Authority

mylan ire healthcare limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - clindamycin phosphate, tretinoin - gel - clindamycin phosphate 10 mg/g tretinoin 0.25 mg/g - anti-acne preparations