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

physicians total care, inc. - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c) - clindamycin phosphate 20 mg in 1 g - clindamycin phosphate vaginal cream 2%, is indicated in the treatment of bacterial vaginosis (formerly referred to as haemophilus vaginitis, gardnerella vaginitis, nonspecific vaginitis, corynebacterium vaginitis, or anaerobic vaginosis). clindamycin phosphate vaginal cream 2%, can be used to treat non-pregnant women and pregnant women during the second and third trimester. (see clinical studies.) note: for purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a ph of greater than 4.5, (b) emits a "fishy" amine odor when mixed with a 10% koh solution, and (c) contains clue cells on microscopic examination. gram's stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent lactobacillus morphology, (b) predominance of gardnerella morphotype, and (c) absent or few white blood cells. other pathogens commonly associated with vulvovaginitis, e.g., trichomonas vagin

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

alphapharm pty ltd - clindamycin phosphate, quantity: 714 mg (equivalent: clindamycin, qty 600 mg) - injection, solution - excipient ingredients: sodium hydroxide; hydrochloric acid; water for injections; disodium edetate - clindamycin viatris is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.,clindamycin viatris is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci and staphylococci.,its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgement of the physician, a penicillin is inappropriate.

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

alphapharm pty ltd - clindamycin phosphate, quantity: 357 mg (equivalent: clindamycin, qty 300 mg) - injection, solution - excipient ingredients: sodium hydroxide; hydrochloric acid; water for injections; disodium edetate - clindamycin viatris is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.,clindamycin viatris is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci and staphylococci.,its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgement of the physician, a penicillin is inappropriate.

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.

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

fresenius kabi usa, llc - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c) - clindamycin phosphate 150 mg in 1 ml - clindamycin injection, usp is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. clindamycin injection, usp is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate.  because of the risk of antibiotic-associated pseudomembranous colitis, as described in the boxed  warning , before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. indicated surgical procedures should be performed in conjunction with antibiotic therapy. clindamycin injection, usp is indicated in the treatment of serious infections caused by susceptible strains of the

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

padagis israel pharmaceuticals ltd - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c), benzoyl peroxide (unii: w9wzn9a0gm) (benzoyl peroxide - unii:w9wzn9a0gm) - clindamycin 10 mg in 1 g - clindamycin phosphate and benzoyl peroxide gel, 1.2%/5% is indicated for the topical treatment of inflammatory acne vulgaris in patients 12 years and older. clindamycin phosphate and benzoyl peroxide gel, 1.2%/5% has not been demonstrated to have any additional benefit when compared with benzoyl peroxide alone in the same vehicle when used for the treatment of non-inflammatory acne. clindamycin phosphate and benzoyl peroxide gel, 1.2%/5% is contraindicated in those individuals who have shown hypersensitivity to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin. anaphylaxis, as well as allergic reactions leading to hospitalization, has been reported in postmarketing use with clindamycin phosphate and benzoyl peroxide gel, 1.2%/5% [see adverse reactions (6.2) ]. clindamycin phosphate and benzoyl peroxide gel, 1.2%/5% is contraindicated in those individuals with a history of regional enteritis, ulcerative colitis, pseudomembranous colitis, or antibiotic-associated colitis [see warni

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

padagis israel pharmaceuticals ltd - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c) - clindamycin 10 mg in 1 g - clindamycin phosphate foam is indicated for topical application in the treatment of acne vulgaris in patients 12 years and older. clindamycin phosphate foam is contraindicated in individuals with a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis (including pseudomembranous colitis). risk summary there are no available data on clindamycin phosphate foam use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. animal reproduction studies have not been conducted with clindamycin phosphate foam. no evidence of fetal harm or malformations was observed in pregnant rats and mice administered daily subcutaneous or oral doses of clindamycin salts during organogenesis at doses that produced exposures up to 84 and 42 times, respectively, the maximum recommended human dose (mrhd) of clindamycin phosphate foam based on body surface area (bsa) comparisons and assuming 100% absorption [see data] . in the u.s. general population, the estimat

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

preferred pharmaceuticals inc. - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c) - clindamycin phosphate topical solution usp, 1% is indicated in the treatment of acne vulgaris. in view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate. (see contraindications, warnings and adverse reactions.) clindamycin phosphate topical solution usp, 1% is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin, a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.

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

teligent pharma, inc. - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c) - clindamycin phosphate topical solution is indicated in the treatment of acne vulgaris. in view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate. (see contraindications, warnings and adverse reactions.) clindamycin phosphate topical solution is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin, a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.

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

encube ethicals private limited - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c) - clindamycin phosphate gel, 1% is indicated in the treatment of acne vulgaris. in view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate (see contraindications, warnings and adverse reactions). clindamycin phosphate gel is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin, a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.