Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1403
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Clindamycin Phosphate (Solution)
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| dailymed-instance:dosage |
Apply a thin film of Clindamycin Topical Solution twice daily to affected area. Keep all liquid dosage forms in containers tightly closed.
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| dailymed-instance:descripti... |
Clindamycin Topical Solution contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter. Clindamycin phosphate is a water-soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The solution contains isopropyl alcohol 39% w/v, propylene glycol, and purified water. May contain sodium hydroxide for pH balance. The structural formula is represented below: The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-(��)-D-galacto-octopyranoside 2-(dihydrogen phosphate).
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| dailymed-instance:clinicalP... |
Although clindamycin phosphate is inactive in vitro, rapid in vivo hydrolysis converts this compound to the antibacterially active clindamycin. Cross resistance has been demonstrated between clindamycin and lincomycin. Antagonism has been demonstrated between clindamycin and erythromycin. Following multiple topical applications of clindamycin phosphate at a concentration equivalent to 10 mg clindamycin per mL in an isopropyl alcohol and water solution, very low levels of clindamycin are present in the serum (0-3 ng/mL) and less than 0.2% of the dose is recovered in urine as clindamycin. Clindamycin activity has been demonstrated in comedones from acne patients. The mean concentration of antibiotic activity in extracted comedones after application of clindamycin topical solution for 4 weeks was 597 mcg/g of comedonal material (range 0-1490). Clindamycin in vitro inhibits all Propionibacterium acnes cultures tested (MICs 0.4 mcg/mL). Free fatty acids on the skin surface have been decreased from approximately 14% to 2% following applicationof clindamycin.
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Clindamycin Phosphate Topical Solution USP, 1% containing clindamycin phosphate equivalent to 10 mg clindamycin per milliliter is available in the following sizes: 1 oz (30 mL) applicator bottle���������������.���NDC 51672-4081-32 oz (60 mL) applicator bottle������������������.NDC 51672-4081-4 Store at 20��-25��C (68��-77��F) [see USP Controlled Room Temperature]. Protect from freezing.
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| dailymed-instance:precautio... |
General: Clindamycin Topical Solution contains an alcohol base which will cause burning and irritation of the eye. In the event of accidental contact with sensitive surfaces (eye, abraded skin, mucous membranes), bathe with copious amounts of cool tap water. The solution has an unpleasant taste and caution should be exercised when applying medication around the mouth. Clindamycin should be prescribed with caution in atopic individuals.<br/>Drug Interactions: Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore it should be used with caution in patients receiving such agents.<br/>Pregnancy:<br/>Teratogenic Effects -- Pregnancy Category B: Reproduction studies have been performed in rats and mice using subcutaneous and oral doses of clindamycin ranging from 100 to 600 mg/kg/day and have revealed no evidence of impaired fertility or harm to the fetus due to clindamycin. There are, however, no adequate and well-controlled studies in pregnant women. Becauseanimal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.<br/>Nursing Mothers: It is not known whether clindamycin is excreted in human milk following use of clindamycin topical solution. 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.<br/>Pediatric Use: Safety and effectiveness in pediatric patients under the age of 12 have not been established.<br/>Geriatric Use: Clinical studies for clindamycin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
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Topically applied clindamycin can be absorbed in sufficient amounts to produce systemic effects.
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| dailymed-instance:genericMe... |
Clindamycin Phosphate
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| dailymed-instance:fullName |
Clindamycin Phosphate (Solution)
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| dailymed-instance:adverseRe... |
In 18 clinical studies of various formulations of clindamycin using placebo vehicle and/or active comparator drugs as controls, patients experienced a number of treatment emergent adverse dermatologic events [see table below]. Orally and parenterally administered clindamycin has been associated with severe colitis which may end fatally. Cases of diarrhea, bloody diarrhea and colitis (including pseudomembranous colitis) have been reported as adverse reactions in patients treated with oral and parenteral formulations of clindamycin and rarely with topical clindamycin Abdominal pain and gastrointestinal disturbances as well as gram-negative folliculitis have also been reported in association with the use of topical formulations of clindamycin.
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| dailymed-instance:indicatio... |
Clindamycin 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.
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| dailymed-instance:name |
Clindamycin Phosphate
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