Clindamycin Phosphate is a human prescription drug labeled by 'Bryant Ranch Prepack'. National Drug Code (NDC) number for Clindamycin Phosphate is 63629-8631. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Clindamycin Phosphate drug includes Clindamycin Phosphate - 10 mg/g . The currest status of Clindamycin Phosphate drug is Active.

Clindamycin phosphate clindamycin phosphate clindamycin phosphate clindamycin allantoin carbomer homopolymer type b (allyl pentaerythritol crosslinked) methylparaben polyethylene glycol 400 propylene glycol sodium hydroxide water chemical-structure.jpg

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.

Indications and usage clindamycin phosphate gel 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 ).

Warnings orally and parenterally administered clindamycin has been associated with severe colitis which may result in patient death. use of the topical formulation of clindamycin results in absorption of the antibiotic from the skin surface. diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin. studies indicate a toxin(s) produced by clostridia is one primary cause of antibiotic-associated colitis. the colitis is usually characterized by severe persistent diarrhea and severe abdominal cramps and may be associated with the passage of blood and mucus. endoscopic examination may reveal pseudomembranous colitis. stool culture for clostridium difficile and stool assay for c. difficile toxin may be helpful diagnostically. when significant diarrhea occurs, the drug should be discontinued. large bowel endoscopy should be considered to establish a definitive diagnosis in cases of severe diarrhea. antiperi Read more...

General clindamycin phosphate should be prescribed with caution in atopic individuals.

Dosage and administration apply a thin film of clindamycin phosphate gel twice daily to affected area.

Contraindications 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.

Adverse reactions in 18 clinical studies of various formulations of clindamycin phosphate using placebo vehicle and/or active comparator drugs as controls, patients experienced a number of treatment emergent adverse dermatologic events [see table below]. number of patients reporting events treatment emergent adverse event solution n=553(%) gel n=148(%) lotion n=160(%) burning 62 (11) 15 (10) 17 (11) itching 36 (7) 15 (10) 17 (11) burning/itching 60 (11) # (-) # (-) dryness 105 (19) 34 (23) 29 (18) erythema 86 (16) 10 (7) 22 (14) oiliness/oily skin 8 (1) 26 (18) 12* (10) peeling 61 (11) # (-) 11 (7) # not recorded * of 126 subjects 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 (see warnings ). Read more...

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.

Pregnancy: teratogenic effects in clinical trials with pregnant women, the systemic administration of clindamycin during the second and third trimesters has not been associated with an increased frequency of congenital abnormalities. there are no adequate studies in pregnant women during the first trimester of pregnancy. clindamycin should be used during the first trimester of pregnancy only if clearly needed.

Pediatric use safety and effectiveness in pediatric patients under the age of 12 have not been established.

Geriatric use clinical studies for clindamycin phosphate 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.

Overdosage topically applied clindamycin phosphate can be absorbed in sufficient amounts to produce systemic effects (see warnings ).

Description clindamycin phosphate gel usp, 1% contains clindamycin phosphate, usp, at a concentration equivalent to 10 mg clindamycin per gram. 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 gel contains allantoin, carbomer 974p, methylparaben, polyethylene glycol 400, propylene glycol, sodium hydroxide, and purified water. 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 -α-d- galacto -octopyranoside 2-(dihydrogen phosphate).

Clinical pharmacology mechanism of action the mechanism of action of clindamycin in treating acne vulgaris is unknown. pharmacokinetics 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. although clindamycin phosphate is inactive in vitro , rapid in vivo hydrolysis converts this compound to the antibacterially active clindamycin. microbiology clindamycin inhibits bacterial protein synthesis by binding to the 23s rna of the 50s subunit of the ribosome. clindamycin is bacteriostatic. antimicrobial activity clindamycin is active in vitro against most isolates of propionibacterium acnes ; however, the clinical significance is unknown. resistance resistance to clindamycin is most often caused by modification of specific bases of the 23s Read more...

Mechanism of action the mechanism of action of clindamycin in treating acne vulgaris is unknown.

Pharmacokinetics 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. although clindamycin phosphate is inactive in vitro , rapid in vivo hydrolysis converts this compound to the antibacterially active clindamycin.

How supplied clindamycin phosphate gel usp, 1% containing clindamycin phosphate equivalent to 10 mg clindamycin per gram is available in the following sizes: 60 gram tube—ndc 63629-8631-1 store at controlled room temperature 20° to 25°c (68° to 77°f) [see usp]. protect from freezing.

Clindamycin phosphate 1% gel, #60 label