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. Patients were evaluated and acne lesions counted at each clinical visit; weeks 2, 4, 6, 8 and 10. Brand names for clindamycin topical include Clindagel, Cleocin T, Clindacin P, and Cleocin Vaginal. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. 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. It also is not known whether Clindamycin and Benzoyl Peroxide Gel, 1%/5% can cause fetal harm when administered to a pregnant woman.It is not known whether Clindamycin and Benzoyl Peroxide Gel, 1%/5% is excreted in human milk after topical application.
USE OF THE TOPICAL FORMULATION OF CLINDAMYCIN RESULTS IN ABSORPTION OF THE ANTIBIOTIC FROM THE SKIN SURFACE.
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 50% v/v, propylene glycol, purified water, and sodium hydroxide (to adjust the pH to between 4.0 - 7.0). The mean concentration of antibiotic activity in extracted comedones after application of clindamycin phosphate topical solution for 4 weeks was 597 mcg/g of comedonal material (range 0–1490). ALLEGAN, Mich., June 27, 2012 /PRNewswire/ -- Perrigo Company (Nasdaq: PRGO;TASE) today announced that it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application (ANDA) for clindamycin phosphate and benzoyl peroxide 1.2% / 5% topical gel, the generic equivalent of Duac® Gel. More than one pledget may be used. Clindamycin and Benzoyl Peroxide Gel, 1%/5% (~2g) was applied topically to the face and back twice daily for four and a half (4.5) days. Perrigo acquired the ANDA in 2009, transferred … 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 Abdominal pain, gastrointestinal disturbances, gram-negative folliculitis, eye pain and contact dermatitis have also been reported in association with the use of topical formulations of clindamycin.Topically applied Clindamycin Phosphate Topical Solution USP, 1% can be absorbed in sufficient amounts to produce systemic effects (see Do not use if the seal on jar is broken. Orally and parenterally administered clindamycin has been associated with severe colitis which may result in patient death. Available for Android and iOS devices. Clindamycin Phosphate Foam, 1% is for topical use only, and not for oral, ophthalmic or intravaginal use.
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.Clindamycin phosphate has molecular weight of 504.97 and its chemical name is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-alpha-D-galacto-octopyranoside 2-(dihydrogen phosphate).Clindamycin and Benzoyl Peroxide Gel, 1%/5% also contains benzoyl peroxide, for topical use.Each gram of Clindamycin and Benzoyl Peroxide Gel, 1%/5% contains, as dispensed, 10 mg (1%) clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of carbomer homopolymer type C, potassium hydroxide, propylene glycol, and purified water.Benzoyl peroxide has been shown to be absorbed by the skin where it is converted to benzoic acid. Peak plasma concentrations (CThe amount of clindamycin excreted in the urine during the 12 hour dosing interval increased from a mean (SD) of 5745 (3130) ng on Day 1 to 12069 (7660) ng on Day 5.
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