clindamycin phosphate

CLINICAL STUDIES In one 12-week multicenter, randomized, evaluator-blind, vehicle-controlled, parallel comparison clinical trial in which patients used Clindamycin Phosphate Topical Gel, 1%, once daily or the vehicle gel once daily, in the treatment of acne vulgaris of mild to moderate severity, Clindamycin Phosphate Topical Gel applied once daily was more effective than the vehicle applied once daily. The mean percent reductions in lesion counts at the end of treatment in this study are shown in the following table: Lesions Clindamycin Phosphate Topical Gel QD N=162 Vehicle Gel QD N=82 Inflammatory 51% 40% P<0.05 Noninflammatory 25% 12% Total 38% 27% There was a trend in the investigator’s global assessment of the results, which favored Clindamycin Phosphate Topical Gel QD over the vehicle QD. In a contact sensitization study, four of the 200 subjects appeared to develop suggestive evidence of allergic contact sensitization to Clindamycin Phosphate Topical Gel. There was no signal for contact sensitization in the clinical trials under normal use conditions.

DOSAGE AND ADMINISTRATION Apply a thin film of, clindamycin phosphate topical lotion, clindamycin phosphate topical gel, clindamycin phosphate topical solution, or use a clindamycin phosphate topical solution pledget for the application of clindamycin phosphate twice daily to affected area. More than one pledget may be used. Each pledget should be used only once and then be discarded. Clindamycin phosphate topical solution is flammable. Avoid fire, flame, and smoking during and immediately following application. Lotion: Shake well immediately before using. Pledget: Remove pledget from foil just before use. Do not use if the seal is broken. Discard after single use. Keep all liquid dosage forms in containers tightly closed.

CONTRAINDICATIONS Clindamycin phosphate topical solution, clindamycin phosphate topical gel and clindamycin phosphate topical lotion are 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 the one well-controlled clinical study comparing Clindamycin Phosphate Topical Gel and its vehicle, the incidence of skin and appendages adverse events occurring in ≥1% of the patients in either group is presented in the following table: Number (%) of Patients Body System/Adverse Event Clindamycin Phosphate Topical Gel QD N=168 Vehicle Gel QD N=84 Skin and Appendages Disorders • Dermatitis 0 (0.0) 1 (1.2) • Dermatitis contact 0 (0.0) 1 (1.2) • Dermatitis fungal 0 (0.0) 1 (1.2) • Folliculitis 0 (0.0) 1 (1.2) • Photosensitivity reaction 0 (0.0) 1 (1.2) • Pruritus 1 (0.6) 1 (1.2) • Rash erythematous 0 (0.0) 0 (0.0) • Skin dry 0 (0.0) 0 (0.0) • Peeling 1 (0.6) 0 (0.0) 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 ). 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. To report SUSPECTED ADVERSE REACTIONS, contact Oceanside Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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.

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

DESCRIPTION Clindamycin phosphate topical solution and clindamycin phosphate topical lotion contain clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter. Clindamycin phosphate topical gel contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram. Each clindamycin phosphate topical solution pledget applicator contains approximately 1 mL of topical solution. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibacterial drug produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The solution contains isopropyl alcohol 50% v/v, propylene glycol, and water. The gel contains allantoin, carbomer 934P, methylparaben, polyethylene glycol 400, propylene glycol, sodium hydroxide, and purified water. The lotion contains cetostearyl alcohol (2.5%); glycerin; glyceryl stearate SE (with potassium monostearate); isostearyl alcohol (2.5%); methylparaben (0.3%); sodium lauroyl sarcosinate; stearic acid; 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). Chemical Structure

OVERDOSAGE Topically applied Clindamycin Phosphate Topical Gel may be absorbed in sufficient amounts to produce systemic effects (see WARNINGS ).

HOW SUPPLIED Clindamycin phosphate topical solution containing clindamycin phosphate equivalent to 10 mg clindamycin per milliliter is available in the following sizes: 30 mL applicator bottle—NDC 59762-3728-1 60 mL applicator bottle—NDC 59762-3728-2 Carton of 60 single-use pledget applicators—NDC 59762-3728-3 Clindamycin phosphate topical gel containing clindamycin phosphate equivalent to 10 mg clindamycin per gram is available in the following sizes: 30 gram tube—NDC 59762-3743-1 60 gram tube—NDC 59762-3743-2 Clindamycin phosphate topical lotion containing clindamycin phosphate equivalent to 10 mg clindamycin per milliliter is available in the following size: 60 mL plastic squeeze bottle—NDC 59762-3744-1 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Protect from freezing. Clindamycin phosphate topical solution is flammable. Keep away from heat, sparks or open flames.