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Each mL of topical solution contains Clindamycin phosphate equivalent to Clindamycin 10 mg.
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 parent antibiotic lincomycin. Clindamycin is active in vitro against Propionibacterium acnes causing acne vulgaris.
In comparison with oral tetracycline, Clindamycin 1% Topical Solution reduced acne lesions by 60% compared to 49% for tetracycline. In additional controlled studies, Clindamycin 1% Topical Solution caused a 58% reduction in acne lesions compared to a 33% reduction with placebo (alcoholic vehicle).
ROSIL (1% Topical Solution) is indicated in the treatment of acne vulgaris.
Apply a thin film of ROSIL (1% Topical Solution) twice daily to affected area.
Patients with known hypersensitivity to Clindamycin or lincomycin.
Patients who have a history of ulcerative colitis or regional enteritis, or a history of antibiotic-associated colitis.
ROSIL (1% Topical Solution) contains an alcoholic vehicle which will cause burning and eye irritation. In the event of accidental contact with sensitive surfaces (eye, abraded skin or mucous membranes), wash with cool tap water.
ROSIL (1% Topical Solution) can be absorbed from skin surface. The drug should be discontinued when significant diarrhea and colitis occurs, and the patient should be advised to consult a physician.
Use in children: Safety and effectiveness of ROSIL (1% Topical Solution) use in children under 12 years have not been established.
Safety for use of ROSIL (1% Topical Solution) in pregnancy and nursing mothers has not been established. 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. Therefore, ROSIL (1% Topical Solution) is not recommended for nursing mothers.
The most common side effects observed with Clindamycin 1% Topical Solution were irritation and erythema (caused by the alcoholic vehicle).
The following adverse reactions were reported: diarrhea, nausea, vomiting, sore throat, headache, dryness, urinary frequency, contact dermatitis, folliculitis, and stinging.
Instruction for use: 1. Wash and keep dry the affected skin area thoroughly.
2. Gently apply a thin film of the solution to affected area.
Do not apply to the eyes or mouth.
Store below 25°C, protect from light.
D10AF01 - clindamycin ; Belongs to the class of topical antiinfective preparations used in the treatment of acne.
Rosil Topical Solution 1%
10 mL x 1's
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