CLINDAMYCIN

Apply a thin film of this medicine twice daily to the affected area. Shake well before use.

The table below lists the adverse reactions identified through clinical trial experience and post-marketing surveillance by system organ class and frequency. Adverse reactions identified from post-marketing experience are included in italics.

The frequency grouping is defined using the following convention:

Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very Rare (<1/10,000) and Not known (frequency cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

8). Use of the topical formulation of clindamycin results in absorption of the antibiotic from the skin surface. Diarrhoea and colitis have been reported infrequently with topical clindamycin. Therefore, the physician should, nonetheless, be alert to the development of antibiotic-associated diarrhoea or colitis.

If significant or prolonged diarrhoea occurs, the drug should be discontinued and appropriate diagnostic procedures and treatment provided as necessary. Diarrhoea, colitis, and pseudomembranous colitis have been observed to begin up to several weeks following cessation of oral and parenteral therapy with clindamycin.

Studies indicate a toxin(s) produced by Clostridium difficile is the major cause of antibiotic-associated colitis. Colitis is usually characterized by persistent, severe diarrhoea and abdominal cramps. Endoscopic examination may reveal pseudomembranous colitis.

Stool culture for C. difficile and/or assay for C. difficile toxin may be helpful to diagnosis. Vancomycin is effective in the treatment of antibiotic-associated colitis produced by C. difficile. The usual dose is 125 - 500 mg orally every 6 hours for 7 - 10 days.

Additional supportive medical care may be necessary. Mild cases of colitis may respond to discontinuance of clindamycin alone. Colestyramine and colestipol resins have been shown to bind C. difficile toxin in vitro, and cholestyramine has been effective in the treatment of some mild cases of antibiotic-associated colitis.

Colestyramine resins have been shown to bind vancomycin; therefore, when both colestyramine and vancomycin are used concurrently, their administration should be separated by at least two hours. The lotion has an unpleasant taste and caution should be exercised when applying medication around the mouth.

This medicine should be prescribed with caution to atopic individuals.

1. This medicine is contraindicated in individuals with a history of inflammatory bowel disease or a history of antibiotic-associated colitis.