Revised SPC: Dalacin T (clindamycin) Topical Solution

Although post-marketing studies have indicated a very low incidence of pseudomembranous colitis with Dalacin T Lotion, the physician should be alert to the development of antibiotic-associated diarrhoea or colitis, and it should be stopped immediately if diarrhoea occurs.

SPS commentary:

The SPC has also been updated to note that fertility studies in rats treated orally with up to 300 mg/kg/day (72-fold the human exposure based on mg/m2) revealed no effects on fertility or mating ability.


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