ABSORPTION OF CLINDAMYCIN AFTER INTRAVAGINAL APPLICATION OF CLINDAMYCIN PHOSPHATE 2-PERCENT CREAM

In recent clinical studies, clindamycin phosphate cream administered i ntravaginally has been shown to be efficacious in the treatment of bac terial vaginosis (BV). In support of the safety profile for this dosag e form, a study assessing the systemic absorption of clindamycin was u ndertaken in five BV patients and six healthy volunteers who were dose d with 5 mt (100 mg) clindamycin phosphate 2% cream intravaginally onc e daily in the evening for 7 days. Two weeks later, a single 100 mg do se of clindamycin phosphate sterile solution was administered as a 4 m in iv infusion. Serial blood samples were collected on days 1, 4, and 7 after dosing with the cream and over a 16 h period after the iv trea tment. Clindamycin concentrations in serum samples were assayed by cap illary gas chromatography. After treatment with the cream, steady-stat e serum clindamycin concentrations were reached by 24 h in all but one subject in each group. Mean absolute bioavailability was 2.7%-4.3% in the BV group and 2.7%-4.7% in the healthy group. These results indica te that systemic exposure to clindamycin from intravaginal administrat ion of clindamycin phosphate cream is minimal.