Jane S. Ricciuti, RPh, MS

Disclosures

September 20, 2002

In This Article

Dermatologic Agents

Duac
(clindamycin, 1%, and benzoyl peroxide, 5%) Topical Gel

Manufacturer: Stiefel Laboratories, Inc

Drug Approval Classification: Original New Drug Application (Approval Date: 8/26/02)

Indication: Duac topical gel is indicated for the topical treatment of inflammatory acne vulgaris. Duac topical gel has not been demonstrated to have any additional benefit when compared with benzoyl peroxide alone in the same vehicle when used for the treatment of noninflammatory acne.

Dosing: Duac topical gel is applied once daily, in the evening or as directed by the physician, to affected areas after the skin is gently washed, rinsed with warm water, and patted dry.

Clinical Summary: Duac topical gel was studied in 1319 patients in 5 randomized, double-blind clinical studies. Duac topical gel was applied once daily for 11 weeks. Patients with inflammatory acne lesions who applied Duac showed greater overall improvement in the global assessment score than did patients who applied benzoyl peroxide alone.

Adverse Effects: Significant warnings for antibiotic-associated colitis are included in the labeling for Duac topical gel. Clindamycin, oral and parenteral formulations, have been associated with severe colitis. Duac topical gel is absorbed through the skin surface, and reports of diarrhea, bloody diarrhea, and colitis (pseudomembranous colitis) have been submitted with topical clindamycin products.

Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents.

Adverse events associated with Duac topical gel include erythema, peeling, burning, and dryness of the skin.

Duac (clindamycin, 1%, and benzoyl peroxide, 5%) Topical Gel Labeling

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