Duac Topical Gel

Duac Topical Gel

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Colitis

Systemic absorption of clindamycin has been demonstrated following topical use of clindamycin. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin. If significant diarrhea occurs, DUAC Gel should be discontinued.

Severe colitis has occurred following oral and parenteral administration of clindamycin with an onset of up to several weeks following cessation of therapy. Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong and/or worsen severe colitis. Severe colitis may result in death.

Studies indicate a toxin(s) produced by Clostridia is one primary cause of antibiotic-associated colitis. The colitis is usually characterized by severe persistent diarrhea and severe abdominal cramps and may be associated with the passage of blood and mucus. Stool cultures for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically.

Ultraviolet Light And Environmental Exposure

Benzoyl peroxide, a component of DUAC Gel, may cause increased sensitivity to sunlight. Minimize sun exposure (including use of tanning beds or sun lamps) following drug application. [See Nonclinical Toxicology] Patients who may be required to have considerable sun exposure due to occupation and those with inherent sensitivity to the sun should exercise particular caution.

Patient Counseling Information

See FDA-approved patient labeling (PATIENT INFORMATION).

  • Patients who develop allergic reactions such as severe swelling or shortness of breath should discontinue use and contact their physician immediately.
  • DUAC Gel may cause irritation such as erythema, scaling, itching, or burning, especially when used in combination with other topical acne therapies.
  • Excessive or prolonged exposure to sunlight should be limited. To minimize exposure to sunlight, a hat or other clothing should be worn. Sunscreen may also be used.
  • DUAC Gel may bleach hair or colored fabric.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Benzoyl peroxide has been shown to be a tumor promoter and progression agent in a number of animal studies. Benzoyl peroxide in acetone at doses of 5 and 10 mg administered twice per week induced squamous cell skin tumors in transgenic TgAC mice in a study using 20 weeks of topical treatment. The clinical significance of this is unknown.

In a 2-year dermal carcinogenicity study in mice, treatment with DUAC Gel at doses up to 8,000 mg/kg/day (16 times the highest recommended adult human dose of 2.5 g DUAC Gel, based on mg/m²) did not cause an increase in skin tumors. However, topical treatment with another formulation containing 1% clindamycin and 5% benzoyl peroxide at doses of 100, 500, or 2,000 mg/kg/day caused a dose-dependent increase in the incidence of keratoacanthoma at the treated skin site of male rats in a 2-year dermal carcinogenicity study in rats.

In a 52-week photocarcinogenicity study in hairless mice (40 weeks of treatment followed by 12 weeks of observation), the median time to onset of skin tumor formation decreased and the number of tumors per mouse increased relative to controls following chronic concurrent topical treatment with DUAC Gel and exposure to ultraviolet radiation.

Genotoxicity studies were not conducted with DUAC Gel. Clindamycin phosphate was not genotoxic in Salmonella typhimurium or in a rat micronucleus test. Benzoyl peroxide has been found to cause DNA strand breaks in a variety of mammalian cell types, to be mutagenic in Salmonella typhimurium tests by some but not all investigators, and to cause sister chromatid exchanges in Chinese hamster ovary cells.

Studies have not been performed with DUAC Gel or benzoyl peroxide to evaluate the effect on fertility. Fertility studies in rats treated orally with up to 300 mg/kg/day of clindamycin (approximately 120 times the amount of clindamycin in the highest recommended adult human dose of 2.5 g DUAC Gel, based on mg/m²) revealed no effects on fertility or mating ability.

Use In Specific Populations

Pregnancy

Pregnancy Category C

There are no adequate and well-controlled studies in pregnant women treated with DUAC Gel. DUAC Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Developmental toxicity studies performed in rats and mice using oral doses of clindamycin up to 600 mg/kg/day (240 and 120 times the amount of clindamycin in the highest recommended adult human dose based on mg/m², respectively) or subcutaneous doses of clindamycin up to 250 mg/kg/day (100 and 50 times the amount of clindamycin in the highest recommended adult human dose based on mg/m², respectively) revealed no evidence of teratogenicity.

Nursing Mothers

It is not known whether DUAC Gel is excreted into human milk after topical application. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Because many drugs are excreted in human milk, caution should be exercised when DUAC Gel is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of DUAC Gel in pediatric patients below the age of 12 have not been established.

Geriatric Use

Clinical studies of DUAC Gel did not include sufficient numbers of subjects ages 65 and over to determine whether they respond differently from younger subjects.

Last reviewed on RxList: 1/21/2014
This monograph has been modified to include the generic and brand name in many instances.

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Duac Topical Gel - User Reviews

Duac Topical Gel User Reviews

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Report Problems to the Food and Drug Administration

 

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