Included as part of the PRECAUTIONS section.

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. When significant diarrhea occurs, ACANYA Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) 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 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.

Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against C. difficile colitis.

Ultraviolet Light and Environmental Exposure

Minimize sun exposure following drug application [See Nonclinical Toxicology].

Patient Counseling Information

See FDA-Approved Patient Labeling.

Instructions for Use

• ACANYA Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) is to be used as directed by the physician. It is for external use only. Avoid contact with eyes, and inside the nose, mouth, and all mucous membranes, as the product may be irritating.
• This medication should not be used for any disorder other than that for which it was prescribed.
• Patients should not use any other topical acne preparation unless otherwise directed by their physician.
• Once a day, wash the affected areas gently with a mild soap, rinse with warm water, and pat dry. After the skin is dry, apply ACANYA Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) as a thin layer to the affected areas (excluding the eyes and lips).
• Do not apply ACANYA Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) to cuts or open wounds.
• Do not wash your face more than 2 to 3 times a day.
• Wash your hands with soap and water after applying ACANYA Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) .
• Patients should be advised not to use more than the recommended amount and not to apply more often than once daily as this will not make for faster results.
• ACANYA Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) may bleach hair or colored fabric.

Skin Irritation

ACANYA Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) may cause irritation such as erythema, scaling, itching, burning, or stinging.

Patients should report any signs or symptoms of local skin irritation to their physician.

Colitis

In the event a patient treated with ACANYA Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) experiences severe diarrhea or gastrointestinal discomfort, ACANYA Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) should be discontinued and a physician should be contacted.

Allergic Reactions

Patients who develop allergic reactions, such as severe swelling, severe itching, or shortness of breath, should discontinue ACANYA Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) and contact their physician immediately. Patients should report signs of severe local adverse reactions to their physician.

Ultraviolet Light and Environmental Exposure

Patient should minimize exposure to natural and avoid artificial sunlight (tanning beds or UVA/B treatment) while using ACANYA Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) . To minimize exposure to sunlight, a wide-brimmed hat or other protective clothing should be worn and a sunscreen with SPF 15 rating or higher should be used.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, mutagenicity and impairment of fertility testing of ACANYA Gel have not been performed.

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 topically twice per week for 20 weeks induced skin tumors in transgenic Tg.AC mice. The clinical significance of this is unknown.

Carcinogenicity studies have been conducted with a gel formulation containing 1% clindamycin and 5% benzoyl peroxide. In a 2-year dermal carcinogenicity study in mice, treatment with the gel formulation at doses of 900, 2700, and 15000 mg/kg/day (1.8, 5.4, and 30 times amount of clindamycin and 3.6, 10.8, and 60 times amount of benzoyl peroxide in the highest recommended adult human dose of 2.5 g ACANYA Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) based on mg/m², respectively) did not cause any increase in tumors. However, topical treatment with a different gel formulation containing 1% clindamycin and 5% benzoyl peroxide at doses of 100, 500, and 2000 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 an oral (gavage) carcinogenicity study in rats, treatment with the gel formulation at doses of 300, 900 and 3000 mg/kg/day (1.2, 3.6, and 12 times amount of clindamycin and 2.4, 7.2, and 24 times amount of benzoyl peroxide in the highest recommended adult human dose of 2.5 g ACANYA Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) based on mg/m², respectively) for up to 97 weeks did not cause any increase in tumors. In a 52-week dermal 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 administration of the higher concentration benzoyl peroxide formulation (5000 and 10000 mg/kg/day, 5 days/week) and exposure to ultraviolet radiation.

Clindamycin phosphate was not genotoxic in the human lymphocyte chromosome aberration assay. Benzoyl peroxide has been found to cause DNA strand breaks in a variety of mammalian cell types, to be mutagenic in S. typhimurium tests by some but not all investigators, and to cause sister chromatid exchanges in Chinese hamster ovary cells.

Fertility studies have not been performed with ACANYA Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) or benzoyl peroxide, but fertility and mating ability have been studied with clindamycin. 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 ACANYA Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) , based on mg/m²) revealed no effects on fertility or mating ability.

Use In Specific Populations

Pregnancy

Pregnancy Category C

There are no well-controlled trials in pregnant women treated with ACANYA Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) . It also is not known whether ACANYA Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) can cause fetal harm when administered to a pregnant woman. ACANYA Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Animal reproductive/developmental toxicity studies have not been conducted with ACANYA Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) or benzoyl peroxide. Developmental toxicity studies of clindamycin performed in rats and mice using oral doses of up to 600 mg/kg/day (240 and 120 times amount of clindamycin in the highest recommended adult human dose based on mg/m², respectively) or subcutaneous doses of up to 200 mg/kg/day (80 and 40 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 clindamycin is excreted in human milk after topical application of ACANYA Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) . 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 use ACANYA Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) while nursing, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness of ACANYA Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) in pediatric patients under the age of 12 have not been evaluated.

Clinical trials of ACANYA Gel included patients 12-17 years of age. [See Clinical Studies]

Geriatric Use

Clinical studies of ACANYA Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) did not include sufficient numbers of patients aged 65 and older to determine whether they respond differently from younger patients.

Last reviewed on RxList: 7/20/2010
This monograph has been modified to include the generic and brand name in many instances.