Acanya Gel

Benzoyl peroxide has an antibacterial effect. It also has a mild drying effect that allows excess oil and dirt to be washed away.

Clindamycin is an antibiotic that prevents bacteria from growing on the skin.

The combination of benzoyl peroxide and clindamycin topical are used to treat acne.

Benzoyl peroxide and clindamycin topical may also be used for purposes not listed in this medication guide.

Do not use this medication if you are allergic to benzoyl peroxide or clindamycin (Cleocin, Clina-Derm, Clindets).

Although this medicine is applied to the skin, your body may absorb enough clindamycin to cause serious side effects. You may not be able to use this medication if you have:

• inflammation of your intestines (also called enteritis);
• ulcerative colitis; or
• if you have ever had severe diarrhea caused by antibiotic medicine.

FDA pregnancy category C. It is not known whether benzoyl peroxide and clindamycin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether benzoyl peroxide and clindamycin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using benzoyl peroxide and clindamycin.

Apply the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Clinical Trials Experience

Because clinical trials are conducted under prescribed conditions, adverse reaction rates observed in the clinical trial may not reflect the rates observed in practice. Because clinical trials are also conducted under widely varying conditions, adverse reactions observed in the clinical trials of a drug cannot always be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The following selected adverse reactions occurred in less than 0.2% of patients treated with ACANYA Gel: application site pain (0.1%); application site exfoliation (0.1%); and application site irritation (0.1%).

During clinical trials, subjects were assessed for local cutaneous signs and symptoms of erythema, scaling, itching, burning and stinging. Most local skin reactions increased and peaked around week 4 and continually decreased over time reaching near baseline levels by week 12. The percentage of subjects that had symptoms present before treatment, the maximum value recorded during treatment, and the percent with symptoms present at week 12 are shown in Table 1.

Table 1: Local Skin Reactions -Percent of Subjects with Symptoms Present. Combined Results from the Two Phase 3 Trials (N = 773)

Postmarketing Experience

Anaphylaxis, as well as allergic reactions leading to hospitalizations, has been reported in postmarketing use of products containing clindamycin/benzoyl peroxide.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Read the entire FDA prescribing information for Acanya (Clindamycin Phosphate 1.2% and Benzoyl Peroxide 2.5%)