Acanya

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.

Benzoyl peroxide and clindamycin topical (for the skin) is a combination medicine used to treat acne.

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

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.

It is not likely that other drugs you take orally or inject will have an effect on topically applied benzoyl peroxide and clindamycin. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Acanya (clindamycin and benzoyl peroxide gel (10-week storage)) or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Acanya. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Acanya® Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older.

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.

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.

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

Although Acanya 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.

It is not known whether Acanya 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 Acanya.

Tell your doctor about all other medicines you use, especially:

• erythromycin topical (Akne-Mycin, Emcin Clear, Eryderm, Erygel, Erythra-Derm, Ery-Sol, and others); or

• erythromycin taken by mouth (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole, and others).

This list is not complete and other drugs may interact with Acanya. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Common side effects of Acanya include: xeroderma. See below for a comprehensive list of adverse effects.

Applies to benzoyl peroxide / clindamycin topical: external gel, external kit