Benzoyl peroxide and clindamycin Topical application

In Canada

• Clindoxyl

Chemical Class: Lincosamide

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For benzoyl peroxide and clindamycin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to benzoyl peroxide and clindamycin or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of benzoyl peroxide and clindamycin combination in children younger than 12 years of age. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of Duac® gel have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.

No information is available on the relationship of age to the effects of Benzaclin® gel in geriatric patients.

Pregnancy

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking benzoyl peroxide and clindamycin, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using benzoyl peroxide and clindamycin with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Erythromycin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of benzoyl peroxide and clindamycin. Make sure you tell your doctor if you have any other medical problems, especially:

• Stomach or bowel problems (eg, antibiotic-associated colitis, pseudomembranous colitis, regional enteritis, ulcerative colitis), history of—Should not be used in patients with these conditions.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad irritation where this drug is used.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Irritation where this drug is used.
• Dry skin.
• Itching.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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

Dermatologic

Dermatologic side effects have included dry skin (12%), pruritus (2%), peeling (2%), erythema (1%), and sunburn (1%) and reactions at the application site (3%).[Ref]

Application site reactions including burning, stinging, and pruritus are frequently reported following topical application of the combination of 5% benzoyl peroxide and 1% clindamycin.[Ref]

Gastrointestinal

Pseudomembranous colitis may be revealed upon endoscopic examination; stool cultures for Clostridium difficile, and stool assays for Clostridium difficile toxin may be helpful diagnostically.[Ref]

Gastrointestinal side effects have been reported with the use of topical clindamycin. Diarrhea, bloody diarrhea, and colitis, including pseudomembranous colitis, have occurred. Colitis usually manifests as severe persistent diarrhea, severe abdominal cramps, and passage of blood and mucous. Some cases of colitis have been fatal. Due to the possible serious nature of pseudomembranous colitis, patients should be advised to discontinue clindamycin therapy and consult a physician if diarrhea occurs.[Ref]

Hypersensitivity

Hypersensitivity side effects have included anaphylaxis and allergic reactions leading to hospitalization during postmarketing experience.

Other

A 14-year-old boy developed reproducible ringing in his right ear and hearing loss while using topical clindamycin and after discontinuing use. He underwent a complete physical exam and labs which failed to find a cause for his symptoms. The patient was restarted on benzoyl peroxide / clindamycin topical and the ringing in his ear increased. He was told to stop all medications and was started on methylprednisolone. The tinnitus decreased in 1 to 2 days with no improvement in the hearing deficit. After the third time he was restarted on benzoyl peroxide/clindamycin gel, the tinnitus returned at an increased level together with right-sided headaches within 1 to 2 days. The patient again stopped using the benzoyl peroxide and clindamycin gel and the tinnitus returned to a low level over 1 to 2 days. It is believed that the clindamycin component played a part in this patient's tinnitus and hearing loss.[Ref]

Other side effects have included one case of ringing in the ear and partial hearing loss believed to be caused by clindamycin.[Ref]

Some side effects of benzoyl peroxide / clindamycin topical may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

12 years or older:

BenzaClin (R) Topical Gel: Apply to affected areas twice daily, morning and evening, or as directed. The skin should be gently washed, rinsed with warm water, and patted dry before application.

Acanya (TM) Gel: Apply a pea-sized amount to the face once daily. Use beyond 12 weeks has not been evaluated.

Duac (R) Topical Gel: Apply to affected areas once daily, in the evening, or as directed. The skin should be gently washed, rinsed with warm water, and patted dry before application.