Acanya

Name: Acanya

What is the dosage for clindamycin and benzoyl peroxide gel?

Clindamycin/benzoyl peroxide should be applied to acne lesions at bedtime (Duac), once daily (Acanya), twice daily, morning and evening (Benzaclin), or as directed by a physician. Affected areas should be washed, rinsed with warm water, and patted dry before applying clindamycin/benzoyl peroxide.

Benzoyl peroxide and clindamycin topical side effects

Benzoyl peroxide can cause a rare but serious allergic reaction or severe skin irritation. These reactions may occur just a few minutes after you apply the medicine, or within a day or longer afterward.

Stop using this medicine and get emergency medical help if you have signs of an allergic reaction: hives, itching; difficult breathing, feeling light-headed; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

  • severe redness, burning, stinging, or peeling of treated skin areas; or

  • diarrhea that is watery or bloody.

Common side effects may include:

  • mild burning or stinging;

  • itching or tingly feeling;

  • dryness or peeling of treated skin; or

  • redness or other irritation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Warnings and 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. When significant diarrhea occurs, Acanya 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 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

Minimize sun exposure including use of tanning beds or sun lamps following drug application [see Nonclinical Toxicology (13.1)].

Use in specific populations

Pregnancy

Pregnancy Category C.

There are no adequate and well-controlled studies in pregnant women treated with Acanya Gel. Acanya Gel 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 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. 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 while nursing, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness of Acanya Gel in pediatric patients under the age of 12 have not been evaluated.

Geriatric Use

Clinical trials of Acanya Gel did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects.

Manufacturer

  • Dow Pharmaceuticals Sciences

Warnings

Contraindications

Hypersensitivity to clindamycin, benozyl peroxide, lincomycin or any of the drug components

History of regional enteritis, ulcerative colitis or antibiotic-associated colitis (including pseudomembranous colitis)

Cautions

Systemic absorption of clindamycin has been demonstrated following topical use; discontinue immediately if significant diarrhea occurs and consider large bowel endoscopy

May cause irritation, especially when used with concomitant topical acne therapy including peeling, desquamating, or abrasive agents

Should be used with caution in atopic individuals

For external use only; avoid contact with eyes and mucous membranes

Minimize sun expsoure following application

May have bleaching effects on hair or colored fabric

Bacterial of fungal superinfection may result from prolonged use

Concomitant topical acne therapy may result in cumulative irritation, especially with the use of peeling, desquamating, or abrasive agents; if this occurs, discontinue and seek medical advice

Do not use clindamycin and erythromycin containing products together

Pharmacology

Mechanism of Action

Clindamycin: Antibacterial agent that binds to the 50S ribosomal subunits of susceptible bacteria and prevents elongation of peptide chains by interfering with peptidyl transfer, thereby suppressing protein synthesis; reduces surface fatty acids on skin; exact mechanism of action in treating acne unknown

Benzoyl peroxide: Elicits action by releasing active oxygen; effective in vitro against Propionibacterium acnes, an anaerobe found in sebaceous follicles and comedones; also elicits a keratolytic and desquamative effect which may also contribute to its efficacy

Acanya side effects

Get emergency medical help if you have any signs of an allergic reaction to Acanya: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using Acanya and call your doctor at once if you have any of these serious side effects:

  • severe redness, burning, stinging, or peeling of treated skin areas; or

  • diarrhea that is watery or bloody.

Less serious Acanya side effects may include:

  • mild burning or stinging;

  • itching or tingly feeling;

  • dryness or peeling of treated skin; or

  • redness or other irritation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

For Healthcare Professionals

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 Acanya may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Benzoyl peroxide / clindamycin topical Pregnancy Warnings

Benzoyl peroxide-clindamycin topical has been assigned to pregnancy category C by the FDA. Animal reproductive studies have not been conducted with benzoyl peroxide and studies with high systemic doses of clindamycin have failed to reveal evidence of teratogenicity. There are no controlled data in human pregnancy. Benzoyl peroxide-clindamycin topical is only recommended for use during pregnancy when benefit outweighs risk.

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