benzoyl peroxide/clindamycin topical (Rx)

Frequency Not Defined

Application site pain

Application site exfoliation

Application site irritation

Erythema

Burning

Pruritus

Sunburn

Scaling

Dryness

Diarrhea

Colitis

Peeling

Postmarketing reports

Anaphylaxis, as well as allergic reactions leading to hospitalization

Urticaria, application site reactions, including discoloration

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

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 irritancy, especially with use of peeling, desquamating, or abrasive agents; if irritancy or dermatitis occurs, reduce frequency of application or temporarily interrupt treatment and resume once irritation subsides; discontinue treatment if irritation persists

Do not use clindamycin and erythromycin containing products together

Colitis

• Systemic absorption of clindamycin has been demonstrated following topical use; diarrhea, and colitis (including pseudomembranous colitis) reported with topical use; discontinue immediately if significant diarrhea occurs and consider large bowel endoscopy
• Severe colitis reported following oral and parenteral administration of clindamycin with onset occurring 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
• Clostridia is one primary cause of antibiotic-associated colitis; 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

Pregnancy

There are no available data on use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; limited published data on use of clindamycin in pregnant women with exposure during first trimester are insufficient to inform a drug-associated risk of pregnancy-related adverse outcomes; in limited published clinical trials with pregnant women, systemic administration of clindamycin during second and third trimesters has not been associated with an increased frequency of major birth defects

Animal data

• In animal reproduction studies, clindamycin did not cause malformations or embryo-fetal development toxicity in pregnant rats and mice when administered during the period of organogenesis at systemic doses up to 240 times maximum recommended human dose (MRHD) of 2.5 g, based on body surface area (BSA) comparisons

Lactation

There are no data on presence of clindamycin or benzoyl peroxide in human milk, effects on breastfed child, or on milk production following topical administration; however, clindamycin has been reported to be present in breast milk in small amounts following oral and parenteral administration

Developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed child from drug or from underlying maternal condition

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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