Clindamycin and Benzoyl Peroxide

Pronunciation

(klin da MYE sin & BEN zoe il peer OKS ide)

U.S. Brand Names

BenzaClin®; Duac™

Synonyms

Benzoyl Peroxide and Clindamycin; Clindamycin Phosphate and Benzoyl Peroxide

Generic Available

No

Use

Topical treatment of acne vulgaris

Pregnancy Risk Factor

C

Pregnancy Implications

Animal reproduction studies have not been conducted; use during pregnancy only if clearly needed.

Lactation

Excretion in breast milk unknown/not recommended

Contraindications

Hypersensitivity to benzoyl peroxide, lincomycin, clindamycin, or any component of the formulation; history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis; concurrent use of erythromycin and clindamycin

Warnings/Precautions

Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with topical clindamycin. Stop the drug if significant diarrhea occurs. Use concomitant topical acne therapy with caution; cumulative irritancy may occur. Bacterial overgrowth of nonsusceptible organisms may occur. Avoid contact with eyes and mucous membranes; not for ophthalmic use. May bleach hair or colored fabric. Safety and efficacy in children <12 years of age have not been established.

Adverse Reactions

Frequency not defined.

Dermatologic: Dry skin, pruritus, peeling, erythema, sunburn, redness, burning

Postmarketing and/or case reports: Colitis, diarrhea, pseudomembranous colitis

Drug Interactions

Erythromycin: Concurrent use may lead to antagonism of antimicrobial effects of clindamycin.

Tretinoin: Increases adverse reactions with concurrent use.

Stability

BenzaClin®: Store at room temperature of 25°C (77°F); do not freeze. Reconstitute clindamycin with purified water; shake well. Add solution to benzoyl peroxide gel and stir until homogenous in appearance. Discard unused portion after 2 months.

Duac™: Prior to dispensing, store in refrigerator, between 2°C to 8°C (36°F to 46°F). Once dispensed, may be stored by patient at room temperature of up to 25°C (77°F) if used within 60 days. Do not freeze.

Mechanism of Action

Clindamycin and benzoyl peroxide have activity against Propionibacterium acnesin vitro. This organism has been associated with acne vulgaris. Benzoyl peroxide releases free-radical oxygen which oxidizes bacterial proteins in the sebaceous follicles decreasing the number of anaerobic bacteria and decreasing irritating-type free fatty acids. Clindamycin reversibly binds to 50S ribosomal subunits preventing peptide bond formation thus inhibiting bacterial protein synthesis; bacteriostatic or bactericidal depending on drug concentration, infection site, and organism.

Pharmacodynamics/Kinetics

See individual agents.

Absorption: Benzoyl peroxide: <2% systemically absorbed

Metabolism: Benzoyl peroxide: Converted to benzoic acid in the skin

Dosage

Topical: Children 12 years and Adults: Apply to affected areas after skin has been cleansed and dried

BenzaClin®: Acne: Apply twice daily (morning and evening)

Duac™: Inflammatory acne: Apply once daily in the evening

Administration

Skin should be clean and dry before applying; avoid applying to inside nose, mouth, eyes, and mucous membranes

Patient Education

Gently wash and dry skin before applying. Avoid contact with eyes, inside nose, mouth and other mucous membranes. Do not use other topical acne products unless recommended by prescriber. May bleach hair or colored fabrics. Protect skin from sunburn. Store at room temperature and throw away any unused portions after 2 months of use. Call prescriber if severe diarrhea, dryness, redness or peeling occurs. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Breast-feeding is not recommended.

Dental Health: Effects on Dental Treatment

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions

No information available to require special precautions

Mental Health: Effects on Mental Status

None reported

Mental Health: Effects on Psychiatric Treatment

None reported

Dosage Forms

Gel, topical:

BenzaClin®: Clindamycin phosphate 1% and benzoyl peroxide 5% (25 g, 50 g)

Duac™: Clindamycin phosphate 1% and benzoyl peroxide 5% (45 g)