benzoyl peroxide/clindamycin topical (Rx)

Brand and Other Names:BenzaClin, Acanya, more...Duac, Onexton

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

clindamycin/benzoyl peroxide

topical gel

  • 1%/5% (BenzaClin)
  • 1.2%/2.5% (Acanya)
  • 1.2%/3.75% (Onexton)
  • 1.2%/5% (Duac)

Acne Vulgaris

BenzaClin: Apply topically q12hr to affected areas after skin is thoroughly washed and patted dry

DUAC: Apply once daily in the evening to affected areas after the skin is thoroughly washed and patted dry

Acanya, Onexton: Apply pea-sized amount qDay to affected areas after skin is thoroughly washed and patted dry

Limitation of use

  • DUAC Gel has not been demonstrated to have any additional benefit when compared with benzoyl peroxide alone in the same vehicle when used for the treatment of non-inflammatory acne

Dosage Forms & Strengths

clindamycin/ benzoyl peroxide

topical gel

  • 1%/5% (BenzaClin)
  • 1.2%/2.5% (Acanya)
  • 1.2%/3.75% (Onexton)
  • 1.2%/5% (Duac)

Acne Vulgaris

<12 years: Safety and efficacy not established

≥12 years

  • BenzaClin: Apply topically qHS to affected areas after skin is thoroughly washed and patted dry
  • DUAC: Apply once daily in the evening to affected areas after the skin is thoroughly washed and patted dry
  • Acanya, Onexton: Apply pea-sized amount qDay to affected areas after skin is thoroughly washed and patted dry
  • Limitation of use
    • DUAC Gel has not been demonstrated to have any additional benefit when compared with benzoyl peroxide alone in the same vehicle when used for the treatment of non-inflammatory acne
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Interactions

Interaction Checker

and benzoyl peroxide/clindamycin topical

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

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            Contraindicated (0)

              Serious - Use Alternative (0)

                Monitor Closely (1)

                • dapsone topical

                  benzoyl peroxide, dapsone topical. unspecified interaction mechanism. Use Caution/Monitor. Coadministration may cause temporary local yellow or orange discoloration of the skin and facial hair.

                Minor (0)

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                  Adverse Effects

                  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

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                  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

                  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
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                  Pregnancy & Lactation

                  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.

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                  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

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                  Images

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                  Patient Handout

                  A Patient Handout is not currently available for this monograph.
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                  Formulary

                  FormularyPatient Discounts

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                  Tier Description
                  1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                  2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                  3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                  4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  NC NOT COVERED – Drugs that are not covered by the plan.
                  Code Definition
                  PA Prior Authorization
                  Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                  QL Quantity Limits
                  Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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                  Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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                  Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.