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Clindamycin and Benzoyl Peroxide

Pronunciation

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

Index Terms

  • Benzoyl Peroxide and Clindamycin
  • Clindamycin Phos/Benzoyl Perox
  • Clindamycin Phosphate and Benzoyl Peroxide

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Gel, topical: Clindamycin 1% and benzoyl peroxide 5% (25 g, 50 g); Clindamycin phosphate 1.2% and benzoyl peroxide 5% (45 g)

Acanya: Clindamycin phosphate 1.2% and benzoyl peroxide 2.5% (50 g)

BenzaClin: Clindamycin 1% and benzoyl peroxide 5% (25 g, 35 g, 50 g)

Duac: Clindamycin phosphate 1.2% and benzoyl peroxide 5% (45 g)

Neuac: Clindamycin phosphate 1.2% and benzoyl peroxide 5% (45 g)

Onexton: Clindamycin phosphate 1.2% and benzoyl peroxide 3.75% (50 g) [contains propylene glycol]

Brand Names: U.S.

  • Acanya
  • BenzaClin
  • Duac
  • Neuac
  • Onexton

Pharmacologic Category

  • Acne Products
  • Topical Skin Product
  • Topical Skin Product, Acne

Pharmacology

Clindamycin and benzoyl peroxide have activity against Propionibacterium acnes in 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; it is bacteriostatic or bactericidal depending on drug concentration, infection site, and organism.

Use: Labeled Indications

Acne: Topical treatment of acne vulgaris

Contraindications

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

Dosing: Adult

Acne: Topical:

Clindamycin 1.2%/benzoyl peroxide 2.5%: Apply pea-sized amount to affected area once daily; use >12 weeks has not been studied.

Clindamycin 1.2%/benzoyl peroxide 3.75%: Apply pea-sized amount to affected area once daily; use >12 weeks has not been studied.

Clindamycin 1%/benzoyl peroxide 5%: Apply to affected area twice daily (morning and evening).

Inflammatory acne: Topical: Clindamycin 1.2%/benzoyl peroxide 5%: Apply to affected area once daily in the evening.

Rosacea (off-label use): Topical: Clindamycin 1%/benzoyl peroxide 5%: Apply to affected area once daily for 12 weeks (Leyden 2004)

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Children ≥12 years and Adolescents: Refer to adult dosing.

Reconstitution

BenzaClin: Prior to dispensing, tap the vial until powder flows freely. Reconstitute clindamycin with purified water; shake well. Add clindamycin solution to benzoyl peroxide gel and stir until homogenous (60-90 seconds).

Administration

Skin should be clean and dry before applying. For external use only; avoid applying to inside nose, mouth, eyes, vagina, mucous membranes, and on areas of broken skin.

Storage

Acanya: Prior to dispensing, store in refrigerator, between 2°C to 8°C (36°F to 46°F); do not freeze. Once dispensed, store at room temperature of ≤25°C (≤77°F), protect from freezing, and use within 10 weeks.

BenzaClin: Store unreconstituted product at room temperature of ≤25°C (≤77°F); do not freeze. Once reconstituted and dispensed, store at room temperature of ≤25°C (≤77°F) and use within 3 months.

Duac: Prior to dispensing, store in refrigerator, between 2°C to 8°C (36°F to 46°F); do not freeze. Once dispensed, store at room temperature of ≤25°C (≤77°F), protect from freezing, and use within 60 days.

Onexton: Prior to dispensing, store in a refrigerator at 2°C to 8°C (36°F to 46°F). Once dispensed, store at or below 25°C (77°F). Protect from freezing.

Drug Interactions

Dapsone (Topical): Benzoyl Peroxide may enhance the adverse/toxic effect of Dapsone (Topical). Specifically, the use of these agents in combination may cause skin and facial hair to temporarily turn a tan or yellow/orange color. Monitor therapy

Erythromycin (Systemic): May diminish the therapeutic effect of Clindamycin (Topical). Avoid combination

Erythromycin (Topical): May diminish the therapeutic effect of Clindamycin (Topical). Avoid combination

Neuromuscular-Blocking Agents: Clindamycin (Topical) may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Monitor therapy

Adverse Reactions

Also see individual agents.

>10%:

Dermatologic: Application site scaling (≤21%), local dryness (≤16%)

Local: Application site erythema (<31%), local desquamation (2% to 19%), application site itching (≤17%)

1% to 10%:

Dermatologic: Sunburn (local; 1%)

Local: Application site burning (≤10%), application site stinging (≤7%), application site reaction (3%)

<1% (Limited to important or life-threatening): Application site pain, contact dermatitis, hypersensitivity reaction, local skin exfoliation

Warnings/Precautions

Concerns related to adverse effects:

• Bleaching effects: Benzoyl peroxide may bleach hair, colored fabric, or carpeting.

• Diarrhea: Systemic absorption may occur after topical use of clindamycin. C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis have been reported and have been observed >2 months postantibiotic treatment. Use of parenteral and systemic clindamycin has resulted in severe colitis (including fatalities). Discontinue drug if significant diarrhea, abdominal cramps, or passage of blood and mucus occurs.

• Hypersensitivity: Anaphylaxis and allergic reactions have been reported.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

• Erythromycin: Concomitant use with erythromycin-containing products is not recommended.

• Sulfone products: Concomitant use of benzoyl peroxide with sulfone products (eg, dapsone, sulfacetamide) may cause temporary discoloration (yellow/orange) of facial hair and skin. Application of products at separate times during the day or washing off benzoyl peroxide prior to application of other products may avoid skin discoloration (Dubina 2009).

• Topical acne products: Use concomitant topical acne therapy with caution; cumulative irritancy may occur.

Other warnings/precautions:

• Appropriate use: For external use only; not for vaginal or ophthalmic use. Avoid contact with mucous membranes. Inform patients to use skin protection and minimize prolonged exposure to sun and avoid tanning beds or sun lamps.

Pregnancy Risk Factor

C

Pregnancy Considerations

Animal reproduction studies have not been conducted with this combination. Refer to individual monographs.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience dry skin or itching. Have patient report immediately to prescriber severe skin irritation or signs of Clostridium difficile (C. diff)-associated diarrhea (abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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