Clindamycin and Benzoyl Peroxide

No information provided.

An in vitro percutaneous penetration study comparing BenzaClin (clindamycin and benzoyl peroxide) Topical Gel and topical 1% clindamycin gel alone, demonstrated there was no statistical difference in penetration between the two drugs. Mean systemic bioavailability of topical clindamycin in BenzaClin (clindamycin and benzoyl peroxide) Topical Gel is suggested to be less than 1%.

Benzoyl peroxide has been shown to be absorbed by the skin where it is converted to benzoic acid. Less than 2% of the dose enters systemic circulation as benzoic acid. It is suggested that the lipophilic nature of benzoyl peroxide acts to concentrate the compound into the lipid-rich sebaceous follicle.

Microbiology

The clindamycin and benzoyl peroxide components individually have been shown to have in vitro activity against Propionibacterium acnes an organism which has been associated with acne vulgaris; however, the clinical significance of this activity against P. acnes was not examined in clinical trials with this product.

Clinical Studies

In two adequate and well controlled clinical studies of 758 patients, 214 used BenzaClin (clindamycin and benzoyl peroxide) , 210 used benzoyl peroxide, 168 used clindamycin, and 166 used vehicle. BenzaClin (clindamycin and benzoyl peroxide) applied twice daily for 10 weeks was significantly more effective than vehicle in the treatment of moderate to moderately severe facial acne vulgaris. Patients were evaluated and acne lesions counted at each clinical visit; weeks 2, 4, 6, 8 and 10. The primary efficacy measures were the lesion counts and the investigator's global assessment evaluated at week 10. Patients were instructed to wash the face with a mild soap, using only the hands. Fifteen minutes after the face was thoroughly dry, application was made to the entire face. Non-medicated make-up could be applied at one hour after the BenzaClin (clindamycin and benzoyl peroxide) application. If a moisturizer was required, the patients were provided a moisturizer to be used as needed. Patients were instructed to avoid sun exposure. Percent reductions in lesion counts after treatment for 10 weeks in these two studies are shown below:

The BenzaClin (clindamycin and benzoyl peroxide) group showed greater overall improvement than the benzoyl peroxide, clindamycin and vehicle groups as rated by the investigator.

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

• Acanya
• BenzaClin
• Duac
• Neuac
• Onexton

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

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)

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 to 90 seconds).

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

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, may occur within minutes to a day or longer, and differ from local skin irritation.

• Skin irritation: Use concomitant topical acne therapy with caution; cumulative irritancy may occur, especially with the use of peeling, desquamating, or abrasive agents.

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.

• 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).

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.