Usual Adult Dose for Acne

Benzoyl peroxide 2.5 %-clindamycin 1.2%: Apply a pea-sized amount topically to the face once a day

• Duration of therapy: Use beyond 12 weeks has not been evaluated

Benzoyl peroxide 3.75%-clindamycin 1.2%: Apply a pea-sized amount topically to the face once a day

• Duration of therapy: Use beyond 12 weeks has not been evaluated

Benzoyl peroxide 5%-clindamycin 1%: Apply topically to the face twice a day, in the morning and evening or as directed

Benzoyl peroxide 5%-clindamycin 1.2%: Apply a thin layer topically to the face once a day in the evening or as directed

Comments: Skin should be thoroughly washed with a mild soap, rinsed with warm water, and gently dried prior to application.

Use: For the topical treatment of acne vulgaris

Usual Pediatric Dose for Acne

12 years or older:
Benzoyl peroxide 2.5 %-clindamycin 1.2%: Apply a pea-sized amount topically to the face once a day

• Duration of therapy: Use beyond 12 weeks has not been evaluated

Benzoyl peroxide 3.75%-clindamycin 1.2%: Apply a pea-sized amount topically to the face once a day

• Duration of therapy: Use beyond 12 weeks has not been evaluated

Benzoyl peroxide 5%-clindamycin 1%: Apply topically to the face twice a day, in the morning and evening or as directed

Benzoyl peroxide 5%-clindamycin 1.2%: Apply a thin layer topically to the face once a day in the evening or as directed

Comments: Skin should be thoroughly washed with a mild soap, rinsed with warm water, and gently dried prior to application.

Use: For the topical treatment of acne vulgaris

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to clindamycin, benzoyl peroxide, lincomycin, or to any components of this formulation
• History of regional enteritis, ulcerative colitis, pseudomembranous colitis, or antibiotic-associated colitis

Safety and efficacy have not been established in patients younger than 12 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• For topical use only; not for oral, ophthalmic, or intravaginal use.
• Contact with mouth, eyes, lips, other mucous membranes, or irritated or broken skin should be avoided.
• Concomitant topical acne products should be used with caution due to possible irritant effect, especially with use of peeling, desquamating, or abrasive agents.

Storage requirements:
Benzoyl peroxide 2.5 %-clindamycin 1.2%:
Prior to dispensing: Store in refrigerator at 2C to 8C (36F to 46F); dispense with 10 week expiration date
After dispensing: Store at room temperature at or below 25C (77F); protect from freezing; keep tightly closed.

Benzoyl peroxide 3.75%-clindamycin 1.2%:
Prior to dispensing: Store in refrigerator at 2C to 8C (36F to 46F); dispense with 10 week expiration date
After dispensing: Store at room temperature at or below 25C (77F); protect from freezing; store pump upright.

Benzoyl peroxide 5%-clindamycin 1%:
Reconstituted: Can be stored at room temperature up to 25°C (77°F) for 3 months; place a 3 month expiration date on the label immediately following mixing.; keep tightly closed; do not freeze.

Benzoyl peroxide 5%-clindamycin 1.2%:
Prior to dispensing: Store in refrigerator at 2C to 8C (36F to 46F); dispense with a 60 day expiration date
After dispensing: Store at room temperature up to 25C (77F); protect from freezing; keep tube tightly closed.

Reconstitution/preparation techniques:

• Benzoyl peroxide 5%-clindamycin 1%: Tap vial so powder flows freely and add indicated amount of purified water to the mark on the vial and immediately shake to completely dissolve drug; if needed, add additional purified water to bring level up to the mark. Add the solution in the vial to the gel and stir until homogenous in appearance; if this drug is dispensed in a pump, reassemble jar with pump dispenser.

Patient advice:

• Discontinue use and contact your physician immediately if allergic reactions, including severe swelling or shortness of breath, occurs.
• Irritation, including erythema, scaling, itching, or burning may occur when used in combination with other topical acne products.
• Exposure to sunlight and sunlamps should be avoided or minimized; if this is not possible, sunscreen and protective clothing should be worn.
• Avoid contact with hair, fabrics, furniture, or carpeting as this drug may bleach hair and color or dye fabrics.