CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CLINDAMYCIN PHOSPHATE (UNII: EH6D7113I8) (CLINDAMYCIN - UNII:3U02EL437C), BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)

Available from:

Actavis Pharma, Inc.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clindamycin phosphate and benzoyl peroxide gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older. Clindamycin phosphate and benzoyl peroxide gel is contraindicated in those individuals who have shown hypersensitivity to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin. Anaphylaxis, as well as allergic reactions leading to hospitalization, has been reported in postmarketing use with clindamycin phosphate and benzoyl peroxide gel [see Postmarketing Experience (6.2)]. Clindamycin phosphate and benzoyl peroxide gel is contraindicated in patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis [see Warnings and Precautions (5.1)]. Risk Summary There are no available data on clindamycin phosphate and benzoyl peroxide gel use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. The limited published data on use of clindamycin in preg

Product summary:

Clindamycin phosphate and benzoyl peroxide gel is supplied in a 50 g pump (NDC 0591-3916-68).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE- CLINDAMYCIN PHOSPHATE AND
BENZOYL PEROXIDE GEL
ACTAVIS PHARMA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLINDAMYCIN PHOSPHATE AND
BENZOYL PEROXIDE GEL SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR CLINDAMYCIN
PHOSPHATE AND BENZOYL PEROXIDE GEL.
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE GEL, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
Clindamycin phosphate and benzoyl peroxide gel is a combination of
clindamycin phosphate (a lincosamide antibacterial)
and benzoyl peroxide indicated for the topical treatment of acne
vulgaris in patients 12 years or older. (1)
DOSAGE AND ADMINISTRATION
Apply a pea-sized amount of clindamycin phosphate and benzoyl peroxide
gel to the face once daily. (2)
Not for oral, ophthalmic, or intravaginal use. (2)
DOSAGE FORMS AND STRENGTHS
Gel, 1.2% clindamycin phosphate/2.5% benzoyl peroxide (3)
CONTRAINDICATIONS
Clindamycin phosphate and benzoyl peroxide gel is contraindicated in:
Patients who have demonstrated hypersensitivity (e.g., anaphylaxis) to
clindamycin, benzoyl peroxide, any components
of the formulation, or lincomycin. (4.1)
Patients with a history of regional enteritis, ulcerative colitis, or
antibiotic–associated colitis. (4.2)
WARNINGS AND PRECAUTIONS
Colitis: Orally and parenterally administered clindamycin has been
associated with severe colitis, which may result in
death. Diarrhea, bloody diarrhea, and colitis (including
pseudomembranous colitis) have been reported with the use of
topical and systemic clindamycin. Clindamycin phosphate and benzoyl
peroxide gel should be discontinued if significant
diarrhea occurs. (5.1)
Ultraviolet Light and Environmental Exposure: Minimize sun exposure
following drug application. (5.2)
ADVERSE REACTIONS
The following selected adverse reactions occurred in less than 0.2% of
patients: application site pain (0.1%); application
site exfoliation (0.1%); and application site irritation