CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE- 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:

Taro Pharmaceuticals U.S.A., Inc.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clindamycin phosphate and benzoyl peroxide gel, 1.2%/5% is indicated for the topical treatment of inflammatory acne vulgaris in patients 12 years and older. Clindamycin phosphate and benzoyl peroxide 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. 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 Adverse Reactions (6.2)]. Clindamycin phosphate and benzoyl peroxide gel is contraindicated in those individuals with a history of regional enteritis, ulcerative colitis, pseudomembranous colitis, or antibiotic-associated colitis [see Warnings and Precautions (5.1)]. Pregnancy

Product summary:

Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% is a white to slightly yellow, opaque gel. It is supplied as follows: Pharmacist:

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE - CLINDAMYCIN PHOSPHATE AND
BENZOYL PEROXIDE GEL
TARO PHARMACEUTICALS U.S.A., 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, 1.2%/5%, 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
inflammatory acne vulgaris. (1.1)
Limitation of Use:
Clindamycin phosphate and benzoyl peroxide 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. (1.2)
DOSAGE AND ADMINISTRATION
Apply a thin layer of clindamycin phosphate and benzoyl peroxide gel
to the face once daily, in the evening. (2)
Not for oral, ophthalmic, or intravaginal use. (2)
DOSAGE FORMS AND STRENGTHS
Gel, 1.2%/5%: Each gram of clindamycin phosphate and benzoyl peroxide
gel contains 12 mg clindamycin phosphate
(equivalent to 10 mg of clindamycin) and 50 mg 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)
Patients with a history of regional enteritis, ulcerative colitis, or
antibiotic-associated colitis (including
pseudomembranous colitis). (4)
WARNINGS AND PRECAUTIONS
Colitis: Clindamycin can cause severe colitis, which may result in
death. Diarrhea, bloody diarrhea, and colitis (including
pseudomembranous colitis) have been reported with the use of
clindamycin. Clindamycin phosphate and benzoyl
peroxide gel should be discont