CLINDAMYCIN - 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:

Prasco Laboratories

INN (International Name):

CLINDAMYCIN PHOSPHATE

Composition:

CLINDAMYCIN 10 mg in 1 g

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, 1.2%/5% 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, 1.2%/5% 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, 1.2%/5%. [See Adverse Reactions (6.2).] Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% is contraindicated in those individuals with a history of regional enteritis, ulcerative colitis, pseudomembranous colitis, or antibiotic-associated colitis [see Warni

Product summary:

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

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

CLINDAMYCIN - BENZOYL PEROXIDE- CLINDAMYCIN PHOSPHATE AND BENZOYL
PEROXIDE GEL
PRASCO LABORATORIES
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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, 1.2%/5% SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR CLINDAMYCIN PHOSPHATE AND
BENZOYL PEROXIDE GEL, 1.2%/5%.
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, 1.2%/5% 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, 1.2%/5% 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
•
•
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, 1.2%/5% is
contraindicated in:
•
•
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
•
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT STIEFEL LABORATORIES,
INC. AT 1-888-784-3335 OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 4/2015
Apply a thin layer of Clindamycin Phosphate and Benzoyl Peroxide Gel,
1.2%/5% to the face once daily, in the
evening. (2)
Not for oral, ophthalmic, or intravaginal use. (2)
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
antib