CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE- clindamycin, 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:

Padagis Israel Pharmaceuticals Ltd

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, opaque gel. It is supplied as follows: Pharmacist:

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE- CLINDAMYCIN, BENZOYL
PEROXIDE GEL
PADAGIS ISRAEL PHARMACEUTICALS LTD
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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, 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, 1.2%/5% 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 Padagis
at 1-866-634-9120 or FDA at 1-800-FDA-
1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
•
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 7/2023
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
antibiotic-associated colitis (including
pseudomembranous co