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:

Oceanside Pharmaceuticals

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 [seeWarnings 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 pre

Product summary:

Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%, a white to off-white smooth gel is supplied as: NDC 68682-132-50                                                     50 g pump

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE- CLINDAMYCIN PHOSPHATE AND
BENZOYL PEROXIDE GEL
OCEANSIDE PHARMACEUTICALS
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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
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•
DOSAGE FORMS AND STRENGTHS
Gel, 1.2% clindamycin phosphate/2.5% benzoyl peroxide (3)
CONTRAINDICATIONS
Clindamycin Phosphate and Benzoyl Peroxide Gel is contraindicated in:
•
•
WARNINGS AND PRECAUTIONS
•
•
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 (0.1%). (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT OCEANSIDE
PHARMACEUTICALS AT 1-800-321-4576 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: 9/2020
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
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)
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)
_Colitis:_ Orally and parenterally administered clindamycin ha