CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE- clindamycin phosphate, benzoyl peroxide gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Padagis Israel Pharmaceuticals Ltd

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% is indicated for the topical treatment of acne vulgaris in patients 12 years or older. Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/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%/2.5%. [See Postmarketing Experience (6.2). ] Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% 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, 1.2%/2.5% use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcome

Product summary:

Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% is a white to off-white smooth gel supplied as:

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE- CLINDAMYCIN PHOSPHATE,
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, 1.2%/2.5%, FOR TOPICAL
USE
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% 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
•
•
DOSAGE FORMS AND STRENGTHS
Gel, 1.2% clindamycin phosphate/2.5% benzoyl peroxide (3)
CONTRAINDICATIONS
Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% is
contraindicated in: (4)
•
•
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 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 AND FDA-APPROVED PATIENT
LABELING.
REVISED: 10/2022
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
Apply a pea-sized amount of Clindamycin Phosphate and Benzoyl Peroxide
Gel, 1.2%/2.5% 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 clinda