Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
Clindamycin Phosphate (UNII: EH6D7113I8) (Clindamycin - UNII:3U02EL437C), Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM)
Taro Pharmaceuticals U.S.A., Inc.
TOPICAL
PRESCRIPTION DRUG
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 [see Warnings 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 preg
Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% is a white to off-white smooth gel supplied as:
Abbreviated New Drug Application
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE- CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE GEL TARO PHARMACEUTICALS U.S.A., INC. ---------- 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 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) DOSAGE FORMS AND STRENGTHS Gel, 1.2% clindamycin phosphate/2.5% 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. (4.1) Patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis. (4.2) WARNINGS AND PRECAUTIONS _Colitis:_ Orally and parenterally administered clindamycin has been associated with severe colitis, which may result in death. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin. Clindamycin phosphate and benzoyl peroxide gel should be discontinued if significant diarrhea occurs. (5.1) _Ultraviolet Light and Environmental Exposure:_ Minimize sun exposure following drug application. (5.2) 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 Læs hele dokumentet