Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
CLINDAMYCIN PHOSPHATE (UNII: EH6D7113I8) (CLINDAMYCIN - UNII:3U02EL437C), BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)
Prasco Laboratories
CLINDAMYCIN PHOSPHATE
CLINDAMYCIN 10 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
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
Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% is a white to slightly yellow, opaque gel. It is supplied as follows:
New Drug Application Authorized Generic
CLINDAMYCIN - BENZOYL PEROXIDE- CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE GEL PRASCO LABORATORIES ---------- 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 Leggi il documento completo