CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE gel

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Zydus Pharmaceuticals USA Inc.

Tuyến hành chính:

TOPICAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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 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 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 Adverse Reactions (6.2).] Clindamycin phosphate and benzoyl peroxide gel is contraindicated in those individuals with a history of regional enteritis, ulcerative colitis, pseudomembranous colitis, or antibiotic-associated colitis [see Warnings and Precautions (5.1)]. Pregnanc

Tóm tắt sản phẩm:

Clindamycin phosphate and benzoyl peroxide gel, 1.2%/5% is a white to off white gel and supplied as follows: NDC 70710-1445-4 in tube of 45 grams Pharmacist:

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE - CLINDAMYCIN PHOSPHATE
AND BENZOYL PEROXIDE GEL
ZYDUS PHARMACEUTICALS USA INC.
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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%/5%, 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 inflammatory acne
vulgaris. (1.1)
Limitation of Use:
Clindamycin phosphate and benzoyl peroxide gel 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 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 is contraindicated in:
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 colitis). (4)
WARNINGS AND PRECAUTIONS
Colitis: Clindamycin can cause severe colitis, which may result in
death. Diarrhea, bloody diarrhea, and
colitis (including pseudomembranous colitis) have been reported with
the use of clindamycin.
Clindamycin phosphate and benzoyl peroxide gel should be discontinued
if significant diarrhea occurs.
(5.1)
Ultraviolet light and environmental exposure (including use of tanning
beds or sun lamps): Minimize
sun exposure following drug application. (5.2)
AD