CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE gel

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

Clindamycin Phosphate (UNII: EH6D7113I8) (Clindamycin - UNII:3U02EL437C), Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM)

Disponible desde:

Taro Pharmaceuticals U.S.A., Inc.

Vía de administración:

TOPICAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Clindamycin phosphate and benzoyl peroxide gel, 1.2%/3.75% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and 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

Resumen del producto:

Clindamycin Phosphate and Benzoyl Peroxide Gel 1.2%/3.75% is a white to off-white smooth gel supplied as a 50 g pump (NDC 51672-1403-4)

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

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 of age and 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/3.75% 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:_ 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:_ Minimize sun exposure
following drug application. (5.2)
ADVERSE REACTIONS
The most common adverse reactions are: burning sensation (0.4%);
contact dermatitis (0.4%); pruritus
(0.4%); and rash (0.4%). (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TARO PHARMACEUTICALS
U.S.A., INC., AT 1-
866-923-