DUAC- clindamycin phosphate and benzoyl peroxide gel

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Stiefel Laboratories Inc

מסלול נתינה (של תרופות):

TOPICAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

DUAC® (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. DUAC 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. DUAC 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 DUAC Gel. [See Adverse Reactions (6.2).] DUAC 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)]. Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women treated with DUAC Gel. DUAC Gel should be used during pregnan

leaflet_short:

DUAC Gel is a white to slightly yellow, opaque gel. It is supplied as follows: Pharmacist:

מצב אישור:

New Drug Application

מאפייני מוצר

DUAC- CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE GEL
STIEFEL LABORATORIES INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DUAC
GEL SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR DUAC GEL.
DUAC (CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE) GEL, 1.2%/5%
FOR TOPICAL USE
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
DUAC 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:
DUAC 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 AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
Gel, 1.2%/5%: Each gram of DUAC Gel contains 12 mg clindamycin
phosphate (equivalent to 10 mg of clindamycin) and 50
mg benzoyl peroxide. (3)
CONTRAINDICATIONS
DUAC Gel 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
FULL PRESCRIBING INFORMATION: CONTENTS*
Apply a thin layer of DUAC Gel 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
antibiotic-associated colitis (including
pseudomembranous colitis). (4)
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. DUAC Gel should be
discontinu