ADAPALENE AND BENZOYL PEROXIDE gel

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

ADAPALENE (UNII: 1L4806J2QF) (ADAPALENE - UNII:1L4806J2QF), BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)

Inapatikana kutoka:

Prasco Laboratories

INN (Jina la Kimataifa):

ADAPALENE

Tungo:

ADAPALENE 1 mg in 1 g

Njia ya uendeshaji:

TOPICAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

 Adapalene and Benzoyl Peroxide gel is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. None Pregnancy Category C. There are no well-controlled trials in pregnant women treated with Adapalene and Benzoyl Peroxide gel. Animal reproduction studies have not been conducted with the combination gel or benzoyl peroxide. Furthermore, such studies are not always predictive of human response; therefore, Adapalene and Benzoyl Peroxide gel should be used during pregnancy only if the potential benefit justifies the risk to the fetus. No teratogenic effects were observed in rats treated with oral doses of 0.15 to 5.0 mg adapalene/kg/day, up to 25 times (mg/m2 /day) the maximum recommended human dose (MRHD) of 2 grams of Adapalene and Benzoyl Peroxide gel. However, teratogenic changes were observed in rats and rabbits when treated with oral doses of ≥ 25 mg adapalene/kg/day representing 123 and 246 times MRHD, respectively. Findings included cleft palate, microphthalmia, encephaloc

Bidhaa muhtasari:

Adapalene and Benzoyl Peroxide gel, 0.1% / 2.5% is white to very pale yellow in color and opaque in appearance, and is supplied as follows: 45 gram pump NDC 66993-869-48 Storage and handling  - Store at 25ºC; excursions permitted to 15º - 30ºC (59º - 86ºF).  - Protect from light.  - Keep out of reach of children.  - Keep away from heat.  - Keep tube tightly closed.

Idhini hali ya:

New Drug Application Authorized Generic

Tabia za bidhaa

ADAPALENE AND BENZOYL PEROXIDE- ADAPALENE AND BENZOYL PEROXIDE GEL
PRASCO LABORATORIES
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ADAPALENE AND BENZOYL PEROXIDE GEL SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ADAPALENE AND
BENZOYL PEROXIDE GEL.
ADAPALENE AND BENZOYL PEROXIDE GEL 0.1% / 2.5% FOR TOPICAL USE
INITIAL U.S. APPROVAL: 2008
INDICATIONS AND USAGE
Adapalene and Benzoyl Peroxide gel is a combination of adapalene, a
retinoid, and benzoyl peroxide, and is indicated for
the topical treatment of acne vulgaris in patients 9 years of age and
older. (1)
DOSAGE AND ADMINISTRATION
Adapalene and Benzoyl Peroxide gel is not for oral, ophthalmic, or
intravaginal use. (2)
Apply a thin film of Adapalene and Benzoyl Peroxide gel to affected
areas of the face and/or trunk once daily after washing.
Use a pea-sized amount for each area of the face (e.g., forehead,
chin, each cheek). Avoid the eyes, lips and mucous
membranes. (2)
DOSAGE FORMS AND STRENGTHS
Each gram of Adapalene and Benzoyl Peroxide gel contains 1 mg (0.1%)
adapalene and 25 mg (2.5%) benzoyl
peroxide. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Ultraviolet Light and Environmental Exposure: Avoid exposure to
sunlight and sunlamps. Wear sunscreen when sun
exposure cannot be avoided. (5.1)
Erythema, scaling, dryness, stinging/burning, irritant and allergic
contact dermatitis may occur with use of Adapalene
and Benzoyl Peroxide gel and may necessitate discontinuation. (5.2)
ADVERSE REACTIONS
Most commonly reported adverse events (≥1%) in patients treated with
Adapalene and Benzoyl Peroxide gel were dry
skin, contact dermatitis, application site burning, application site
irritation and skin irritation. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PRASCO LABORATORIES, AT
1-866-525-0688, OR FDA AT 1-
800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH_
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 4/2017
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USA