ADAPALENE AND BENZOYL PEROXIDE- adapalene and benzoyl peroxide topical gel

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Alembic Pharmaceuticals Inc.

관리 경로:

TOPICAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Adapalene and benzoyl peroxide topical gel is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. Adapalene and benzoyl peroxide topical gel is contraindicated in patients with a history of hypersensitivity reactions to benzoyl peroxide or any components of the formulation in adapalene and benzoyl peroxide topical gel. Risk Summary Available pharmacovigilance data with adapalene and benzoyl peroxide topical gel use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.  Animal reproduction studies have not been conducted with the combination gel. Adapalene gel, 0.3% Available data from clinical trials with adapalene gel 0.3% use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of adapalene to pregnant rats and rabbits during organogenesis at dose exposures 41 and 81 times, respectively, the human exposure at the maximum recommended human dose (MRHD) of 2 g resulted in fetal skeletal and visceral malformations (see Data) . Benzoyl peroxide gel, 2.5% The systemic exposure of benzoyl peroxide is unknown.  Based on published literature, benzoyl peroxide is rapidly metabolized to benzoic acid (an endogenous substance), which is eliminated in the urine. Hence, maternal use is not expected to result in fetal exposure of the drug.  The background risk of major birth defects and miscarriage for the indicated population is unknown.  All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data  No malformations were observed in rats treated with oral adapalene doses of 0.15 to 5.0 mg/kg/day, up to 8 times the MRHD of 2 grams of adapalene and benzoyl peroxide topical gel based on a mg/m2 comparison. However, malformations were observed in rats and rabbits when treated with oral doses of  ≥ 25 mg/kg/day adapalene (41 and 81 times the MRHD, respectively, based on a mg/m2 comparison). Findings included cleft palate, microphthalmia, encephalocele, and skeletal abnormalities in rats and umbilical hernia, exophthalmos, and kidney and skeletal abnormalities in rabbits. Dermal adapalene embryofetal development studies in rats and rabbits at doses up to 6.0 mg/kg/day (9.7 and 19.5 times the MRHD, respectively, based on a mg/m2 comparison) exhibited no fetotoxicity and only minimal increases in skeletal variations (supernumerary ribs in both species and delayed ossification in rabbits). Risk Sumary   Adapalene gel, 0.3% There are no data on the presence of adapalene topical gel or its metabolite in human milk, the effects on the breastfed infant, or the effects on milk production. In animal studies, adapalene is present in rat milk with oral administration of the drug. When a drug is present in animal milk, it is likely that the drug will be present in human milk. It is possible that topical administration of large amounts of adapalene could result in sufficient systemic absorption to produce detectable quantities in human milk (see Clinical Considerations).   Benzoyl peroxide gel, 2.5% The systemic exposure of benzoyl peroxide is unknown. Based on the published literature, benzoyl peroxide is rapidly metabolized to benzoic acid (an endogenous substance), which is eliminated in the urine. Any amount of benzoyl peroxide excreted into human milk by a nursing mother would be expected to be rapidly metabolized by tissue and stomach esterases. There are no data on the presence of benzoyl peroxide in human milk, its effects on the breastfed infant or its effects on milk production.  The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for adapalene and benzoyl peroxide topical gel and any potential adverse effects on the breastfed child from adapalene and benzoyl peroxide topical gel or from the underlying maternal condition. Clinical Considerations   To minimize potential exposure to the breastfed infant via breastmilk, use adapalene and benzoyl peroxide topical gel on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply adapalene and benzoyl peroxide topical gel directly to the nipple and areola to avoid direct infant exposure. Safety and effectiveness of adapalene and benzoyl peroxide topical gel in pediatric patients under the age of 12 have not been established. Clinical studies of adapalene and benzoyl peroxide topical gel did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects.

제품 요약:

Adapalene and benzoyl peroxide topical gel, 0.3%/2.5% is white to very pale yellow in color and opaque in appearance, and is supplied as follows: 

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

ADAPALENE AND BENZOYL PEROXIDE- ADAPALENE AND BENZOYL PEROXIDE
TOPICAL GEL
ALEMBIC PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ADAPALENE AND
BENZOYL PEROXIDE TOPICAL GEL SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
ADAPALENE AND BENZOYL PEROXIDE TOPICAL GEL.
ADAPALENE AND BENZOYL PEROXIDE TOPICAL GEL
INITIAL U.S. APPROVAL: 2015
INDICATIONS AND USAGE
Adapalene and benzoyl peroxide topical gel, is a combination of
adapalene, a retinoid, and benzoyl
peroxide and is indicated for the topical treatment of acne vulgaris
in adults and pediatric patients 12
years of age and older. (1)
DOSAGE AND ADMINISTRATION
For topical use only
Adapalene and benzoyl peroxide topical gel is not for oral, ophthalmic
or intravaginal use. (2)
Apply a thin layer of adapalene and benzoyl peroxide topical gel to
affected areas of the face and/or
trunk once daily after washing. (2)
Use a pea-sized amount for each area of the face (e.g., forehead,
chin, each cheek). (2)
Avoid the eyes, lips, and mucous membranes. (2)
DOSAGE FORMS AND STRENGTHS
Topical Gel, 0.3%/2.5%. (3)
CONTRAINDICATIONS
Adapalene and benzoyl peroxide topical gel is contraindicated in
patients with a history of hypersensitivity
reactions to benzoyl peroxide or any components of the formulation in
adapalene and benzoyl peroxide
topical gel. (4)
WARNINGS AND PRECAUTIONS
_Hypersensitivity_: Severe hypersensitivity reactions, including
anaphylaxis and angioedema, have been
reported with the use of benzoyl peroxide products. (5.1)
_Photosensitivity_: Avoid exposure to sunlight and sunlamps. Wear
broad spectrum sunscreen and
protective clothing when sun exposure cannot be avoided. (5.2)
_Skin Irritation_: Erythema, scaling, dryness, stinging/burning,
irritant and allergic contact dermatitis may
occur with use of adapalene and benzoyl peroxide topical gel and may
necessitate discontinuation.
(5.3)
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥1%) are skin
i