ADAPALENE AND BENZOYL PEROXIDE gel

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Bryant Ranch Prepack

Via di somministrazione:

TOPICAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% 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, 0.3%/2.5% 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, 0.3%/2.5%. Risk Summary Available pharmacovigilance data with Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% 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, 0.3%/2.5% 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 Summary 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, 0.3%/2.5% and any potential adverse effects on the breastfed child from Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% 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, 0.3%/2.5% 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, 0.3%/2.5% directly to the nipple and areola to avoid direct infant exposure. Safety and effectiveness of Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% in pediatric patients under the age of 12 have not been established. Clinical studies of adapalene and benzoyl peroxide topical gel, 0.3%/2.5% did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects.

Dettagli prodotto:

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 a 45 gram pump (NDC 63629-9322). 16.2 Storage and handling • Store at controlled room temperature 20° – 25°C (68° – 77°F) with excursions permitted to 15° – 30°C (59° – 86°F) [see USP controlled room temperature]. • Keep away from heat. • Protect from light. • Keep out of reach of children. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

ADAPALENE AND BENZOYL PEROXIDE- ADAPALENE AND BENZOYL PEROXIDE GEL
BRYANT RANCH PREPACK
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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, 0.3%/2.5%
INITIAL U.S. APPROVAL: 2015
INDICATIONS AND USAGE
Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% 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
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•
•
•
•
DOSAGE FORMS AND STRENGTHS
Topical Gel, 0.3%/2.5%. (3)
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
•
•
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥1%) are skin
irritation, eczema, atopic dermatitis and
skin burning sensation. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PADAGIS AT
1-866-634-9120 OR FDA AT 1-
800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 1/2024
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
For topical use only
Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% is not for oral,
ophthalmic, or intravaginal
use. (2)
Apply a thin layer of Adapalene and Benzoyl Peroxide Topical Gel,
0.3%/2.5% 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)
Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% 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, 0.3%/2.5%. (4)
_Hypersensitivity:_ Severe hypersensiti