ADAPALENE gel

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

ADAPALENE (UNII: 1L4806J2QF) (ADAPALENE - UNII:1L4806J2QF)

から入手可能:

Taro Pharmaceuticals U.S.A., Inc.

INN（国際名）:

Adapalene

構図:

Adapalene 3 mg in 1 g

投与経路:

TOPICAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Adapalene Gel, 0.3% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. Adapalene Gel, 0.3% is contraindicated in patients who have known hypersensitivity to adapalene or any excipient of Adapalene Gel, 0.3% [see WARNINGS AND PRECAUTIONS (5.1)] . Risk Summary 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 40 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) . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 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 mg/kg/day, up to 8 times the MRHD based on a mg/m 2 comparison. However, malformations were observed in rats and rabbits when treated with oral doses of ≥ 25 mg/kg/day adapalene (40 and 81 times the MRHD, respectively, based on a mg/m 2 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 mg/kg/day (9.7 and 19.5 times the MRHD, respectively, based on a mg/m 2 comparison) exhibited no fetotoxicity and only minimal increases in skeletal variations (supernumerary ribs in both species and delayed ossification in rabbits). Risk Summary There are no data on the presence of topical adapalene 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) . The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Adapalene Gel, 0.3% and any potential adverse effects on the breastfed child from Adapalene Gel, 0.3%, or from the underlying maternal condition. Clinical Considerations To minimize potential exposure to the breastfed infant via breastmilk, use Adapalene Gel, 0.3% on the smallest area of skin and for the shortest duration possible while breastfeeding. Avoid application of Adapalene Gel, 0.3% to areas with increased risk for potential ingestion by or ocular exposure to the breastfeeding child. Safety and effectiveness have not been established in pediatric patients below the age of 12. Clinical studies of Adapalene Gel, 0.3% did not include subjects 65 years of age and older to determine whether they respond differently than younger subjects. Safety and effectiveness in geriatric patients age 65 and above have not been established.

製品概要:

Adapalene Gel, 0.3% is supplied in the following sizes. 45 g tube – NDC 51672-1377-6 45 g pump – NDC 51672-1377-9 S torage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. Keep out of reach of children.

認証ステータス:

Abbreviated New Drug Application

製品の特徴

ADAPALENE- ADAPALENE GEL
TARO PHARMACEUTICALS U.S.A., INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ADAPALENE GEL SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ADAPALENE GEL.
ADAPALENE GEL, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
Adapalene Gel, 0.3%, is a retinoid, indicated for the topical
treatment of acne vulgaris in patients 12 years
of age and older. ( 1)
DOSAGE AND ADMINISTRATION
Wash affected areas gently with a non-medicated soap. ( 2)
Apply a thin film of Adapalene Gel, 0.3% to the entire face and other
affected areas of the skin once
daily in the evening. ( 2) For topical use only. Not for ophthalmic,
oral or intravaginal use. ( 2)
DOSAGE FORMS AND STRENGTHS
Gel, 0.3% ( 3)
CONTRAINDICATIONS
Contraindicated in patients who have known hypersensitivity to
adapalene or any excipient of Adapalene
Gel, 0.3%. ( 4)
WARNINGS AND PRECAUTIONS
_Allergic/Hypersensitivity Reactions:_Allergy/ hypersensitivity
reactions include anaphylaxis, angioedema,
face edema, eyelid edema, lip swelling, and pruritis. Discontinue
Adapalene Gel, 0.3% in the event of an
allergic/hypersensitivity reaction. ( 5.1)
_Ultraviolet Light and Environmental Exposure:_Avoid exposure to
sunlight and sunlamps. Wear
sunscreen when sun exposure cannot be avoided ( 5.2).
_Local Cutaneous Reactions:_Erythema, scaling, dryness, and
stinging/burning were reported with use of
Adapalene Gel, 0.3%. Concomitant use of other potentially irritating
topical products (medicated or
abrasive soaps and cleansers, soaps and cosmetics that have a strong
drying effect and products with
high concentrations of alcohol, astringents, spices, or lime) should
be approached with caution. ( 5.3).
ADVERSE REACTIONS
The most frequently reported (≥ 1%) adverse reactions were erythema,
scaling, dryness, and/or
burning/stinging. ( 6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TARO PHARMACEUTICALS
U.S.A., INC. AT 1-
866-923-4914 OR FDA AT 1-800-FDA-1088 OR W