ADAPALENE- adapalene lotion

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Owen Laboratories, Inc.

ИНН (Международная Имя):

ADAPALENE

состав:

ADAPALENE .1 g in 100 mL

Администрация маршрут:

topical

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Adapalene lotion is indicated for the topical treatment of acne vulgaris in patients 12 years and older. None. Pregnancy Category C. There are no well-controlled trials in pregnant women treated with adapalene lotion. Therefore, adapalene lotion should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal reproduction studies have not been conducted with adapalene lotion. Furthermore, such studies are not always predictive of human response. Human Data In clinical trials involving adapalene lotion, 0.1% in the treatment of acne vulgaris, women of childbearing potential initiated treatment only after a negative pregnancy test. Two women became pregnant while using adapalene lotion, 0.1%. One patient delivered a healthy full term baby and the other patient electively terminated her pregnancy. Animal Data 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 hu

Обзор продуктов:

Adapalene lotion, 0.1%, is a white to off-white liquid packaged in a 2 oz (59 mL) bottle which is equipped with a lotion dispensing pump. Adapalene lotion is supplied as follows: 2 oz bottle pump NDC 69007-912-02 Storage and handling

Статус Авторизация:

New Drug Application Authorized Generic

Характеристики продукта

ADAPALENE- ADAPALENE LOTION
OWEN LABORATORIES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ADAPALENE LOTION SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR ADAPALENE LOTION.
ADAPALENE LOTION, 0.1%
FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
Adapalene lotion is a retinoid product indicated for the topical
treatment of acne vulgaris in patients 12 years and older. (1)
DOSAGE AND ADMINISTRATION
Apply a thin layer of adapalene lotion to the entire face and other
affected areas of the skin once daily, after washing gently
with a mild soapless cleanser.
Dispense a nickel size amount of adapalene lotion (3-4 actuations of
the pump) to cover the entire face. Avoid application to
the areas of skin around eyes, lips and mucous membranes. (2)
adapalene lotion is for topical use only and not for oral, ophthalmic,
or intravaginal use. (2)
DOSAGE FORMS AND STRENGTHS
Lotion, 0.1%. (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, and stinging/ burning may occur with use
of adapalene lotion. (5.2)
ADVERSE REACTIONS
Dry skin of mild to moderate severity was the most frequently reported
(≥ 1%) treatment related adverse event.
Erythema, scaling, dryness, burning/ stinging were also seen during
treatment. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GALDERMA LABORATORIES,
L.P. AT 1-866-735-4137 OR FDA
AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
DRUG INTERACTIONS
Concomitant use of topical products with a strong drying effect can
increase skin irritation. Use with caution, especially in
using preparations containing sulfur, resorcinol, or salicylic acid in
combination with adapalene lotion. (7.1)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 7/2014
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATI