AZELAIC ACID gel

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

Azelaic Acid (UNII: F2VW3D43YT) (Azelaic Acid - UNII:F2VW3D43YT)

Доступна с:

Taro Pharmaceuticals U.S.A., Inc.

Администрация маршрут:

TOPICAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Azelaic acid gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. Limitations of Use Although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. None. Risk Summary Azelaic acid is minimally absorbed systemically following topical route of administration, and maternal use is not expected to result in fetal exposure to the drug [see Clinical Pharmacology (12.3)]. In animal reproduction studies, embryofetal toxicity was noted when azelaic acid was administered orally during the period of organogenesis at doses 162, 19, and 65 times the maximum recommended human dose (MRHD) in rats, rabbits, and monkeys, respectively. Maternal toxicity was noted at these doses but no malformations were observed in these embryofetal developmental studies (see Data). The background risk of maj

Обзор продуктов:

How Supplied Azelaic acid gel, 15% is a white to yellowish white opaque gel supplied in a 50 g tube (NDC 51672-1389-3). Storage and Handling Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

AZELAIC ACID- AZELAIC ACID GEL
TARO PHARMACEUTICALS U.S.A., INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AZELAIC ACID GEL SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AZELAIC ACID
GEL.
AZELAIC ACID GEL, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1995
INDICATIONS AND USAGE
Azelaic acid gel, 15% is indicated for topical treatment of the
inflammatory papules and pustules of mild to
moderate rosacea. (1)
Limitations of Use
Efficacy for treatment of erythema in rosacea in the absence of
papules and pustules has not been
evaluated. (1)
DOSAGE AND ADMINISTRATION
Apply a thin layer twice daily to affected area(s). (2)
Use only very mild soaps or soapless cleansing lotion and pat dry with
a soft towel before applying
azelaic acid gel. (2)
Wash hands immediately following application. (2)
Cosmetics may be applied after the application of azelaic acid gel has
dried. (2)
Avoid use of alcoholic cleansers, tinctures and astringents, abrasives
and peeling agents. (2)
For topical use. (2)
Not for oral, ophthalmic or intravaginal use. (2)
DOSAGE FORMS AND STRENGTHS
Gel, 15% (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
_Hypersensitivity:_ Hypersensitivity reactions, including cases of
angioedema, eye swelling, facial
swelling, dyspnea, urticaria, and adverse skin reactions, have been
reported. In case of known
hypersensitivity to any component of the gel, avoid the use of azelaic
acid gel. If hypersensitivity
develops, discontinue treatment and institute appropriate therapy.
(5.1)
_Skin Reactions:_ Skin irritation (i.e. pruritus, burning or stinging)
may occur, usually during the first few
weeks of treatment. If sensitivity or severe irritation develops and
persists, discontinue treatment and
institute appropriate therapy. (5.2)
_Hypopigmentation:_ Isolated cases of hypopigmentation occurred after
azelaic acid use. Monitor
patients with dark complexion for early signs of hypopigmentation.
(5.2)
_Eye and Mucous Membrane Irritation:_ A