ADAPALENE gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Alembic Pharmaceuticals Inc.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Adapalene gel, 0.3% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. Adapalene gel is contraindicated in patients who have known hypersensitivity to adapalene or any excipient of adapalene gel [see WARNINGS AND PRECAUTIONS (5.1)]. Risk Summary Available data from clinical trials with adapalene 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. 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

Product summary:

Adapalene gel USP, 0.3% is supplied in the following size. 15 g tube – NDC 62332-549-15 45 g tube – NDC 62332-549-45 45 g pump – NDC 62332-549-46 Storage : Store at controlled room temperature 68° to 77°F (20° to 25°C) with excursions permitted between 59° to 86°F (15° to 30°C) [See USP Controlled Room Temperature]. Protect from freezing. Keep out of reach of children.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ADAPALENE- ADAPALENE GEL
ALEMBIC PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED 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, to the entire face and any 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. (4)
WARNINGS AND PRECAUTIONS
_Allergic/ Hypersensitivity Reactions:_Allergy/hypersensitivity
reactions include anaphylaxis, angioedema,
urticaria, and pruritis. Discontinue adapalene gel 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. 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 dry skin,
skin discomfort, pruritus,
desquamation, and sunburn. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ALEMBIC
PHARMACEUTICALS, INC. AT 1-866-
210-9797 OR FDA AT 1-800-FDA-1088 OR