ADAPALENE- adapalene gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Owen Laboratories, Inc.

INN (International Name):

ADAPALENE

Composition:

ADAPALENE 3 mg in 1 g

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, 0.3% should not be administered to individuals who are hypersensitive to adapalene or any of the components in the gel vehicle. Teratogenic effects. Pregnancy Category C. Retinoids may cause fetal harm, when administered to pregnant women. Adapalene has been shown to be teratogenic in rats and rabbits when administered orally (see Animal Data below). There are no adequate and well-controlled studies in pregnant women. Adapalene gel, 0.3% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The safety and efficacy of adapalene gel, 0.3% in pregnancy has not been established. Human Data In clinical trials involving adapalene gel, 0.3% in the treatment of acne vulgaris, women of child-bearing potential initiated treatment only after having had a negative pregnancy test and used effective birth control measures during therapy. However

Product summary:

Adapalene gel, 0.3% is supplied in the following size. 45g pump – NDC 69007-918-25 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). Protect from freezing. Keep out of reach of children.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

ADAPALENE- ADAPALENE GEL
OWEN LABORATORIES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ADAPALENE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ADAPALENE GEL, 0.3%
ADAPALENE GEL, 0.3%
FOR TOPICAL USE ONLY
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
Apply a thin film of adapalene gel, 0.3% to the entire face and any
other affected areas of the skin once daily in the evening,
after washing gently with a non-medicated soap. (2)
For topical use only. Not for ophthalmic, oral or intravaginal use.
(2)
DOSAGE FORMS AND STRENGTHS
Each gram of adapalene gel, 0.3% contains 3 mg adapalene in an
off-white aqueous gel. (3)
CONTRAINDICATIONS
Adapalene gel, 0.3% should not be administered to individuals who are
hypersensitive to adapalene or any of the
components in the gel vehicle. (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 were reported with
use of adapalene gel. (5.2)
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 GALDERMA LABORATORIES,
L.P. AT 1-866-735-4137 OR FDA
AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH._
DRUG INTERACTIONS
As adapalene gel has the potential to induce local irritation in some
patients, 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. Use with
caution, especially when using preparations containing sulfur,
re