ADAPALENE gel

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Sandoz Inc.

INN (nemzetközi neve):

ADAPALENE

Összetétel:

ADAPALENE 3 mg in 1 g

Az alkalmazás módja:

TOPICAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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.  Ho

Termék összefoglaló:

Adapalene Gel USP, 0.3% is supplied in the following size. 45 g tube – NDC 0781-7142-19 45 g pump - NDC 0781-7142-70 Storage: Store at 20° – 25ºC (68º – 77ºF); excursions permitted to 15º – 30ºC (59º – 86ºF) [see USP Controlled Room Temperature].  Protect from freezing.  Keep out of reach of children.

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

ADAPALENE- ADAPALENE GEL
SANDOZ 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, 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 USP, 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 SANDOZ INC. AT
1-800-525-8747 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,
resorcinol, or salicy