Pajjiż: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
Adapalene (UNII: 1L4806J2QF) (ADAPALENE - UNII:1L4806J2QF)
Prasco Laboratories
Adapalene
Adapalene 3 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
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,
Adapalene Gel, 0.3% is supplied in the following size. 45g tube – NDC 66993-884-45 45g pump – NDC 66993-884-48 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.
New Drug Application Authorized Generic
ADAPALENE - ADAPALENE GEL PRASCO LABORATORIES ---------- 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 PRASCO LABORATORIES AT 1-866-525-0688 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, o Aqra d-dokument sħiħ