Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
tazarotene (UNII: 81BDR9Y8PS) (tazarotene - UNII:81BDR9Y8PS)
Allergan, Inc.
tazarotene
tazarotene 0.5 mg in 1 g
CUTANEOUS
PRESCRIPTION DRUG
TAZORAC® (tazarotene) Cream, 0.05% and 0.1% are indicated for the topical treatment of patients with plaque psoriasis. TAZORAC (tazarotene) Cream, 0.1% is also indicated for the topical treatment of patients with acne vulgaris. TAZORAC Cream is contraindicated in : - Pregnancy. Retinoids may cause fetal harm when administered to a pregnant female [see Warnings and Precautions (5.1), Use in Specific Populations (8.1, 8.3)] . - Individuals who have known hypersensitivity to any of its components [see Warnings and Precautions (5.2)]. Risk Summary Based on data from animal reproduction studies, retinoid pharmacology, and the potential for systemic absorption, TAZORAC Cream may cause fetal harm when administered to a pregnant female and is contraindicated during pregnancy. Safety in pregnant females has not been established. The potential risk to the fetus outweighs the potential benefit to the mother from TAZORAC Cream during pregnancy; therefore, TAZORAC Cream should be discontinued as soon as pregnancy is re
TAZORAC Cream is a white cream available in concentrations of 0.05% and 0.1%. It is supplied in a collapsible aluminum tube with a tamper-evident aluminum membrane over the opening and a white polypropylene screw cap, in 30 g and 60 g sizes. Storage: Store at 20°C to 25°C (68°F to 77°F). Excursions permitted from -5°C to 30°C (23°F to 86°F).
New Drug Application
TAZORAC- TAZAROTENE CREAM ALLERGAN, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE TAZORAC CREAM SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TAZORAC CREAM. TAZORAC (TAZAROTENE) CREAM, 0.05% AND 0.1%, FOR TOPICAL USE INITIAL U.S. APPROVAL: 1997 INDICATIONS AND USAGE TAZORAC Cream 0.05% and 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis. (1.1) TAZORAC Cream 0.1% is indicated for the topical treatment of acne vulgaris. (1.2) DOSAGE AND ADMINISTRATION Apply a thin layer of TAZORAC Cream only to the affected area once daily in the evening. (2.1, 2.2) Not for ophthalmic, oral, or intravaginal use. (2.2) If contact with eyes occurs, rinse thoroughly with water. (2.2) DOSAGE FORMS AND STRENGTHS Cream, 0.05% and 0.1%. (3) CONTRAINDICATIONS Pregnancy (4, 8.1) Hypersensitivity (4) WARNINGS AND PRECAUTIONS Embryofetal Toxicity: TAZORAC Cream contains tazarotene, which is a teratogenic substance. TAZORAC Cream is contraindicated in pregnancy. Females of child-bearing potential should have a negative pregnancy test within 2 weeks prior to initiating treatment and use an effective method of contraception during treatment. (5.1) Local Irritation: Some individuals may experience excessive pruritus, burning, skin redness or peeling. If these effects occur, discontinue until the integrity of the skin has been restored, or reduce dosing interval, or in the case of psoriasis, may switch to the lower concentration. TAZORAC Cream should not be used on eczematous skin, as it may cause severe irritation. (5.2) Photosensitivity and Risk for Sunburn: Avoid exposure to sunlight, sunlamps, and weather extremes. Wear sunscreen daily. TAZORAC Cream should be administered with caution if the patient is also taking drugs known to be photosensitizers. (5.3) ADVERSE REACTIONS Plaque psoriasis: Most common adverse reactions occurring in 10 to 23% of patients are pruritus, erythema, and burning. (6.1) Acne Vulgaris: Most common adver Đọc toàn bộ tài liệu