Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
TAZAROTENE (UNII: 81BDR9Y8PS) (TAZAROTENE - UNII:81BDR9Y8PS)
Almirall, LLC
CUTANEOUS
PRESCRIPTION DRUG
TAZORAC® (tazarotene) Gel, 0.05% and 0.1% are indicated for the topical treatment of patients with plaque psoriasis of up to 20% body surface area involvement. TAZORAC (tazarotene) Gel, 0.1% is also indicated for the topical treatment of patients with facial acne vulgaris of mild to moderate severity. The efficacy of TAZORAC Gel in the treatment of acne previously treated with other retinoids or resistant to oral antibiotics has not been established. The safety of TAZORAC Gel use on more than 20% body surface area has not been established in psoriasis or acne [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )]. TAZORAC Gel 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, ret
TAZORAC (tazarotene) Gel is a translucent, aqueous gel, available in concentrations of 0.05% and 0.1%. It is available in a collapsible aluminum tube with a tamper-evident aluminum membrane over the opening and a white propylene screw cap, in 30 g and 100 g sizes. TAZORAC Gel 0.05% 30 g NDC 16110-833-30 TAZORAC Gel 0.05% 100 g NDC 16110-833-10 TAZORAC Gel 0.1% 30 g NDC 16110-042-30 TAZORAC Gel 0.1% 100 g NDC 16110-042-10 Storage: Store at 20°C to 25°C (68°F to 77°F). Excursions permitted from 15°C to 30°C (59°F to 86°F).
New Drug Application
TAZORAC- TAZAROTENE GEL ALMIRALL, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE TAZORAC GEL SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TAZORAC GEL. TAZORAC (TAZAROTENE) GEL, 0.05% AND 0.1%, FOR TOPICAL USE INITIAL U.S. APPROVAL: 1997 INDICATIONS AND USAGE TAZORAC Gel, 0.05% and 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis of up to 20% body surface area involvement. (1.1) TAZORAC Gel, 0.1% is indicated for the topical treatment of mild to moderate facial acne vulgaris. (1.2) Limitations of Use The safety of TAZORAC Gel use on more than 20% body surface area has not been established._ _(1.3) DOSAGE AND ADMINISTRATION Apply a thin layer of TAZORAC Gel 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 Gel, 0.05% and 0.1% (3) CONTRAINDICATIONS Pregnancy (4, 8.1) Hypersensitivity (4) WARNINGS AND PRECAUTIONS Embryofetal Toxicity: TAZORAC Gel contains tazarotene, which is a teratogen. TAZORAC Gel 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: Excessive pruritus, burning, skin redness or peeling can occur. If these reactions occur, discontinue until the integrity of the skin has been restored, or consider reducing dosing frequency or in the case of psoriasis, consider switching to the lower concentration. TAZORAC Gel 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 Gel should be administered with caution if the patient is also taking drugs known to be photosensitizers. (5.3) ADVERSE REACTIONS Plaque Pso Đọc toàn bộ tài liệu