TAZORAC- tazarotene cream

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

tazarotene (UNII: 81BDR9Y8PS) (tazarotene - UNII:81BDR9Y8PS)

Beschikbaar vanaf:

Almirall, LLC

Toedieningsweg:

CUTANEOUS

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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

Product samenvatting:

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).

Autorisatie-status:

New Drug Application

Productkenmerken

TAZORAC- TAZAROTENE CREAM
ALMIRALL, LLC
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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 advers