Tazarotene

Tazarotene gel, 0.05% is a retinoid indicated for the topical treatment of plaque psoriasis of up to 20% body surface area involvement. ( 1.1 ) Limitations of Use The safety of tazarotene gel use on more than 20% body surface area has not been established. ( 1.3 )

1.1Plaque Psoriasis

Tazarotene gel, 0.05% is indicated for the topical treatment of patients with plaque psoriasis of up to 20% body surface area involvement.

1.3Limitations of Use

The safety of tazarotene gel use on more than 20% body surface area has not been established in psoriasis [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )].

Tazarotene 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 )]. Pregnancy ( 4 , 8.1 ) Hypersensitivity ( 4 )

Embryofetal Toxicity: Tazarotene gel contains tazarotene, which is a teratogen. Tazarotene 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.

Tazarotene 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. Tazarotene gel should be administered with caution if the patient is also taking drugs known to be photosensitizers. ( 5.3 )

5.1Embryofetal Toxicity Based

on data from animal reproduction studies, retinoid pharmacology and the potential for systemic absorption, tazarotene gel may cause fetal harm when administered to a pregnant female and is contraindicated during pregnancy. Tazarotene elicits malformations and developmental effects associated with retinoids after topical and oral administration to pregnant rats and rabbits during organogenesis. Systemic exposure to tazarotenic acid is dependent upon the extent of the body surface area treated.