"The US Food and Drug Administration (FDA) has approved a foam containing calcipotriene and betamethasone dipropionate (Enstilar, Leo Pharma Inc) for topical treatment of plaque psoriasis in adults 18 years of age and older, according to a "...
In human dermal safety studies, tazarotene 0.05% and 0.1% gels did not induce allergic contact sensitization, phototoxicity or photoallergy.
The most frequent adverse events reported with TAZORAC® (tazarotene gel) Gel 0.05% and 0.1% were limited to the skin. Those occurring in 10 to 30% of patients, in descending order, included pruritus, burning/stinging, erythema, worsening of psoriasis, irritation, and skin pain. Events occurring in 1 to 10% of patients included rash, desquamation, irritant contact dermatitis, skin inflammation, fissuring, bleeding, and dry skin. Increases in “psoriasis worsening” and “sun-induced erythema” were noted in some patients over the 4th to 12th months as compared to the first three months of a 1 year study. In general, the incidence of adverse events with TAZORAC® (tazarotene gel) Gel 0.05% was 2 to 5% lower than that seen with TAZORAC® (tazarotene gel) Gel 0.1%.
The most frequent adverse events reported with TAZORAC® (tazarotene gel) Gel 0.1% in the treatment of acne occurring in 10 to 30% of patients, in descending order, included desquamation, burning/stinging, dry skin, erythema and pruritus. Events occurring in 1 to 10% of patients included irritation, skin pain, fissuring, localized edema and skin discoloration.
The following adverse reactions have been identified during postmarketing use of TAZORAC® (tazarotene gel) Gel 0.05% and 0.1% in clinical practice. Because they are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to TAZORAC® (tazarotene gel) Gel. The reactions include: blister, rash, skin discoloration (including skin hyperpigmentation or skin hypopigmentation), and pain.
Read the Tazorac (tazarotene gel) Side Effects Center for a complete guide to possible side effects
Concomitant dermatologic medications and cosmetics that have a strong drying effect should be avoided. It is also advisable to “rest” a patient's skin until the effects of such preparations subside before use of TAZORAC® (tazarotene gel) Gel is begun.
In a study of 27 healthy female subjects between the ages of 20 – 55 years receiving a combination oral contraceptive tablet containing 1 mg norethindrone and 35 μg ethinyl estradiol, concomitant use of tazarotene did not affect the pharmacokinetics of norethindrone and ethinyl estradiol over a complete cycle.
The impact of tazarotene on the pharmacokinetics of progestin only oral contraceptives (i.e., minipills) has not been evaluated.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/19/2011
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