Safety in pregnant females has not been established. Reactions occurring in greater than 1 to less than 10% of subjects, in descending order, included irritation, desquamation, stinging, contact dermatitis, dermatitis, eczema, worsening of psoriasis, skin pain, rash, hypertriglyceridemia, dry skin, skin inflammation, and peripheral edema.Tazorac Cream, 0.1% was associated with a greater degree of local irritation than the 0.05% cream. The highest value was 2.4 ng/mL. If these effects occur, the medication should either be discontinued until the integrity of the skin is restored, or the dosing should be reduced to an interval the patient can tolerate. 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 recognized In animal reproduction studies with pregnant rats, tazarotene dosed topically during organogenesis at 2 times the maximum systemic exposure in subjects treated with the maximum recommended human dose (MRHD) of tazarotene cream, 0.1% resulted in reduced fetal body weights and reduced skeletal ossification. Frequency of application should be closely monitored by careful observation of the clinical therapeutic response and skin tolerance.
In animal reproduction studies with pregnant rabbits dosed topically with tazarotene gel at 26 times the maximum systemic exposure in subjects treated with the MRHD of tazarotene cream, 0.1%, there was a single incident of known retinoid malformations, including spina bifida, hydrocephaly, and heart anomalies.In animal reproduction studies with pregnant rats and rabbits, tazarotene dosed orally during organogenesis at 2 and 52 times, respectively, the maximum systemic exposure in subjects treated with the MRHD of tazarotene cream, 0.1% resulted in malformations, fetal toxicity, developmental delays, and/or behavioral delays. Each gram of Tazorac Cream, 0.05% and 0.1% contains 0.5 and 1 mg of tazarotene, respectively in a white cream base.Tazarotene is a member of the acetylenic class of retinoids.
If contact with mucous membranes occurs, rinse thoroughly with water It is recommended that treatment starts with TAZORAC Cream, 0.05%, with strength increased to 0.1% if tolerated and medically indicated. Wash your hands before and after use. Advise patients to avoid using TAZORAC if also taking other medicines may increase sensitivity to sunlight.This Patient Information has been approved by the U.S. Food and Drug AdministrationAll trademarks are the property of their respective owners.For more information call 1-800-678-1605 or go to www.tazorac.com.The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Little parent compound could be detected in the plasma. Tazorac Cream therapy should begin during a menstrual period Local tolerability reactions (including blistering and skin desquamation) and hypersensitivity adverse reactions (including urticaria) have been observed with topical tazarotene. After single topical doses of Pregnancy testing is recommended for females of reproductive potential within 2 weeks prior to initiating Tazorac Cream therapy which should begin during a menstrual period.Based on animal studies, Tazorac Cream may cause fetal harm when administered to a pregnant woman The safety and efficacy of Tazorac Cream have not been established in patients with psoriasis under the age of 18 years, or in patients with acne under the age of 12 years.Tazorac Cream for the treatment of acne has not been clinically tested in persons 65 years of age or older.Of the total number of subjects in clinical trials of Tazorac Cream for plaque psoriasis, 120 were over the age of 65. Based on data from another study, the maximum systemic exposure in the rat would be equivalent to the maximum systemic exposure in subjects treated with the MRHD of tazarotene cream, 0.1%.There is no information regarding the presence of tazarotene in human milk, the effects on the breastfed infant, or the effects on milk production. Patients with sunburn should be advised not to use Tazorac Cream until fully recovered. I've cried and not wanted to go out in public but in the long run- I promise it's worth it.
In patients treated topically over sufficient body surface area, exposure could be in the same order of magnitude as in orally treated animals. Alternatively, patients with psoriasis who are being treated with the 0.1% concentration can be switched to the lower concentration. If you get Tazorac (tazarotene gel) in any of these areas, rinse well with water. Common side effects of Tazorac include:burning sensation of skin, exacerbation of psoriasis, pruritus, skin irritation, stinging of the skin, erythema of skin, localized erythema, skin pain, and xeroderma. You may use a cream or lotion to soften or moisten your skin at least 1 hour before you apply Tazorac Gel.
Because unaffected skin may be more susceptible to irritation, application of TAZORAC Cream to these areas should be carefully avoided. Do not wash your hands after use if putting this on your hand.
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