Acnitaz (tazarotene) Gel 0.1% is indicated for the topical treatment of patients with stable plaque psoriasis of up to 20% body surface area involvement. Acnitaz (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 Acnitaz Gel in the treatment of acne previously treated with other retinoids or resistant to oral antibi otics has not been established.
Pregnancy Category X: Women of child-bearing potential should be warned of the potential risk and use adequate birth-control measures when Acnitaz Gel is used. The possibility that a woman of childbearing potential is pregnant at the time of institution of therapy should be considered. A negative result for pregnancy test having sensitivity down to at least 50 mIU/ mL for hCG should be obtained within 2 weeks prior to Acnitaz Gel therapy, which should begin during a normal menstrual period.
Acnitaz Gel should be applied only to the affected areas. For external use only. Avoid contact with eyes, eyelids, and mouth. If contact with eyes occurs, rinse thoroughly with water.
The safety of use of Acnitaz Gel over more than 20% of body surface area has not been established in psoriasis or acne.
Retinoids should not be used on eczematous skin, as they may cause severe irritation.
Because of heightened burning susceptibility, exposure to sunlight (including sunlamps) should be avoided unless deemed medically necessary, and in such cases, exposure should be minimized during the use of Acnitaz. Patients must be warned to use sunscreens (minimum SPF of 15) and protective clothing when using Acnitaz Gel.
Patients with sunburn should be advised not to use Acnitaz Gel until fully recovered. Patients who may have considerable sun exposure due to their occupation and those patients with inherent sensitivity to sunlight should exercise particular caution when using Acnitaz Gel and ensure that the precautions outlined in the Information for Patients subsection are observed.
Acnitaz Gel should be administered with caution if the patient is also taking drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the increased possibility of aug mented photosensitivity. Some individuals may experience excessive pruritus, burning, skin redness or peeling. 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. However, efficacy at reduced frequency of application has not been established.
Weather extremes, such as wind or cold, may be more irritating to patients using Acnitaz Gel.
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 Acnitaz Gel is begun.
Retinoids may cause fetal harm when administered to a pregnant woman. Acnitaz Gel is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued and the patient apprised of the potential hazard to the fetus.
Women of child-bearing potential should be warned of the potential risk and use adequate birth-control measures when Acnitaz Gel is used. The possibility that a woman of childbearing potential is pregnant at the time of institution of therapy should be considered. A negative result for pregnancy test having sensitivity down to at least 50 mIU/mL for human chorionic gonadotropin (hCG) should be obtained within 2 weeks prior to Acnitaz Gel therapy, which should begin during a normal menstrual period.
Acnitaz Gel is contraindicated in individuals who have shown hypersensitivity to any of its components.