Tazarotene

Tazarotene 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 augmented photosensitivity.

Patients should be advised to avoid excessive exposure to UV light (including sunlight, use of a solarium, PUVA or UVB therapy) during treatment with tazarotene.

Tazarotene gel is contraindicated in pregnancy, or in women planning a pregnancy. If the product 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 foetus. Women of child-bearing potential should be warned of the potential risk and use adequate birth control measures when Tazarotene 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 a sensitivity down to at least 50 mIU/mL for human chorionic gonadotropin (hCG) should be obtained within 2 weeks prior to Tazarotene gel therapy, which should begin during a normal menstrual period.

Although in animals no malformations were observed after dermal application, skeletal alterations were seen in the foetuses, which may be attributable to systemic retinoid effects. Teratogenic effects were observed after oral administration.

Although no data are available on the excretion of tazarotene in human milk, animal data indicate that excretion into milk is possible. For that reason tazarotene gel should not be used during breast-feeding.

Orally administered retinoids have been associated with congenital abnormalities. When used in accordance with the prescribing information, topically administered retinoids are generally assumed to result into low systemic exposure due to minimal dermal absorption. However, there could be individual factors (e.g. damaged skin barrier, excessive use) that contribute to an increased systemic exposure.

None known.