Tazarotene (7 brand names, 4 dosage forms, 1 route)
Available dosage forms: GEL, CREAM, LOTION, AEROSOL, FOAM.
Routes of administration: TOPICAL.
Brand Names
- ARAZLO
- AVAGE
- DUOBRII
- FABIOR
- HALOBETASOL PROPIONATE AND TAZAROTENE
- TAZAROTENE
- TAZORAC
Dosage and Administration
Trilitas™ gel is for topical use only. Trilitas™ gel is not for ophthalmic, oral, or intravaginal use. Avoid accidental transfer of Trilitas™ gel into eyes, mouth, or other mucous membranes. If contact with mucous membranes occurs, rinse thoroughly with water [see Warnings and Precautions (5.2)]. Wash hands thoroughly after application.
Contraindications
Trilitas™ 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)].
Adverse Reactions
The following serious adverse reactions are discussed in more detail in other sections of the labeling: Embryofetal toxicity [see Warnings and Precautions (5.1)] Photosensitivity and Risk of Sunburn [see Warnings and Precautions (5.3)]
Drug Interactions
No formal drug-drug interaction studies were conducted with Trilitas™ gel. In a trial of 27 healthy female subjects between the ages of 20–55 years receiving a combination oral contraceptive tablet containing 1 mg norethindrone and 35 mcg ethinyl estradiol, concomitant use of tazarotene administered as 1.1 mg orally (mean ± SD Cmax and AUC0-24 of tazarotenic acid were 28.9 ± 9.4 ng/mL and 120.6 ± 28.5 ng∙hr/mL, respectively) 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.
Mechanism of Action
Tazarotene is a retinoid prodrug which is converted to its active form, the carboxylic acid of tazarotene, by deesterification. Tazarotenic acid binds to all three members of the retinoic acid receptor (RAR) family: RARα, RARβ, and RARγ, but shows relative selectivity for RARβ, and RARγ and may modify gene expression. The clinical significance of these findings for the treatment of plaque psoriasis and facial acne vulgaris is unknown.
Overdosage
Excessive topical use of Trilitas™ gel, 0.1% may lead to marked redness, peeling, or discomfort [see Warnings and Precautions (5.2)]. Trilitas™ gel, 0.1% is not for oral use. Oral ingestion of the drug may lead to the same adverse effects as those associated with excessive oral intake of Vitamin A (hypervitaminosis A) or other retinoids. If oral ingestion occurs, the patient should be monitored, and appropriate supportive measures should be administered as necessary.