Tazarotene
Generic Name: tazarotene
Brand Names:
Fabior
11 DESCRIPTION FABIOR (tazarotene) Foam, 0.1% contains the compound tazarotene, a member of the acetylenic class of retinoids. It is for topical use only. Chemically, tazarotene is ethyl 6-[(4,4-dimethylthiochroman-6-yl)ethynyl]nicotinate. The structural formula is represented below: Molecular Formula: C 21 H 21 NO 2 S Molecular Weight: 351.46 Tazarotene is a pale yellow to yellow substance.
Overview
11 DESCRIPTION FABIOR (tazarotene) Foam, 0.1% contains the compound tazarotene, a member of the acetylenic class of retinoids. It is for topical use only. Chemically, tazarotene is ethyl 6-[(4,4-dimethylthiochroman-6-yl)ethynyl]nicotinate. The structural formula is represented below: Molecular Formula: C 21 H 21 NO 2 S Molecular Weight: 351.46 Tazarotene is a pale yellow to yellow substance.
Uses
1 INDICATIONS AND USAGE FABIOR ® (tazarotene) Foam, 0.1% is indicated for the topical treatment of acne vulgaris in patients 12 years of age or older. FABIOR Foam is a retinoid indicated for the topical treatment of acne vulgaris in patients 12 years of age or older. ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION FABIOR Foam is for topical use only. FABIOR Foam is not for oral, ophthalmic, or intravaginal use. FABIOR Foam should be applied once daily in the evening after washing with a mild cleanser and fully drying the affected area. Dispense a small amount of foam into the palm of the hand. Using fingertips, apply only enough foam to lightly cover the entire affected areas of the face and/or upper trunk with a thin layer; gently massage the foam into the skin until the foam disappears. Avoid the eyes, lips, and mucous membranes. Wash hands after application. Patients may use moisturizer as needed. If undue irritation (redness, peeling, or discomfort) occurs, patients should reduce frequency of application or temporarily interrupt treatment.
Side Effects
6 ADVERSE REACTIONS Most common adverse reactions reported at an incidence ≥6% are application site irritation, application site dryness, application site erythema, and application site exfoliation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma at 1-844-825-8500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data reflect exposure to FABIOR Foam in 744 subjects with acne vulgaris.
Interactions
7 DRUG INTERACTIONS No formal drug-drug interaction studies were conducted with FABIOR Foam. Concomitant dermatologic medications and cosmetics that have a strong drying effect should be avoided. It is recommended to postpone treatment until the effects of these products subside before use of FABIOR Foam is started. Concomitant use with oxidizing agents, such as benzoyl peroxide, may cause degradation of tazarotene and may reduce the clinical efficacy of tazarotene. If combination therapy is required, they should be applied at different times of the day (e.g., one in the morning and the other in the evening). The impact of tazarotene on the pharmacokinetics of progestin-only oral contraceptives (i.e., minipills) has not been evaluated.
Warnings
5 WARNINGS AND PRECAUTIONS Fetal Risk: FABIOR Foam contains tazarotene, which is a teratogenic substance. FABIOR Foam is contraindicated in pregnancy. Females of childbearing potential should have a negative pregnancy test within 2 weeks prior to initiating treatment and use an effective method of contraception during treatment. ( 5.1 ) Local Irritation: Use with caution in patients with a history of local tolerability reactions or local hypersensitivity. ( 5.2 ) Potential Irritant Effect with Concomitant Topical Medications: Use with caution because a cumulative irritant effect may occur. ( 5.3 ) Photosensitivity and Risk for Sunburn: Avoid exposure to sunlight, sunlamps, and weather extremes. Wear sunscreen daily. ( 5.4 ) Contents are flammable. 4 CONTRAINDICATIONS FABIOR Foam is contraindicated in pregnancy. FABIOR Foam may cause fetal harm when administered to a pregnant woman. Tazarotene elicits teratogenic and developmental effects associated with retinoids after topical or systemic administration in rats and rabbits [see Use in Specific Populations (8.1) ].
Pregnancy
8.1 Pregnancy FABIOR Foam is contraindicated in pregnancy [see Contraindications (4) ]. There are no adequate and well-controlled studies with FABIOR Foam in pregnant women. FABIOR Foam is contraindicated in females who are or may become pregnant [see Contraindications (4) ]. Females of child-bearing potential should be warned of the potential risk and use adequate birth-control measures when FABIOR Foam is used. The possibility that a female of child-bearing potential is pregnant at the time of institution of therapy should be considered.
Storage
Storage and Handling: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). See USP-controlled room temperature. Store upright. Protect from freezing. Flammable. Avoid fire, flame, or smoking during and immediately following application. Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures above 120°F (49°C).
Frequently Asked Questions
What is Tazarotene used for?▼
1 INDICATIONS AND USAGE FABIOR ® (tazarotene) Foam, 0.1% is indicated for the topical treatment of acne vulgaris in patients 12 years of age or older. FABIOR Foam is a retinoid indicated for the topical treatment of acne vulgaris in patients 12 years of age or older. ( 1 )
What are the side effects of Tazarotene?▼
6 ADVERSE REACTIONS Most common adverse reactions reported at an incidence ≥6% are application site irritation, application site dryness, application site erythema, and application site exfoliation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma at 1-844-825-8500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data reflect exposure to FABIOR Foam in 744 subjects with acne vulgaris.
Can I take Tazarotene during pregnancy?▼
8.1 Pregnancy FABIOR Foam is contraindicated in pregnancy [see Contraindications (4) ]. There are no adequate and well-controlled studies with FABIOR Foam in pregnant women. FABIOR Foam is contraindicated in females who are or may become pregnant [see Contraindications (4) ]. Females of child-bearing potential should be warned of the potential risk and use adequate birth-control measures when FABIOR Foam is used. The possibility that a female of child-bearing potential is pregnant at the time of institution of therapy should be considered.
What are the important warnings for Tazarotene?▼
5 WARNINGS AND PRECAUTIONS Fetal Risk: FABIOR Foam contains tazarotene, which is a teratogenic substance. FABIOR Foam is contraindicated in pregnancy. Females of childbearing potential should have a negative pregnancy test within 2 weeks prior to initiating treatment and use an effective method of contraception during treatment. ( 5.1 ) Local Irritation: Use with caution in patients with a history of local tolerability reactions or local hypersensitivity. ( 5.2 ) Potential Irritant Effect with Concomitant Topical Medications: Use with caution because a cumulative irritant effect may occur. ( 5.3 ) Photosensitivity and Risk for Sunburn: Avoid exposure to sunlight, sunlamps, and weather extremes. Wear sunscreen daily. ( 5.4 ) Contents are flammable. 4 CONTRAINDICATIONS FABIOR Foam is contraindicated in pregnancy. FABIOR Foam may cause fetal harm when administered to a pregnant woman. Tazarotene elicits teratogenic and developmental effects associated with retinoids after topical or systemic administration in rats and rabbits [see Use in Specific Populations (8.1) ].
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.