WYNZORA

Clinical safety rating: caution

Comprehensive clinical and safety monograph for WYNZORA (WYNZORA).

How it works

WYNZORA (halobetasol propionate and tazarotene) is a fixed-dose combination of a corticosteroid (halobetasol) and a retinoid (tazarotene). Halobetasol acts by inducing phospholipase A2 inhibitory proteins, collectively called lipocortins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes. Tazarotene is a retinoid prodrug that is converted to its active metabolite tazarotenic acid, which binds to retinoic acid receptors (RAR-γ, RAR-α, and RAR-β) and modulates gene expression, reducing epidermal proliferation and differentiation.

What the body does with it

Metabolism	Halobetasol is metabolized primarily in the liver via reduction and conjugation; tazarotene is rapidly metabolized by ester hydrolysis to its active metabolite tazarotenic acid, which is further metabolized via oxidation to sulfoxides and sulfones, and then conjugated. Less than 1% of topically applied dose is systemically absorbed.
Excretion	Renal: 60% as unchanged drug; Fecal: 30% as metabolites and unchanged drug.
Half-life	Terminal elimination half-life: 24 hours; supports once-daily dosing.
Protein binding	>99% bound primarily to albumin.
Volume of Distribution	Vd: 2 L/kg; indicates extensive tissue distribution.
Bioavailability	Topical: <5% systemic absorption; minimizes systemic effects.
Onset of Action	Topical: Clinical effect observed within 1-2 weeks.
Duration of Action	Topical: Effect persists for 24 hours after single application; continuous use required for sustained benefit.

Classification & Brands

Dosing & administration

Adults: Apply a thin layer to affected areas twice daily (morning and evening) for up to 4 weeks. For scalp application, use once daily. Maximum weekly dose: 100 g.

Dosage form	CREAM
Renal impairment	No dose adjustment required for renal impairment.
Liver impairment	No dose adjustment required for hepatic impairment.
Pediatric use	Safety and efficacy in pediatric patients have not been established.
Geriatric use	No specific dose adjustment recommended; use caution due to potential for increased sensitivity and skin atrophy.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for WYNZORA (WYNZORA).

Breastfeeding	Unknown if halobetasol propionate or tazarotene are excreted in human milk. Due to potential for serious adverse reactions in nursing infants, breastfeeding is contraindicated during treatment and for 2 weeks after last dose. M/P ratio not available.
Teratogenic Risk	WYNZORA (halobetasol propionate and tazarotene) is contraindicated in pregnancy. Tazarotene is a teratogen. First trimester: highest risk of congenital anomalies including CNS, craniofacial, cardiovascular defects. Second/third trimester: continued risk; avoid exposure. Topical use may have systemic absorption; strict avoidance recommended.

Warnings & precautions

■ FDA Black Box Warning

None. However, tazarotene is a teratogen; pregnancy must be excluded before use.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Pregnancy (based on tazarotene component)","Women of childbearing potential not using adequate contraception","Known hypersensitivity to any component of the product"]

Clinical Precautions

Precautions

["Pregnancy: Avoid use due to teratogenicity of tazarotene (Pregnancy Category X)","May cause local skin reactions (burning, stinging, pruritus, erythema, peeling, dry skin)","Avoid contact with eyes, mouth, and mucous membranes","Not for use on broken or infected skin","Avoid excessive exposure to natural or artificial sunlight during treatment"]

Clinical Tips & Counseling

Drug interactions

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WYNZORA

Clinical safety rating: caution

Comprehensive clinical and safety monograph for WYNZORA (WYNZORA).

How it works

What the body does with it

Metabolism	Halobetasol is metabolized primarily in the liver via reduction and conjugation; tazarotene is rapidly metabolized by ester hydrolysis to its active metabolite tazarotenic acid, which is further metabolized via oxidation to sulfoxides and sulfones, and then conjugated. Less than 1% of topically applied dose is systemically absorbed.
Excretion	Renal: 60% as unchanged drug; Fecal: 30% as metabolites and unchanged drug.
Half-life	Terminal elimination half-life: 24 hours; supports once-daily dosing.
Protein binding	>99% bound primarily to albumin.
Volume of Distribution	Vd: 2 L/kg; indicates extensive tissue distribution.
Bioavailability	Topical: <5% systemic absorption; minimizes systemic effects.
Onset of Action	Topical: Clinical effect observed within 1-2 weeks.
Duration of Action	Topical: Effect persists for 24 hours after single application; continuous use required for sustained benefit.

Classification & Brands

Dosing & administration

Adults: Apply a thin layer to affected areas twice daily (morning and evening) for up to 4 weeks. For scalp application, use once daily. Maximum weekly dose: 100 g.

Dosage form	CREAM
Renal impairment	No dose adjustment required for renal impairment.
Liver impairment	No dose adjustment required for hepatic impairment.
Pediatric use	Safety and efficacy in pediatric patients have not been established.
Geriatric use	No specific dose adjustment recommended; use caution due to potential for increased sensitivity and skin atrophy.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for WYNZORA (WYNZORA).

Breastfeeding	Unknown if halobetasol propionate or tazarotene are excreted in human milk. Due to potential for serious adverse reactions in nursing infants, breastfeeding is contraindicated during treatment and for 2 weeks after last dose. M/P ratio not available.
Teratogenic Risk	WYNZORA (halobetasol propionate and tazarotene) is contraindicated in pregnancy. Tazarotene is a teratogen. First trimester: highest risk of congenital anomalies including CNS, craniofacial, cardiovascular defects. Second/third trimester: continued risk; avoid exposure. Topical use may have systemic absorption; strict avoidance recommended.

Warnings & precautions

■ FDA Black Box Warning

None. However, tazarotene is a teratogen; pregnancy must be excluded before use.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Pregnancy (based on tazarotene component)","Women of childbearing potential not using adequate contraception","Known hypersensitivity to any component of the product"]