THE MERCK MANUAL: The Merck Manual of Diagnosis and Therapy
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Tazarotene Drug Information Provided by Lexi-Comp

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Pronunciation

(taz AR oh teen)

Generic Available (U.S.)

No

Brand Names: U.S.

  • Avage®
  • Tazorac®

Brand Names: Canada

  • Tazorac®

Pharmacologic Category

  • Acne Products
  • Keratolytic Agent
  • Topical Skin Product, Acne

Pharmacologic Category Synonyms

  • Topical Skin Product, Acne
  • Acne Product, Topical

Use: Labeled Indications

Topical treatment of facial acne vulgaris; topical treatment of stable plaque psoriasis; mitigation (palliation) of facial skin wrinkling, facial mottled hyper-/hypopigmentation, and benign facial lentigines

Pregnancy Risk Factor

X

Pregnancy Considerations

May cause fetal harm if administered to a pregnant woman. A negative pregnancy test should be obtained within 2 weeks prior to treatment; treatment should begin during a normal menstrual period.

Lactation

Excretion in breast milk unknown/use caution

Contraindications

Hypersensitivity to tazarotene, other retinoids or vitamin A derivatives (isotretinoin, tretinoin, etretinate), or any component of the formulation; use in women of childbearing potential who are unable to comply with birth control requirements; pregnancy (negative pregnancy test required)

Warnings/Precautions

Concerns related to adverse effects:

• Photosensitivity: May cause photosensitivity; exposure to sunlight should be avoided unless deemed medically necessary, and in such cases, exposure should be minimized (including use of sunscreens/protective clothing). Risk may be increased by concurrent therapy with known photosensitizers (thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides).

•Skin irritation: Treatment can increase skin sensitivity to weather extremes of wind or cold. Also, concomitant topical medications (eg, medicated or abrasive soaps, cleansers, or cosmetics with a strong drying effect) should be used with caution due to increased skin irritation.

Special populations:

• Women of childbearing potential: Must use adequate contraceptive measures because of potential teratogenicity.

Dosage form specific issues:

• Gel: Safety and efficacy of gel applied over >20% of BSA have not been established.

Other warnings/precautions:

• Appropriate use: For external use only; avoid contact with eyes, eyelids, and mouth. Not for use on eczematous, broken, or sunburned skin; not for treatment of lentigo maligna. Avoid application over extensive areas.

Adverse Reactions

Percentage of incidence varies with formulation and/or strength:

>10%: Dermatologic: Burning/stinging, desquamation, dry skin, erythema, irritation, pruritus, skin pain, worsening of psoriasis

1% to 10%:

Cardiovascular: Peripheral edema

Dermatologic: Cheilitis, contact dermatitis, discoloration, eczema, fissuring, inflammation, localized bleeding, rash

Endocrine & metabolic: Hypertriglyceridemia

Frequency not defined: Dermatologic: Photosensitization

Postmarketing and/or case reports: Blistering

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Storage

Store at 25°C (77°F).

Mechanism of Action

Synthetic, acetylenic retinoid which modulates differentiation and proliferation of epithelial tissue and exerts some degree of anti-inflammatory and immunological activity

Pharmacodynamics/Kinetics

Duration: Therapeutic: Psoriasis: Effects have been observed for up to 3 months after a 3-month course of topical treatment

Absorption: Minimal following cutaneous application (≤6% of dose)

Distribution: Retained in skin for prolonged periods after topical application.

Protein binding: >99%

Metabolism: Prodrug, rapidly metabolized via esterases to an active metabolite (tazarotenic acid) following topical application and systemic absorption; tazarotenic acid undergoes further hepatic metabolism

Half-life elimination: 18 hours

Excretion: Urine and feces (as metabolites)

Dosage

Topical: Note: In patients experiencing excessive pruritus, burning, skin redness, or peeling, discontinue until integrity of the skin is restored, or reduce dosing to an interval the patient is able to tolerate.

Children ≥12 years and Adults:

Acne: Tazorac® cream/gel 0.1%: Apply a thin film (2 mg/cm2) to affected area once daily

Psoriasis: Tazorac® gel: Initial: 0.05%: Apply once daily to psoriatic lesions using enough (2 mg/cm2) to cover only the lesion with a thin film to no more than 20% of body surface area. May increase strength to 0.1% if tolerated and necessary.

Children ≥17 years and Adults: Palliation of fine facial wrinkles, facial mottled hyper-/hypopigmentation, benign facial lentigines: Avage™: Apply a pea-sized amount once daily

Adults: Psoriasis: Tazorac® cream: Initial: 0.05%: Apply once daily to psoriatic lesions using enough (2 mg/cm2) to cover only the lesion with a thin film. May increase strength to 0.1% if tolerated and necessary.

Administration: Topical

Do not apply to eczematous or sunburned skin; avoid eyes and mouth

Acne: Apply in evening after gently cleansing and drying face; apply enough to cover entire affected area.

Palliation of fine facial wrinkles, facial mottled hyper-/hypopigmentation, benign facial lentigines: Apply to clean dry face at bedtime; lightly cover entire face including eyelids if desired. Emollients or moisturizers may be applied before or after; if applied before tazarotene, ensure cream or lotion has absorbed into the skin and has dried completely.

Psoriasis: Apply in evening. If a bath or shower is taken prior to application, dry the skin before applying. If emollients are used, apply them at least 1 hour prior to application. Unaffected skin may be more susceptible to irritation, avoid application to these areas.

Monitoring Parameters

Disease severity in plaque psoriasis during therapy (reduction in erythema, scaling, induration); pregnancy test prior to treatment of female patients

Patient Education

This medication is for external use only; avoid using near eyes or mouth. Severe skin reactions may occur. Avoid any other skin products (including cosmetics or personal products that may contain medications, alcohols, or irritants) that are not approved by your prescriber. May cause photosensitivity, which will cause severe rash or burning (use sunblock SPF 15 or higher, wear protective clothing and eyewear, and avoid direct sunlight, sunlamps, or tanning beds). Report redness or discoloration, irritation, burning, stinging, excessive dryness, or worsening of condition.

Application: Wash affected area gently and completely dry before applying medication. Apply a thin layer to cover affected area. Wash off any medication that gets on unaffected skin areas and wash hands thoroughly after application.

Geriatric Considerations

No differences in safety or efficacy were seen when the cream formulation was administered to patients >65 years of age; may experience increased sensitivity. Increased incidence of adverse effects and lower treatment success rates were observed with the gel formulation in the treatment of psoriasis.

Dental Health: Effects on Dental Treatment

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions

No information available to require special precautions

Mental Health: Effects on Mental Status

None reported

Mental Health: Effects on Psychiatric Treatment

Use caution with drugs known to cause photosensitivity (psychotropics), effects may be augmented

Nursing: Physical Assessment/Monitoring

Assess for accumulated photosensitivity.

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Cream, topical:

Avage®: 0.1% (30 g) [contains benzyl alcohol]

Tazorac®: 0.05% (30 g, 60 g); 0.1% (30 g, 60 g) [contains benzyl alcohol]

Gel, topical:

Tazorac®: 0.05% (30 g, 100 g); 0.1% (30 g, 100 g) [contains benzyl alcohol]

Pricing: U.S. (www.drugstore.com)

Cream (Avage)

0.1% (30): $245.98

Cream (Tazorac)

0.05% (30): $209.98

0.05% (60): $445.00

0.1% (30): $245.98

0.1% (60): $480.01

Gel (Tazorac)

0.05% (30): $209.98

0.05% (100): $750.95

0.1% (30): $250.98

0.1% (100): $818.00

International Brand Names

  • Aguder (CN)
  • Avage (NZ, SG)
  • Ful Lee (TW)
  • Pzoret (CO)
  • Sumaytene (TW)
  • Suretin (CH, IT, MX)
  • Tarac (TW)
  • Tazoderm Forte (IN)
  • Tazorac (CZ)
  • Tazoten (TW)
  • Zorac (AT, AU, BE, BG, BR, DE, ES, FR, GB, GR, IE, IL, IT, NZ, PL, SE)
  • Zorac Gel (IL)

Lexi-Comp.com

Last full review/revision December 2011

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