TazaroteneU.S. Brand Names: Avage™; Tazorac�(r)
Generic Available: No
Canadian Brand Names: Tazorac�(r)
Use: Topical treatment of facial acne vulgaris; topical treatment of stable plaque psoriasis of up to 20% body surface area involvement; mitigation (palliation) of facial skin wrinkling, facial mottled hyper/hypopigmentation, and benign facial lentigines
Pregnancy Risk Factor: X
Pregnancy Implications: May cause fetal harm if administered to a pregnant woman. A negative pregnancy test should be obtained 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: Women of childbearing potential must use adequate contraceptive measures because of potential teratogenicity. 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) during use of tazarotene. Risk may be increased by concurrent therapy with known photosensitizers (thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides). 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; specifically, safety and efficacy of gel applied over >20% of BSA have not been established. Safety and efficacy in children <12 years of age have not been established.
Adverse Reactions: Percentage of incidence varies with formulation and/or strength: >10%: Dermatologic: Burning/stinging, desquamation, dry skin, erythema, pruritus, skin pain, worsening of psoriasis 1% to 10%: Dermatologic: Contact dermatitis, discoloration, fissuring, hypertriglyceridemia, inflammation, irritation, localized bleeding, rash Frequency not defined: Dermatologic: Photosensitization Neuromuscular & skeletal: Peripheral neuropathy
Overdosage/Toxicology: Excessive topical use may lead to marked redness, peeling, or discomfort. Oral ingestion may lead to the same adverse effects as those associated with excessive oral intake of Vitamin A (hypervitaminosis A) or other retinoids. Treatment: If oral ingestion occurs, monitor the patient and administer appropriate supportive measures as necessary
Drug Interactions: Increased toxicity: Sulfur, benzoyl peroxide, salicylic acid, resorcinol, or any product with strong drying effects (including alcohol-containing compounds): Potentiates adverse reactions Photosensitizing medications (thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides): Augment phototoxicity
Stability: Store at room temperature of 25°C (77°F), away from heat and direct light; do not freeze.
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�(r) cream/gel 0.1%: Cleanse the face gently. After the skin is dry, apply a thin film of tazarotene (2 mg/cm2) once daily, in the evening, to the skin where the acne lesions appear; use enough to cover the entire affected area Psoriasis: Tazorac�(r) gel 0.05% or 0.1%: Apply once daily, in the evening, 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. If a bath or shower is taken prior to application, dry the skin before applying. Unaffected skin may be more susceptible to irritation, avoid application to these areas. 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 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. Adults: Psoriasis: Tazorac�(r) cream 0.05% or 0.1%: Apply once daily, in the evening, 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. If a bath or shower is taken prior to application, dry the skin before applying. Unaffected skin may be more susceptible to irritation, avoid application to these areas.
Administration: Do not apply to eczematous or sunburned skin; apply thin film to affected areas; avoid eyes and mouth
Monitoring Parameters: Disease severity in plaque psoriasis during therapy (reduction in erythema, scaling, induration); routine blood chemistries (including transaminases) are suggested during long-term topical therapy; pregnancy test prior to treatment of female patients
Patient Education: Inform prescriber of all prescriptions, OTC medications, or herbal products you are taking, and any allergies you have. This medication is for external use only; avoid using near eyes or mouth. Use exactly as directed; do not use more than recommended (severe skin reactions may occur). Avoid any other skin products (including cosmetics or personal products that may contain medications, spices, 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, open sores, bleeding, burning, stinging, excessive dryness, or swelling of skin; or worsening of condition. Pregnancy/breast-feeding precautions: Inform prescriber if you are pregnant. Do not get pregnant during treatment. Consult prescriber for instruction on appropriate contraceptive measures. This drug may cause severe fetal defects. Do not allow anyone who may be or become pregnant to touch this medication. Consult prescriber if breast-feeding. 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.
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
Dosage Forms: Cream: Avage™: 0.1% (15 g, 30 g) [contains benzyl alcohol] Tazorac�(r): 0.05% (15 g, 30 g, 60 g); 0.1% (15 g, 30 g, 60 g) [contains benzyl alcohol] Gel (Tazorac�(r)): 0.05% (30 g, 100 g); 0.1% (30 g, 100 g) [contains benzyl alcohol]
International Brand Names: Tazorac�(r) (CA, CZ); Zorac�(r) (AT, CH, DE, ES, FI, FR, GB, HR, IE, IT, PL, SE)
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