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standards of non-Merck sources.
Pronunciation
(taz AR oh teen)
U.S. Brand Names
Generic Available
No
Canadian Brand Names
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
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 Considerations
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
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:
• Pediatrics: Safety and efficacy have not been established in children <12 years of age.
• 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, 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
Drug Interactions
There are no known significant interactions.
Storage
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® 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® 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® 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: Topical
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
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.
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 potential for interactions with other prescriptions, OTC medications, or herbal products patient may be taking (eg, accumulated photosensitivity). Assess therapeutic effectiveness and adverse response on a regular basis during therapy. Teach patient proper use, side effects/appropriate interventions, and adverse reactions to report. Pregnancy risk factor X: Determine that patient is not pregnant before beginning treatment. Do not give to women of childbearing age unless they are capable of complying with contraceptive use. Instruct patients of childbearing age about appropriate contraceptive measures.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream:
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 (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): $138.47
Cream (Tazorac)
0.05% (30): $123.19
0.05% (60): $261.67
0.1% (30): $135.11
0.1% (60): $274.62
Gel (Tazorac)
0.05% (30): $128.28
0.05% (100): $396.75
0.1% (30): $135.11
0.1% (100): $420.70
International Brand Names
Lexi-Comp.com
Last full review/revision June 2009
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