Tazarotene

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It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Your pharmacist can provide more information about tazarotene topical.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Psoriasis: 1 week

Acne (Fabior, Tazorac 0.1% cream, Tazorac 0.1% gel): Topical treatment of acne vulgaris in patients 12 years and older.

Psoriasis:

Tazorac 0.05% and 0.1% cream: Topical treatment of plaque psoriasis in patients 18 years and older (US labeling) or patients 12 years and older (Canadian labeling).

Tazorac 0.05% and 0.1% gel: Topical treatment of stable plaque psoriasis of up to 20% body surface area involvement in patients 12 years and older.

Wrinkling, hyper- and hypopigmentation, lentigines (Avage): Adjunctive agent for use in the mitigation (palliation) of facial fine wrinkling, facial mottled hyper- and hypopigmentation, and benign facial lentigines in patients 17 years and older who use comprehensive skin care and sunlight avoidance programs.

Limitations of use: Does not eliminate or prevent wrinkles, repair sun-damaged skin, reverse photoaging, or restore more youthful or younger skin. Has not demonstrated a mitigating effect on significant signs of chronic sunlight exposure such as coarse or deep wrinkling, tactile roughness, telangiectasia, skin laxity, keratinocytic atypia, melanocytic atypia, or dermal elastosis. Safety and effectiveness for the prevention or treatment of actinic keratoses, skin neoplasms, or lentigo maligna has not been established. Safe and effective daily use >52 weeks is not known.

Cream: Store at 25°C (77°F); excursions are permitted between -5°C to 30°C (23°F to 86°F).

Foam: Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C to 30°C (59°F to 86°F). Store upright and protect from freezing. Foam is 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 49°C (120°F).

Gel: Store at 25°C (77°F); excursions are permitted between 15°C to 30°C (59°F to 86°F).

Concerns related to adverse effects:

• Photosensitivity: May cause photosensitivity; exposure to ultraviolet rays (including sunlight/sunlamps) should be avoided unless deemed medically necessary, and in such cases, exposure should be minimized. Risk may be increased by concurrent therapy with known photosensitizers (thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides); avoid coadministration. Use with caution in patients with a personal or family history of skin cancer. Daily sunscreen use and other protective measures recommended. Patients with sunburn should discontinue use until sunburn has healed.

• Skin irritation: Use with caution in patients with a history of local tolerability reactions or local hypersensitivity; excessive burning, pruritus, peeling, and skin redness may occur, especially during the early weeks of treatment. Treatment can increase skin sensitivity to weather extremes of wind or cold. Concomitant topical medications (eg, medicated or abrasive soaps, cleansers, or cosmetics with a strong drying effect) should be avoided due to increased skin irritation. Reduce frequency or discontinue use until irritation disappears.

Special populations:

• Women of childbearing potential: Consider the possibility of pregnancy prior to initiation of therapy; a negative pregnancy test should be obtained within 2 weeks prior to treatment and treatment should begin during a normal menstrual period. Must use adequate contraceptive measures to avoid pregnancy during treatment.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer’s labeling.

• Foam: Propellant is flammable; avoid fire and smoking during and immediately after use.

• 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, abraded, broken, or sunburned skin; not for treatment of lentigo maligna. Avoid application over extensive areas. The efficacy of tazarotene gel in the treatment of acne previously treated with other retinoids or resistant to oral antibiotics has not been established.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience short-term pain, itching, burning, stinging, or peeling. Have patient report immediately to prescriber sunburn, edema, or severe skin irritation (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Commonly reported side effects of tazarotene topical include: burning sensation, burning sensation of skin, desquamation, exacerbation of psoriasis, pruritus, skin irritation, stinging of the skin, erythema, localized erythema, skin pain, and xeroderma. See below for a comprehensive list of adverse effects.

Applies to tazarotene topical: topical cream, topical foam, topical gel

Dermatologic

Very common (10% or more): Desquamation (29%), dry skin (27%), erythema (21%), burning sensation (14%)
Common (1% to 10%): Pruritus, irritation, nonspecific rash, irritant contact dermatitis, skin pain, worsening of psoriasis, stinging sensation, inflammation
Uncommon (0.1% to 1%): Cheilitis, excoriated skin, eczema, erythema sun-induced, papules, skin tightness, worsened acne
Postmarketing reports: Blister, dermatitis, urticaria, skin exfoliation, swelling at or near application sites, skin discoloration (including skin hyperpigmentation or skin hypopigmentation)[Ref]

Metabolic

Common (1% to 10%): Hypertriglyceridemia[Ref]

Other

Common (1% to 10%): Facial pain[Ref]

Ocular

Common (1% to 10%): Eyelid edema, eyelid irritation, eyelid inflammation[Ref]

Immunologic

Uncommon (0.1% to 1%): Infection[Ref]

Respiratory

Uncommon (0.1% to 1%): Pharyngitis[Ref]

Nervous system

Uncommon (0.1% to 1%): Headache, hypesthesia[Ref]

Some side effects of tazarotene topical may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Data not available