(taz AR oh teen)
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, Tazorac 0.1% cream [Canadian labeling; not in US labeling]): 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. Use for greater than 52 weeks has not been established.
Hypersensitivity to tazarotene or any component of the formulation; women who are or may become pregnant
Documentation of allergenic cross-reactivity for retinoids is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.
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.
Acne: Topical:
Fabior: Apply a small amount to affected area once daily in the evening.
Tazorac cream/gel 0.1%: Apply a thin film (2 mg/cm2) to affected area once daily in the evening.
Palliation of fine facial wrinkles, facial mottled hyper-/hypopigmentation, benign facial lentigines: Topical: Avage: Apply a pea-sized amount to entire face once daily at bedtime.
Psoriasis: Topical: Tazorac cream/gel: 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.
Refer to adult dosing.
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.
Acne: Children ≥12 years and Adolescents: Refer to adult dosing.
Psoriasis: Children ≥12 years and Adolescents: Topical: Tazorac gel (US labeling) or Tazorac gel/cream (Canadian labeling): Refer to adult dosing.
Palliation of fine facial wrinkles, facial mottled hyper-/hypopigmentation, benign facial lentigines: Adolescents ≥17 years: Topical: Avage: Refer to adult dosing.
For topical use only; not for oral, ophthalmic, or intravaginal use. Do not cover treated areas with dressings or bandages. Do not apply to eczematous, abraded, broken, or sunburned skin.
Acne: Apply in evening after gently cleansing and drying face; apply enough to cover entire affected area.
Foam: Dispense a small amount of foam into palm of the hand. Use fingertips to lightly cover the entire affected area of the face and/or upper trunk with a thin layer; massage into skin until foam disappears. Wash hands after use. Moisturizer may be used if necessary.
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; ensure first cream or lotion has absorbed into the skin and has dried completely before applying tazarotene.
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.
Cream:
US labeling: Store at 25 � �C (77 � �F); excursions are permitted between -5 � �C to 30 � �C (23 � �F to 86 � �F).
Canadian labeling: Store at 15 � �C to 25 � �C (59 � �F to 77 � �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). Protect from freezing. Foam is flammable; avoid high temperatures.
Gel: Store at 25 � �C (77 � �F); excursions are permitted between 15 � �C to 30 � �C (59 � �F to 86 � �F).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, External:
Avage: 0.1% (30 g) [contains benzyl alcohol]
Tazorac: 0.05% (30 g, 60 g); 0.1% (30 g, 60 g) [contains benzyl alcohol]
Foam, External:
Fabior: 0.1% (50 g, 100 g)
Gel, External:
Tazorac: 0.05% (30 g, 100 g); 0.1% (30 g, 100 g) [contains benzyl alcohol]
There are no known significant interactions.
Disease severity in plaque psoriasis during therapy (reduction in erythema, scaling, induration); clinical response and skin tolerance; pregnancy test prior to treatment of female patients
Percentage of incidence varies with formulation and/or strength:
>10%: Dermatologic: Desquamation (0.1% cream 40%; foam 6%), erythema (0.1% cream 34%; foam 6%), burning sensation of skin (26%), xeroderma (7% to 16%), skin irritation (10% to 14%), exacerbation of psoriasis, skin pain
1% to 10%:
Cardiovascular: Peripheral edema
Dermatologic: Pruritus (0.1% cream 10%; foam 1%), contact dermatitis (8%), stinging of the skin (3%), skin rash ( ≤3%), cheilitis (1%), dermatitis (1%), skin photosensitivity (1%), eczema, skin discoloration, skin fissure
Endocrine & metabolic: Hypertriglyceridemia
Local: Application site pain (1%), local hemorrhage
Ophthalmic: Ocular irritation (including edema, irritation, and inflammation of the eye or eyelid; 4%)
<1% (Limited to important or life-threatening): Impetigo, skin blister
Concerns related to adverse effects:
- Photosensitivity: May cause photosensitivity; exposure to 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). 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; burning, excessive 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.
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Adverse events were observed in animal reproduction studies. Use in pregnancy is contraindicated. A negative pregnancy test should be obtained within 2 weeks prior to treatment; treatment should begin during a normal menstrual period.
Synthetic, acetylenic retinoid which modulates differentiation and proliferation of epithelial tissue and exerts some degree of anti-inflammatory and immunological activity
Minimal following cutaneous application ( ≤6% of dose)
Retained in skin for prolonged periods after topical application.
Prodrug, rapidly metabolized via esterase hydrolysis to an active metabolite (tazarotenic acid) following topical application and systemic absorption; tazarotenic acid undergoes further hepatic metabolism
Urine and feces (as metabolites)
Psoriasis: 1 week
Therapeutic: Psoriasis: Effects have been observed for up to 3 months after a 3-month course of topical treatment
Cream, gel: ~18 hours (tazarotenic acid); Foam: ~8 hours
>99% (tazarotenic acid)
- 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.