No

Keratolytic Agent

Topical treatment of facial acne vulgaris; topical treatment of stable plaque psoriasis of up to 20% body surface area involvement

X

Hypersensitivity to tazarotene and other retinoids or vitamin A derivatives (isotretinoin, tretinoin, etretinate); pregnancy

Use with caution in patients who are breast-feeding. Use with caution in patients with eczema or open wounds (increased irritation and absorption may occur). Because of heightened burning susceptibility, exposure to sunlight should be avoided unless deemed medically necessary, and in such cases, exposure should be minimized during use of tazarotene. Administer with caution if the patient is also taking drugs known to be photosensitizers (thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the increased possibility of augmented photosensitivity. Patients should be warned to use sunscreens (SPF minimum of 15) and protective clothing when using tazarotene. Application may cause a transitory feeling of burning or stinging. For external use only; avoid contact with eyes, eyelids, and mouth. The safety of use over >20% of body surface area has not been established.

>10%: Local: Pruritus, burning/stinging, erythema, worsening of psoriasis, irritation, skin pain

1% to 10%: Dermatologic: Rash, desquamation, irritant contact dermatitis, skin inflammation, fissure, bleeding, dry skin, skin discoloration

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

Store gel at room temperature, away from heat and direct light; do not freeze

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

Absorption: Minimal following cutaneous application of 0.05 or 0.1% gel ( less than or equal to 6% of dose)

Distribution: Retained in skin for prolonged periods after topical application. Therapeutic effects have been observed for up to 3 months after a 3-month course of topical treatment in patients with psoriasis.

Metabolism: Tazarotene is a prodrug which is rapidly metabolized by esterases to an active metabolite (tazarotenic acid) following topical application and systemic absorption. Tazarotenic acid is further metabolized in the liver.

Elimination: Primarily in the bile as tazarotene and tazarotenic acid

Children >12 years and Adults: Topical:

Psoriasis: Apply tazarotene 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 the gel. Because unaffected skin may be more susceptible to irritation, avoid application of tazarotene to these areas. Tazarotene was investigated for up to 12 months during clinical trials for psoriasis.

Disease severity in plaque psoriasis during therapy (reduction in erythema, scaling, induration); routine blood chemistries (including transaminases) are suggested during long-term topical therapy

None noted

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

No information available to require special precautions

No effects or complications reported

Do not take this medication if you have had an allergic reaction to tazarotene. Do not use tazarotene if you are pregnant or planning to become pregnant. Tazarotene may cause birth defects or be harmful to an unborn baby if used during pregnancy. This may be more likely if the medicine is used on large areas of skin.

Acne patients: Gently wash and dry your face. Apply a thin layer of medication to cover the acne. Your acne should start to clear up in about 4 weeks.

Psoriasis patients: If using the medication after bathing or showering, make sure your skin is completely dry before applying the medication. Apply a thin layer to lesions.

Wash off any medication that gets on skin areas that do not need to be treated. The medication can irritate skin that does not need treatment. Do not bandage or cover the treated skin. Ask your physician or pharmacist before taking any other medication, including over-the-counter products. Talk with your physician or pharmacist before using medicated cosmetics or shampoos, abrasive soaps or cleansers, products with alcohol, spice, or lime in them, other acne medicines, hair removal products, or products that dry your skin.

This medication may make your skin sensitive to sunlight and cause a rash or sunburn. Avoid spending long periods of time in direct sunlight and protect your skin with clothing and a strong sunscreen when you are outdoors. Do not use a sunlamp or tanning booth. Call your physician if you have blistering or crusting skin, severe redness, pain, or swelling on the areas that you use the medication.

Gel, topical: 0.05% (30 g, 100 g), 0.1% (30 g, 100 g)