Tazarotene Topical Dosage

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Acne

Tazorac(R) topical cream 0.1%:
For the topical treatment of patients with acne vulgaris: Cleanse the face gently. After the skin is dry, apply a thin layer (2 mg/cm2) once a day, in the evening, to the skin areas where acne lesions appear. Use enough to cover the entire affected area.

Topical foam 0.1%:
For the topical treatment of acne vulgaris: After washing with a mild cleanser and fully drying the affected area, tazarotene topical foam should be applied once a day in the evening. Dispense a small amount of foam into the palm of the hand. Using fingertips, apply only enough foam to lightly cover the entire affected areas of the face and/or upper trunk with a thin layer; gently massage the foam into the skin until the foam disappears.

Topical gel 0.1%:
For the topical treatment of patients with facial acne vulgaris of mild to moderate severity: Cleanse the face gently. After the skin is dry, apply a thin film (2 mg/cm2) once a day, in the evening, to the skin where acne lesions appear. Use enough to cover the entire affected area.

Usual Adult Dose for Psoriasis

Tazorac(R) topical cream 0.05% and 0.1%:
For the topical treatment of patients with plaque psoriasis: Apply once a day, in the evening, to psoriatic lesions, using enough (2 mg/cm2) to cover only the lesion with a thin film. If a bath or shower is taken prior to application, the skin should be dry before applying the cream. Because unaffected skin may be more susceptible to irritation, application of tazarotene topical cream to these areas should be carefully avoided.

Topical gel 0.05% and 0.1%:
For the topical treatment of patients with stable plaque psoriasis of up to 20% body surface area involvement: Apply once a day, 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, the skin should be dry before applying the gel. Because unaffected skin may be more susceptible to irritation, application of tazarotene topical gel to these areas should be carefully avoided.

Treatment should start with tazarotene topical cream or gel 0.05%, with strength increased to 0.1% if tolerated and medically indicated.

Usual Pediatric Dose for Acne

12 years or older:
Tazorac(R) topical cream 0.1%:
For the topical treatment of patients with acne vulgaris: Cleanse the face gently. After the skin is dry, apply a thin layer (2 mg/cm2) once a day, in the evening, to the skin areas where acne lesions appear. Use enough to cover the entire affected area.

Topical foam 0.1%:
For the topical treatment of acne vulgaris: After washing with a mild cleanser and fully drying the affected area, tazarotene topical foam should be applied once a day in the evening. Dispense a small amount of foam into the palm of the hand. Using fingertips, apply only enough foam to lightly cover the entire affected areas of the face and/or upper trunk with a thin layer; gently massage the foam into the skin until the foam disappears.

Topical gel 0.1%:
For the topical treatment of patients with facial acne vulgaris of mild to moderate severity: Cleanse the face gently. After the skin is dry, apply a thin film (2 mg/cm2) once a day, in the evening, to the skin where acne lesions appear. Use enough to cover the entire affected area.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

Tazarotene topical is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, treatment should be discontinued and the possible risk to the fetus should be discussed with the patient. Women of childbearing potential should be warned of the potential risk and use adequate birth control measures when tazarotene topical is used. A negative pregnancy test should be obtained within 2 weeks prior to therapy, which should begin during a normal menstrual period.

Tazarotene topical is for external use on affected areas only. For tazarotene topical gel and cream [marketed as Tazorac(R)], contact with eyes, eyelids, and mouth should be avoided. For tazarotene topical cream [marketed as Avage(R)], contact with eyes and mouth should be avoided. For tazarotene topical foam, contact with the mouth, eyes, and mucous membranes should be avoided. Accidental contact should be rinsed well with water.

Tazarotene topical cream and gel may cause excessive irritation in the skin of sensitive individuals. In some cases it may be necessary to temporarily discontinue therapy, lower the concentration (in patients with psoriasis), or reduce the dosing to an interval the patient can tolerate. Therapy can be resumed or the drug concentration or application frequency can be increased as the patient is able to tolerate the treatment. Application frequency should be closely monitored by careful observation of the clinical therapeutic response and skin tolerance. Efficacy has not been established for less than once daily dosing frequencies.

If undue irritation (redness, peeling, or discomfort) occurs with tazarotene topical foam, patients should reduce frequency of application or temporarily interrupt treatment. Treatment may be resumed once irritation subsides. Treatment should be discontinued if irritation persists.

Concomitant topical acne therapy should be used with caution as a cumulative irritant effect may occur. If irritancy or dermatitis occurs, the application frequency should be reduced or treatment should be temporarily interrupted and resumed once the irritation subsides. Treatment should be discontinued if the irritation persists.

Safety of tazarotene topical gel has not been established when applied to over 20% of the body surface area.

Due to increased susceptibility to burning, exposure to sunlight (including sunlamps) should be avoided unless deemed medically necessary; in such cases, exposure should be minimized during use of tazarotene topical. Patients must be warned to use sunscreens (minimum SPF of 15) and protective clothing when using tazarotene topical. Patients with sunburn should be advised not to use tazarotene topical until fully recovered. Patients who may have considerable sun exposure due to their occupation and those patients with inherent sensitivity to sunlight should exercise particular caution.

Tazarotene topical should be used with caution in patients also taking drugs known to be photosensitizers due to the increased possibility of augmented photosensitivity.

Due to the potential for photosensitivity resulting in greater risk for sunburn, tazarotene topical foam should be used with caution in patients with a personal or family history of skin cancer.

Avage(R) topical cream should be used under medical supervision as an adjunct to a comprehensive skin care and sunlight avoidance program that includes the use of effective sunscreens (minimum SPF of 15) and protective clothing. The duration of the mitigating effects on facial fine wrinkling, mottled hypo- and hyperpigmentation, and benign facial lentigines following discontinuation of Avage(R) topical cream has not been studied.

Some facial pigmented lesions may be lentigo maligna instead of lentigines. Facial pigmented lesions of concern should be carefully assessed by a qualified physician before application of Avage(R) topical cream. Lentigo maligna should not be treated with Avage(R) topical cream.

Safety and effectiveness of Avage(R) topical cream have not been established for the prevention or treatment of actinic keratoses, skin neoplasms, or lentigo maligna. Safety and effectiveness of Avage(R) topical cream have not been established for daily use beyond 52 weeks.

Safety and effectiveness for the treatment of acne have not been established in pediatric patients less than 12 years of age. Safety and effectiveness for the treatment of psoriasis have not been established in pediatric patients (less than 18 years of age). Safety and effectiveness of tazarotene topical cream have not been established in pediatric patients less than 17 years of age with facial fine wrinkling, facial mottled hypo- and hyperpigmentation, and benign facial lentigines.

Dialysis

Data not available

Other Comments

Hands should be washed after application of tazarotene topical unless treating hands for psoriasis.

Tazarotene topical cream and gel were investigated for up to 12 weeks during clinical trials for acne. Tazarotene topical gel was investigated for up to 12 months during clinical trials for psoriasis.

Avage(R) topical cream does not eliminate or prevent wrinkles, repair sundamaged skin, reverse photoaging, or restore more youthful or younger skin. It has not shown 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.

The propellant in tazarotene topical foam is flammable. Patients should be instructed to avoid fire, flame, and/or smoking during and immediately following application.

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