Tazarotene

TAZORAC ® Cream 0.05% and 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis. ( 1.1 ) TAZORAC Cream 0.1% is indicated for the topical treatment of acne vulgaris. ( 1.2 ) 1.1 Plaque Psoriasis TAZORAC ® (tazarotene) Cream, 0.05% and 0.1% are indicated for the topical treatment of patients with plaque psoriasis. 1.2 Acne Vulgaris TAZORAC (tazarotene) Cream, 0.1% is also indicated for the topical treatment of patients with acne vulgaris.

• Apply a thin layer of TAZORAC Cream only to the affected area once daily in the evening
• Not for ophthalmic, oral, or intravaginal use
• If contact with eyes occurs, rinse thoroughly with water
• Important Administration Instructions TAZORAC Cream is for topical use only
• TAZORAC Cream is not for ophthalmic, oral, or intravaginal use
• If contact with mucous membranes occurs, rinse thoroughly with water [see Warnings and Precaution ]
• Wash hands thoroughly after application
• Psoriasis It is recommended that treatment starts with TAZORAC Cream, 0.05%, with strength increased to 0.1% if tolerated and medically indicated
• Apply a thin film (2 mg/cm 2 ) of TAZORAC Cream once per day, in the evening, to cover only the psoriatic lesions
• If a bath or shower is taken prior to application, the skin should be dry before applying the cream
• If emollients are used, they should be applied at least an hour before application of TAZORAC Cream
• Because unaffected skin may be more susceptible to irritation, application of TAZORAC Cream to these areas should be carefully avoided
• Acne Cleanse the face gently
• After the skin is dry, apply a thin layer (2 mg/cm 2 ) of TAZORAC Cream 0.1% once per day, in the evening, to the skin areas where acne lesions appear

Cream, 0.05% and 0.1%. Each gram of TAZORAC Cream, 0.05% and 0.1% contains 0.5 mg and 1 mg of tazarotene, respectively in a white cream base. Cream, 0.05% and 0.1%. ( 3 )

The safety and efficacy of TAZORAC Cream have not been established in patients with psoriasis under the age of 18 years, or in patients with acne under the age of 12 years.

TAZORAC Cream for the treatment of acne has not been clinically tested in persons 65 years of age or older. Of the total number of subjects in clinical trials of TAZORAC Cream for plaque psoriasis, 120 were over the age of 65. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. …

• Advise the patient to read the FDA-approved patient labeling (Patient Information)
• Embryofetal Toxicity Inform females of reproductive potential of the potential risk to a fetus
• Advise these patients to use effective contraception during treatment with TAZORAC Cream
• Advise patients to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions and Use in Specific Populations ]
• Photosensitivity and Risk of Sunburn Advise patients to avoid excessive sun exposure and to use of sunscreens and protective measures (hat, visor)
• Advise patients to avoid using TAZORAC if also taking other medicines may increase sensitivity to sunlight. …

• TAZORAC Cream is contraindicated in: Pregnancy
• Retinoids may cause fetal harm when administered to a pregnant female [see Warnings and Precautions , Use in Specific Populations ]
• Individuals who have known hypersensitivity to any of its components [see Warnings and Precautions ]
• Pregnancy Hypersensitivity

No formal drug-drug interaction studies were conducted with TAZORAC Cream. In a trial of 27 healthy female subjects between the ages of 20–55 years receiving a combination oral contraceptive tablet containing 1 mg norethindrone and 35 mcg ethinyl estradiol, concomitant use of tazarotene administered as 1.1 mg orally (mean ± SD C max and AUC 0-24 of tazarotenic acid were 28.9 ± 9.4 ng/mL and 120.6 ± 28.5 ng • hr/mL) did not affect the pharmacokinetics of norethindrone and ethinyl estradiol over a complete cycle. The impact of tazarotene on the pharmacokinetics of progestin only oral contraceptives (i.e., minipills) has not been evaluated.

Embryofetal Toxicity: TAZORAC Cream contains tazarotene, which is a teratogenic substance. TAZORAC Cream is contraindicated in pregnancy. Females of child-bearing potential should have a negative pregnancy test within 2 weeks prior to initiating treatment and use an effective method of contraception during treatment. ( 5.1 ) Local Irritation: Some individuals may experience excessive pruritus, burning, skin redness or peeling. If these effects occur, discontinue until the integrity of the skin has been restored, or reduce dosing interval, or in the case of psoriasis, may switch to the lower concentration. …

The following serious adverse reactions are discussed in more detail in other sections of the labeling: Embryofetal toxicity [see Warnings and Precautions ( 5.1 )] Photosensitivity and Risk of Sunburn [see Warnings and Precautions ( 5.3 )] Plaque psoriasis: Most common adverse reactions occurring in 10 to 23% of patients are pruritus, erythema, and burning. ( 6.1 ) Acne Vulgaris: Most common adverse reactions occurring in 10 to 30% of patients are desquamation, dry skin, erythema, and burning sensation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Allergan at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . …

8.1 Pregnancy Risk Summary Based on data from animal reproduction studies, retinoid pharmacology, and the potential for systemic absorption, TAZORAC Cream may cause fetal harm when administered to a pregnant female and is contraindicated during pregnancy. Safety in pregnant females has not been established. …

Excessive topical use of TAZORAC Cream, 0.05% and 0.1% may lead to marked redness, peeling, or discomfort [see Warnings and Precautions ( 5.2 )] . TAZORAC Cream, 0.05% and 0.1% are not for oral use. Oral ingestion of the drug may lead to the same adverse effects as those associated with excessive oral intake of Vitamin A (hypervitaminosis A) or other retinoids. If oral ingestion occurs, the patient should be monitored, and appropriate supportive measures should be administered as necessary.

Storage: Store at 20°C to 25°C (68°F to 77°F). Excursions permitted from -5°C to 30°C (23°F to 86°F).

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.