TAZORAC Cream (2020)

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Almirall, LLC

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1. Indications and Usage

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 ...

2. Dosage and Administration

2.1 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 ...

3. Dosage Forms and Strengths

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.

4. Contraindications

TAZORAC Cream is contraindicated in: Pregnancy. Retinoids may cause fetal harm when administered to a pregnant female [see Warnings and Precautions (5.1), Use in Specific Populations (8.1, 8.3)] ...

5. Warnings and Precautions

5.1 Embryofetal Toxicity Systemic exposure to tazarotenic acid is dependent upon the extent of the body surface area treated. In patients treated topically over sufficient body surface area, exposure could ...

6. Adverse Reactions

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 ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during postapproval use of tazarotene. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...

7. Drug Interactions

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 ...

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 ...

8.2. Lactation

Risk Summary There is no information regarding the presence of tazarotene in human milk, the effects on the breastfed infant, or the effects on milk production. After single topical doses of 14 ...

8.3. Females and Males of Reproductive Potential

Pregnancy Testing Pregnancy testing is recommended for females of reproductive potential within 2 weeks prior to initiating TAZORAC Cream therapy which should begin during a menstrual period. Contraception ...

8.4. Pediatric Use

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.

8.5. Geriatric Use

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 ...

10. Overdosage

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. ...

11. Description

TAZORAC (tazarotene) Cream, 0.05% and 0.1% is for topical use and contains the active ingredient, tazarotene. Each gram of TAZORAC Cream, 0.05% and 0.1% contains 0.5 and 1 mg of tazarotene, respectively ...

12.1. Mechanism of Action

Tazarotene is a retinoid prodrug which is converted to its active form, the carboxylic acid of tazarotene, by deesterification. Tazarotenic acid binds to all three members of the retinoic acid receptor ...

12.3. Pharmacokinetics

Following topical application, tazarotene undergoes esterase hydrolysis to form its active metabolite, tazarotenic acid. Little parent compound could be detected in the plasma. Tazarotenic acid was highly ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis A long-term study of tazarotene following oral administration of 0.025, 0.050, and 0.125 mg/kg/day to rats showed no indications of increased carcinogenic risks. Based on pharmacokinetic ...

14. Clinical Studies

In two 12-week vehicle-controlled clinical trials, TAZORAC Cream, 0.05% and 0.1% was significantly more effective than vehicle in reducing the severity of stable plaque psoriasis. TAZORAC Cream, 0.1% and ...

16.1. How Supplied

TAZORAC Cream is a white cream available in concentrations of 0.05% and 0.1%. It is supplied in a collapsible aluminum tube with a tamper-evident aluminum membrane over the opening and a white polypropylene ...

16.2. Storage and Handling

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).

17. Patient Counseling Information

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 ...