TAZAROTENE TOPICAL CREAM 0.001 30 G
Generic: Tazarotene
TAZAROTENE TOPICAL CREAM 0.001 30 G
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Identification
Tazarotene
Tazarotene
Sun Pharmaceutical Industries, Inc.
HUMAN PRESCRIPTION DRUG
Administration
CREAM
TOPICAL
ANDA208258
Active Ingredients
| Ingredient | Strength |
|---|---|
| TAZAROTENE | 1 mg/g |
Pharmacological Class
Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.
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Clinical Drug Information
Indications & Usage
1 INDICATIONS AND USAGE Tazarotene cream 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis. ( 1.1 ) Tazarotene cream 0.1% is indicated for the topical treatment of acne vulgaris. ( 1.2 ) 1.1 Plaque Psoriasis Tazarotene cream, 0.1% is indicated for the topical treatment of patients with plaque psoriasis. 1.2 Acne Vulgaris Tazarotene cream, 0.1% is also indicated for the topical treatment of patients with acne vulgaris.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Apply a thin layer of tazarotene cream only to the affected area once daily in the evening. ( 2.1 , 2.2 ) Not for ophthalmic, oral, or intravaginal use. ( 2.2 ) If contact with eyes occurs, rinse thoroughly with water. ( 2.2 ) 2.1 Important Administration Instructions Tazarotene cream is for topical use only. Tazarotene cream is not for ophthalmic, oral, or intravaginal use. If contact with mucous membranes occurs, rinse thoroughly with water [see Warnings and Precautions (5.2) ] . Wash hands thoroughly after application. 2.2 Psoriasis It is recommended that treatment starts with tazarotene cream, 0.05%, with strength increased to 0.1% if tolerated and medically indicated. Apply a thin film (2 mg/cm 2 ) of tazarotene 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 tazarotene cream. Because unaffected skin may be more susceptible to irritation, application of tazarotene cream to these areas should be carefully avoided. 2.3 Acne Cleanse the face gently. After the skin is dry, apply a thin layer (2 mg/cm 2 ) of tazarotene cream 0.1% once per day, in the evening, to the skin areas where acne lesions appear. Use enough to cover the entire affected area. Use effective sunscreens and wear protective clothing while using tazarotene cream [see Warnings and Precautions (5.3) ].
Adverse Reactions
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 [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 Sun Pharmaceutical Industries, Inc., at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 drug and may not reflect the rates observed in clinical practice. In human dermal safety trials, tazarotene cream, 0.05% and 0.1% did not induce allergic contact sensitization, phototoxicity, or photoallergy. Psoriasis The most frequent adverse reactions reported with tazarotene cream, 0.05% and 0.1% occurring in 10 to 23% of subjects, in descending order, included pruritus, erythema, and burning. Reactions occurring in greater than 1 to less than 10% of subjects, in descending order, included irritation, desquamation, stinging, contact dermatitis, dermatitis, eczema, worsening of psoriasis, skin pain, rash, hypertriglyceridemia, dry skin, skin inflammation, and peripheral edema. Tazarotene cream, 0.1% was associated with a greater degree of local irritation than the 0.05% cream. The rates of irritation adverse reactions reported during psoriasis trials with tazarotene cream, 0.1% were 0.1 to 0.4% higher than those reported for tazarotene cream, 0.05%. Acne The most frequent adverse reactions reported during clinical trials with tazarotene cream 0.1% in the treatment of acne, occurring in 10 to 30% of subjects, in descending order included desquamation, dry skin, erythema, and burning sensation. Reactions occurring in 1 to 5% of subjects included pruritus, irritation, face pain, and stinging. 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 to reliably estimate their frequency or establish a causal relationship to drug exposure. Skin and subcutaneous tissue disorders: blister, dermatitis, urticaria, skin exfoliation, skin discoloration (including skin hyperpigmentation or skin hypopigmentation), swelling at or near application sites, and pain.
Information for Patients
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 to use effective contraception during treatment with tazarotene cream. Advise patients to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1 , 8.3) ]. 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 tazarotene if also taking other medicines may increase sensitivity to sunlight. Important Administration Instructions Advise the patient of the following: For the patient with psoriasis, apply tazarotene cream only to psoriasis skin lesions, avoiding uninvolved skin. If undue irritation (redness, peeling, or discomfort) occurs, reduce frequency of application or temporarily interrupt treatment. Treatment may be resumed once irritation subsides [see Dosage and Adminstration (2.1) ]. Moisturizers may be used as frequently as desired. Patients with psoriasis may use a cream or lotion to soften or moisten skin at least 1 hour before applying tazarotene cream. Avoid contact with the eyes. If tazarotene cream gets in or near eyes, rinse thoroughly with water. Seek medical attention if eye irritation continues. Tazarotene cream is for topical use only. Do not apply to eyes, mouth, or other mucous membrane. Not for ophthalmic, oral, or intravaginal use. Wash hands thoroughly after applying tazarotene cream.
Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.