Tazarotene 1 mg/g
Tazarotene · CREAM · Cosette Pharmaceuticals, Inc.
Tazarotene is a cream containing tazarotene at 1 mg/g, taken topical. Manufactured by Cosette Pharmaceuticals, Inc..
Key Facts
- Brand Name
- Tazarotene
- Generic Name
- Tazarotene
- NDC Code (Product)
0713-0670- Manufacturer
- Cosette Pharmaceuticals, Inc.
- Strength
- 1 mg/g
- Dosage Form
- CREAM
- Route
- TOPICAL
- Marketing Status
- Application #
- ANDA208662
- Drug Class
- Retinoid [EPC]
- Marketing Start
- 12/22/2017
Recall History
Allergan Sales, LLC
Failed Content Uniformity Specifications.
Mayne Pharma Inc
Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point.
Allergan Sales, LLC
Failed Content Uniformity Specifications
Allergan Sales, LLC
Failed Content Uniformity Specifications
Allergan Sales, LLC
Failed Content Uniformity Specifications.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing 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 Precaution ( 5.2) ] . Wash hands thoroughly after application. 2.2 Psoriasis Apply a thin film (2 mg/cm 2 ) of tazarotene cream 0.1% 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 w…
Contraindications
4 CONTRAINDICATIONS Tazarotene 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) ] . Individuals who have known hypersensitivity to any of its components [see Warnings and Precautions ( 5.2) ] . Pregnancy ( 4 , 8.1 ) Hypersensitivity ( 4 )
Drug Interactions
7 DRUG INTERACTIONS No formal drug-drug interaction studies were conducted with tazarotene cream. In a trial of 27 healthy female subjects between the ages of 20 to 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.
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 Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or contact 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 ta…
Frequently Asked Questions
What is Tazarotene used for?
Tazarotene contains Tazarotene. It is a cream taken topical. Consult your doctor for specific uses.
Is Tazarotene a controlled substance?
Tazarotene is not classified as a controlled substance by the DEA.
What is the generic name for Tazarotene?
The generic name for Tazarotene is Tazarotene. There are 8 other brand versions of Tazarotene.
What is the NDC code for Tazarotene 1 mg/g?
The NDC (National Drug Code) for Tazarotene 1 mg/g is 0713-0670, listed by Cosette Pharmaceuticals, Inc..