Tazarotene (Tazorac)

Trade Name : TAZORAC

Allergan, Inc.

CREAM

Strength 0.5 mg/g

TAZAROTENE Retinoid [EPC],Retinoids [CS]

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Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Tazarotene (Tazorac) which is also known as TAZORAC and Manufactured by Allergan, Inc.. It is available in strength of 0.5 mg/g per ml. Read more

Tazarotene (Tazorac) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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About GNH

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TAZORAC Cream 0.05% and 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis. ()n
TAZORAC Cream 0.1% is indicated for the topical treatment of acne vulgaris. ()n

No data

Apply a thin layer of TAZORAC Cream only to the affected area once daily in the evening. (, )n
Not for ophthalmic, oral, or intravaginal use. ()n
If contact with eyes occurs, rinse thoroughly with water. ()n

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.n
Cream, 0.05% and 0.1%. ()n

TAZORAC Cream is contraindicated in :n

Pregnancy (, )n
Hypersensitivity ()n

No data

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. ()n
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. TAZORAC Cream should not be used on eczematous skin, as it may cause severe irritation. ()n
Photosensitivity and Risk for Sunburn: Avoid exposure to sunlight, sunlamps, and weather extremes. Wear sunscreen daily. TAZORAC Cream should be administered with caution if the patient is also taking drugs known to be photosensitizers. ()n

The following serious adverse reactions are discussed in more detail in other sections of the labeling:n
To report SUSPECTED ADVERSE REACTIONS, contact Allergan at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Plaque psoriasis: Most common adverse reactions occurring in 10 to 23% of patients are pruritus, erythema, and burning. ()n
Acne Vulgaris: Most common adverse reactions occurring in 10 to 30% of patients are desquamation, dry skin, erythema, and burning sensation. ()n

No formal drug-drug interaction studies were conducted with TAZORAC Cream.n
In a trial of 27 healthy female subjects between the ages of 20u201355 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 u00b1 SD C and AUC of tazarotenic acid were 28.9 u00b1 9.4 ng/mL and 120.6 u00b1 28.5 nghr/mL) did not affect the pharmacokinetics of norethindrone and ethinyl estradiol over a complete cycle.n
The impact of tazarotene on the pharmacokinetics of progestin only oral contraceptives (i.e., minipills) has not been evaluated.n

No data

Excessive topical use of TAZORAC Cream, 0.05% and 0.1% may lead to marked redness, peeling, or discomfort .n
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.n

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 in a white cream base.n
Tazarotene is a member of the acetylenic class of retinoids. Chemically, tazarotene is ethyl 6-[(4,4-dimethylthiochroman-6-yl)ethynyl]nicotinate. The compound has an empirical formula of CHNOS and molecular weight of 351.46. The structural formula is shown below:n
TAZORAC Cream contains the following inactive ingredients: benzyl alcohol 1%; carbomer 1342; carbomer homopolymer type B; edetate disodium; medium chain triglycerides; mineral oil; purified water; sodium hydroxide; sodium thiosulfate; and sorbitan monooleate.n

No data

No data

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 0.05% demonstrated superiority over vehicle cream as early as 1 week and 2 weeks, respectively, after starting treatment.n In these trials, the primary efficacy endpoint was u201cclinical success,u201d defined as the proportion of subjects with none, minimal, or mild overall lesional assessment at Week 12, and shown in Table 1. u201cClinical successu201d was also significantly greater with TAZORAC Cream, 0.05% and 0.1% versus vehicle at most follow-up visits.n
At the end of 12 weeks of treatment, TAZORAC Cream, 0.05% and 0.1% was consistently superior to vehicle in reducing the plaque thickness of psoriasis. Improvements in erythema and scaling were generally significantly greater with TAZORAC Cream, 0.05% and 0.1% than with vehicle. TAZORAC Cream, 0.1% was also generally more effective than TAZORAC Cream, 0.05% in reducing the severity of the individual signs of disease. However, TAZORAC Cream, 0.1% was associated with a greater degree of local irritation than TAZORAC Cream, 0.05%.n
Acne:
In two large vehicle-controlled trials, subjects age 12 years and over with facial acne vulgaris of a severity suitable for monotherapy with a topical agent were enrolled. After face cleansing in the evening, TAZORAC Cream, 0.1% was applied once daily to the entire face as a thin layer. TAZORAC Cream, 0.1% was significantly more effective than vehicle in the treatment of facial acne vulgaris. Efficacy results after 12 weeks of treatment are shown in Table 3:n

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 screw cap, in 30 g and 60 g sizes.n
Storage:

Advise the patient to read the FDA-approved patient labeling (Patient Information).n

72709US11n

tttttttNDC 0023-9155-60u00a0 u00a0 u00a0 u00a0 u00a0 n
60 grams
TAZORACn- (TAZAROTENE)n- Array
For Topical Use Onlyn- Not for Ophthalmic Use
ALLERGAN

tttttttNDC 0023-9156-60u00a0 u00a0 u00a0 u00a0 u00a0 n
60 grams
TAZORACn- (TAZAROTENE)n- Array
For Topical Use Onlyn- Not for Ophthalmic Use
ALLERGAN

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Tazarotene (Tazorac)

Trade Name : TAZORAC

CREAM

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Tazarotene (Tazorac)

Trade Name : TAZORAC

CREAM

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

COMPANY

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QUICK LINKS

CONTACT US

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you’re looking for?