Tazarotene (Tazorac)

Trade Name : TAZORAC

Allergan, Inc.

GEL

Strength 1 mg/g

TAZAROTENE Retinoid [EPC],Retinoids [CS]

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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 1 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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Limitations of Use

TAZORAC Gel is for topical use only. TAZORAC Gel is not for ophthalmic, oral, or intravaginal use. Avoid accidental transfer of TAZORAC Gelu00a0into eyes, mouth, or other mucous membranes. If contact with mucous membranes occurs, rinse thoroughly with water n n n
Wash hands thoroughly after application.

Apply a thin layer of TAZORAC Gel 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. ()

Gel, 0.05% and 0.1%, in 30 g and 100 g tubes. Each gram of TAZORAC Gel, 0.05% and 0.1% contains 0.5 mg and 1 mg of tazarotene, respectively in a translucent, aqueous gel.
Gel, 0.05% and 0.1% ()

TAZORAC Gel is contraindicated in:u00a0

Pregnancy (, )n
Hypersensitivity ()

No data

Embryofetal Toxicity: TAZORAC Gelcontains tazarotene, which is a teratogen.TAZORACGel 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: Excessive pruritus, burning, skin redness or peeling can occur. If these reactions occur, discontinue until the integrity of the skin has been restored, or consider reducing dosing frequency or in the case of psoriasis, consider switching to the lower concentration. TAZORAC Gel 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. TAZORACGel should be administered with caution if the patient is also taking drugs known to be photosensitizers. ()

The following serious adverse reactions are discussed in more detail in other sections of the labeling:
u2022nttu00a0u00a0u00a0u00a0u00a0ntEmbryofetal toxicityn n n
u2022nttu00a0u00a0u00a0u00a0u00a0ntPhotosensitivity and Risk of Sunburn n n n

Plaque Psoriasis: Most common adverse reactions occurring in 10 to 30% of patients are pruritus, burning/stinging, erythema, worsening of psoriasis, irritation, and skin pain. ()n
Acne Vulgaris: Most common adverse reactions occurring in 10 to 30% of patients are desquamation, burning/stinging, dry skin, erythema and pruritus. ()

No formal drug-drug interaction studies were conducted with TAZORAC Gel.
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 ngu2022hr/mL, respectively) 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.

No data

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

TAZORAC(tazarotene) Gel, 0.05% and 0.1% is for topical use and contains the active ingredient, tazarotene.u00a0Each gram of TAZORAC Gel, 0.05% and 0.1% contains 0.5 and 1 mg of tazarotene, respectively in a translucent, aqueous gel.u00a0
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 C21H21NO2S and molecular weight of 351.46. The structural formula is shown below:
TAZORAC Gel contains the following inactive ingredients:
benzyl alcohol 1%;ascorbic acid; butylated hydroxyanisole; butylated hydroxytoluene; carbomer homopolymer type B; edetate disodium; hexylene glycol; poloxameru00a0407; polyethylene glycolu00a0400; polysorbateu00a040; purified water; and tromethamine.

No data

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 data from a shorter-term study in rats, the highest dose of 0.125 mg/kg/day was anticipated to give systemic exposure in the rat 0.3 times that seen in subjects treated with the MRHD of tazarotene gel, 0.1%.
A long-term study with topical administration of up to 0.1% tazarotene in a gel formulation in mice terminated at 88 weeks showed that dose levels of 0.05, 0.125, 0.25, and 1 mg/kg/day (reduced to 0.5 mg/kg/day for males after 41 weeks due to severe dermal irritation) revealed no apparent carcinogenic effects when compared to vehicle control animals. Systemic exposure at the highest dose was 2 times that seenu00a0in subjects treated with the MRHD ofu00a0tazarotene gel, 0.1%.
Tazarotene was non-mutagenic in the Ames assay and did not produce structural chromosomal aberrations in a human lymphocyte assay. Tazarotene was non-mutagenic in the CHO/HGPRT mammalian cell forward gene mutation assay and was non-clastogenic in the in vivo mouse micronucleus test.
No impairment of fertility occurred in rats when male animals were treated for 70 days prior to mating and female animals were treated for 14 days prior to mating and continuing through gestation and lactation with topical doses of tazarotene gel up to 0.125 mg/kg/day. Based on data from another study, the systemic drug exposure in the rat at the highest dose was 0.3 times that observed in subjects treated with the MRHD of tazarotene gel, 0.1%. u00a0u00a0u00a0
No impairment of mating performance or fertility was observed in male rats treated for 70 days prior to mating with oral doses of up to 1 mg/kg/day tazarotene, which produced systemic exposure that was approximately equivalent to that observed in subjects treated with the MRHD of tazarotene gel, 0.1%.
No impairment of mating performance or fertility was observed in female rats treated for 15 days prior to mating and continuing through gestation day 7 with oral dosesu00a0of tazarotene up to 2 mg/kg/day. However, there was a significant decrease in the number of estrous stages and an increase in developmental effects at that dose, which produced systemic exposure 2 times that observed in subjects treated with the MRHD of tazarotene gel, 0.1%u00a0n n .

Psoriasis:
Plaque elevation, scaling, and erythema scored on a 0-4 scale with 0=none, 1=mild, 2=moderate, 3=severe and 4=very severe.
B*=Mean Baseline Severity: C-12*=Mean Change from Baseline at end of 12 weeks of therapy:
C-24*=Mean Change from Baseline at week 24 (12 weeks after the end of therapy).
Global improvement over baseline at the end of 12u00a0weeks of treatment in these two trials is shown in Table 2.
The 0.1% gel was more effective than the 0.05% gel, but the 0.05% gel was associated with less local irritation than the 0.1% gel n n n n .
Acne:
Global improvement over baseline at the end of 12 weeks of treatment in these two trialsu00a0is shown in Table 4.

TAZORAC (tazarotene) Gel is a translucent, aqueous gel,u00a0available in concentrations of 0.05% and 0.1%. It is available in a collapsible aluminum tube with a tamper-evident aluminum membrane over the opening and a white propylene screw cap, in 30 g and 100 g sizes.
TAZORAC Gel 0.05%u00a0nttu00a0u00a0u00a0u00a0u00a0nt30 gnttu00a0u00a0u00a0u00a0u00a0ntNDC 0023-8335-03
TAZORAC Gel 0.05% nttu00a0u00a0u00a0u00a0u00a0nt100 gnttu00a0u00a0u00a0u00a0u00a0ntNDC 0023-8335-10u00a0
TAZORAC Gel 0.1% nttu00a0u00a0u00a0u00a0u00a0nt30 gnttu00a0u00a0u00a0u00a0u00a0ntNDC 0023-0042-03
TAZORAC Gel 0.1% nttu00a0u00a0u00a0u00a0u00a0nt100 gnttu00a0u00a0u00a0u00a0u00a0ntNDC 0023-0042-10
Storage: Store at 20u00baC to 25u00baC (68u00baF to 77u00baF).u00a0Excursions permitted from 15u00baC to 30u00baC (59u00baF to 86u00baF).

Advise the patient to read the FDA-approved patient labeling ().
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 Gel. Advise patients to inform their healthcare provider of a known or suspected pregnancy n n n n n n .
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 Gel if also taking other medicines may increase sensitivity to sunlight.
Important Administration Instructions
Advise the patient of the following:
1. For the patient with psoriasis, apply TAZORAC Gel only to psoriasis skin lesions, avoiding uninvolved skin.
2. If undue irritation (redness, peeling, or discomfort) occurs, reduce frequency of application or temporarily interrupt treatment. Treatment may be resumed once irritation subsides n n .
3. Moisturizers may be used as frequently as desired.
4. Patients with psoriasis may use a cream or lotion to soften or moisten skin at least 1 hour before applying TAZORAC Gel.
5. Avoid contact with the eyes. If TAZORAC Gel gets in or near eyes, rinse thoroughly with water. Seek medical attention if eye irritation continues.
6. TAZORAC Gel is for topical use only. Do not apply to eyes, mouth, or other mucous membrane. Not for ophthalmic, oral, or intravaginal use.
7. Wash hands thoroughly after applying TAZORAC Gel.
Revised: n- 04n- /n- 2018
Distributed by: Allergan USA, Inc.Madison, NJ 07940
u00a9 2018 Allergan. All rights reserved.All trademarks are the property of their respective owners.
71722US17
Pharmacist: Please cut or tear at dotted line and provide this patient package insert to your customer.

u00a0u00a0u00a0This Patient Information has been approved by the U.S. Food and Drug Administration nttu00a0u00a0u00a0u00a0u00a0ntu00a0u00a0u00a0u00a0u00a0Revised: April/2018
71722US17

NDC 0023-8335-10TAZORAC(tazarotene)gel, 0.05%100 gramsRx Only

NDC 0023-0042-10TAZORAC(tazarotene)gel, 0.1%100 gramsRx Only

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Tazarotene (Tazorac)

Trade Name : TAZORAC

GEL

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

GEL

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

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Swiss Drugs

NZ Drugs

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