Tazarotene (Avage)

Trade Name : AVAGE

Allergan, Inc.

CREAM

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 (Avage) which is also known as AVAGE and Manufactured by Allergan, Inc.. It is available in strength of 1 mg/g per ml. Read more

Tazarotene (Avage) 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

No data

AVAGE (tazarotene) Cream, 0.1% is indicated as an adjunctive agent for use in the mitigation (palliation) of facial fine wrinkling, facial mottled hyper- and hypopigmentation, and benign facial lentigines in patients who use comprehensive skin care and sunlight avoidance programs.n
Limitations of Use:
AVAGE Cream, 0.1% is a retinoid indicated as an adjunctive agent for use in the mitigation (palliation) of facial fine wrinkling, facial mottled hyper- and hypopigmentation, and benign facial lentigines in patients who use comprehensive skin care and sunlight avoidance programs. ()n
Limitations of Use:

Does not eliminate or prevent wrinkles or restore more youthful skin. ()n
Does not repair sun damaged skin or reverse photoaging. ()n
Safety and effectiveness for the prevention or treatment of actinic keratoses, skin neoplasms, or lentigo maligna have not been established. (, )n

No data

Apply a pea-sized amount of AVAGE Cream to lightly cover the entire face once daily at bedtime. ()n
If contact with eyes occurs, rinse thoroughly with water. ()n
Not for ophthalmic, oral, or intravaginal use. ()n

Cream: 1 mg of tazarotene per gram (0.1%) of white cream in 30 gram tubes.n
Cream, 0.1%. ()n

AVAGE Cream is contraindicated in :n

Pregnancy. (, )n
Known Hypersensitivity. ()n

No data

Embryo-Fetal Toxicity
Local Irritation
Photosensitivity and Risk of Sunburn
Lentigo Maligna

The following serious adverse reactions are discussed in more detail in other sections of the labeling:n
Most common adverse events (occurring in u226510% of patients) are desquamation, erythema, burning sensation, dry skin, skin irritation, and pruritus. ()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.

No formal drug-drug interaction studies were conducted with AVAGE Cream.n
In a trial of 27 healthy female subjects between the ages of 20-55 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 u00b1 SD C and AUC of tazarotenic acid were 28.9 u00b1 9.4 ng/mL and 120.6 u00b1 28.5 ng*h/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

AVAGE Cream is 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, monitor the patient closely and administer appropriate supportive measures, as necessary.n

AVAGE Cream, 0.1% is for topical use and contains the active ingredient, tazarotene. Each gram of AVAGE Cream, 0.1% contains 1 mg of tazarotene in a white cream base.n
Tazarotene is a member of the acetylenic class of retinoids. Chemically, tazarotene isn
ethyl 6-[2-(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
AVAGE Cream contains the following inactive ingredients: benzyl alcohol 1%, carbomer homopolymer type B; carbomer 1342, edetate disodium, medium chain triglycerides, mineral oil, purified water, sodium thiosulfate, sorbitan monooleate, and sodium hydroxide to adjust pH.n

No data

A long term study of tazarotene following oral administration of 0.025, 0.050, and 0.125u00a0mg/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 equivalent to the maximum systemic exposure in subjects treated with the MRHD of tazarotene cream 0.1%.n
A long-term topical application study 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 represented 8 times the maximum systemic exposure in subjects treated with the MRHD of tazarotene cream 0.1%.n
Tazarotene was non-mutagenic in the Ames assay and did not produce structural chromosomal aberrations in a human lymphocyte assay. Tazarotene was also non-mutagenic in the CHO/HGPRT mammalian cell forward gene mutation assay and was non-clastogenic in the in vivo mouse micronucleus test.n
No impairment of fertility occurred in rats when male animals were treated for 70 days prior to mating and female animals were treated for 14u00a0days prior to mating and continuing through gestation and lactation with topical doses of tazarotene gel up to 0.125u00a0mg/kg/day. Based on data from another study, the systemic drug exposure in the rat would be equivalent to the maximum systemic exposure in subjects treated with the MRHD of tazarotene cream 0.1%.n
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 represented 4 times the maximum systemic exposure in subjects treated with the MRHD of tazarotene cream 0.1%.n
No effect on parameters of mating performance or fertility was observed in female rats treated for 15 days prior to mating and continuing through day 7 of gestation with oral doses of 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 represented 7 times the maximum systemic exposure in subjects treated with the MRHD of tazarotene cream 0.1% .n

Two double-blind, randomized vehicle-controlled trials (Trial 1 and Trial 2) enrolled 1131 subjects with mild to severe fine wrinkling, facial mottled hyper- and hypo-pigmentation, and benign facial lentigines because of sun overexposure. Both trials compared the application of AVAGE cream 0.1% to its vehicle once daily for 24 weeks to the facial skin. Treatment was as an adjunct to a comprehensive skin care and sun avoidance program that included use of sunscreens, protective clothing, and non-prescription emollient cream.n
In both trials, the endpoint was the proportion of subjects achieving an improvement of at least one grade from baseline in fine wrinkling, mottled hypo- and hyper-pigmentation, and benign facial lentigines. At two to four week intervals, the severity of fine wrinkling, mottled hyper- and hypo-pigmentation, and benign facial lentigines were graded on a using a 5-point photonumeric scale (0 = none, 1 = minimal, 2 = mild, 3 = moderate, and 4 = severe).n
Of 1131 subjects, approximately 97% of subjects in clinical trials were white (Caucasian) with 80% of subjects in the clinical studies having Fitzpatrick skin type classifications I-III. The distribution of subject skin types were: Type I u201312%; Type II u2013 26%; Type III u2013 40%; and Type IV 22%. Subjects with skin types V and VI were not studied. Insufficient number of non-white subjects (Asian, Hispanic, or other) were studied to make an adequate determination of efficacy of AVAGE Cream in such subjects.n
Fine Wrinkling was graded on a 5-point scale (0=none, 1=minimal, 2=mild, 3=moderate, 4=severe) using a photonumeric guideline for investigators.n
Mottled hyperpigmentation was graded on a 5-point scale (0=none, 1=minimal, 2=mild, 3=moderate, 4=severe) using a photonumeric guideline for investigators.n
In the 24 week trials, efficacy was also demonstrated in mottled hypopigmentation and benign facial lentigines, which were secondary endpoints in those trials.n
The duration of the mitigating effects on facial fine wrinkling, mottled hyper- and hypopigmentation, and benign facial lentigines following discontinuation of AVAGE Cream has not been studied.n

AVAGE (tazarotene) Cream 0.1%, containing 1 mg of tazarotene per gram of white cream is available in a 30 gram collapsible aluminum tube with a tamper-evident aluminum membrane over the opening and a white polypropylene screw cap (NDC 0023-9236-30).n
Storage:

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

73291US11

NDC 0023-9236-30 n
Arrayn- AVAGEn n- Array
30 grams
For Dermatologic Use OnlyNot for Ophthalmic Use
ALLERGANn

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Tazarotene (Avage)

Trade Name : AVAGE

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 (Avage)

Trade Name : AVAGE

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

SERVICES

QUICK LINKS

CONTACT US

Can’t find what
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