Avage

Avage

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Questions & Answers

Side Effects & Adverse Reactions

Pregnancy Category X. See CONTRAINDICATIONS section. Women of child-bearing potential should be warned of the potential risk and use adequate birth-control measures when AVAGE® Cream is used. The possibility that a woman of child-bearing potential is pregnant at the time of institution of therapy should be considered. A negative result for pregnancy test having a sensitivity down to at least 50 milli International Units per mL for hCG should be obtained within 2 weeks prior to AVAGE® Cream therapy, which should begin during a normal menstrual period.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.)

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. AVAGE® (TAZAROTENE) Cream 0.1% DOES NOT ELIMINATE or PREVENT WRINKLES, REPAIR SUN-DAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE MORE YOUTHFUL or YOUNGER SKIN.

  • AVAGE® (tazarotene) Cream 0.1% has NOT DEMONSTRATED A MITIGATING EFFECT on significant signs of chronic sunlight exposure such as coarse or deep wrinkling, tactile roughness, telangiectasia, skin laxity, keratinocytic atypia, melanocytic atypia, or dermal elastosis.
  • AVAGE® (tazarotene) Cream 0.1% should be used under medical supervision as an adjunct to a comprehensive skin care and sunlight avoidance program that includes the use of effective sunscreens (minimum SPF of 15) and protective clothing.
  • Neither the safety nor the effectiveness of AVAGE® (tazarotene) Cream 0.1% for the prevention or treatment of actinic keratoses, skin neoplasms, or lentigo maligna has been established.
  • Neither the safety nor the efficacy of using AVAGE® (tazarotene) Cream 0.1% daily for greater than 52 weeks has been established, and daily use beyond 52 weeks has not been systematically and histologically investigated in adequate and well-controlled trials (see WARNINGS section).

History

There is currently no drug history available for this drug.

Other Information

AVAGE® Cream is a white cream and contains the compound tazarotene; this formulation of tazarotene cream is also marketed for the treatment of plaque psoriasis and acne vulgaris as TAZORAC® (tazarotene) Cream, 0.1%. Tazarotene is a member of the acetylenic class of retinoids and is represented by the following structural formula:

Structural Formula

Formula: C21H21NO2S        Molecular Weight: 351.46
Chemical Name: Ethyl 6-[2-(4,4-dimethylthiochroman-6-yl)ethynyl] nicotinate

Contains:

Active: Tazarotene 0.1% (w/w)

Preservative: Benzyl alcohol 1% (w/w)

Inactives: 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.

Avage Manufacturers


  • Allergan, Inc.
    Avage (Tazarotene) Cream [Allergan, Inc.]

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