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Avage

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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.

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FDA Safety Alerts

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Manufacturer Warnings

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

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FDA Labeling Changes

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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).
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History

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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.

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Avage Manufacturers

  • Allergan, Inc.
    Avage | Allergan, Inc.
    No Recall

    Avage | Allergan, Inc.

    Avage | Allergan, Inc.
    General

    Application may cause excessive irritation in the skin of certain sensitive individuals. In cases where it has been necessary to temporarily discontinue therapy, or the dosing has been reduced to an interval the patient can tolerate, therapy can be resumed, or the frequency of application can be increased as the patient becomes able to tolerate the treatment. Frequency of application should be closely monitored by careful observation of the clinical therapeutic response and skin tolerance. Efficacy has not been established for less than once daily dosing frequencies.

    Apply a pea-sized amount once a day at bedtime to lightly cover the entire face including the eyelids if desired. Facial moisturizers may be used as frequently as desired. If any makeup is present it should be removed before applying AVAGE® (tazarotene) Cream 0.1% to the face. If the face is washed or a bath or shower is taken prior to application, the skin should be dry before applying the cream. If emollients or moisturizers are used, they can be applied either before or after application of tazarotene cream ensuring that the first cream or lotion has absorbed into the skin and has dried completely. Frequency of application should be closely monitored by careful observation of the clinical therapeutic response and skin tolerance. If the frequency of dosing is reduced, it should be noted that efficacy at a reduced frequency of application has not been established. The duration of the mitigating effects on facial fine wrinkling, mottled hypo- and hyperpigmentation, and benign facial lentigines following discontinuation of AVAGE® (tazarotene) Cream 0.1% has not been studied.

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