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Estrace Vaginal Cream

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Estrace Vaginal Cream

INDICATIONS

ESTRACE (estradiol vaginal cream, USP, 0.01%) is indicated in the treatment of vulvar and vaginal atrophy.

DOSAGE AND ADMINISTRATION

Use of ESTRACE (estradiol vaginal cream, USP, 0.01%), alone or in combination with a progestin, should be limited to the shortest duration consistent with treatment goals and risks for the individual woman. Patients should reevaluate periodically as clinically appropriate (e.g., 3-month to 6-month intervals) to determine if treatment is still necessary (see BOXED WARNINGS and WARNINGS). For treatment of vulvar and vaginal atrophy associated with the menopause, the lowest dose and regimen that will control symptoms should be chosen and medication should be discontinued as promptly as possible. For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.

Attempts to discontinue or taper medication should be made at 3-month to 6-month intervals.

Usual Dosage: The usual dosage range is 2 to 4 g (marked on the applicator) daily for one or two weeks, then gradually reduced to one half initial dosage for a similar period. A maintenance dosage of 1 g, one to three times a week, may be used after restoration of the vaginal mucosa has been achieved.

NOTE: The number of doses per tube will vary with dosage requirements and patient handling.

HOW SUPPLIED

ESTRACE® (estradiol vaginal cream, USP, 0.01%).

N 0430-3754-14: Tube containing 1 ½ oz (42.5 g) with a calibrated plastic applicator for delivery of 1, 2, 3, or 4 g.

Store at room temperature. Protect from temperatures in excess of 40° C (104° F).

Keep ESTRACE Vaginal Cream (estradiol vaginal cream) out of the reach of children.

Manufactured by: Contract Pharmaceuticals Limited, Buffalo, NY 14213-1091 for Warner Chilcott (US), LLC, Rockaway, NJ 07866. Marketed by: Warner Chilcott (US), LLC Rockaway, NJ 07866 1-800-521-8813. Revised: August 2008.

Last reviewed on RxList: 3/31/2009
This monograph has been modified to include the generic and brand name in many instances.

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