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Femtrace (Estradiol Acetate Oral) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Femtrace therapy is indicated in the treatment of moderate to severe vasomotor symptoms associated with the menopause.

DOSAGE AND ADMINISTRATION

When estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be reevaluated 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 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.

Femtrace therapy consists of a single tablet to be taken once daily.

Three doses of Femtrace are available, 0.45 mg/day, 0.9 mg/day and 1.8 mg/day, for the treatment of moderate to severe vasomotor symptoms associated with the menopause.

Patients should be started at the lowest dose.

HOW SUPPLIED

Femtrace (estradiol acetate tablets) is available in bottles of 100 tablets.

NDC 0430-0389-24 Femtrace 0.45 mg (estradiol acetate tablets) are cream, round tablets debossed with “WC 389” on one side and the tablet logo on the other side.

NDC 0430-0390-24 Femtrace 0.9 mg (estradiol acetate tablets) are white, round tablets debossed with “WC 390” on one side and the tablet logo on the other side.

NDC 0430-0391-24 Femtrace 1.8 mg (estradiol acetate tablets) are yellow, round tablets debossed with “WC 391” on one side and the tablet logo on the other side.

Keep out of reach of children.

STORAGE

Store at 25˚ C (77˚ F); excursions permitted to 15˚ - 30˚ C (59˚ - 86˚ F) [see USP Controlled Room Temperature]

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