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Estratest

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Estratest

Estratest

INDICATIONS

ESTRATEST (esterified estrogens and methyltestosterone) and ESTRATEST (esterified estrogens and methyltestosterone) H.S. Tablets are indicated in the:

  • Treatment of moderate to severe vasomotor symptoms associated with the menopause in those patients not improved by estrogens alone. (There is no evidence that estrogens are effective for nervous symptoms or depression without associated vasomotor symptoms, and they should not be used to treat such conditions.)

ESTRATEST (esterified estrogens and methyltestosterone) and ESTRATEST (esterified estrogens and methyltestosterone) H.S. Tablets have not been shown to be effective for any purpose during pregnancy and its use may cause severe harm to the fetus.

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.

Given cyclically for short-term use only

For treatment of moderate to severe vasomotor symptoms associated with the menopause in patients not improved by estrogen alone.

The lowest dose that will control symptoms should be chosen and medication should be discontinued as promptly as possible.

Administration should be cyclic (e.g., three weeks on and one week off). Attempts to discontinue or taper medication should be made at three- to six-month intervals.

Usual Dosage Range

1 tablet of ESTRATEST (esterified estrogens and methyltestosterone) or 1 to 2 tablets of ESTRATEST (esterified estrogens and methyltestosterone) H.S. daily as recommended by the physician.

Treated patients with an intact uterus should be monitored closely for signs of endometrial cancer and appropriate diagnostic measures should be taken to rule out malignancy in the event of persistent or recurring abnormal vaginal bleeding.

HOW SUPPLIED

ESTRATEST (esterified estrogens and methyltestosterone) Tablets (Imprinted "SOLVAY 1026")

Bottles of 100..................................................................NDC 0032-1026-01
Bottles of 1000................................................................NDC 0032-1026-10

ESTRATEST (esterified estrogens and methyltestosterone) Tablets (dark green, capsule shaped, sugar-coated oral tablets) contains: 1.25 mg of Esterified Estrogens, USP and 2.5 mg of Methyltestosterone, USP.

ESTRATEST (esterified estrogens and methyltestosterone) H.S. Tablets (Imprinted "SOLVAY 1023")

Bottles of 100................................................................NDC 0032-1023-01

ESTRATEST (esterified estrogens and methyltestosterone) H.S. "Half-Strength" Tablets (light green, capsule shaped, sugar-coated oral tablets) contains: 0.625 mg of Esterified Estrogens, USP and 1.25 mg of Methyltestosterone, USP.

Keep ESTRATEST (esterified estrogens and methyltestosterone) and ESTRATEST (esterified estrogens and methyltestosterone) H.S. Tablets out of reach of children.

Store at controlled room temperature 15° to 30°C (59° to 86°F).

Solvay Pharmaceuticals, Inc. Marietta, GA 30062. FDA rev date: n/a

Last reviewed on RxList: 7/18/2008
This monograph has been modified to include the generic and brand name in many instances.

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