Estratest (Esterified Estrogens) - Indications and Dosage

INDICATIONS AND USAGE

ESTRATEST® and ESTRATEST® H.S. 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® and ESTRATEST® H.S. HAVE NOT BEEN SHOWN TO BE EFFECTIVE FOR ANY PURPOSE DURING PREGNANCY AND ITS USE MAY CAUSE SEVERE HARM TO THE FETUS (See BOX WARNINGS).

DOSAGE AND ADMINISTRATION

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® or 1 to 2 tablets of ESTRATEST® 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® (Imprinted "SOLVAY 1026")

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

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

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

ESTRATEST® H.S. (Imprinted "SOLVAY 1023")

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

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

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