EEMT HS- estrogens, esterified and methyltestosterone tablet, coated EEMT- estrogens, esterified and methyltestosterone tablet,

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

METHYLTESTOSTERONE (UNII: V9EFU16ZIF) (METHYLTESTOSTERONE - UNII:V9EFU16ZIF), ESTROGENS, ESTERIFIED (UNII: 3ASP8Q3768) (ESTROGENS, ESTERIFIED - UNII:3ASP8Q3768)

Available from:

CREEKWOOD PHARMACEUTICAL, INC,

INN (International Name):

ESTROGENS, ESTERIFIED

Composition:

ESTROGENS, ESTERIFIED 1.25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE FULL STRENGTH and ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH 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.) ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE FULL STRENGTH and ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH HAVE NOT BEEN SHOWN TO BE EFFECTIVE FOR ANY PURPOSE DURING PREGNANCY AND ITS USE MAY CAUSE SEVERE HARM TO THE FETUS (SEE BOXED WARNING). Estrogens should not be used in women with any of the following conditions: - Known or suspected cancer of the breast except in appropriately selected patients being treated for metastatic disease. - Known or suspected estrogen-dependent neoplasia. - Known or suspected pregnancy (See Boxed Warning). - Undiagnose

Product summary:

ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLETS Full Strength in bottles of 100. ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLETS Full Strength light green, capsule-shaped, film-coated, oral tablets, debossed "SYNTHO" on one side and "231" on other. Contains: 1.25 mg of Esterified Estrogens, USP and 2.5 mg of Methyltestosterone, USP. ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLETS Half Strength in bottles of 100. ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLETS Half Strength light blue, capsule-shaped, film-coated, oral tablets, debossed "SYNTHO" on one side and "230" on other. Contains: 0.625 mg of Esterified Estrogens, USP and 1.25 mg of Methyltestosterone, USP. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.] Rx only

Authorization status:

unapproved drug other

Summary of Product characteristics

EEMT HS- ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE TABLET, COATED
EEMT- ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE TABLET, COATED
CREEKWOOD PHARMACEUTICAL, INC,
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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PHYSICIAN LABELING
ESTERIFIED ESTROGENS
AND
METHYLTESTOSTERONE
TABLETS
WARNINGS
1. ESTROGENS HAVE BEEN REPORTED TO INCREASE THE RISK OF
ENDOMETRIAL CARCINOMA
Three independent case control studies have reported an increased risk
of endometrial cancer in
postmenopausal women exposed to exogenous estrogens for prolonged
periods.1-3 This risk
was independent of the other known risk factors for endometrial
cancer. These studies are further
supported by the finding that incidence rates of endometrial cancer
have increased sharply since
1969 in eight different areas of the United States with
population-based cancer reporting systems,
an increase which may be related to the rapidly expanding use of
estrogens during the last
decade.4
The three case control studies reported that the risk of endometrial
cancer in estrogen users was
about 4.5 to 13.9 times greater than in nonusers. The risk appears to
depend on both duration of
treatment1 and on estrogen dose.3 In view of these findings, when
estrogens are used for the
treatment of menopausal symptoms, the lowest dose that will control
symptoms should be utilized
and medication should be discontinued as soon as possible. When
prolonged treatment is
medically indicated, the patient should be reassessed on at least a
semiannual basis to determine
the need for continued therapy. Although the evidence must be
considered preliminary, one study
suggests that cyclic administration of low doses of estrogen may carry
less risk than continuous
administration,3 it therefore appears prudent to utilize such a
regimen.
Close clinical surveillance of all women taking estrogens is
important. In all cases of
undiagnosed persistent or