Esterified Estrogens and Methyltestosterone

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Method Pharmaceuticals, LLC

INN (International Name):

ESTROGENS, ESTERIFIED

Sammensetning:

ESTROGENS, ESTERIFIED 0.625 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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: 1.       Known or suspected cancer of the breast except in appropriately selected patients being treated for metastatic disease. 2.       Known or suspected estrogen-dependent ne

Produkt oppsummering:

ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLETS Full Strength in bottles of 100. ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLETS Full Strength light green, oval-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

Autorisasjon status:

unapproved drug other

Preparatomtale

ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE- ESTERIFIED ESTROGENS,
METHYLTESTOSTERONE TABLET
METHOD PHARMACEUTICALS, LLC
_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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ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE
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.
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.
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,
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 re