COVARYX HS- estrogens, esterified and methyltestosterone tablet, coated COVARYX- estrogens, esterified and methyltestosterone t

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:

CENTRIX PHARMACEUTICAL, INC,

INN (International Name):

ESTROGENS, ESTERIFIED

Sammensetning:

ESTROGENS, ESTERIFIED 1.25 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

COVARYXT® and COVARYX® 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.) COVARYXT® and COVARYX® 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 BOXED WARNINGS). 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 WARNINGS). - Undiagnosed abnormal genital bleeding. - Active thrombophlebitis or thromboembolic disorders. - A past history of thrombophlebitis, thrombosis, or thromboembolic disorders associated with previ

Produkt oppsummering:

COVARYX® is a combination of Esterified Estrogens and Methyltestosterone. COVARYX® is supplied in bottles of 100 Tablets. Each light yellow, capsule-shaped, film coated tablet debossed "C010" on obverse and plain on the reverse contains 1.25 mg of Esterified Estrogens, USP and 2.5 mg of Methyltestosterone, USP (NDC 11528-010-01). COVARYX® H.S. (Half-Strength) is a combination of Esterified Estrogens and Methyltestosterone. COVARYX® H.S. is supplied in bottles of 100 Tablets. Each light pink, capsule-shaped, film coated tablet debossed "C020" on obverse and plain on the reverse contains 0.625 mg of Esterified Estrogens, USP and 1.25 mg of Methyltestosterone, USP (NDC 11528-020-01). Store at 20º-25ºC (68º-77ºF); excursions permitted to 15º-30ºC (59º-86ºF). [See USP Controlled Room Temperature.] COVARYX® is a combination of Esterified Estrogens and Methyltestosterone. COVARYX® is supplied in bottles of 100 Tablets. Each light yellow, capsule-shaped, film coated tablet debossed "C010" on obverse and plain on the reverse contains 1.25 mg of Esterified Estrogens, USP and 2.5 mg of Methyltestosterone, USP. COVARYX® H.S. (Half-Strength) is a combination of Esterified Estrogens and Methyltestosterone. COVARYX® H.S. is supplied in bottles of 100 Tablets. Each light pink, capsule-shaped, film coated tablet debossed "C020" on obverse and plain on the reverse contains 0.625 mg of Esterified Estrogens, USP and 1.25 mg of Methyltestosterone, USP. Store at 20º-25ºC (68º-77ºF); excursions permitted to 15º-30ºC (59º-86ºF). [See USP Controlled Room Temperature.] Distributed by: Centrix Pharmaceutical, Inc. Birmingham, AL 35242 USA Manufactured by: ANDAPharm, LLC Ft. Lauderdale, FL 33309 USA CENTRIX®, the Centrix Pharmaceutical logo, and COVARYX® are registered trademarks of Centrix Pharmaceutical, Inc. ©2007 Centrix Pharmaceutical, Inc. Iss.04/07

Autorisasjon status:

unapproved drug other

Preparatomtale

COVARYX HS- ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE TABLET,
COATED
COVARYX- ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE TABLET, COATED
CENTRIX 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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COVARYX
WARNINGS
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.4 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 recurring
abnormal vaginal bleeding, adequate diag