DUAVEE- conjugated estrogens/bazedoxifene tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

ESTROGENS, CONJUGATED (UNII: IU5QR144QX) (ESTROGENS, CONJUGATED - UNII:IU5QR144QX), BAZEDOXIFENE ACETATE (UNII: J70472UD3D) (BAZEDOXIFENE - UNII:Q16TT9C5BK)

Tilgjengelig fra:

U.S. Pharmaceuticals

INN (International Name):

ESTROGENS, CONJUGATED

Sammensetning:

ESTROGENS, CONJUGATED 0.45 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

DUAVEE is indicated in women with a uterus for: - Use DUAVEE for the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary. - When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medication should be carefully considered. DUAVEE is contraindicated in women with any of the following conditions: - Undiagnosed abnormal uterine bleeding - Known, suspected, or past history of breast cancer - Known or suspected estrogen-dependent neoplasia - Active deep venous thrombosis, pulmonary embolism, or history of these conditions - Active arterial thromboembolic disease (for example, stroke, myocardial infarction) or history of these conditions - Hypersensitivity (for example, anaphylaxis, angioedema) to estrogens, bazedoxifene, or any ingredients -

Produkt oppsummering:

DUAVEE tablets contain 0.45 mg conjugated estrogens and 20 mg bazedoxifene. The tablets are oval, biconvex, and pink, branded with "0.45/20" in black ink on one side. DUAVEE® tablets are supplied as follows: Storage Blisters DUAVEE tablets should be stored at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature. Dispense product in the original package. Tablets should not be removed from blisters until immediately before use. Protect from moisture. After opening foil pouch, product must be used within 60 days.

Autorisasjon status:

New Drug Application

Preparatomtale

DUAVEE- CONJUGATED ESTROGENS/BAZEDOXIFENE TABLET, FILM COATED
U.S. PHARMACEUTICALS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DUAVEE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR DUAVEE.
DUAVEE (CONJUGATED ESTROGENS/BAZEDOXIFENE) TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 2013
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, AND PROBABLE
DEMENTIA
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
WOMEN TAKING DUAVEE SHOULD NOT TAKE ADDITIONAL ESTROGENS (5.1)
THERE IS AN INCREASED RISK OF ENDOMETRIAL CANCER IN A WOMAN WITH A
UTERUS WHO USES UNOPPOSED
ESTROGENS (5.1, 5.3)
ESTROGEN THERAPY SHOULD NOT BE USED FOR THE PREVENTION OF
CARDIOVASCULAR DISEASE OR DEMENTIA (5.2,
5.4 )
THE WOMEN'S HEALTH INITIATIVE (WHI) ESTROGEN-ALONE SUBSTUDY REPORTED
INCREASED RISKS OF STROKE AND
DEEP VEIN THROMBOSIS (DVT) (5.2)
THE WHI MEMORY STUDY (WHIMS) ESTROGEN-ALONE ANCILLARY STUDY OF WHI
REPORTED AN INCREASED RISK OF
PROBABLE DEMENTIA IN POSTMENOPAUSAL WOMEN 65 YEARS OF AGE AND OLDER
(5.4)
INDICATIONS AND USAGE
DUAVEE is a combination of conjugated estrogens with an estrogen
agonist/antagonist indicated for treatment of the
following conditions in women with a uterus:
Treatment of moderate to severe vasomotor symptoms associated with
menopause (1.1)
Prevention of postmenopausal osteoporosis (1.2)
Limitation of Use: DUAVEE should be used for the shortest duration
consistent with treatment goals and risks for the
individual woman (1.3)
DOSAGE AND ADMINISTRATION
Take one tablet orally once daily (2)
DOSAGE FORMS AND STRENGTHS
Tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20 mg
(3)
CONTRAINDICATIONS
Undiagnosed abnormal uterine bleeding (4, 5.3)
Known, suspected, or past history of breast cancer (4, 5.3)
Known or suspected estrogen-dependent neoplasia (4, 5.3)
Active or past history of venous thromboembolism (4, 5.2)
Active or past history of arterial thromboembolism (4, 5.2)
Hypersensitivity (angioedema, anaphylax