AMABELZ- estradiol and norethindrone acetate tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E), NORETHINDRONE (UNII: T18F433X4S) (NORETHINDRONE - UNII:T18F433X4S)

Διαθέσιμο από:

Lupin Pharmaceuticals, Inc.

INN (Διεθνής Όνομα):

ESTRADIOL

Σύνθεση:

ESTRADIOL 1 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

  Limitation of Use When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, topical vaginal products should be considered. Limitation of Use 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. Amabelz is contraindicated in women with any of the following conditions:     •    Undiagnosed abnormal genital bleeding     •    Known, suspected, or history of breast cancer     •    Known, past or suspected estrogen-dependent neoplasia     •    Active DVT, PE, or history of these conditions     •    Active arterial thromboembolic disease (for example stroke and MI), or a history of these conditions     •    Known anaphylactic reaction or angioedema or hypersensitivity to Amabelz     •    Known liver impairment or disease     •    Known protein C, protein S, or antithrombin deficiency, or other

Περίληψη προϊόντος:

Amabelz 1 mg/0.5 mg is a white to off-white, round shaped film-coated tablet debossed with "M54" on one side and "LU" on other side. Amabelz 1 mg/0.5 mg is available in a wallet (NDC 68180-830-11) containing 28 tablets enclosed in a pouch, such 3 pouches are packed in a carton (NDC 68180-830-13). Amabelz 0.5 mg/0.1 mg is a white to off-white, round shaped film-coated tablet debossed with "M53" on one side and "LU" on other side. Amabelz 0.5 mg/0.1 mg is available in a wallet (NDC 68180-829-11) containing 28 tablets enclosed in a pouch, such 3 pouches are packed in a carton (NDC 68180-829-13). Store in a dry place protected from light. Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

AMABELZ- ESTRADIOL AND NORETHINDRONE ACETATE TABLET
LUPIN PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMABELZ SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR AMABELZ.
AMABELZ™ (ESTRADIOL AND NORETHINDRONE ACETATE TABLETS USP), FOR ORAL
USE
INITIAL U.S. APPROVAL: 1998
WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER, ENDOMETRIAL CANCER
AND
PROBABLE DEMENTIA
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
ESTROGEN PLUS PROGESTIN THERAPY • ESTROGEN PLUS PROGESTIN THERAPY SHOULD NOT BE USED FOR THE
PREVENTION OF CARDIOVASCULAR DISEASE OR
DEMENTIA (5.1, 5.3) • THE WOMEN'S HEALTH INITIATIVE (WHI) ESTROGEN PLUS PROGESTIN
SUBSTUDY REPORTED INCREASED RISKS OF
DEEP VEIN THROMBOSIS (DVT),
PULMONARY EMBOLISM (PE), STROKE AND MYOCARDIAL INFARCTION (MI) (5.1) • THE WHI ESTROGEN PLUS PROGESTIN SUBSTUDY REPORTED INCREASED RISKS
OF INVASIVE BREAST CANCER (5.2) • THE WHI MEMORY STUDY (WHIMS) ESTROGEN PLUS PROGESTIN ANCILLARY
STUDY OF WHI REPORTED AN
INCREASED RISK OF PROBABLE DEMENTIA IN POSTMENOPAUSAL WOMEN 65 YEARS
OF AGE AND OLDER (5.3)
ESTROGEN-ALONE THERAPY • THERE IS AN INCREASED RISK OF ENDOMETRIAL CANCER IN A WOMAN WITH
A UTERUS WHO USE UNOPPOSED
ESTROGENS (5.2) • ESTROGEN-ALONE THERAPY SHOULD NOT BE USED FOR THE PREVENTION OF
CARDIOVASCULAR DISEASE OR DEMENTIA
(5.2, 5.3) • THE WHI ESTROGEN-ALONE SUBSTUDY REPORTED INCREASED RISKS OF
STROKE AND DVT (5.1) • THE WHIMS ESTROGEN-ALONE ANCILLARY STUDY OF WHI REPORTED AN
INCREASED RISK OF PROBABLE DEMENTIA
IN POSTMENOPAUSAL WOMEN 65 YEARS OF AGE AND OLDER (5.3)
RECENT MAJOR CHANGES
Contraindications (4) 10/2013
Warnings and Precautions, Hereditary Angioedema (5.15) 10/2013
INDICATIONS AND USAGE
Amabelz is an estrogen and progestin combination indicated in a woman
with a uterus for:
Amabelz 1 mg/0.5 mg and 0.5 mg/0.1 mg are indicated in a woman with a
uterus for:
• Treatment of Moderate to Severe Vasomotor Symptoms due to
Menopause (1.1)
• P