ESTRADIOL AND NORETHINDRONE ACETATE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E), NORETHINDRONE ACETATE (UNII: 9S44LIC7OJ) (NORETHINDRONE - UNII:T18F433X4S)

Tilgjengelig fra:

Mylan Pharmaceuticals Inc.

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Estradiol and norethindrone acetate tablets are indicated for:   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, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis. Estradiol and norethindrone acetate tablets are contraindicated in women with any of the following conditions: Estradiol and norethindrone acetate tablets are not indicated for use in pregnancy. There are no data with the use of estradiol and norethindrone acetate tablets in pregnant women; however, epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalities and limb-reduction defects) following exposure to combined hormonal contraceptives (estrogen and progestins) before conception or during early pregnancy. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Estrogens plus progestogens are present in human milk and can reduce milk production in breast-feeding women. This reduction can occur at any time but is less likely to occur once breast-feeding is well established. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for estradiol and norethindrone acetate tablets and any potential adverse effects on the breastfed child from estradiol and norethindrone acetate tablets or from the underlying maternal condition. Estradiol and norethindrone acetate tablets are not indicated for use in pediatric patients. Clinical studies have not been conducted in the pediatric population. There have not been sufficient numbers of geriatric women involved in clinical studies utilizing estradiol and norethindrone acetate tablets to determine whether those over 65 years of age differ from younger subjects in their response to estradiol and norethindrone acetate tablets. In the WHI estrogen plus progestin substudy (daily CE [0.625 mg] plus MPA [2.5 mg] versus placebo), there was a higher relative risk of nonfatal stroke and invasive breast cancer in women greater than 65 years of age [see Clinical Studies (14.5)] . In the WHI estrogen-alone substudy (daily CE [0.625 mg]-alone versus placebo), there was a higher relative risk of stroke in women greater than 65 years of age [see Clinical Studies (14.5)] . In the WHIMS ancillary studies of postmenopausal women 65 to 79 years of age, there was an increased risk of developing probable dementia in women receiving estrogen plus progestin or estrogen-alone when compared to placebo. It is unknown whether this finding applies to younger postmenopausal women [see Warnings and Precautions (5.3), and Clinical Studies (14.6)] . Since both ancillary studies were conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women8 [see Warnings and Precautions (5.3), and Clinical Studies (14.6)] .

Produkt oppsummering:

Estradiol and Norethindrone Acetate Tablets USP, 1 mg/0.5 mg are orange, round, unscored, uncoated tablets, debossed with “263 ” on one side and plain on the other side. They are available as follows:  NDC 0378-7295-53 Carton of 3 pouches, each pouch contains 1 blister pack with 28 tablets and carton of 3 monocartons, each monocarton contains 1 blister pack with 28 tablets Estradiol and Norethindrone Acetate Tablets USP, 0.5 mg/0.1 mg are light orange, round, unscored, uncoated tablets, debossed with “55 ” on one side and plain on the other side. They are available as follows: NDC 0378-7294-53 Carton of 3 pouches, each pouch contains 1 blister pack with 28 tablets and carton of 3 monocartons, each monocarton contains 1 blister pack with 28 tablets Store in dry place protected from light. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]  

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

ESTRADIOL AND NORETHINDRONE ACETATE- ESTRADIOL AND NORETHINDRONE
ACETATE TABLET
MYLAN PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ESTRADIOL AND
NORETHINDRONE ACETATE TABLETS SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION
FOR ESTRADIOL AND NORETHINDRONE ACETATE TABLETS.
ESTRADIOL AND NORETHINDRONE ACETATE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
WARNING: CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA, BREAST CANCER,
AND ENDOMETRIAL CANCER
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ESTROGEN PLUS PROGESTIN THERAPY
•
•
•
•
ESTROGEN-ALONE THERAPY
•
•
•
•
RECENT MAJOR CHANGES
Warnings and Precautions, Malignant Neoplasms (5.2) 11/2023
INDICATIONS AND USAGE
Estradiol and norethindrone acetate tablets are an estrogen and
progestin combination indicated in a
woman with a uterus for:
•
•
Limitations of Use:
When prescribing solely for the treatment of moderate to severe
symptoms of vulvar and vaginal atrophy
due to menopause, first consider the use of topical vaginal products.
•
Limitations of Use:
When prescribing solely for the prevention of postmenopausal
osteoporosis, first consider the use of non-
estrogen medications. Consider estrogen therapy only for women at
significant risk of osteoporosis.
DOSAGE AND ADMINISTRATION
•
•
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)
DO NOT USE ESTROGEN PLUS PROGESTOGEN THERAPY FOR THE PREVENTION OF
CARDIOVASCULAR DISEASE OR DEMENTIA (5.1, 5.3)
THERE IS AN INCREASED RISK OF ENDOMETRIAL CANCER IN A WOMAN WITH A