NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL tablet

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

NORETHINDRONE ACETATE (UNII: 9S44LIC7OJ) (NORETHINDRONE - UNII:T18F433X4S), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)

から入手可能:

Glenmark Pharmaceuticals Inc., USA

INN（国際名）:

NORETHINDRONE ACETATE

構図:

NORETHINDRONE ACETATE 0.5 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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. Norethindrone acetate and ethinyl estradiol tablets are contraindicated in women with any of the following conditions: Risk Summary Norethindrone acetate and ethinyl estradiol tablets are not indicated for use in pregnancy. There are no data with the use of norethindrone acetate and ethinyl estradiol tablets in pregnant women; however, epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to combined (estrogens and progestins) product 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. Risk Summary 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 development and health benefits of breastfeeding should be considered along with the mother’s clinical need for norethindrone acetate and ethinyl estradiol tablets and any potential adverse effects on the breastfed child from norethindrone acetate and ethinyl estradiol tablets or from the underlying maternal condition. Norethindrone acetate and ethinyl estradiol 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 norethindrone acetate and ethinyl estradiol tablets to determine whether those over 65 years of age differ from younger subjects in their response to norethindrone acetate and ethinyl estradiol tablets. The Women’s Health Initiative Studies 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)] . The Women’s Health Initiative Memory Study 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 [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)] .

製品概要:

Norethindrone Acetate and Ethinyl Estradiol Tablets, USP are available in the following strengths and package sizes: Norethindrone Acetate and Ethinyl Estradiol Tablets, USP 0.5 mg/2.5 mcg, are light pink to pink, round, flat-faced, beveled edge, uncoated, tablets debossed with “D5” on one side and plain on the other side. Each tablet contains 0.5 mg norethindrone acetate, USP and 2.5 mcg ethinyl estradiol, USP and are available as: NDC 68462-656-90 Bottle of 90 Tablets Norethindrone Acetate and Ethinyl Estradiol Tablets, USP 1 mg/5 mcg are white to off-white, round, flat-faced, beveled edge, uncoated tablets debossed with “D6” on one side plain on the other side. Each tablet contains 1 mg norethindrone acetate, USP and 5 mcg ethinyl estradiol, USP and are available as: NDC 68462-657-90 Bottle of 90 Tablets Store 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]. Keep norethindrone acetate and ethinyl estradiol tablets out of the reach of children.

認証ステータス:

Abbreviated New Drug Application

製品の特徴

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL- NORETHINDRONE ACETATE
AND ETHINYL ESTRADIOL TABLET
GLENMARK PHARMACEUTICALS INC., USA
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NORETHINDRONE
ACETATE AND ETHINYL ESTRADIOL SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION
FOR NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL.
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1968
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
Boxed Warning 5/2023
Warnings and Precautions, Malignant Neoplasms (5.2) 11/2023
INDICATIONS AND USAGE
Norethindrone acetate and ethinyl estradiol tablets are a combination
of an estrogen and progestin
indicated in a woman with a uterus for:
•
•
DOSAGE AND ADMINISTRATION
•
DOSAGE FORMS AND STRENGTHS
•
•
THE WOMEN’S HEALTH INITIATIVE (WHI) ESTROGEN PLUS PROGESTIN SUBSTUDY
REPORTED
INCREASED RISKS OF PULMONARY EMBOLISM (PE), DEEP VEIN THROMBOSIS
(DVT), STROKE,
AND MYOCARDIAL INFARCTION (MI) (5.1)
THE WHI ESTROGEN PLUS PROGESTIN SUBSTUDY REPORTED INCREASED RISK 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 OF DEMENTIA (5.1, 5.3)
THERE IS AN INCREASED RISK OF ENDOMETRIAL CANCER IN A WOMAN WITH A
UTERUS WHO
USES UNOPPOSED ESTROGENS (5.2)
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)
DO NOT USE ESTROGEN-ALONE THERAPY FOR THE PREVENTIO