JINTELI- norethindrone acetate and ethinyl estradiol tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Teva Pharmaceuticals USA, Inc.

INN (Kansainvälinen yleisnimi):

NORETHINDRONE ACETATE

Koostumus:

NORETHINDRONE ACETATE 1 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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. Jinteli is contraindicated in women with any of the following conditions: - Undiagnosed abnormal genital bleeding [see Warnings and Precautions ( 5.2)]. - Breast cancer or a history of breast cancer [see Warnings and Pr ecautions (5.2)]. - Estrogen-dependent neoplasia [see Warnings and Precautions (5.2)]. - Active DVT, PE or a history of these conditions [see Warnings and Precautions (5.1)]. - Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions [see Warnings and Precautions (5.1)]. - Known anaphylactic reaction, angioedema, or hypersensitivity to Jinteli - Hepatic impairment or disease. - Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.  Risk Summary Jinteli is not indicated for use in pregnancy. There are no data with the use of Jinteli 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 breastfeeding women. This reduction can occur at any time but is less likely to occur once breastfeeding is well-established. The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for Jinteli and any potential adverse effects on the breastfed child from Jinteli or from the underlying maternal condition. Jinteli is 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 Jinteli to determine whether those over 65 years of age differ from younger subjects in their response to Jinteli. 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)] .

Tuoteyhteenveto:

Jinteli® (norethindrone acetate and ethinyl estradiol tablets, USP) is available in the following strength and package sizes: 1 mg/5 mcg - White, round, flat-faced, beveled-edge, unscored tablets, debossed with stylized b on one side and 125 on the other side. Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep this and all medications out of the reach of children.

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

JINTELI- NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET
TEVA PHARMACEUTICALS USA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
JINTELI
SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR JINTELI
.
JINTELI (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
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 OR DEMENTIA (5.1, 5.3)
ESTROGEN-ALONE THERAPY
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 PREVENTION OF
CARDIOVASCULAR DISEASE OR
DEMENTIA (5.1, 5.3)
RECENT MAJOR CHANGES
Boxed Warning 5/2023
Warnings and Precautions, Malignant Neoplasms (5.2) 11/2023
INDICATIONS AND USAGE
Jinteli is a combination of an estrogen and progestin indicated in a
woman with a uterus for:
Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause
(1.1)
Prevention of Postmenopausal Osteoporosis (1.2)
DOSAGE AND ADMINISTRATION
One tablet orally once daily (2.1, 2.2)
DOSAGE FORMS A