Jinteli

Jinteli
(northindrone acetate and ethinyl estradiol) Tablets, USP

WARNING

Estrogens and progestins should not be used for the prevention of cardiovascular disease or dementia. (See WARNINGS, Cardiovascular Disorders and Dementia.)

The Women's Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo. (See CLINICAL PHARMACOLOGY, Clinical Studies and WARNINGS, Cardiovascular Disorders and Malignant Neoplasms, Breast Cancer.)

The Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with oral conjugated estrogens plus medroxyprogesterone acetate relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. (See CLINICAL PHARMACOLOGY, Clinical Studies, WARNINGS, Dementia and PRECAUTIONS, Geriatric Use.)

Other doses of oral conjugated estrogens with medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

DRUG DESCRIPTION

Jinteli™ (norethindrone acetate and ethinyl estradiol tablets, USP) is a continuous dosage regimen of a progestin-estrogen combination for oral administration.

Each white tablet contains 1 mg norethindrone acetate [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17α)-] and 5 mcg ethinyl estradiol [19-Norpregna-1,3,5(10)-trien-20-yne-3, 17-diol, (17α)-]. Each tablet also contains the following ingredients: calcium stearate, lactose monohydrate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate.

The structural formulas are as follows:

Norethindrone acetate -Structural Formula Illustration

Norethindrone Acetate C22H28O3    Molecular Weight: 340.47

Ethinyl Estradiol - Structural Formula Illustration

Ethinyl Estradiol C20H24O2     Molecular weight 296.41

Last reviewed on RxList: 3/31/2014
This monograph has been modified to include the generic and brand name in many instances.

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