Application Nr Approved Date Route Status External Links
ANDA076221 2009-11-06 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Jintelitm (norethindrone Acetate And Ethinyl Estradiol Tablets, Usp) Are Indicated In Women With An Intact Uterus For The: Treatment Of Moderate To Severe Vasomotor Symptoms Associated With The Menopause. Prevention Of Postmenopausal Osteoporosis. When Prescribing Solely For The Prevention Of Postmenopausal Osteoporosis, Therapy Should Only Be Considered For Women At Significant Risk Of Osteoporosis. Non-Estrogen Medications Should Be Carefully Considered. The Mainstays For Decreasing The Risk Of Postmenopausal Osteoporosis Are Weight Bearing Exercise, Adequate Calcium And Vitamin D Intake, And When Indicated, Pharmacologic Therapy. Postmenopausal Women Require An Average Of 1500 Mg/day Of Elemental Calcium. Therefore, When Not Contraindicated, Calcium Supplementation May Be Helpful For Women With Suboptimal Dietary Intake. Vitamin D Supplementation Of 400-800 Iu/day May Also Be Required To Ensure Adequate Daily Intake In Postmenopausal Women. Risk Factors For Osteoporosis Include Low Bone Mineral Density, Low Estrogen Levels, Family History Of Osteoporosis, Previous Fracture, Small Frame (low Bmi), Light Skin Color, Smoking, And Alcohol Intake. Response To Therapy Can Be Predicted By Pre-Treatment Serum Estradiol, And Can Be Assessed During Treatment By Measuring Biochemical Markers Of Bone Formation/resorption, And/or Bone Mineral Density. Estrogen Therapy Reduces Bone Resorption And Retards Or Halts Postmenopausal Bone Loss. Studies Have Shown A Risk Ratio Of About 0.4 For Hip And Wrist Fractures In Women Whose Estrogen Therapy Was Begun Within A Few Years Of Menopause, Compared To Women Taking Calcium And Vitamin D Alone. Studies Also Suggest That Estrogen Reduces The Rate Of Vertebral Fractures. Even When Started As Late As 6 Years After Menopause, Estrogen Reduces Further Loss Of Bone Mass For As Long As Treatment Is Continued. When Estrogen Therapy Is Discontinued, Bone Mass Declines At A Rate Comparable To The Immediate Postmenopausal Period. Data From The Women's Health Initiative Study Showed That Use Of Estrogen Plus Progestin (dose Equivalent To 0.625 Ce And 2.5 Mg Mpa) Resulted In About 5 Less Hip Fractures Per 10,000 Women-Years, Compared To Use Of Placebo (risk Ratio About 0.66).

All Formulated Excipients (2 Total)

Name Structure Kind Function Status
1. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
2. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved

Active Ingredients ( 2 Total)

Name Structure ZINC ID(s)
1. Ethinyl Estradiol
2. Norethindrone Acetate

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