Application Nr Approved Date Route Status External Links
ANDA076812 None None None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage: Prefest Is Indicated In Women Who Have A Uterus For The: Treatment Of Moderate To Severe Vasomotor Symptoms Associated With The Menopause. Treatment Of Moderate To Severe Symptoms Of Vulvar And Vaginal Atrophy Associated With The Menopause. When Prescribed Solely For The Treatment Of Symptoms Of Vulvar And Vaginal Atrophy, Topical Vaginal Products Should Be Considered. 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 And Nonestrogen 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 To 800 Iu/day May Also Be Required To Ensure Adequate Daily Intake In Postmenopausal Women.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Estradiol/norgestimate

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