FDA label
What is Vivelle-Dot used for?
Vivelle-Dot contains estradiol. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for Vivelle-Dot lists 4 uses: Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause; Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy Due to Menopause; Treatment of Hypoestrogenism Due to Hypogonadism, Castration, or Primary Ovarian Failure; Prevention of Postmenopausal Osteoporosis.
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Vivelle-Dot, patch, extended release
Indications and Usage, quoted from the label by Sandoz Inc (NDA020538). Cross-references to other label sections are left out.
Vivelle-Dot is indicated for:
Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause
.
Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy Due to Menopause
Limitations of Use: When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy, first consider the use of topical vaginal products.
Treatment of Hypoestrogenism Due to Hypogonadism, Castration, or Primary Ovarian Failure
.
Prevention of Postmenopausal Osteoporosis
Limitations 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.
Source: DailyMed label, set id 5ccb77f9-d47b-4381-ad5c-5b92524e1c4a, version 17, effective November 17, 2023. NDC 66758-145, one of 5 listings for this product.
Questions
What is Vivelle-Dot used for?
The FDA label for Vivelle-Dot lists 4 uses: Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause; Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy Due to Menopause; Treatment of Hypoestrogenism Due to Hypogonadism, Castration, or Primary Ovarian Failure; Prevention of Postmenopausal Osteoporosis.
What drug class is Vivelle-Dot?
FDA lists estradiol in the Estrogen established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
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