Mimvey

Indications
Dosage
How Supplied

INDICATIONS

Mimvey (estradiol and norethindrone acetate tablets, USP) 1 mg/0.5 mg are indicated in women who have a uterus for the:

  1. Treatment of moderate to severe vasomotor symptoms associated with menopause.
  2. 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 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 to 800 IU/day may also be required to ensure adequate daily intake in postmenopausal women. Mimvey is also indicated in women who have a uterus for the:
  3. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with menopause. When used solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.

DOSAGE AND ADMINISTRATION

Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be re-evaluated periodically as clinically appropriate (e.g., 3 to 6 month intervals) to determine if treatment is still necessary (See BOXED WARNINGS and WARNINGS). For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.

Mimvey (estradiol and norethindrone acetate tablets, USP) therapy consists of a single tablet to be taken once daily.

  1. For the treatment of moderate to severe vasomotor symptoms associated with menopause, and the 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 non-estrogen medications should be carefully considered.
  2. For the treatment of moderate to severe symptoms of vulvar and vaginal atrophy. When used solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.

Patients should be started at the lowest dose.

HOW SUPPLIED

Mimvey (estradiol and norethindrone acetate tablets, USP) are available as:

1 mg/0.5 mg: White, round, film-coated, unscored tablet, debossed with stylized b on one side and 34 on the other side.
Available in blister cards of 28 tablets.
1 blister card per carton NDC 0093-5455-28
5 blister cards per carton NDC 0093-5455-42

Store in a dry place protected from light.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Manufactured For: Teva Pharmaceuticals, USA Sellersville, PA 18960. Issued MAY 2009

Last reviewed on RxList: 4/1/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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