Activella is indicated in women who have a uterus for the:

1.Treatment of moderate to severe vasomotor symptoms associated with the menopause.

2.Treatment of moderate to severe vulvar and vaginal atrophy associated with the menopause. When used solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.

3.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 400-800 IU/day may also be required to ensure adequate daily intake in postmenopausal women.

When estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. 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 reevaluated 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.

Activella therapy consists of a single tablet to be taken once daily.

For the treatment of moderate to severe vasomotor symptoms associated with the menopause, treatment of vulvar and vaginal atrophy, and the prevention of postmenopausal osteoporosis ¾Activella 1 mg E₂/0.5 mg NETA daily. The doses of 17 beta-estradiol and norethindrone acetate in Activella may not be the lowest effective dose-combination for the treatment of vasomotor symptoms and prevention of postmenopausal osteoporosis.

Activella, 1mg estradiol and 0.5 mg norethindrone acetate, is a white, film-coated tablet, engraved with NOVO 288 on one side and the APIS bull on the other. It is round, 6mm in diameter and bi-convex.

Activella is supplied as:

28 tablets in a calendar dial pack dispenser NDC 0009-5174-02.

Store in a dry place protected from light. Store at 25° C (77° F), excursions permitted to 15-30° C (59-86°F) [See USP Controlled Room Temperature]

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