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Activella

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Activella

INDICATIONS

Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause

Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause Limitation of Use

When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, topical vaginal products should be considered.

Prevention of Postmenopausal Osteoporosis

Limitation of Use

When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medication should be carefully 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. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.

Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause

Activella therapy consists of a single tablet to be taken once daily for the treatment of moderate to severe vasomotor symptoms due to menopause.

  • Activella 1 mg/0.5 mg
  • Activella 0.5 mg/0.1 mg

Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause

Activella therapy consists of a single tablet to be taken once daily for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause.

  • Activella 1 mg/0.5 mg

Prevention of Postmenopausal Osteoporosis

Activella therapy consists of a single tablet to be taken once daily for the prevention of postmenopausal osteoporosis.

  • Activella 1 mg/0.5 mg
  • Activella 0.5 mg/0.1 mg

HOW SUPPLIED

Dosage Forms And Strengths

Activella tablets are available in two strengths:

  • Each tablet of Activella 1 mg/ 0.5 mg contains 1 mg of estradiol and 0.5 mg of norethindrone acetate. The tablets are white, round, bi-convex, film-coated tablets engraved with NOVO 288 on one side and the APIS bull on the other.
  • Each tablet of Activella 0.5 mg/ 0.1 mg contains 0.5 mg of estradiol and 0.1 mg of norethindrone acetate. The tablets are white, round, bi-convex, film-coated tablets engraved with NOVO 291 on one side and the APIS bull on the other.

Activella 1 mg/0.5 mg 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. (NDC 0169-5174-02). It is supplied as 28 tablets in a calendar dial pack dispenser.

Activella 0.5 mg/0.1 mg is a white, film-coated tablet, engraved with NOVO 291 on one side and the APIS bull on the other. It is round, 6mm in diameter and bi-convex. (NDC 0169-5175-10). It is supplied as 28 tablets in a calendar dial pack dispenser.

Storage and Handling

Store in a dry place protected from light. Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).

Manufactured by: Novo Nordisk A/S 2880 Bagsvaerd, Denmark. Date of Issue: 10/2013

Last reviewed on RxList: 11/4/2013
This monograph has been modified to include the generic and brand name in many instances.

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Activella - User Reviews

Activella User Reviews

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