Short answer: The Activella label dose is one tablet by mouth once daily. For hot flashes and for preventing osteoporosis, either the 1 mg/0.5 mg or the 0.5 mg/0.1 mg strength is listed; for vaginal atrophy symptoms, the 1 mg/0.5 mg strength is listed. The label calls for the lowest effective dose for the shortest duration, with periodic checks on whether treatment is still needed.
This is what the FDA label says. Follow your prescriber. Your prescriber may use a different dose or pace than the label's standard schedule.
What Activella is approved for: Activella combines estradiol with the progestin norethindrone acetate in one daily tablet. It is approved to treat moderate to severe hot flashes and moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, and to prevent postmenopausal osteoporosis (sections 1.1 to 1.3). For vaginal symptoms alone the label says to first consider vaginal products, and for bone alone, non-estrogen medicines first.
Source
ACTIVELLA (estradiol/norethindrone acetate) tablets, prescribing information and Patient Information. Amneal Pharmaceuticals. DailyMed, version published June 3, 2024. DailyMed setid d4b0c1dd-aae9-4ca2-958c-71dbe5d0fab0
A single Activella tablet is taken by mouth once daily (sections 2.1 to 2.3). The Patient Information says to take 1 tablet at the same time each day.
There are two strengths: 1 mg estradiol/0.5 mg norethindrone acetate and 0.5 mg estradiol/0.1 mg norethindrone acetate (section 3).
Each carton holds one blister pack of 28 tablets (section 16.1).
The table below is the label's schedule, from the Dosage and Administration section. Numbers are copied exactly; the section is in brackets.
| Use | Dose | Strengths listed |
|---|---|---|
| Moderate to severe hot flashes | 1 tablet orally once daily | 1 mg/0.5 mg or 0.5 mg/0.1 mg |
| Vulvar and vaginal atrophy symptoms | 1 tablet orally once daily | 1 mg/0.5 mg |
| Prevention of postmenopausal osteoporosis | 1 tablet orally once daily | 1 mg/0.5 mg or 0.5 mg/0.1 mg |
Estrogen, alone or with a progestogen, is used at the lowest effective dose for the shortest duration consistent with treatment goals and risks, and women are re-evaluated periodically to see if treatment is still needed.
When prescribing only for vulvar and vaginal atrophy, topical vaginal products are considered first.
When prescribing only to prevent osteoporosis, non-estrogen medicines are considered first, and estrogen only for women at significant risk.
If feasible, estrogens are stopped at least 4 to 6 weeks before surgery linked to a higher risk of blood clots, or during long immobilization.
Talks about the dose and whether treatment is still needed happen regularly (every 3 to 6 months).
The Activella label gives no missed-dose instruction. The Patient Information says to take 1 tablet at the same time each day. Ask your prescriber what to do if a tablet is missed.
In Dose Track you set up Activella as a protocol with the dose and schedule your prescriber gave you. A protocol can hold dose steps, each with its own dose and length in days or weeks, so a step-up plan like the one on the label can be entered once and the app moves to the next step on its own. Reminders follow the schedule, and every dose is logged with the date and time, so you can see which step you are on and when your last dose was. The app follows what you enter; it does not choose or change a dose.
This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.