Activella Tablet: Uses, Dosage, Side Effects, Precautions and Alternates

Quick overview

Activella Tablet is a prescription hormone replacement therapy that combines estradiol, an estrogen, with norethindrone acetate, a progestin. It is given to women who still have a uterus to treat menopause symptoms such as hot flashes and vaginal dryness, and to help prevent bone thinning after menopause. It carries warnings about blood clots, stroke, heart attack, and certain cancers, and is taken as one tablet by mouth once a day.

What is Activella Tablet

Activella is a prescription hormone replacement therapy (HRT) tablet that combines two hormones, estradiol (an estrogen) and norethindrone acetate (a progestin). It is given to women who still have a uterus to treat menopause symptoms and to help prevent bone thinning after menopause.

Activella Tablet uses

• Treating moderate-to-severe hot flashes and night sweats caused by menopause
• Treating moderate-to-severe vaginal dryness, irritation, and pain with sex caused by menopause
• Preventing osteoporosis (bone loss) after menopause in women at significant risk

Benefits of Activella Tablet

• Reduces hot flashes, night sweats, and flushing
• Improves vaginal dryness and irritation
• Helps prevent bone loss and osteoporosis after menopause
• The progestin ingredient helps protect the uterus lining from overgrowth caused by estrogen

How Activella Tablet works

Activella replaces two hormones your body makes less of after menopause. The estrogen part eases hot flashes, night sweats, and vaginal dryness, and helps protect bones. The progestin part balances the estrogen's effect on the uterus lining to help lower the risk of unhealthy growth there.

Activella Tablet dosage

Take one tablet by mouth once a day at the same time every day. Taking the tablet with food may help reduce nausea. You can use the calendar on the package to help keep track of your daily dose.

Available forms and strengths

• Film-coated oral tablet
• 0.5 mg/0.1 mg
• 1 mg/0.5 mg

Side effects of Activella Tablet

Common

• Breast pain or tenderness
• Headache or migraine
• Nausea, bloating, or stomach upset
• Irregular vaginal bleeding or spotting
• Weight changes
• Back pain
• Upper respiratory tract infection (cough, cold, sore throat, congestion)
• Sinus infection
• Trouble sleeping
• Mood swings
• Fatigue
• Dizziness

Serious

• Signs of blood clots: trouble breathing, leg pain or swelling, skin warm to the touch
• Signs of heart attack: chest pain, arm pain, shortness of breath, cold sweats, lightheadedness
• Signs of stroke: sudden weakness on one side of the body, drooping face, changes in speech or vision, confusion, severe headache
• Signs of high calcium levels: tiredness, muscle weakness, nausea, vomiting, constipation
• Signs of low calcium levels: muscle spasms or twitching, numbness and tingling in fingers, toes, or around the mouth
• Unusual vaginal bleeding, vaginal discharge, or pelvic pain
• Yellowing of the skin or eyes
• Severe or sudden headache or sudden vision changes

Warnings and precautions

• This medicine can increase the risk of blood clots, stroke, and heart attack, and this risk can continue even after stopping the medicine.
• Using this medicine for a long time may raise the risk of endometrial, breast, or uterine cancer.
• This medicine may raise the risk of dementia, especially in women 65 and older, and should not be used to try to prevent dementia or heart disease.
• This medicine should not be used by women who have or have had breast cancer, an estrogen-sensitive cancer, unexplained vaginal bleeding, active or past blood clots, stroke or heart attack, or liver disease.
• This medicine can increase the chance of developing gallbladder disease.
• This medicine is not meant for use during pregnancy. If you think you might be pregnant while using it, tell your doctor right away.
• Estrogen and progestin hormones pass into breast milk and can reduce milk supply, so talk with your doctor about the benefits and risks if you are breastfeeding.
• No specific renal dosage adjustment is established. Patients with kidney disease require individualized assessment, particularly if fluid retention or cardiovascular conditions are present.
• This medicine should not be used if you have liver disease or impairment, and caution is needed if you have a history of jaundice linked to past hormone use or pregnancy.
• No major direct interaction with alcohol is established, but alcohol may worsen hot flashes or interfere with symptom management.
• Activella is not generally considered sedating. However, dizziness, headache, or other impairing effects may affect driving ability.

Storage

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

When to see a doctor

• Get emergency help right away for chest pain, trouble breathing, facial drooping, weakness on one side of the body, severe headache, or sudden changes in speech or vision, as these can be signs of a blood clot, stroke, or heart attack.
• Contact your doctor immediately if you have chest pain, confusion, difficulty speaking, double vision, headaches, or inability to move your arms, legs, or face.
• Check with your doctor right away if you have abnormal vaginal bleeding.
• Check with your doctor right away if you have stomach pain, nausea, and vomiting, which could be signs of gallbladder problems.
• Check with your doctor immediately if you have a severe headache or sudden loss of vision or other vision changes.

Alternatives

• Prempro
• Bijuva
• Estradiol