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Activella (estradiol and norethindrone acetate)

Indications

• Activella is used to treat symptoms of menopause such as hot flashes, night sweats, and vaginal dryness.
• It helps prevent osteoporosis in postmenopausal women by maintaining bone density.
• Activella is prescribed to treat moderate to severe vasomotor symptoms associated with menopause.
• It is used to manage vulvar and vaginal atrophy due to menopause.

Dosage and Administration

• Take Activella exactly as prescribed by your doctor, usually once daily. You can take Activella with or without food.
• Follow your doctor’s instructions regarding the duration of therapy; it is often prescribed for short-term use.
• Use the lowest effective dose for the shortest duration consistent with your treatment goals.
• Have regular check-ups with your doctor to monitor your progress and assess the need for continuing treatment.
• Do not skip doses or stop taking Activella without consulting your doctor, as it can affect the treatment outcome.
• Avoid smoking while taking Activella, as it increases the risk of serious cardiovascular side effects.
• Do not take Activella if you are pregnant or planning to become pregnant.
• Do not take more than the prescribed dose, as it can increase the risk of severe side effects.
• Avoid using Activella if you have a history of hormone-dependent cancers, such as breast or uterine cancer.

Mechanism of Action

Activella contains a combination of estradiol, a form of estrogen, and norethindrone acetate, a form of progestin. Estradiol replaces the estrogen that your body loses during menopause, relieving menopausal symptoms. Norethindrone acetate helps protect the lining of your uterus from overgrowth that can occur with estrogen use alone, reducing the risk of uterine cancer.

Contraindications

• Do not take Activella if you have undiagnosed abnormal vaginal bleeding.
• Avoid Activella if you have a known allergy to estradiol, norethindrone acetate, or any of its ingredients.
• Do not use Activella if you have a history of breast cancer, hormone-dependent tumors, or active liver disease.
• Avoid taking Activella if you have a history of blood clots, stroke, or heart attack.
• Do not use Activella if you are pregnant or breastfeeding.

Side Effects

Common Side Effects

• Headache
• Nausea
• Breast tenderness
• Abdominal pain
• Bloating

Serious Side Effects

• Increased risk of blood clots, stroke, and heart attack
• Severe allergic reactions, including rash, itching, swelling, and trouble breathing
• Vision changes, such as sudden loss of vision or blurred vision
• Unusual vaginal bleeding or spotting
• Signs of liver problems, such as yellowing of the skin or eyes, dark urine, and severe stomach pain

Precautions

• Inform your doctor about all other medications you are taking, including over-the-counter drugs and supplements.
• Report any unusual vaginal bleeding immediately to your doctor.
• Have regular physical exams, including breast exams and mammograms, while taking Activella.
• Discuss the risks and benefits of Activella with your doctor if you have a history of cardiovascular disease or risk factors for it.
• Monitor your blood pressure regularly, as Activella can cause an increase in blood pressure.
• If you have diabetes, monitor your blood sugar levels closely, as estrogen can affect blood glucose control.

Storage Instructions

• Store Activella at room temperature, between 20°C to 25°C (68°F to 77°F).
• Keep the tablets in a dry place and in their original container, tightly closed.
• Store Activella out of reach of children and pets.

References

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020907s019lbl.pdf