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Estradiol and Norethindrone

Generic name: estradiol and norethindrone (oral) [ESS-tra-DYE-ole-and-nor-ETH-in-drone]

Brand names: Activella, Mimvey
Oral tablet: (0.5 mg–0.1 mg; 1 mg–0.5 mg)
Drug classes: Combinations of sex hormones

What is Estradiol and Norethindrone?

Estradiol is a type of estrogen. It is a female hormone that regulates many bodily processes.Norethindrone is an alternative form of progesterone. This female hormone regulates ovulation.Combination medicine consisting of estradiol (estradiol) and norethindrone (norethindrone), is used for the treatment of menopause, such as vaginal changes and hot flashes . It also prevents osteoporosis in women who are menopausal.This medication guide does not list all possible uses for estradiol or norethindrone.

Side effects of Estradiol and Norethindrone

If you experience any of the following symptoms of an allergy reaction, seek immediate medical attention: difficulty breathing, hives, swelling in your lips, face, throat, or tongue.

Norethindrone and estradiol can cause severe side effects. If you experience:

  • Symptoms of a heart attack: chest pressure or pain, spreading pain to the jaw or shoulder, nausea, and sweating.
  • Signs of stroke: sudden numbness, weakness, or headache (especially on one side), slurred or shaky speech, or problems with balance or vision;
  • Signs of blood clots: sudden vision loss, chest pain that stabs, shortness of breath, blood in the cough, or pain or heat in both legs.
  • You may experience swelling in the stomach or tenderness.
  • Jaundice
  • Memory problems, confusion, and unusual behaviors;
  • Unusual vaginal bleeding and pelvic pain
  • A lump on your breast, or
  • High levels of calcium are accompanied by nausea, vomiting, and constipation. Other symptoms include muscle weakness, pain in the bones, fatigue, or increased thirst.

Some of the common side effects associated with estradiol or norethindrone include:

  • Nausea, vomiting, bloating, and stomach cramps;
  • Fluid retention (swelling, rapid weight gain);
  • Headache;
  • Breast pain
    hair loss on the scalp
  • Bleeding, vaginal itching, or discharge.

There may be other side effects. For medical advice on side effects, call your doctor.Call the FDA's hotline at 1-800-FDA-1088 if you experience side effects.

Warnings

Estradiol or norethindrone should be avoided if a woman has had a hysterectomy or suffers from undiagnosed bleeding in the vaginal area, liver disease or bleeding disorders, is undergoing major surgery, or if she's had heart attacks, strokes, blood clots, cancers of the breast, uterus/cervix, or vagina.Avoid using it if pregnant.Norethindrone and estradiol may increase the risk that you develop a condition that may lead to cancer of the uterus. Do not ignore any abnormal vaginal bleeding.This medicine should not be taken to treat strokes or dementia.

Before you take this drug

This medicine should not be used if:

  • Unusual vaginal bleeding not checked by your doctor
  • Liver disease
  • A bleeding disorder;
  • History of heart attack, stroke or blood clot
  • A history of cancers of the breast, uterus, cervix, or vagina

If you're pregnant, do not take estradiol or norethindrone. Inform your doctor immediately if a pregnancy occurs during treatment.This medicine increases your risk of blood clots and strokes. This medicine can increase your risk of blood clots, strokes, and heart attacks.This medicine can actually increase the risk of heart disease, stroke, or dementia.

If you've ever:

  • Heart disease
  • If you have liver disease or jaundice due to pregnancy, taking hormones, or being pregnant,
  • Hereditary Angioedema
  • Epilepsy
  • Kidney disease
  • Gallbladder Disease
  • Asthma;
  • Epilepsy and other seizure disorders
  • Migraines;
  • Lupus;
  • Porphyria
  • Endometriosis or uterine fibroid tumors;
  • High levels of calcium are found in the blood.

This medicine can increase the risk of breast cancer, uterine cancer, or ovarian cancer. Speak to your doctor about the risk.Breast milk production can be slowed by estradiol or norethindrone. Inform your doctor that you are breastfeeding.

How to take  Estradiol and Norethindrone?

Read all the instructions or guides that come with your medication and follow all the directions. Follow the directions on your prescription label.Estradiol can increase the risk that you develop a condition that could lead to uterine carcinoma. If you experience any abnormal vaginal bleeding, call your doctor immediately.You may have to temporarily stop taking this medication if you are going through major surgery or if you will need long-term rest. You should let any doctor who treats you know that you use estradiol or norethindrone.You should have your doctor check on you regularly (every three to six months) in order to decide whether or not to continue the treatment. You should self-examine for lumps in your breasts every month and get a mammogram once a year when using estradiol or norethindrone.Keep away from heat, moisture, and light.

What happens if I miss the dose?

As soon as possible, take the missed dose.If your next dose is approaching quickly, skip any missed ones and wait until it arrives to take your full dosage.You should not take more medicine to compensate for a missed dose.

What happens if I overdose?

Call 1-800-222-1222 for poison help or seek immediate medical attention.

What should be avoided?

Smoking is harmful. While using norethindrone and estradiol, your chances of getting a stroke or heart attack, as well as blood clots, are increased.Grapefruit can cause unwanted side effects when combined with norethindrone or estradiol. Use grapefruit-based products as little as possible.

Interaction with other drug

It is sometimes not safe to take certain drugs at the same time. Some medications can cause side effects that increase or decrease the effectiveness of another drug you are taking.Estradiol, norethindrone, and other drugs may affect each other. These include prescription drugs, over-the-counter medications, vitamins, and herbal products. This list does not include all interactions. Inform your doctor of all medications you are currently taking and those that you will stop or start using.