ethinyl estradiol and norethindrone (HRT)

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Pronunciation: ETH in ill ESS tra DYE ole and nor ETH in drone

Brand: femhrt, femhrt 0.5 mg/2.5 mcg, Jinteli

What is the most important information I should know about ethinyl estradiol and norethindrone?

You should not use this medicine if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, if you have recently had a stroke or heart attack, if you have had your uterus removed (hysterectomy), or if you have ever had an allergic reaction to birth control pills or other hormones.

Do not use if you are pregnant.

Ethinyl estradiol and norethindrone may increase your risk of developing a condition that may lead to uterine cancer. Call your doctor at once if you have any unusual vaginal bleeding while using this medicine.

Ethinyl estradiol and norethindrone should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions. Long-term use may also increase your risk of breast cancer or blood clot.

What is ethinyl estradiol and norethindrone?

Ethinyl estradiol is a form of estrogen. Estrogen is a female sex hormone necessary for many processes in the body.

Norethindrone is a form of progesterone. Progesterone is a female hormone important for the regulation of ovulation and menstruation.

Ethinyl estradiol and norethindrone is a combination medicine used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. It is also used to prevent osteoporosis.

Estradiol and norethindrone may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking ethinyl estradiol and norethindrone?

Do not use ethinyl estradiol and norethindrone if you are pregnant. Use effective birth control, and tell your doctor right away if you become pregnant.

You should not use this medicine if you are allergic to it, or if you have:

  • abnormal vaginal bleeding that a doctor has not checked;
  • a hormone-related cancer such as breast or uterine cancer;
  • a history of heart attack, stroke, or blood clot (especially in your lung or your lower body);
  • a hereditary clotting deficiency (protein C, protein S, or antithrombin);
  • a history of having your uterus removed (hysterectomy);
  • liver disease; or
  • a history of liver problems or jaundice caused by birth control pills or other hormones.

Ethinyl estradiol and norethindrone will not prevent heart disease, heart attack, stroke, breast cancer, or dementia, and may actually increase your risk of developing these conditions. Long-term use may also increase your risk of breast cancer or blood clot. Talk with your doctor about your individual risks.

To make sure ethinyl estradiol and norethindrone is safe for you, tell your doctor if you have:

  • continued vaginal bleeding after menopause;
  • high blood pressure or heart disease;
  • a thyroid disorder;
  • lupus;
  • hereditary angioedema;
  • endometriosis;
  • bone cancer;
  • high cholesterol or triglycerides (a type of fat in the blood);
  • gallbladder disease;
  • diabetes;
  • high or low levels of calcium in your blood;
  • asthma;
  • epilepsy or other seizure disorder;
  • migraines; or
  • risk factors for coronary artery disease (such as diabetes, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease, being older than 40, or if you have had a hysterectomy).

Ethinyl estradiol and norethindrone can pass into breast milk and may harm a nursing baby. This medicine may also slow breast milk production. Do not use if you are breast-feeding a baby.

How should I take ethinyl estradiol and norethindrone?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Try to take this medicine at the same time each day.

Use ethinyl estradiol and norethindrone regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

This medicine may increase your risk of developing a condition that may lead to uterine cancer. Your doctor may prescribe a progestin to take while you are using ethinyl estradiol and norethindrone, to help lower this risk. Report any unusual vaginal bleeding right away.

Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment. Self-examine your breasts for lumps on a monthly basis, and have regular mammograms.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using ethinyl estradiol and norethindrone.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, or vaginal bleeding.

What should I avoid while taking ethinyl estradiol and norethindrone?

Avoid smoking while using this medication. Smoking can increase your risk of blood clots, stroke, or heart attack caused by taking hormones.

What are the possible side effects of ethinyl estradiol and norethindrone?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using ethinyl estradiol and norethindrone and call your doctor at once if you have:

  • abnormal vaginal bleeding;
  • a breast lump;
  • sudden vision problems;
  • confusion, problems with memory or concentration;
  • jaundice (yellowing of the skin or eyes);
  • heart attack symptoms --chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
  • signs of a stroke --sudden numbness or weakness (especially on one side of the body), sudden severe headache, problems with speech or balance;
  • signs of a blood clot in the lung --chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
  • signs of a blood clot in your leg --pain, swelling, warmth, or redness in one or both legs; or
  • abnormal levels of calcium in your blood --nausea, vomiting, constipation, increased thirst or urination, numbness or tingly feeling around your mouth, fast or slow heart rate, muscle weakness or tightness, bone pain, confusion, lack of energy, or tired feeling.

Common side effects may include:

  • stomach pain;
  • breast tenderness;
  • light vaginal bleeding or spotting;
  • swelling, rapid weight gain; or
  • headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect ethinyl estradiol and norethindrone?

Other drugs may interact with ethinyl estradiol and norethindrone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about ethinyl estradiol and norethindrone.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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