estradiol and norethindrone (transdermal)

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Pronunciation: ES tra DYE ol and nor ETH in drone

Brand: Combipatch

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

You should not use this medicine if you have any of the following conditions: abnormal vaginal bleeding, liver disease, a hormone-related cancer such as breast or uterine cancer, a bleeding or blood-clotting disorder, or a history of heart attack, stroke, or blood clot.

Do not use if you are pregnant.

This medicine 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.

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 are estradiol and norethindrone?

Estradiol is a form of estrogen, a female sex hormone that regulates many processes in the body.

Norethindrone is a form of progesterone, a female hormone important for regulating ovulation and menstruation.

Estradiol and norethindrone transdermal (skin patch) is a combination medicine used to treat menopause symptoms such as hot flashes and vaginal changes (itching, burning, dryness). This medicine is also used before menopause to treat a lack of estrogen caused by conditions such as hypogonadism, primary ovarian failure, or surgical removal of the ovaries.

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

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

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

  • a history of heart attack, stroke, or blood clot (especially in your lung or your lower body);
  • liver disease;
  • abnormal vaginal bleeding that has not been checked by a doctor;
  • a history of breast, uterine, or hormone-related cancer;
  • a bleeding or blood-clotting disorder;
  • if you have had a hysterectomy; or
  • if you are pregnant or may become pregnant.

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. Talk with your doctor about your individual risks before using this medicine long-term.

To make sure this medicine is safe for you, tell your doctor if you have:

  • unusual vaginal bleeding;
  • heart disease;
  • risk factors for coronary artery disease (such as diabetes, lupus, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease);
  • liver or kidney disease;
  • hereditary angioedema;
  • lupus;
  • asthma;
  • epilepsy or other seizure disorder;
  • migraines;
  • porphyria;
  • gallbladder disease;
  • endometriosis or uterine fibroid tumors;
  • a thyroid disorder; or
  • high levels of calcium levels in your blood (hypercalcemia).

Do not use estradiol and norethindrone if you are pregnant. Tell your doctor right away if you become pregnant during treatment.

Estradiol and norethindrone can pass into breast milk. This medicine may slow breast milk production. Do not use if you are breast-feeding a baby.

How should I use estradiol and norethindrone?

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

Estradiol and norethindrone 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 estradiol, to help lower this risk. Report any unusual vaginal bleeding right away.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Apply the patch to clean, dry skin on your lower abdomen. Avoid using lotions, oils, or powder on the patch-wearing area. Press the patch firmly into place for at least 10 seconds. You may leave the patch on while bathing, showering, or swimming.

Do not wear more than one estradiol and norethindrone patch at a time. Using extra skin patches will not make the medication more effective. Never cut a skin patch.

If a patch falls off, try sticking back into place. If it does not stick well, put on a new patch.

Remove the skin patch after 3 or 4 days (or 2 times per week) and replace it with a new one.

After removing a skin patch: fold it in half firmly with the sticky side in, and place in a trash container out of the reach of children and pets. Do not flush an estradiol and norethindrone skin patch down a toilet.

Choose a different place on your body to wear the patch each time you put on a new one. Do not use the same skin area twice within the same week.

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 estradiol and norethindrone.

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 a mammogram every year while using estradiol and norethindrone.

Store at room temperature away from moisture and heat. Keep each skin patch in the foil pouch until ready to use. After opening a pouch, you must use the skin patch right away. Discard the empty pouch in a place children and pets cannot get to.

What happens if I miss a dose?

Apply the next patch as soon as you remember, and follow your regular schedule for changing the patch. Do not apply extra skin patches 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.

What should I avoid while using estradiol and norethindrone?

Grapefruit and grapefruit juice may interact with this medicine and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

What are the possible side effects of 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.

Call your doctor at once if you have:

  • confusion, depression, unusual thoughts or behavior;
  • unusual or heavy vaginal bleeding;
  • a lump in your breast;
  • 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, slurred speech, problems with vision 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
  • liver problems --nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • nausea, vomiting, bloating, stomach cramps;
  • light vaginal bleeding or spotting;
  • vaginal itching or discharge;
  • headache;
  • breast pain; or
  • redness or irritation where the patch is worn.

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 estradiol and norethindrone?

Other drugs may interact with 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 estradiol and norethindrone transdermal.

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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