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Generic Name: ethinyl estradiol and norethindrone (HRT) (ETH in ill ess tra DYE ole/ nor ETH in drone )
Brand Names: femhrt, femhrt 1/5

What are ethinyl estradiol and norethindrone?

Ethinyl estradiol is a female sex hormone that is involved in the development and maintenance of the female reproductive system.

Norethindrone is a female hormone, usually called "progesterone." It is important for the regulation of ovulation and menstruation.

Together, ethinyl estradiol and norethindrone are used to treat the symptoms of menopause, such as feelings of warmth in the face, neck and chest, or sudden intense spells of heat and sweating ("hot flashes" or "hot flushes"), and to prevent thinning bones (osteoporosis).

Ethinyl estradiol and norethindrone may also be used for purposes other than those listed in this medication guide.

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

Ethinyl estradiol increases the risk of developing endometrial hyperplasia, a condition that may lead to cancer of the lining of the uterus. Taking a progestin, such as norethindrone, with ethinyl estradiol lowers the risk of developing this condition. Visit your doctor regularly and report any unusual vaginal bleeding right away.

Treatment with estrogens and progestins long-term may increase the risk of heart attack, stroke, breast cancer, and blood clots in the lungs or legs. Because of these risks, you should contact your doctor or healthcare provider to discuss your individual risks and benefits before taking an estrogen and progesterone combination long-term. You should also talk to your doctor or healthcare provider on a regular basis (for example, every 3-6 months) about whether you should continue this treatment.

Have yearly physical exams and examine your breasts for lumps on a monthly basis while taking ethinyl estradiol and norethindrone.

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

Treatment with estrogens and progestins long-term may increase the risk of heart attack, stroke, breast cancer, and blood clots in the lungs or legs. Because of these risks, you should contact your doctor or healthcare provider to discuss your individual risks and benefits before taking an estrogen and progesterone combination long-term. You should also talk to your doctor or healthcare provider on a regular basis (for example, every 3-6 months) about whether you should continue this treatment.

• a circulation, bleeding, or blood-clotting disorder;

• undiagnosed, abnormal vaginal bleeding; or

• any type of breast, uterine, or hormone-dependent cancer.

Taking ethinyl estradiol and norethindrone may be dangerous in some cases if you have any of the conditions listed above.

Before taking ethinyl estradiol and norethindrone, tell your doctor if you have

• high blood pressure, angina, or heart disease;

• high levels of cholesterol or triglycerides in the blood;

• liver disease;
• kidney disease;

• asthma;

• epilepsy;

• migraines;

• diabetes;

• depression;

• gallbladder disease;

• uterine fibroids; or

• had a hysterectomy (uterus removed).

You may not be able to take ethinyl estradiol and norethindrone, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

How should I take ethinyl estradiol and norethindrone?

Take ethinyl estradiol and norethindrone exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Try to take your doses at the same time each day.

It is important to take ethinyl estradiol and norethindrone regularly to get the most benefit.

Have yearly physical exams and examine your breasts for lumps on a monthly basis while taking ethinyl estradiol and norethindrone.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the dose you missed and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Symptoms of a ethinyl estradiol and norethindrone overdose might include nausea, vomiting, and vaginal bleeding.

What should I avoid while taking my ethinyl estradiol and norethindrone?

There are no restrictions on food, beverages, or activity while taking ethinyl estradiol and norethindrone unless your doctor directs otherwise.

My ethinyl estradiol and norethindrone side effects

Ethinyl estradiol increases the risk of developing endometrial hyperplasia, a condition that may lead to cancer of the lining of the uterus. Taking a progestin, such as norethindrone, with ethinyl estradiol lowers the risk of developing this condition. Visit your doctor regularly and report any unusual vaginal bleeding right away.

Treatment with estrogens and progestins long-term may increase the risk of heart attack, stroke, breast cancer, and blood clots in the lungs or legs. Because of these risks, you should contact your doctor or healthcare provider to discuss your individual risks and benefits before taking an estrogen and progesterone combination long-term. You should also talk to your doctor or healthcare provider on a regular basis (for example, every 3-6 months) about whether you should continue this treatment.

• an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

• shortness of breath or pain in your chest;

• a painful, red, swollen leg;

• abnormal vaginal bleeding;

• pain, swelling, or tenderness in the abdomen;

• severe headache or vomiting, dizziness, faintness or changes in vision or speech;

• yellowing of the skin or eyes; or

• a lump in a breast.

Other, less serious side effects may be more likely to occur. Continue to take ethinyl estradiol and norethindrone and talk to your doctor if you experience

• nausea and vomiting;

• tenderness or enlargement of the breasts;

• swelling of your hands or feet;

• spotty darkening of the skin, particularly on the face;

• changes in your menstrual cycle, such as irregular bleeding or spotting;

• headache;

• depression; or

• vaginal yeast infections.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect ethinyl estradiol and norethindrone?

Before taking ethinyl estradiol and norethindrone, tell your doctor if you are taking any of the following medicines:

• rifampin (Rifadin);

• an anticoagulant (blood thinner) such as warfarin (Coumadin);

• seizure medications such as phenytoin (Dilantin), carbamazepine (Tegretol), or phenobarbital (Luminal, Solfoton);

• a thyroid medication such as levothyroxine (Synthroid, Levoxyl, Levothroid, and others);

• insulin or an oral diabetes medicine such as glipizide (Glucotrol), glyburide (Diabeta, Micronase), and others; or

• tamoxifen (Nolvadex).

You may not be able to take ethinyl estradiol and norethindrone, or you may require a dosage adjustment or special monitoring during your treatment if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with ethinyl estradiol and norethindrone. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

Where can I get more information?

• Your pharmacist has additional information about ethinyl estradiol and norethindrone written for health professionals that you may read.

• 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.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.