Ethinyl estradiol and norethindrone HRT

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 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.

The combination of ethinyl estradiol and norethindrone is 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 other purposes not listed in this medication guide.

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

This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. Do not use this medication 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.

Before taking ethinyl estradiol and norethindrone, tell your doctor if you have high blood pressure or heart disease, high cholesterol, gallbladder disease, diabetes, asthma, seizures, liver disease, a thyroid disorder, high levels of calcium in your blood, migraine headaches or a history of depression, fibroid tumors in your uterus, or a history of breast cancer or an abnormal mammogram.

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

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using ethinyl estradiol and norethindrone.

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

This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. Do not use this medication 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 blood clot or circulation problems;

  • 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.

Before using this medication, tell your doctor if you have any of the following conditions.

  • high blood pressure or heart disease;

  • high cholesterol, gallbladder disease, or diabetes;

  • asthma;

  • epilepsy or other seizure disorder;

  • liver disease;

  • a thyroid disorder;

  • high levels of calcium in your blood;

  • migraine headaches or a history of depression;

  • fibroid tumors in your uterus; or

  • a history of breast cancer or an abnormal mammogram.

If you have any of these conditions, you may need a dose adjustment or special tests to safely use this medication.

The hormones in this medication can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby.

How should I take ethinyl estradiol and norethindrone?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label.

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

If you need to have any type of medical tests or surgery, or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using hormones.

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

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using ethinyl estradiol and norethindrone.

Store this medication at room temperature away from moisture and heat.

See also: Ethinyl estradiol and norethindrone dosage in more detail

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?

An overdose of ethinyl estradiol and norethindrone is unlikely to threaten life. Call an emergency room or poison control center for advice.

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?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using this medication.

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

My ethinyl estradiol and norethindrone side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:
  • sudden numbness or weakness, especially on one side of the body;

  • sudden headache, confusion, pain behind the eyes, problems with vision, speech, or balance;

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling; or

  • gallbladder problems (pain in your upper right stomach area with nausea and vomiting);

  • jaundice (yellowing of the skin or eyes); or

  • a breast lump.

Less serious side effects may include:

  • mild nausea, vomiting, stomach pain;

  • breast tenderness or swelling;

  • freckles or darkening of facial skin;

  • increased hair growth, loss of scalp hair;

  • changes in weight or appetite;

  • problems with contact lenses;

  • runny nose;

  • vaginal itching or discharge;

  • changes in your menstrual periods, decreased sex drive; or

  • headache, dizziness, sleep problems.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Ethinyl estradiol and norethindrone Dosing Information

Usual Adult Dose for Contraception:

Ethinyl estradiol-norethindrone products are packaged in 21 or 28 day dosage preparations. The last seven tablets in 28 day dosage preparations are hormonally inert.Regardless of the number of tablets in a package, the cycle length for oral contraceptives is generally considered to be 28 days. (The first day of menstrual bleeding is counted as day 1.)Initiation of Oral Contraceptive TherapyThis product can be administered in two ways:When initiating a Sunday start regimen, the first tablet may be taken on the first Sunday after menstruation begins. If a period begins on a Sunday, the first tablet may be taken on that day. When initiating a Sunday start regimen, another contraceptive method should be used until after the first 7 consecutive days of administration. For a 28 day package, one tablet is taken daily for 28 days and a new package begun on the following day. For a 21 day package, one tablet is taken daily for 21 days followed by 7 days with no medication. A new package of contraceptives is begun on the following day.When initiating a Day 1 start regimen, the first tablet is taken on the first day on menstruation. Such initiation may increase the risk of spotting and breakthrough bleeding but decrease the risk of early ovulation and pregnancy. For a 28 day package, one tablet is taken daily for 28 days and a new package begun on the following day. For a 21 day package, one tablet is taken daily for 21 days followed by 7 days with no medication. A new package of contraceptives is begun on the following day.Many clinicians recommend that additional contraceptive methods be used during the first cycle of hormonal therapy in order to reduce the risk of unintended pregnancy.Missed Doses:If a woman misses one dose of active tablets, the missed dose should be taken as soon as it is remembered and the normal schedule should be resumed. If a woman misses two doses in week 1 or week 2 of the cycle, 2 tablets may be taken as soon as they are remembered and 2 tablets taken the next day and the normal schedule may be resumed. (Additional contraceptive methods should be used for 7 days.)If a woman misses two doses in week 3 or three doses at any time in the cycle, Day 1 starters should discard the current package and begin a new package that same day. Sunday starters should take 1 tablet daily from the current package until Sunday, when the current package is discarded and a new package begun. (Additional contraceptive methods should be used until the woman has taken at least 7 days of hormonal therapy from the new package.)

Usual Adult Dose for Postmenopausal Symptoms:

ethinyl estradiol-norethindrone 5 mcg/1 mg and 2.5 mcg-0.5 mg (Femhrt):1 tablet orally once a day.When used solely for the prevention of postmenopausal osteoporosis, approved non-estrogen treatments should be carefully considered, and estrogens and combined estrogen-progestin products should only be considered for women with significant risk of osteoporosis that outweighs the risk of the drug. When used solely for the treatment of vulvar and vaginal atrophy, topical vaginal products should be considered. The U.S. Preventive Services Task Force (USPSTF) recommends against the routine use of estrogen and progestin for the prevention of chronic conditions in postmenopausal women

Usual Adult Dose for Prevention of Osteoporosis:

ethinyl estradiol-norethindrone 5 mcg/1 mg and 2.5 mcg-0.5 mg (Femhrt):1 tablet orally once a day.When used solely for the prevention of postmenopausal osteoporosis, approved non-estrogen treatments should be carefully considered, and estrogens and combined estrogen-progestin products should only be considered for women with significant risk of osteoporosis that outweighs the risk of the drug. When used solely for the treatment of vulvar and vaginal atrophy, topical vaginal products should be considered. The U.S. Preventive Services Task Force (USPSTF) recommends against the routine use of estrogen and progestin for the prevention of chronic conditions in postmenopausal women

Usual Adult Dose for Abnormal Uterine Bleeding:

Ethinyl estradiol-norethindrone products are packaged in 21 or 28 day dosage preparations. The last seven tablets in 28 day dosage preparations are hormonally inert.Regardless of the number of tablets in a package, the cycle length for oral contraceptives is generally considered to be 28 days. (The first day of menstrual bleeding is counted as day 1.)This product can be administered in two ways:When initiating a Sunday start regimen, the first tablet may be taken on the first Sunday after menstruation begins. If a period begins on a Sunday, the first tablet may be taken on that day. When initiating a Sunday start regimen, another contraceptive method should be used until after the first 7 consecutive days of administration. For a 28 day package, one tablet is taken daily for 28 days and a new package begun on the following day. For a 21 day package, one tablet is taken daily for 21 days followed by 7 days with no medication. A new package of contraceptives is begun on the following day.When initiating a Day 1 start regimen, the first tablet is taken on the first day on menstruation. Such initiation may increase the risk of spotting and breakthrough bleeding but decrease the risk of early ovulation and pregnancy. For a 28 day package, one tablet is taken daily for 28 days and a new package begun on the following day. For a 21 day package, one tablet is taken daily for 21 days followed by 7 days with no medication. A new package of contraceptives is begun on the following day.Missed Doses:If a woman misses one dose of active tablets, the missed dose should be taken as soon as it is remembered and the normal schedule should be resumed. If a woman misses two doses in week 1 or week 2 of the cycle, 2 tablets may be taken as soon as they are remembered and 2 tablets taken the next day and the normal schedule may be resumed.If a woman misses two doses in week 3 or three doses at any time in the cycle, Day 1 starters should discard the current package and begin a new package that same day. Sunday starters should take 1 tablet daily from the current package until Sunday, when the current package is discarded and a new package begun.

Usual Adult Dose for Acne:

Ethinyl estradiol-norethindrone products are packaged in 21 or 28 day dosage preparations. The last seven tablets in 28 day dosage preparations are hormonally inert.Regardless of the number of tablets in a package, the cycle length for oral contraceptives is generally considered to be 28 days. (The first day of menstrual bleeding is counted as day 1.)This product can be administered in two ways:When initiating a Sunday start regimen, the first tablet may be taken on the first Sunday after menstruation begins. If a period begins on a Sunday, the first tablet may be taken on that day. When initiating a Sunday start regimen, another contraceptive method should be used until after the first 7 consecutive days of administration. For a 28 day package, one tablet is taken daily for 28 days and a new package begun on the following day. For a 21 day package, one tablet is taken daily for 21 days followed by 7 days with no medication. A new package of contraceptives is begun on the following day.When initiating a Day 1 start regimen, the first tablet is taken on the first day on menstruation. Such initiation may increase the risk of spotting and breakthrough bleeding but decrease the risk of early ovulation and pregnancy. For a 28 day package, one tablet is taken daily for 28 days and a new package begun on the following day. For a 21 day package, one tablet is taken daily for 21 days followed by 7 days with no medication. A new package of contraceptives is begun on the following day.Missed Doses:If a woman misses one dose of active tablets, the missed dose should be taken as soon as it is remembered and the normal schedule should be resumed. If a woman misses two doses in week 1 or week 2 of the cycle, 2 tablets may be taken as soon as they are remembered and 2 tablets taken the next day and the normal schedule may be resumed.If a woman misses two doses in week 3 or three doses at any time in the cycle, Day 1 starters should discard the current package and begin a new package that same day. Sunday starters should take 1 tablet daily from the current package until Sunday, when the current package is discarded and a new package begun.

Usual Adult Dose for Endometriosis:

Ethinyl estradiol-norethindrone products are packaged in 21 or 28 day dosage preparations. The last seven tablets in 28 day dosage preparations are hormonally inert.Regardless of the number of tablets in a package, the cycle length for oral contraceptives is generally considered to be 28 days. (The first day of menstrual bleeding is counted as day 1.)This product can be administered in two ways:When initiating a Sunday start regimen, the first tablet may be taken on the first Sunday after menstruation begins. If a period begins on a Sunday, the first tablet may be taken on that day. When initiating a Sunday start regimen, another contraceptive method should be used until after the first 7 consecutive days of administration. For a 28 day package, one tablet is taken daily for 28 days and a new package begun on the following day. For a 21 day package, one tablet is taken daily for 21 days followed by 7 days with no medication. A new package of contraceptives is begun on the following day.When initiating a Day 1 start regimen, the first tablet is taken on the first day on menstruation. Such initiation may increase the risk of spotting and breakthrough bleeding but decrease the risk of early ovulation and pregnancy. For a 28 day package, one tablet is taken daily for 28 days and a new package begun on the following day. For a 21 day package, one tablet is taken daily for 21 days followed by 7 days with no medication. A new package of contraceptives is begun on the following day.Missed Doses:If a woman misses one dose of active tablets, the missed dose should be taken as soon as it is remembered and the normal schedule should be resumed. If a woman misses two doses in week 1 or week 2 of the cycle, 2 tablets may be taken as soon as they are remembered and 2 tablets taken the next day and the normal schedule may be resumed.If a woman misses two doses in week 3 or three doses at any time in the cycle, Day 1 starters should discard the current package and begin a new package that same day. Sunday starters should take 1 tablet daily from the current package until Sunday, when the current package is discarded and a new package begun.

Usual Adult Dose for Gonadotropin Inhibition:

Ethinyl estradiol-norethindrone products are packaged in 21 or 28 day dosage preparations. The last seven tablets in 28 day dosage preparations are hormonally inert.Regardless of the number of tablets in a package, the cycle length for oral contraceptives is generally considered to be 28 days. (The first day of menstrual bleeding is counted as day 1.)This product can be administered in two ways:When initiating a Sunday start regimen, the first tablet may be taken on the first Sunday after menstruation begins. If a period begins on a Sunday, the first tablet may be taken on that day. When initiating a Sunday start regimen, another contraceptive method should be used until after the first 7 consecutive days of administration. For a 28 day package, one tablet is taken daily for 28 days and a new package begun on the following day. For a 21 day package, one tablet is taken daily for 21 days followed by 7 days with no medication. A new package of contraceptives is begun on the following day.When initiating a Day 1 start regimen, the first tablet is taken on the first day on menstruation. Such initiation may increase the risk of spotting and breakthrough bleeding but decrease the risk of early ovulation and pregnancy. For a 28 day package, one tablet is taken daily for 28 days and a new package begun on the following day. For a 21 day package, one tablet is taken daily for 21 days followed by 7 days with no medication. A new package of contraceptives is begun on the following day.Missed Doses:If a woman misses one dose of active tablets, the missed dose should be taken as soon as it is remembered and the normal schedule should be resumed. If a woman misses two doses in week 1 or week 2 of the cycle, 2 tablets may be taken as soon as they are remembered and 2 tablets taken the next day and the normal schedule may be resumed.If a woman misses two doses in week 3 or three doses at any time in the cycle, Day 1 starters should discard the current package and begin a new package that same day. Sunday starters should take 1 tablet daily from the current package until Sunday, when the current package is discarded and a new package begun.

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:

  • acetaminophen (Tylenol);

  • cyclosporine (Neoral, Gengraf, Sandimmune);

  • prednisolone (Orapred);

  • theophylline (Respbid, Theo-Dur);

  • St. John's wort;

  • an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., E-Mycin, Ery-Tab, Erythrocin), itraconazole (Sporanox), or ketoconazole (Nizoral);

  • seizure medication such as carbamazepine (Carbatrol, Tegretol) or phenobarbital (Solfoton);

  • rifampin (Rifadin, Rifamate, Rimactane); or

  • HIV or AIDS medication such as ritonavir (Norvir, Kaletra).

This list is not complete and there may be other drugs that can interact with ethinyl estradiol and norethindrone. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

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.
  • 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.
Copyright 1996-2006 Cerner Multum, Inc. Version: 3.04. Revision Date: 4/12/2009 4:40:30 PM.