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ethinyl estradiol and norethindrone

Generic Name: ethinyl estradiol and norethindrone (HRT) (ETH in ill ess tra DYE ole/ nor ETH in drone)
Brand Name: femhrt, femhrt 0.5 mg/2.5 mcg, Jinteli

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 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.

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.

Slideshow: 2014 Update: First Time Brand-to-Generic Switches

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.

You should not use ethinyl estradiol and norethindrone 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 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.

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

  • 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.

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?

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 your 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.

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

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.

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.

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.

Ethinyl estradiol and norethindrone side effects

Get emergency medical help if you have any of these 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:

  • a breast lump;

  • 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;

  • symptoms of a heart attack--chest pain or heavy feeling, pain spreading to the jaw or shoulder, nausea, sweating, general ill feeling; or

  • liver or gallbladder problems--pain in your upper right stomach area with nausea and vomiting, jaundice (yellowing of the skin or eyes).

Common 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.

See also: Side effects (in more detail)

Ethinyl estradiol and norethindrone dosing information

Usual Adult Dose for Acne:

Contraception:
Ethinyl estradiol-norethindrone products are packaged in 21 or 28 day dosage preparations.
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 Therapy
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.

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.)

Acne:
-Use Estrostep Fe (R) for the treatment of acne only if the patient desires an oral contraceptive for birth control and plans to stay on it for at least 6 months.
-The timing and initiation of dosing with Estrostep FE (R) should follow the guidelines for use as an oral contraceptive.

Usual Adult Dose for Contraception:

Contraception:
Ethinyl estradiol-norethindrone products are packaged in 21 or 28 day dosage preparations.
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 Therapy
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.

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.)

Acne:
-Use Estrostep Fe (R) for the treatment of acne only if the patient desires an oral contraceptive for birth control and plans to stay on it for at least 6 months.
-The timing and initiation of dosing with Estrostep FE (R) should follow the guidelines for use as an oral contraceptive.

Usual Adult Dose for Postmenopausal Symptoms:

ethinyl estradiol-norethindrone 5 mcg/1 mg and 2.5 mcg-0.5 mg (Femhrt):

The initial dosage of ethinyl estradiol-norethindrone recommended in patients with an intact uterus for the prevention of osteoporosis is one tablet (5 mcg/1 mg) orally daily.
Comments: 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

The initial dosage of ethinyl estradiol-norethindrone recommended in patients with an intact uterus for moderate to severe vasomotor symptoms associated with menopause is one tablet (2.5 mcg/ 0.5 mg or 5 mcg/1 mg) orally daily.
Comment: Patients should be reevaluated at 3 to 6 month intervals to determine if treatment is necessary.

Usual Adult Dose for Prevention of Osteoporosis:

ethinyl estradiol-norethindrone 5 mcg/1 mg and 2.5 mcg-0.5 mg (Femhrt):

The initial dosage of ethinyl estradiol-norethindrone recommended in patients with an intact uterus for the prevention of osteoporosis is one tablet (5 mcg/1 mg) orally daily.
Comments: 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

The initial dosage of ethinyl estradiol-norethindrone recommended in patients with an intact uterus for moderate to severe vasomotor symptoms associated with menopause is one tablet (2.5 mcg/ 0.5 mg or 5 mcg/1 mg) orally daily.
Comment: Patients should be reevaluated at 3 to 6 month intervals to determine if treatment is necessary.

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.
  • Disclaimer: 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 1996-2012 Cerner Multum, Inc. Version: 4.03. Revision Date: 2013-10-14, 12:37:20 PM.

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