Ethinyl estradiol and norethindrone birth control

Ethinyl estradiol and norethindrone is a combination drug that contains female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ethinyl estradiol and norethindrone is used as contraception to prevent pregnancy.

There are many brands and forms of ethinyl estradiol and norethindrone available. Not all brands are listed on this leaflet, and not all brands are used for contraception.

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

Taking birth control pills can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, or if you are overweight. Your risk of stroke or blood clot is highest during your first year of taking birth control pills. Your risk is also high when you restart birth control pills after not taking them for 4 weeks or longer.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. Your risk increases the older you are and the more you smoke. You should not take combination birth control pills if you smoke and are over 35 years old.

Do not use if you are pregnant or think you might be pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills.

You should not take birth control pills if you have:

• untreated or uncontrolled high blood pressure;

• heart disease (coronary artery disease, uncontrolled heart valve disorder, history of heart attack, stroke, or blood clot);

• a blood-clotting disorder or circulation problems;

• problems with your eyes, kidneys or circulation caused by diabetes;

• a history of hormone-related cancer such as breast or uterine cancer;

• unusual vaginal bleeding that has not been checked by a doctor;

• liver disease or liver cancer;

• severe migraine headaches (with aura, numbness, weakness, or vision changes), especially if you are older than 35;

• a history of jaundice caused by pregnancy or birth control pills; or

• if you smoke and are over 35 years old.

To make sure birth control pills are safe for you, tell your doctor if you have:

• high blood pressure, varicose veins;

• high cholesterol or triglycerides, or if you are overweight;

• a history of depression;

• underactive thyroid;

• gallbladder disease;

• diabetes;

• seizures or epilepsy;

• a history of irregular menstrual cycles;

• tuberculosis; or

• a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.

The hormones in birth control pills 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.

Follow the patient instructions provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions. Missing a pill increases your risk of becoming pregnant.

If you miss one active pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

If you miss two active pills in a row in Week 1 or 2, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss two active pills in a row in Week 3, throw out the rest of the pack and start a new pack the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack that day.

If you miss three active pills in a row in Week 1, 2, or 3, throw out the rest of the pack and start a new pack on the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack that day.

If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.

If you miss a reminder pill, throw it away and keep taking one reminder pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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.