ethinyl estradiol and levonorgestrel

Generic Name: ethinyl estradiol and levonorgestrel (ETH in ill ess tra DYE ol and LEE vo nor JESS trel)
Brand Name: Alesse, Altavera, Amethyst, Aviane, Enpresse, Lessina, Levlen, Levora, Lutera, Lybrel, Nordette, Orsythia, Portia, Sronyx, Tri-Levlen, Triphasil-21, Triphasil-28, Trivora-28

What is ethinyl estradiol and levonorgestrel?

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

Ethinyl estradiol and levonorgestrel 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 levonorgestrel?

Do not use birth control pills if you are pregnant or if you have recently had a baby.

You should not take birth control pills if you have any of the following conditions: uncontrolled high blood pressure, heart disease, a blood-clotting disorder, circulation problems, diabetic problems with your eyes or kidneys, unusual vaginal bleeding, liver disease or liver cancer, severe migraine headaches, if you smoke and are over 35, or if you have ever had breast or uterine cancer, jaundice caused by birth control pills, a heart attack, a stroke, or a blood clot.

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You may need to use back up birth control, such as condoms or a spermicide, when you first start using this medication or if you miss a dose. Follow your doctor's instructions.

Missing a pill increases your risk of becoming pregnant. Carefully follow the "missed dose" instructions if you forget to take your birth control pills.

Some drugs can make birth control pills less effective in preventing pregnancy, including antibiotics, hepatitis C medications, HIV/AIDS medications, seizure medications, or barbiturate sedatives. Tell your doctor about all other medications you use.

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

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. 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 you can safely take birth control pills, tell your doctor if you have any of these other conditions:

  • 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.

How should I take ethinyl estradiol and levonorgestrel?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

You will take your first pill on the first day of your period or on the first Sunday after your period begins. You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not take one pill daily. Get your prescription refilled before you run out of pills completely.

The 28 day birth control pack contains seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Use a back-up birth control if you are sick with severe vomiting or diarrhea.

If you need surgery or medical tests 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 birth control pills.

While taking birth control pills, you will need to visit your doctor regularly.

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

What happens if I miss a dose?

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.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

What should I avoid while taking ethinyl estradiol and levonorgestrel?

Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills, especially if you are older than 35.

This medication will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Ethinyl estradiol and levonorgestrel 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 birth control pills and call your doctor at once if you have a serious side effect such as:

  • sudden numbness or weakness, especially on one side of the body;

  • sudden and severe headache, confusion, problems with vision, speech, or balance;

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

  • sudden cough, wheezing, rapid breathing, coughing up blood;

  • pain, swelling, warmth, or redness in one or both legs;

  • a change in the pattern or severity of migraine headaches;

  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • swelling in your hands, ankles, or feet;

  • a breast lump; or

  • symptoms of depression (sleep problems, weakness, tired feeling, mood changes).

Less serious side effects may include:

  • mild nausea (especially when you first start taking this medicine), vomiting, bloating, stomach cramps;

  • breast tenderness or swelling, nipple discharge;

  • freckles or darkening of facial skin, increased hair growth, loss of scalp hair;

  • changes in weight or appetite;

  • problems with contact lenses;

  • vaginal itching or discharge; or

  • changes in your menstrual periods, decreased sex drive.

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.

See also: Side effects (in more detail)

Ethinyl estradiol and levonorgestrel dosing information

Usual Adult Dose for Contraception:

Ethinyl estradiol-levonorgestrel products are packaged in 21, 28 and 91 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, except for the 91 day dosage preparation which considers the cycle to be 91 days. (The first day of menstrual bleeding is counted as day 1.) One product (marketed as Lybrel) is supplied in a 28 day package in which all the tablets contain the same active ingredients (no placebo tablets). The tablets are given continuously and gradually reduce or stop menstruation in most women. Thus there is no cycle length with this product.


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. For a 91 day package, one tablet is taken daily for 91 days and a new package begun on the following day. The manufacturer of the 91-day preparation recommends only the Sunday start regimen.

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 Abnormal Uterine Bleeding:

Ethinyl estradiol-levonorgestrel 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-levonorgestrel 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-levonorgestrel 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 Postcoital Contraception:

Ethinyl estradiol-levonorgestrel 30 mcg-150 mcg (Levlen or Nordette), 4 tablets no later than 72 hours after having unprotected sex followed by 4 more tablets exactly 12 hours after the first dose.

Ethinyl estradiol-levonorgestrel 30 mcg-125 mcg (Tri-Levlen or Triphasil), 4 tablets no later than 72 hours after having unprotected sex followed by 4 more tablets exactly 12 hours after the first dose. Note that only the phase 3 cycle of these triphasic contraceptives contain sufficient hormone to act as a postcoital contraceptive.

Ethinyl estradiol-levonorgestrel 50 mcg-250 mcg (Preven), 2 tablets no later than 72 hours after having unprotected sex followed by 2 more tablets exactly 12 hours after the first dose.

Patients should be advised to begin therapy at a time that it will make it convenient to take the second dose 12 hours later. Pretreatment with a long acting antinauseant such as meclizine will lessen the incidence of nausea.

What other drugs will affect ethinyl estradiol and levonorgestrel?

Some drugs can make birth control pills less effective, which may result in pregnancy. Before using birth control pills, tell your doctor if you are using any of the following drugs:

  • bosentan (Tracleer);

  • an antibiotic or tuberculosis medication;

  • drugs to treat hepatitis C, HIV, or AIDS;

  • phenobarbital (Solfoton) and other barbiturates;

  • St. John's wort; or

  • seizure medications.

Tell your doctor about all other medicines you use, especially:

  • dantrolene (Dantrium);

  • tizanidine (Zanaflex); or

  • tranexamic acid (Cyklokapron, Lysteda).

This list is not complete and other drugs may interact with birth control pills. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. 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 levonorgestrel.
  • 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: 10.02. Revision Date: 2012-05-02, 1:03:53 PM.

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