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ethinyl estradiol and levonorgestrel

Generic Name: ethinyl estradiol and levonorgestrel (EC) (ETH ih nill ess tra DYE all and lee voe nor JESS trell)
Brand Name: Preven EC, Seasonique

What is ethinyl estradiol and levonorgestrel (EC)?

Ethinyl estradiol and levonorgestrel are forms of estrogen and progesterone, which are both female hormones involved in conception.

Ethinyl estradiol and levonorgestrel are used together in this product as an emergency contraceptive (EC) to prevent pregnancy after contraceptive failure or unprotected intercourse. Ethinyl estradiol and levonorgestrel prevent ovulation (the release of an egg from an ovary), disrupt fertilization (joining of the egg and sperm), and inhibit implantation (attachment of a fertilized egg to the uterus).

Ethinyl estradiol and levonorgestrel (EC) 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 levonorgestrel (EC)?

The first dose of ethinyl estradiol and levonorgestrel (EC) must be taken as soon as possible and within 72 hours of having unprotected sex, and the second dose 12 hours following the first, to be effective.

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Ethinyl estradiol and levonorgestrel (EC) does not protect you from sexually transmitted diseases--including HIV and AIDS.

What should I discuss with my healthcare provider before using ethinyl estradiol and levonorgestrel (EC)?

Before taking ethinyl estradiol and levonorgestrel (EC), tell your doctor if you

  • have high blood pressure, angina, or heart disease;

  • have had a stroke;

  • have a bleeding or blood-clotting disorder;

  • have breast, uterine, or another hormone-related cancer;

  • have liver disease;

  • have undiagnosed, abnormal vaginal bleeding;

  • have migraines or severe, recurrent headaches;

  • have diabetes; or

  • smoke.

You may not be able to take ethinyl estradiol and levonorgestrel (EC), or you may require special monitoring during treatment if you have any of the conditions listed above.

Ethinyl estradiol and levonorgestrel (EC) should not be used at any time during pregnancy except in an attempt to prevent pregnancy within 72 hours following unprotected sexual intercourse.

The hormones in ethinyl estradiol and levonorgestrel (EC) pass into breast milk and may affect milk production. Do not take ethinyl estradiol and levonorgestrel (EC) without first talking to your doctor if you are breast-feeding a baby.

How should I take ethinyl estradiol and levonorgestrel (EC)?

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

Read the entire patient information book before using the ethinyl estradiol and levonorgestrel emergency contraceptive kit.

Use the pregnancy test provided to determine if you are already pregnant from sex earlier in the month or in a previous month. Ethinyl estradiol and levonorgestrel (EC) will not be effective if you are already pregnant.

To use the pregnancy test:

  • Remove the test stick from the foil wrapper and take off the protective cap covering the absorbent tip. Hold the test stick with the absorbent tip pointing downward and place the tip into your urine stream for at least five seconds so that the entire tip is wet.

  • Do not urinate on the windows of the test stick.

  • Remove the test stick from your urine stream and lay the test stick on a flat surface with the windows facing up. Wait at least three minutes after exposure to your urine, but not more than 20 minutes, for the results. The test is ready to be read when you see a pink/purple line in the square control window. You must see a line in the square control window in order for the test to be valid. Contact your doctor if you do not see the pink/purple line in the square control window.

If a pink/purple line appears in the round window, you are pregnant. Do not take ethinyl estradiol and levonorgestrel (EC), it will not work. Contact your doctor immediately. The test may show that you are pregnant when you are not if you have had a miscarriage or have given birth within the past 8 weeks. Ask your doctor for help in interpreting the test if you have recently been pregnant.

If no pink/purple line appears in the round window, the test is negative and you are not pregnant. Take two ethinyl estradiol and levonorgestrel (EC) tablets as soon as possible and within 72 hours of having unprotected sex. Take the second dose of two tablets 12 hours after the first dose.

The first dose of ethinyl estradiol and levonorgestrel (EC) must be taken as soon as possible and within 72 hours of having unprotected sex, and the second dose 12 hours following the first, to be effective.

If you vomit within one hour of taking either dose of ethinyl estradiol and levonorgestrel (EC), contact your doctor.

Schedule a follow-up visit with your doctor for three weeks after taking ethinyl estradiol and levonorgestrel (EC).

Contact your doctor as soon as possible if you miss your period following the use of ethinyl estradiol and levonorgestrel (EC).

Ethinyl estradiol and levonorgestrel (EC) is not intended for use as ongoing pregnancy protection and should not be used as a routine form of contraception.

Store ethinyl estradiol and levonorgestrel (EC) at room temperature away from moisture and heat.

What happens if I miss a dose?

Contact your doctor if you miss a dose of ethinyl estradiol and levonorgestrel (EC). Missing a dose of ethinyl estradiol and levonorgestrel (EC) increases the risk of becoming pregnant. It is very important to take the two doses of pills 12 hours apart.

What happens if I overdose?

Death or serious side effects are not likely to occur from an overdose of ethinyl estradiol and levonorgestrel (EC). Consult your doctor, an emergency room, or a poison control center for advice.

Symptoms of an overdose of ethinyl estradiol and levonorgestrel (EC) include nausea, vomiting, and menstrual bleeding.

What should I avoid while taking ethinyl estradiol and levonorgestrel (EC)?

Ethinyl estradiol and levonorgestrel (EC) does not protect you from sexually transmitted diseases--including HIV and AIDS.

Avoid smoking. Smoking increases your risk of developing a heart attack, stroke, or blood clot while taking ethinyl estradiol and levonorgestrel (EC).

Ethinyl estradiol and levonorgestrel (EC) side effects

If you experience any of the following serious side effects, stop taking ethinyl estradiol and levonorgestrel (EC) and seek emergency medical attention:

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

  • sudden shortness of breath, sudden pain or heaviness in the chest, or coughing up blood (possible heart attack or blood clot in the lung);

  • pain, redness, swelling, or numbness of an arm or leg (possible blood clot in an arm or leg);

  • severe headache, sudden difficulty seeing or speaking, dizziness, weakness, numbness, or fainting;

  • severe pain or tenderness in the stomach area; or

  • liver damage (yellowing of the skin or eyes, nausea, abdominal pain or discomfort, unusual bleeding or bruising, severe fatigue).

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

  • headache or mild dizziness;

  • nausea or vomiting;

  • changes in menstrual bleeding (spotting, earlier or later menstrual period, heavier or lighter menstrual bleeding, longer or shorter menstrual period); or

  • breast tenderness.

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.

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 (EC)?

Some drugs may decrease the effectiveness of ethinyl estradiol and levonorgestrel (EC), which may result in pregnancy. Before taking ethinyl estradiol and levonorgestrel (EC), talk to your doctor if you are taking any of the following medicines:

  • a penicillin antibiotic such as amoxicillin (Amoxil, Trimox, Augmentin, others), penicillin (Veetids, Pen Vee K, Bicillin, Permapen, others), ampicillin (Principen, Omnipen, Totacillin, others), bacampicillin (Spectrobid), carbenicillin (Geocillin), cloxacillin (Cloxapen, Tegopen), dicloxacillin (Dynapen, Dycill, others), nafcillin (Unipen, others), or oxacillin (Bactocill, others);

  • a tetracycline antibiotic such as demeclocycline (Declomycin), doxycycline (Doryx, Doxy, Vibramycin, Vibra-Tabs, others), minocycline (Minocin), or tetracycline (Sumycin, Achromycin, Robitet, Panmycin, others);

  • a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton);

  • a seizure or pain medicine such as phenytoin (Dilantin), primidone (Mysoline), ethosuximide (Zarontin), carbamazepine (Tegretol), and others; or

  • rifampin (Rifadin).

You may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with ethinyl estradiol and levonorgestrel (EC). Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

Where can I get more information?

  • Your pharmacist has additional information about ethinyl estradiol and levonorgestrel (EC) written for health professionals that you may read.

What does my medication look like?

Ethinyl estradiol and levonorgestrel (EC) is available with a prescription under the brand name Preven Emergency Contraceptive Kit (or Preven EC). Other brand name or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

  • 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: 2.03. Revision Date: 6/28/06 12:10:38 PM.

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