ethinyl estradiol and norgestimate

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ethinyl estradiol and norgestimate

Pronunciation:ETH in ill ess tra DYE ol and nor JESS ti mate
Brand:Mononessa, Ortho Tri-Cyclen, Ortho Tri-Cyclen Lo, Ortho-Cyclen, Previfem, Sprintec, Tri-Lo-Sprintec, Tri-Previfem, Tri-Sprintec, TriNessa

Mononessa

round, blue, imprinted with 526, WATSON

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Previfem

round, imprinted with 748, LOGO TRIANGLE

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TriNessa

round

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Tri-Previfem

round, imprinted with 746, 747, 748, or 749, LOGO

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

nopregThis medication can harm an unborn baby or cause birth defects. Do not use birth control pills if you are pregnant or if you have recently had a baby.
donotYou should not take birth control pills if you have coronary artery disease, severe heart valve disorder, uncontrolled high blood pressure, a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, unusual vaginal bleeding, liver disease or liver cancer, severe migraine headaches, or a history of jaundice caused by pregnancy or birth control pills.

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.

smokingTaking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all the prescription and over-the-counter medications you use, including vitamins, minerals and herbal products. Do not start using a new medication without telling your doctor.

What is ethinyl estradiol and norgestimate?

Ethinyl estradiol and norgestimate contains a combination of 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 norgestimate is used as contraception to prevent pregnancy. It is also used to treat severe acne.

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

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

nopregThis 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 (6 weeks if you are breast-feeding).
donotYou should not take birth control pills if you have:
  • coronary artery disease, a severe or uncontrolled heart valve disorder, untreated or uncontrolled high blood pressure;
  • a history of a stroke, blood clot, or circulation problems;
  • a 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; or
  • a history of jaundice caused by pregnancy or birth control pills.

To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:

  • high blood pressure, heart disease, congestive heart failure, angina (chest pain), or a history of heart attack;
  • high cholesterol or triglycerides, or if you are overweight;
  • a history of depression;
  • gallbladder disease;
  • diabetes;
  • seizures or epilepsy;
  • a history of irregular menstrual cycles; or
  • a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.
nobrfeedThe 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 norgestimate?

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. Take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).

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.

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.

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

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 use this medication regularly. Get your prescription refilled before you run out of pills completely.

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.

Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

rtStore at room temperature away from moisture and heat.

What happens if I miss a dose?

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 one or two, 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.

If you miss two "active" pills in a row in week three, or if you miss three pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new one 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 one that day.

donotIf 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 any reminder pills, throw them away and keep taking one 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?

emtSeek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include severe nausea or vaginal bleeding.

What should I avoid while taking ethinyl estradiol and norgestimate?

smokingDo not smoke while using birth control pills, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

Birth control pills 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.

What are the possible side effects of ethinyl estradiol and norgestimate?

emtGet 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.
donotStop taking this medicine 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 severe headache, confusion, problems with vision, speech, or balance;
  • sudden cough, wheezing, rapid breathing, coughing up blood;
  • pain, swelling, warmth, or redness in one or both legs;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • a change in the pattern or severity of migraine headaches;
  • pain in your upper stomach, jaundice (yellowing of the skin or eyes);
  • a lump in your breast;
  • swelling in your hands, ankles, or feet; or
  • symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects may include:

  • mild nausea or vomiting, appetite or weight changes;
  • breast swelling or tenderness;
  • headache, nervousness, dizziness;
  • problems with contact lenses;
  • freckles or darkening of facial skin, loss of scalp hair; or
  • vaginal itching or discharge.

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.

What other drugs will affect ethinyl estradiol and norgestimate?

Some drugs can make ethinyl estradiol and norgestimate less effective, which may result in pregnancy. Before using ethinyl estradiol and norgestimate, tell your doctor if you are using any of the following drugs:

  • bosentan (Tracleer);
  • St. John's wort;
  • an antibiotic;
  • HIV or AIDS medications;
  • phenobarbital (Solfoton) and other barbiturates; or
  • seizure medication.

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 norgestimate.


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.

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