Ortho Tri-Cyclen Ortho Tri-Cyclen

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Ortho Tri-Cyclen

Generic Name: ethinyl estradiol and norgestimate (ETH in ill ess tra DY ol and nor JESS tim ayt)
Brand Names: Ortho Cyclen, Ortho Tri-Cyclen, Ortho Tri-Cyclen Lo

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 mucous 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 other than those listed in this medication guide.

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

Do not use this medication if you are pregnant or if you have recently had a baby. Do not use this medication 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, liver disease or liver cancer, migraine headaches, or a history of jaundice caused by 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.

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

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 (6 weeks if you are breast-feeding). Do not use this medication if you have:

  • a history of a stroke, blood clot, or circulation problems;

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

  • abnormal vaginal bleeding;

  • liver disease or liver cancer;

  • severe migraine headaches; or

  • a history of jaundice caused by birth control pills.

Before using this medication, tell your doctor if you have any of the following conditions. You may not be able to use birth control pills, or you may need a dosage adjustment or special tests during treatment.

  • high blood pressure, heart disease, congestive heart failure, angina (chest pain), or a history of heart attack;

  • high cholesterol 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.

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 norgestimate?

Take this medication exactly as it was prescribed for you. Do not take larger amounts, or take it for longer than recommended by your doctor. You will 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.

You 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 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 birth control pills.

Your doctor will need to see you on a regular basis while you are using this medication. Do not miss any appointments.

Store this medication 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 following the missed pills.

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.

If you miss three "active" pills in a row during any of the first 3 weeks, 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 one 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 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?

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of an overdose may include nausea, vomiting, and vaginal bleeding.

What should I avoid while taking ethinyl estradiol and norgestimate?

Do 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.

Ethinyl estradiol and norgestimate side effects

Get 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. Stop using this medication and call your doctor at once if you have any of these serious side effects:

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

  • sudden headache, confusion, pain behind the eyes, problems with vision, speech, or balance;

  • 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;

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

  • swelling in your hands, ankles, or feet; or

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

Continue using the medication and talk to your doctor if you have any of these less serious side effects:

  • mild nausea, vomiting, bloating, stomach cramps;

  • breast pain, 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;

  • vaginal itching or discharge;

  • changes in your menstrual periods; or

  • headache, nervousness, dizziness, tired feeling.

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.

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:

  • phenylbutazone (Azolid, Butazolidin);

  • St. John"s wort;

  • antibiotics such as amoxicillin (Augmentin), ampicillin (Omnipen), doxycycline (Doryx, Vibramycin), griseofulvin (Grisactin, Grifulvin V, Fulvicin PG), minocycline (Minocin), penicillin (Veetids, Pen Vee K, Bicillin), rifampin (Rifadin), rifabutin (Mycobutin), tetracycline (Sumycin, Achromycin, Robitet), and others;

  • seizure medicines such as phenytoin (Dilantin), carbamazepine (Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), topiramate (Topamax), or primidone (Mysoline);

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

  • HIV medicines such as amprenavir (Agenerase), atazanavir (Reyataz), tipranavir (Aptivus), indinavir (Crixivan), saquinavir (Invirase), lopinavir/ritonavir (Kaletra), fosamprenavir (Lexiva), ritonavir (Norvir), or nelfinavir (Viracept).

There may be other drugs not listed that can affect birth control pills. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist has additional information about ethinyl estradiol and norgestimate written for health professionals that you may read.

What does my medication look like?

Ethinyl estradiol and norgestimate is available with a prescription under the brand names Ortho Cyclen and Ortho Tri-Cyclen. Ohter brands and generic forms 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.
  • 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 1996-2006 Cerner Multum, Inc. Version: 7.01. Revision Date: 7/26/06 2:19:57 PM.



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