Ortho Tri-Cyclen contains a combination of female hormones (ethinyl estradiol and norgestimate) 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.
Ortho Tri-Cyclen is used as contraception to prevent pregnancy.
Ortho Tri-Cyclen may also be used for purposes not listed in this medication guide.
Important information
Do not use Ortho Tri-Cyclen if you are pregnant or if you have recently had a baby. You should not take Ortho Tri-Cyclen 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.
You may need to use back up birth control, such as condoms or a spermicide, when you first start using Ortho Tri-Cyclen 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 Ortho Tri-Cyclen.
Some drugs can make Ortho Tri-Cyclen 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.
Before taking this medicine
Smoking can increase your risk of blood clots, stroke, or heart attack while taking Ortho Tri-Cyclen, especially if you are older than 35 years of age. Your risk increases the more you smoke. You should not take combination birth control pills such as ethinyl estradiol and desogestrel if you smoke and are older than 35 years of age.
Ortho Tri-Cyclen 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 Ortho Tri-Cyclen.
You should not take Ortho Tri-Cyclen if you have:
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unusual vaginal bleeding that has not been checked by a doctor;
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chest pain;
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history of heart attack, stroke, or blood clot;
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uncontrolled heart valve disorder;
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untreated or uncontrolled high blood pressure;
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problems with your eyes, kidneys or circulation caused by diabetes;
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a history of hormone-related cancer such as breast or uterine cancer;
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liver cancer;
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a history of jaundice caused by pregnancy or birth control pills; or
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severe migraine headaches (with aura, numbness, weakness, or vision changes).
To make sure Ortho Tri-Cyclen are safe for you, tell your doctor if you have:
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heart disease, high blood pressure;
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high cholesterol or triglycerides;
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a history of depression;
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gallbladder disease;
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liver or kidney disease;
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diabetes;
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seizures or epilepsy;
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a history of irregular menstrual cycles; or
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a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.
The hormones in Ortho Tri-Cyclen can pass into breast milk and may harm a nursing baby. Ortho Tri-Cyclen may also slow breast milk production. Do not use if you are breast feeding a baby.
How should I take Ortho Tri-Cyclen?
Take Ortho Tri-Cyclen 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 Ortho Tri-Cyclen. 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 Ortho Tri-Cyclen for a short time. Any doctor or surgeon who treats you should know that you are using Ortho Tri-Cyclen.
While taking Ortho Tri-Cyclen, you will need to visit your doctor regularly.
Store Ortho Tri-Cyclen at room temperature away from moisture and heat.
What happens if I miss a dose?
Follow the patient instructions provided with your Ortho Tri-Cyclen. 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.
What should I avoid while taking Ortho Tri-Cyclen?
Do not smoke while taking Ortho Tri-Cyclen, especially if you are older than 35 years of age.
Ortho Tri-Cyclen 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.
Ortho Tri-Cyclen side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Ortho Tri-Cyclen: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using Ortho Tri-Cyclen and call your doctor at once if you have:
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signs of a stroke - sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
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signs of a blood clot in the lung - chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
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signs of a blood clot in your leg - pain, swelling, warmth, or redness in one or both legs;
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heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
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liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
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a change in the pattern or severity of migraine headaches;
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swelling in your hands, ankles, or feet;
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a breast lump; or
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symptoms of depression - sleep problems, weakness, tired feeling, mood changes.
Common Ortho Tri-Cyclen side effects may include:
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nausea, vomiting;
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breast tenderness;
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freckles or darkening of facial skin, loss of scalp hair;
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headache, dizziness, nervousness;
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problems with contact lenses;
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changes in weight or appetite;
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irregular menstrual bleeding or spotting;
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vaginal itching or discharge; or
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rash.
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)
What other drugs will affect Ortho Tri-Cyclen?
Some drugs can make Ortho Tri-Cyclen less effective, which may result in pregnancy. Other drugs may interact with ethinyl estradiol and desogestrel, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
