Drug Uses

Ortho Tri-Cyclen is an estrogen and progestin combination used to prevent pregnancy. It may also be used to regulate the menstrual cycle, treat symptoms of menopause, or treat other conditions as determined by your doctor.

How Taken

THE RIGHT WAY TO TAKE THE PILL IS TO TAKE ONE PILL EVERY DAY AT THE SAME TIME. If you miss pills you could get pregnant. This includes starting the pack late. The more pills you miss, the more likely you are to get pregnant. MANY WOMEN HAVE SPOTTING OR LIGHT BLEEDING, OR MAY FEEL SICK TO THEIR STOMACH DURING THE FIRST 1-3 PACKS OF PILLS. If you feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If it doesn't go away, check with your health care professional. MISSING PILLS CAN ALSO CAUSE SPOTTING OR LIGHT BLEEDING, even when you make up these missed pills. On the days you take 2 pills to make up for missed pills, you could also feel a little sick to your stomach. IF YOU HAVE VOMITING OR DIARRHEA, or IF YOU TAKE SOME MEDICINES, including some antibiotics, your pills may not work as well. Use a back-up method (such as condoms or spermicides) until you check with your health care professional IF YOU HAVE TROUBLE REMEMBERING TO TAKE THE PILL, talk to your health care professional about how to make pill-taking easier or about using another method of birth control. IF YOU HAVE ANY QUESTIONS OR ARE UNSURE ABOUT THE INFORMATION IN THIS LEAFLET, call your health care professional.

Warnings/Precautions

Smoking cigarettes while using Ortho Tri-Cyclen may increase your risk of stroke, heart attack, blood clots, high blood pressure, or other diseases of the heart and blood vessels. If you have vomiting or diarrhea for any reason, your medicine may not work as well. Taking certain antibiotics or anticonvulsants while you are using Ortho Tri-Cyclen may decrease the effectiveness of Ortho Tri-Cyclen. To prevent pregnancy, use an additional form of birth control until your next period. If you have any questions, contact your doctor, nurse, or pharmacist. Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Ortho Tri-Cyclen. If you wear contact lenses and you develop problems with them, contact your doctor. Before you begin taking any new medicine, either prescription or over-the-counter, check with your doctor or pharmacist. Ortho Tri-Cyclen may cause dark skin patches on your face. Exposure to the sun may make these patches darker. If patches develop, use a sunscreen or protective clothing when exposed to the sun, sunlamps, or tanning booths. Use of Ortho Tri-Cyclen will not prevent the spread of sexually transmitted diseases (STDs). Do not use Ortho Tri-Cyclen if you are pregnant. If you suspect that you could be pregnant, contact your doctor immediately. Ortho Tri-Cyclen is excreted in breast milk. If you are or will be breast-feeding while you are using Ortho Tri-Cyclen, check with your doctor or pharmacist to discuss the risks to your baby.

Missed Dose

If you miss one dose, take the dose as soon as you remember or take two pills at the time of your next regularly scheduled dose. There is little likelihood that ovulation will occur. You may, however, want to use a second method of birth control such as a condom or a spermicidal cream, jelly, or foam for at least 7 consecutive days following the missed tablet to ensure protection from pregnancy. If you miss two tablets in a row, take the two missed tablets as soon as you remember or with your next regularly scheduled dose (three total). Or, you may take two tablets each for the next two regularly scheduled doses (one missed tablet plus one regularly scheduled tablet for 2 days in a row). Chances are much greater that you may ovulate so you must use another form of birth control for at least 7 days following the missed tablets. It is even better to use a second method of birth control until your next period. If you miss three tablets in a row, throw away the package and start a new package on the 7th day after the last day you took a pill. Use another method of birth control until you have taken a pill for 7 days in a row. Your period should occur during the 7 days without pills. If it doesn't, have a pregnancy test before beginning a new package of pills.

Possible Side Effects

Side effects may go away during treatment, include nausea, vomiting, bleeding between menstrual periods, breast tenderness, or weight change. If they continue or are bothersome, check with your doctor. Check with your doctor as soon as possible if you experience persistent or recurrent abnormal vaginal bleeding, a missed menstrual period, dizziness or fainting, swelling of fingers or ankles, headache, or difficulty wearing contact lenses. Contact your doctor immediately if you experience sharp or crushing chest pain, sudden shortness of breath, sudden severe headache or leg pain, yellow skin or eyes, changes in vision, numbness of an arm or leg, or severe stomach pain. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist.

Storage

Store at room temperature away from light and moisture. Keep this and all medications out of the reach of children.

Overdose

Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. Over dosage may cause nausea and withdrawal bleeding may occur in females.

More Information

Your health care professional will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and the health care professional believes that it is a good medical practice to postpone it. You should be reexamined at least once a year. Be sure to inform your health care professional if there is a family history of any of the conditions listed previously in this leaflet. Be sure to keep all appointments with your health care professional, because this is a time to determine if there are early signs of side effects of oral contraceptive use. Do not use the drug for any condition other than the one for which it was prescribed. This drug has been prescribed specifically for you; do not give it to others who may want birth control pills.

Disclaimer

This drug information is for your information purposes only, it is not intended that this information covers all uses, directions, drug interactions, precautions, or adverse effects of your medication. This is only general information, and should not be relied on for any purpose. It should not be construed as containing specific instructions for any particular patient. We disclaim all responsibility for the accuracy and reliability of this information, and/or any consequences arising from the use of this information, including damage or adverse consequences to persons or property, however such damages or consequences arise. No warranty, either expressed or implied, is made in regards to this information.

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Birth Control for Women with Epilepsy Is there any way to be sure that I don't get pregnant? All available birth control methods can be used by persons with epilepsy. These include: * barriers: diaphragms, spermicidal vaginal creams, intrauterine devices (IUDs) and condoms; * timing: the "rhythm method" where intercourse is avoided during a woman's ovulation period or withdrawal by the man prior to ejaculation; * hormonal contraception: birth control pills, hormone implants, or hormone injections. Of these, hormonal contraception is the most reliable method for most women, but it is not 100% effective, especially in women with epilepsy. Keep in mind that even in the general population there is always a slight chance of an unwanted pregnancy despite appropriate use of contraceptives. If you have decided that you never want to have children, you can talk to your doctor about an operation called a tubal ligation. This procedure is the most secure way to ensure that you will never become pregnant. If you are in a monogamous relationship (only one male partner) he can have a similar operation, a vasectomy. This would not protect you from pregnancy with other male partners. These are serious decisions, and you need to think about them carefully before choosing either of these procedures. How do I know which method is best for me? You need to work with your gynecologist and your neurologist to choose the birth control method that is most appropriate for you. It is possible that your antiepileptic drug (AED) may make your hormonal birth control less reliable, resulting in an unwanted pregnancy. You and your physicians may consider different combinations of hormonal birth control and seizure medications to find the one that works best for you. How will my seizure medication affect my hormonal birth control? There are complex interactions between the hormones (estrogen and progesterone) contained in birth control pills or devices, and some of the medications used to control seizures. Some of these medications increase the breakdown of contraceptive hormones in the body, making them less effective in preventing pregnancy. The seizure medications that have this effect are often called "liver enzyme-inducing" drugs because the liver is the organ that breaks down these hormones. They are carbamazepine (Tegretol, Carbatrol), oxcarbazepine (Trileptal), phenytoin (Dilantin), phenobarbital (Luminal), primidone (Mysoline), and topiramate (Topamax). Valproate (Depakote) and felbamate (Felbatol) do not increase breakdown of hormones, and may even increase hormonal levels, which may require an adjustment in the dose of your birth control. Gabapentin (Neurontin), lamotrigine (Lamictal), levetiracetam (Keppra), and tiagabine (Gabitril) have no effect on this system and do not interfere with the effectiveness of hormonal birth control. Are there special concerns about "the pill" for women with epilepsy? Yes, there are. The popular low-dose combined oral contraceptive pill has a relatively small amount of estrogen (less than 35 micrograms). That's not enough to protect women with epilepsy who take enzyme-inducing AEDs from becoming pregnant. You may need contraceptive pills with higher doses of estrogen, and even then, there is a risk of unexpected pregnancy. It is a good idea to use barrier methods (a diaphragm, spermicidal cream or a condom) in addition to the contraceptive pill, if you are taking one of the seizure medications that speed up the breakdown of the hormones in birth control pills. Are there problems with other forms of hormonal birth control? Hormonal implants, like levonorgestrel (Norplant) which is placed under the skin, may not provide effective birth control protection if you are taking certain epilepsy drugs. The medications that cause the most problems with Norplant are the "liver enzyme-inducing" seizure medications such as carbamazepine (Tegretol, Carbatrol), oxcarbazepine (Trileptal), phenytoin (Dilantin), phenobarbital (Luminal), primidone (Mysoline), and topiramate (Topamax). These antiepileptic drugs increase the rate of breakdown of birth control hormones. Medroxyprogesterone (Depo-Provera) is a hormonal injection used for birth control and it may need to be given more frequently in women with epilepsy taking medications such as those mentioned earlier. If you are using one of these forms of birth control, and you take one of the liver enzyme-inducing medications, it is a good idea to use a second barrier method of contraception in addition, such as a diaphragm, a spermicidal cream, or have your partner use a condom. Are there any warning signals if my contraception is not working? Breakthrough bleeding while you're on hormonal contraception, for example during the middle of your cycle, could be a sign that you are ovulating and may become pregnant. If you are using birth control pills, bleeding at any other time than when you switch from the active to the inactive pills may indicate that the pills are not working. If bleeding occurs, ask your doctor to help you select an additional form of contraception such as a diaphragm, spermicidal vaginal cream, or condom. It is important for you to know that hormonal contraception can fail without signs of breakthrough bleeding. Does it matter that my periods aren't regular? Yes, because it may make hormonal birth control and timing methods more complicated. Usually, irregular menstrual cycles mean that hormones are out of balance in some way. It is important for your gynecologist and your neurologist to know if your periods are irregular so that they can help you choose the best method of contraception. It may be necessary to consult with an endocrinologist, a doctor who specializes in diagnosing and treating hormonal problems. Will my seizure pattern change if I use hormonal birth control? Current research does not indicate changes in seizure frequency when women with epilepsy use hormonal birth control, but individual reports suggest they may change. Some women have reported more seizures, some have reported less. If you notice a change in your seizure pattern when you use hormonal birth control, contact your physician.

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