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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Judih Goldkis
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"I have 4 children. They consist of a 5 year old son, a 3 year old daughter and 2 cats. Pill time has never been easy, especially for my son. Because of the ordeal, I even opted to skip a few doses on more than one occasion. However, once I heard about Ortho Tricyclen I tried it. Well, I no longer have to “hunt” the kids down and force the medicine in their mouths. Thank you, Ortho Tricyclen!"

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More Highlights

Different definition / meanings for the word "new drug application":
An application requesting FDA approval to market a new drug for human use in interstate commerce. The application must contain, among other things, data from specific technical viewpoints for FDA review--including chemistry, pharmacology, medical, biopharmaceutics, statistics, and, for anti-infectives, microbiology.

What are the differences between Ortho Tricyclen brand-name drugs and Ortho Tricyclen generic drugs?
You probably know that pharmaceutical companies carry out extensive research and clinical testing to win approval from the Food and Drug Administration for new drugs. The new drug is then protected by patent for at least 10 years. Hence, a brand-name drug. When the patent expires another drug company can "copy the recipe" for Ortho Tricyclen brand drug. This "copy" is called a generic drug. The FDA requires that generic drugs have the same active chemical composition, be dispensed in the same dosage form such as a tablet or capsule and be taken in the same dosage as the brand-name drug.

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