Ortho Tri-Cyclen Lo

Generic name: Norgestimate and ethinyl estradiol

What is Ortho Tri-Cyclen Lo?

Ortho Tri-Cyclen Lo tablets are used to prevent pregnancy in women who elect to use oral contraceptives as a method of birth control.

What is the most important information I should know about Ortho Tri-Cyclen Lo?

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age, especially over 35 years and with heavy smoking (15 or more cigarettes per day). You should not smoke while you are taking oral contraceptives.

Oral contraceptive use is associated with increased risks of myocardial infarction, thromboembolism, stroke, hepatic neoplasia, and gallbladder disease. Although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors, the risk increases in the presence of hypertension, hyperlipidemia, obesity, diabetes, or if you have or have had clotting disorders, heart attack, stroke, angina pectoris, cancer of the breast or sex organs, or malignant or benign liver tumors.

Women who have or had breast cancer should not use oral contraceptives.

You may experience breakthrough bleeding or spotting while taking oral contraceptives, especially during the first 3 months of use. You may also have irregular periods. If you have missed more than 2 periods in a row, it is recommended to determine if you are pregnant. If you are pregnant, stop taking the pill.

Call your doctor immediately if you experience chest pain, cough up blood, or you experience sudden shortness of breath; pain the calf of your leg; severe headache or vomiting, dizziness or fainting; vision or speech disturbances; weakness, or numbness in the arm or leg; sudden partial or complete vision loss, breast lumps, severe pain in the stomach area, sleep difficulties, depressed or change in mood; lack of energy; yellowing of the skin or eyeballs with fever, dark urine, light bowel movements, loss of appetite. These signs and symptoms could be an indication of a serious medical condition.

Ortho Tri-Cyclen Lo does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Stop taking the drug if your skin turns yellow, as you may have developed jaundice.

Contact lens wearers who develop visual changes should contact an ophthalmologist.

Who should not take Ortho Tri-Cyclen Lo?

You should not use the pill if you are over the age of 35 and are a heavy smoker, have a history of heart attack or stroke, blood clots in the legs, lungs or eyes, a history of blood clots in the deep veins of your legs, chest pain, known or suspected breast cancer or cancer of the lining of the uterus, cervix or vagina, unexplained vaginal bleeding, yellowing of the whites of the eyes or of the skin during pregnancy or during previous use of the pill, liver tumor, known or suspected pregnancy.

Do not use this medication if you plan to have surgery with prolonged bedrest, if you have very high blood pressure, elevated cholesterol or triglycerides, or diabetes with complications of the kidneys, eyes, nerves, or blood vessels. Also, do not use this drug if you have migraines or other headaches, epilepsy, mental depression, gallbladder, liver, heart, or kidney disease, history of scanty or irregular menstrual periods, or if you are allergic to any of the ingredients in Ortho Tri-Cyclen Lo.

What should I tell my doctor before I take the first dose of Ortho Tri-Cyclen Lo?

Tell your doctor if you have ever had any of the conditions above and also about all prescription, over-the-counter, and herbal medication you are taking before beginning treatment with Ortho Tri-Cyclen Lo. Also, talk to your doctor about your complete medical history, especially if you have had a heart attack, stroke, blood clots, chest pain, gallbladder, liver, heart, or kidney disease, disease or cancer of the breast or sex organs, liver tumors, high blood pressure, high cholesterol or triglycerides, water retention, mental depression, migraines or headaches, diabetes, irregular menstrual bleeding or periods, wear contact lenses, smoke, will undergo surgery and need a long period of bed rest, or you are pregnant or planning to become pregnant, or breastfeeding.

What is the usual dosage?

The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval.

Sunday Start: When taking Ortho Tri-Cyclen Lo the first white "active" tablet should be taken on the first Sunday after menstruation begins. If the menstrual period begins on Sunday, the first white "active" tablet should be taken that day. Take one white, light blue or dark blue "active" tablet daily for 21 days followed by one dark green "reminder" tablet daily for 7 days. After 28 tablets have been taken, a new course is started the next day (Sunday). For the first cycle of a Sunday Start regimen, another method of contraception should be used until after the first 7 consecutive days of administration.

Day 1 Start: The dosage of Ortho Tri-Cyclen Lo for the initial cycle of therapy is one white, light blue or dark blue "active" tablet administered daily from the 1st day through the 21st day of the menstrual cycle, counting the first day of menstrual flow as "Day 1" followed by one dark green "reminder" tablet daily for 7 days. Take the tablets without interruption for 28 days. After 28 tablets have been taken, start a new course the next day.

How should I take Ortho Tri-Cyclen Lo?

You should take Ortho Tri-Cyclen Lo once daily at the same time every day.

What should I avoid while taking Ortho Tri-Cyclen Lo?

Avoid smoking while taking Ortho Tri-Cyclen Lo. Also, avoid getting pregnant while taking Ortho Tri-Cyclen Lo.

What are possible food and drug interactions associated with Ortho Tri-Cyclen Lo?

If Ortho Tri-Cyclen Lo is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before coming Ortho Tri-Cyclen Lo with the following: acetaminophen, antibiotics, ascorbic acid, atorvastatin, bosentan, carbamazepine, clofibric acid, cyclosporine, felbamate, griseofulvin, itraconazole, ketoconazole, morphine, oxcarbazepine, phenobarbital, phenylbutazone, phenytoin, prednisolone, protease inhibitors like ritonavir, rifampin, salicylic acid, St. John's wort (hypericum perforatum), temazepam, theophylline, and topiramate.

What are the possible side effects of Ortho Tri-Cyclen Lo?

Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.

Side effects may include: vaginal bleeding, spotty darkening of the skin (especially on the face), weight changes, nausea, vomiting, change in appetite, headache, nervousness, depression, dizziness, loss of scalp hair, rash, vaginal bleeding, infections, water retention causing swelling of the fingers or ankles and raised blood pressure weight changes

Can I receive Ortho Tri-Cyclen Lo if I am pregnant or breastfeeding?

Oral contraceptives should not be used if you are pregnant or nursing.

What should I do if I miss a dose of Ortho Tri-Cyclen Lo?

If you miss 1 white, light blue, or dark blue "active" pill, take it as soon as you remember. Take the next pill at your regular time. This means you can take 2 pills in 1 day. You do not need a backup birth control method if you have intercourse.

If you miss 2 white or light blue "active" pills in a row in week 1 or week 2, take 2 pills on the day you remember and 2 pills the next day. Then take 1 pill a day until you finish the pack. You could become pregnant if you have intercourse in the 7 days after you miss pills. You must use another birth control method (such as condoms or spermicides) as a backup method for those 7 days.

If you miss 2 dark blue "active" pills in a row in week 3, follow these instructions: If you are a Sunday starter, keep taking 1 pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack on that same day.

If you are a day 1 starter, throw out the rest of the pack and start a new pack that same day. You may not have your period this month; this is normal. If you miss your period 2 months in a row, call your doctor; you might be pregnant.

You could become pregnant if you have intercourse in the 7 days after you miss pills. You must use another birth control method (such as condoms or spermicides) as a backup method for those 7 days.

If you miss 3 or more white, light blue, or dark blue "active" pills in a row during the first 3 weeks: follow these instructions:

If you are a Sunday starter, keep taking 1 pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack on that same day.

If you are a day 1 starter, throw out the rest of the pack and start a new pack that same day. You may not have your period this month, but this is normal. If you miss your period 2 months in a row, call your doctor because you might be pregnant.

You could become pregnant if you have sex in the 7 days after you miss pills. You must use another birth control method (such as condoms or spermicides) as a backup method for those 7 days.

If you forget any of the 7 dark green "reminder" pills in week 4, throw away the pills you missed. Keep taking 1 pill every day until the pack is finished. You do not need a backup contraceptive method.

If you are not sure what to do about your missed pills, use a backup method each time you have intercourse and keep taking 1 "active" pill every day until you consult your doctor.

How should I store Ortho Tri-Cyclen Lo?

Store at room temperature in its original package.