|Brand Name:||Ortho Tri-Cyclen|
|Active Ingredient:||norgestimate/ethinyl estradiol|
|*Date Approved by the FDA:||December 31, 1996|
|*Approval by FDA does not mean that the drug is available for consumers at this time|
What is Ortho Tri-Cyclen used for?
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.
Who should not take Ortho Tri-Cyclen?
Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels from the use of hormonal birth control methods. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use hormonal birth control methods should not smoke.
Ortho Tri-Cyclen should not be used by women who have:
- a history of heart attack or stroke
- blood clots in the legs, lungs (pulmonary embolism), or eyes
- a history of blood clots in the deep veins of the 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 (jaundice) during pregnancy or during previous use of hormonal contraceptives
- liver tumor (benign or cancerous)
- known or suspected pregnancy
- severe high blood pressure
- diabetes with complications of the kidneys, eyes, nerves, or blood vessels
- an allergy to Ortho Tri-Cyclen or to any of its ingredients
General Precautions with Ortho Tri-Cyclen:
Smoking cigarettes while using this medicine 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 this medicine may decrease the effectiveness of this medicine. 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 this medicine. 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. This medicine 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 this medicine will not prevent the spread of sexually transmitted diseases (STDs). Do not use this medicine if you are pregnant. If you suspect that you could be pregnant, contact your doctor immediately. This medicine is excreted in breast milk. If you are or will be breast-feeding while you are using this medicine, check with your doctor or pharmacist to discuss the risks to your baby. If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include restlessness, tremor, rapid breathing, nausea, vomiting, diarrhea, and stomach cramps.
- have high blood pressure, diabetes, or high cholesterol
- have or have had clotting disorders, heart attack, stroke, chest pain (angina pectoris), and cancer of the breast or reproductive organs, jaundice, or malignant or benign liver tumors
What should I tell my health care provider?
Tell your health care provider:
- about all your medical conditions
- if you smoke cigarettes
- about all the medications you take, including prescription and nonprescription medications, vitamins, and herbal supplements. Some medicines can affect Ortho Tri-Cyclen and make it less effective.
What are some possible side effects of Ortho Tri-Cyclen? (This is NOT a complete list of side effects reported with Ortho Tri-Cyclen. Your health care provider can discuss with you a more complete list of side effects.)
Some common side effects with combination hormonal contraceptives like Ortho Tri-Cyclen are:
- breast tenderness and enlargement
- menstrual changes
- abdominal cramps and bloating
- vaginal discharge
Ortho Tri-Cyclen may also cause skin irritation at the application site.
For more detailed information about Ortho Tri-Cyclen, ask your health care provider and pharmacist.
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