Ortho Tri-Cyclen Generic (Tri Femynor)
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Ortho Tri-Cyclen Generic (Tri Femynor)
(Norgestimate and Ethinyl Estradiol tablets, 0.18 mg, 0.215 mg, 0.25 mg/0.035 mg)
This Ortho Tri-Cyclen Generic is a combination of female hormones (norgestimate and ethinyl estradiol) 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.
Taking an Ortho Tri-Cyclen Generic can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, or if you are overweight. Your risk of stroke or blood clot is highest during your first year of taking birth control pills. Your risk is also high when you restart birth control pills after not taking them for 4 weeks or longer.
Smoking can greatly increase your risk of blood clots, stroke, or heart attack. Your risk increases the older you are and the more you smoke. You should not take combination birth control pills if you smoke and are over 35 years old.
Do not use if you are pregnant. Stop taking this medicine and tell your doctor 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 birth control pills.
You should not take an Ortho Tri-Cyclen Generic if you have:
- untreated or uncontrolled high blood pressure
- heart disease (coronary artery disease, uncontrolled heart valve disorder, history of heart attack, stroke, or blood clot)
- chest pain
- unusual vaginal bleeding that has not been checked by a doctor
- problems with your eyes, kidneys or circulation caused by diabetes
- a history of hormone-related cancer such as breast or uterine cancer
- liver cancer
- a history of jaundice caused by pregnancy or birth control pills
- severe migraine headaches (with aura, numbness, weakness, or vision changes)
Tell your doctor if you have:
- heart disease, high blood pressure
- high cholesterol or triglycerides
- a history of depression
- gallbladder disease
- liver or kidney disease
- seizures or epilepsy
- a history of irregular menstrual cycles
- a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram
The hormones in an Ortho Tri-Cyclen Generic can pass into breast milk and may harm a nursing baby. It may also slow breast milk production. Do not use if you are breast feeding a baby.
For a complete list of important safety information, click here
IMPORTANT SAFETY INFORMATION
INDICATION AND USAGE OF TRI FEMYNOR®
Tri Femynor is a combined oral contraceptive (COC) indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
SELECTED SAFETY INFORMATION
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with the extent of smoking (in epidemiologic studies, 15 or more cigarettes per day was associated with a significantly increased risk) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.
BRIEF SUMMARY: CONSULT THE PACKAGE INSERT FOR COMPLETE PRESCRIBING INFORMATION
Combined oral contraceptives (COC's), including Tri Femynor, should not be used in women with any of the following conditions:
- Thrombophlebitis or thromboembolic disorders
- A past history of deep vein thrombophlebitis or thromboembolic disorders
- Cerebral vascular or coronary artery disease
- Known or suspected carcinoma of the breast
- Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
- Undiagnosed abnormal genital bleeding
- Cholestatic jaundice of pregnancy or jaundice with prior pill use
- Hepatic adenomas or carcinomas
- Known or suspected pregnancy
WARNINGS AND PRECAUTIONS
- Thrombotic and other vascular events- Stop Tri Femynor if an arterial or venous thrombotic event occurs, 4 weeks before and 2 weeks after major surgeries or surgeries known to have an elevated risk of thromboembolism, or if there is an unexplained loss or change of vision (Evaluate for retinal thrombosis immediately.). Combined oral contraceptives should be used with caution in women with cardiovascular risk factors.
- Carcinoma of the breast- Women with current or past history of breast cancer should not use Tri Femynor.
- Liver Disease- Discontinue Tri Femynor if jaundice develops. Hepatic adenomas and very rare hepatocellular carcinoma (> 8 years use) are associated with COC use.
- High Blood pressure- Women with well-controlled hypertension should be monitored closely. Women with uncontrolled hypertension should not use Tri Femynor.
- Other warnings and precautions include gall bladder disease, carbohydrate and lipid metabolic effects, headache, bleeding irregularities including amenorrhea, COC use before and during pregnancy, depression, and interference with laboratory tests.
ADVERSE REACTIONS / SIDE EFFECTS
The most serious reactions are discussed above and include serious cardiovascular events and smoking, vascular events and liver disease. Commonly reported adverse reactions include irregular uterine bleeding, nausea, breast tenderness and headache.
Patients should be counseled that Tri Femynor does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Please see full prescribing information here.
To report SUSPECTED ADVERSE REACTIONS, call 1-855-888-2467 or report via the FDA MedWatch Program at www.fda.gov/medwatch or 1-800-FDA-1088.