Tri-Previfem is a combination of Ethinyl estradiol and norgestimate which is used to prevent pregnancy. It is a birth control pill that contains two types of hormones, ethinyl estradiol and norgestimate, and when taken properly, prevents pregnancy. It works by stopping a womans egg from fully developing each month. The egg can no longer accept a sperm and fertilization (pregnancy) is prevented.
Ethinyl estradiol and norgestimate combination is also used to treat moderate acne in females (at least 15 years of age) who started having menstrual period and also wants to use this medicine for birth control.
No contraceptive method is 100 percent effective. Birth control methods such as having surgery to become sterile or not having sex are more effective than birth control pills. Discuss your options for birth control with your doctor.
This medicine does not prevent HIV infection or other sexually transmitted diseases. It will not help as emergency contraception, such as after unprotected sexual contact.
This medicine is available only with your doctors prescription.
It is very important that you use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.
To make using oral contraceptives as safe and reliable as possible, you should understand how and when to take them and what effects may be expected.
This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
This medicine is available in blister packs with a Dialpak® tablet dispenser or a Veridate® tablet dispenser. Each blister pack contains 28 tablets with different colors that need to be taken in the same order as directed on the blister pack.
When you begin using this medicine, your body will require at least 7 days to adjust before a pregnancy will be prevented. Use a second form of contraception, such as a condom, spermicide, or diaphragm, for the first 7 days of your first cycle of pills.
Take this medicine at the same time each day. Birth control pills work best when no more than 24 hours pass between doses.
Do not skip or delay taking your pill by more than 24 hours. If you miss a dose, you could get pregnant. Ask your doctor for ways to help you remember to take your pills or about using another method of birth control.
You may feel sick or nauseated, especially during the first few months that you take this medicine. If your nausea is continuous and does not go away, call your doctor.
Follow the instructions in the patient leaflet or call your doctor if you vomit or have diarrhea within 3 to 4 hours of taking this medicine.
The dose of this medicine will be different for different patients. Follow your doctors orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
Your doctor may ask you to begin your dose on the first day of your menstrual period (called Day 1 start) or on the first Sunday after your menstrual period starts (called Sunday start). When you begin on a certain day it is important that you follow that schedule, even if you miss a dose. Do not change your schedule on your own. If the schedule that you use is not convenient, talk with your doctor about changing it. For a Sunday start, you need to use another form of birth control (eg, condom, diaphragm, spermicide) for the first 7 days.
You should begin your next and all subsequent 28-day regimens of therapy on the same day of the week as the first regimen began and follow the same schedule.
Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body.
For oral dosage form (tablets):
For contraception (to prevent pregnancy):
Adults and teenagers—
Ortho-Cyclen®: One blue tablet (active) taken at the same time each day for 21 consecutive days followed by one dark green (inert) tablet daily for 7 days per menstrual cycle.
Ortho Tri-Cyclen®: One white, light blue, or blue tablet (active) taken at the same time each day for 21 consecutive days followed by one dark green (inert) tablet daily for 7 days per menstrual cycle.
Ortho Tri-Cyclen® Lo: One white, light blue, or dark blue tablet (active) taken at the same time each day for 21 consecutive days followed by one dark green (inert) tablet daily for 7 days per menstrual cycle.
Children—Use and dose must be determined by your doctor.
Adults and teenagers 15 years of age and older—One white, light blue, or blue tablet (active) taken at the same time each day for 21 consecutive days followed by one dark green (inert) tablet daily for 7 days per menstrual cycle.
Teenagers and children younger than 15 years of age—Use and dose must be determined by your doctor.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Incidence not known
Absent, missed, or irregular menstrual periods
change in vision
changes in skin color
chest pain or discomfort
dizziness or lightheadedness
hives or welts
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
loss of appetite
medium to heavy, irregular vaginal bleeding between regular monthly periods, which may require the use of a pad or a tampon
pain or discomfort in the arms, jaw, back, or neck
pain, tenderness, or swelling of the foot or leg
pains in the chest, groin, or legs, especially in the calves of the legs
pounding in the ears
redness of the skin
severe headaches of sudden onset
slow or fast heartbeat
sudden loss of coordination or slurred speech
sudden troubled breathing
unusual tiredness or weakness
vomiting of blood
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Incidence not known
blotchy spots on the exposed skin
breast enlargement or tenderness
feeling sad or empty
itching of the vagina or outside the genitals
loss of interest or pleasure
pain during sexual intercourse
thick, white curd-like vaginal discharge without odor or with mild odor
trouble wearing contact lenses
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
St Johns Wort
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
There have been no reports of serious ill effects from overdosage of oral contraceptives, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.