Drug Uses
Triphasil is an oral contraceptive (commonly known as "the Pill") containing two active ingredients (levonorgestrel and ethinyloestradiol) that are similar to hormones that your body naturally produces. Triphasil is used to prevent pregnancy or to regulate your menstrual cycle.
How Taken
To achieve maximum contraceptive effectiveness, Triphasil-21 Tablets must be taken exactly as directed and at intervals not exceeding 24 hours.
Triphasil-21 Tablets are a three-phase preparation. The dosage of Triphasil-21 Tablets is one tablet daily for 21 consecutive days per menstrual cycle in the following order: 6 brown tablets (phase 1), followed by 5 white tablets (phase 2), and then followed by the last 10 light-yellow tablets (phase 3), according to the prescribed schedule. Tablets are then discontinued for 7 days (three weeks on, one week off). It is recommended that Triphasil-21 Tablets be taken at the same time each day, preferably after the evening meal or at bedtime. During the first cycle of medication, the patient should be instructed to take one Triphasil-21 Tablet daily in the order of 6 brown, 5 white and, finally, 10 light-yellow tablets, for twenty-one (21) consecutive days, beginning on day one (1) of her menstrual cycle.
Warnings/Precautions
Tell your doctor your entire medical history, including family medical history, especially: asthma, high blood pressure, kidney disease, liver heart disease, stroke, history of jaundice (yellowing skin/eyes) or high blood pressure during pregnancy, excessive weight gain or fluid retention during menstrual cycle, blood clots, heart attack, seizures, migraine headaches, breast cancer, high blood level of cholesterol or lipids (fats), diabetes, depression. Depending on strength, this drug may cause a patchy, darkening of the skin on the face (melasma). Higher strengths are more likely to cause melasma. Sunlight may intensify this darkening and you may need to avoid prolonged sun exposure and sunlamps. Consult your doctor regarding use of sunscreens and protective clothing. It may take a long time for you to become pregnant after you stop taking birth control pills. Consult your doctor. Do not smoke cigarettes. Birth-control pills slightly increase your risk of strokes, blood clots, high blood pressure, heart attacks, gallbladder disease, vision problems, and liver tumors. Cigarette smoking (especially 15 or more cigarettes daily) and age (women older than 35/smokers or 40/nonsmokers years of age) further increase the risk of stroke, blood clots, high blood pressure and heart attacks. Ask your pharmacist or doctor for a copy of the patient labeling which explain these risks in more detail. Consult your doctor for any questions, including possible use in non-smokers over 40 years of age. If you are near-sighted or wear contact lenses, you may develop vision problems. Also, your tolerance of the lenses may decrease. Contact your eye doctor if these problems occur. Before having surgery, including dental surgery, tell the doctor that you take birth control pills. This drug must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. Triphasil passes into breast milk. This may affect milk production and may have harmful effects on a nursing infant. Consult your doctor before breast-feeding.
Missed Dose
The pill may not be as effective if you miss brown, white or light yellow "active" pills, and particularly if you miss the first few brown or the last few light-yellow "active" pills in a pack.
If you MISS 1 brown, white or light-yellow active pill:
1. Take it as soon as you remember. Take the next pill at your regular time. This means you may take 2 pills in 1 day.
2. You do not need to use a back-up birth-control method if you have sex.
3. You MAY BECOME PREGNANT if you have sex in the 7 days after you miss pills. You MUST use another birth-control method (such as condoms, spermicide, or sponge) as a back-up for those 7 days.
If you MISS 2 brown, white or light-yellow active pills in a row in THE 3rd WEEK:
1. If you are a Day 1 Starter:
THROW OUT the rest of the pill pack and start a new pack that same day.
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 of pills that same day.
2. You may not have your period this month but this is expected. However, if you miss your period 2 months in a row, call your doctor or clinic because you might be pregnant.
3. You MAY BECOME PREGNANT if you have sex in the 7 days after you miss pills. You MUST use another birth-control method (such as condoms, spermicide, or sponge) as a back-up for those 7 days.
If you MISS 3 OR MORE brown, white or light-yellow active pills in a row (during the first
3 weeks):
1. If you are a Day 1 Starter:
THROW OUT the rest of the pill pack and start a new pack that same day.
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 of pills that same day.
2. You may not have your period this month but this is expected. However, if you miss your period 2 months in a row, call your doctor or clinic because you might be pregnant.
3. You MAY BECOME PREGNANT if you have sex in the 7 days after you miss pills. You
MUST use another birth-control method (such as condoms, spermicide, or sponge) as a back-up for those 7 days.
Possible Side Effects
Triphasil may cause dizziness, headache, lightheadedness, stomach upset, bloating, or nausea. If these effects persist or worsen, contact your doctor. Notify your doctor if you experience: severe depression, groin or calf pain, sudden severe headache, chest pain, shortness of breath, lumps in the breast, weakness or tingling in the arms or legs, yellowing of the eyes or skin. If you notice other effects not listed above, contact your doctor or pharmacist.
Storage
Store at room temperature between 59 and 86 degrees F (between 15 and 30 degrees C) away from moisture and sunlight. Do not store in the bathroom.
Overdose
Serious ill effects have not been reported following ingestion of large doses of oral contraceptives by young children. Over dosage may cause nausea and withdrawal bleeding in females. In case of over dosage, contact your health-care provider or pharmacist.
More Information
Your health-care provider 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 provider believes that it is appropriate to postpone it. You should be re-examined at least once a year. Be sure to inform your health-care provider 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 provider, 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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More HighlightsDifferent 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 Triphasil brand-name drugs and Triphasil 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 Triphasil 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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