The following information is a summary about TRI-SPRINTEC. It
is not intended to replace a doctor's instructions.
Tablets
Chemical Name: NORGESTIMATE
(nor-JES-ti-mate) and ETHINYL ESTRADIOL (ETH-in-il ess-tra-DYE-ole)
Common uses
Ethinyl estradiol and norgestimate contains a combination of female hormones 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. Ethinyl estradiol and norgestimate is used as contraception to prevent pregnancy. It is also used to treat severe acne. Ethinyl estradiol and norgestimate may also be used for other purposes not listed here.
Before using
Do not use this medication if you are pregnant or if you have recently had a baby. Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, migraine headaches, or a history of jaundice caused by birth control pills.
You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35. Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all the prescription and over-the-counter medications you use, including vitamins, minerals and herbal products. Do not start using a new medication without telling your doctor.
Directions
Take this medication exactly as it was prescribed for you. Do not take larger amounts, or take it for longer than recommended by your doctor. You will take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).
You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.
The 28-day birth control pack contains seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.
You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.
Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not use this medication regularly. Get your prescription refilled before you run out of pills completely.
If you need to have any type of medical tests or surgery, or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.
Your doctor will need to see you on a regular basis while you are using this medication. Do not miss any appointments.
Cautions
This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away 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 (6 weeks if you are breast-feeding). Do not use this medication if you have:
a history of a stroke, blood clot, or circulation problems;
a hormone-related cancer such as breast or uterine cancer;
abnormal vaginal bleeding;
liver disease or liver cancer;
severe migraine headaches; or
a history of jaundice caused by birth control pills.
Before using this medication, tell your doctor if you have any of the following conditions. You may need a dose adjustment or special tests to safely take birth control pills.
high blood pressure, heart disease, congestive heart failure, angina (chest pain), or a history of heart attack;
high cholesterol or if you are overweight;
a history of depression;
gallbladder disease;
diabetes;
seizures or epilepsy;
a history of irregular menstrual cycles; or
a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.
The hormones in this medication can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby.
Possible side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:
sudden numbness or weakness, especially on one side of the body;
sudden headache, confusion, problems with vision, speech, or balance;
chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
a change in the pattern or severity of migraine headaches;
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
swelling in your hands, ankles, or feet; or
symptoms of depression (sleep problems, weakness, mood changes).
Less serious side effects may include:
mild nausea, vomiting, bloating, stomach cramps;
breast pain, tenderness, or swelling;
freckles or darkening of facial skin;
increased hair growth, loss of scalp hair;
changes in weight or appetite;
problems with contact lenses;
vaginal itching or discharge;
changes in your menstrual periods; or
headache, nervousness, dizziness, tired feeling.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.
Drug interactions
Some drugs can make ethinyl estradiol and norgestimate less effective, which may result in pregnancy. Before using ethinyl estradiol and norgestimate, tell your doctor if you are using any of the following drugs:
phenylbutazone (Azolid, Butazolidin);
St. John's wort;
an antibiotic;
seizure medicines such as phenytoin (Dilantin), carbamazepine (Tegretol), oxcarbazepine (Trileptal), topiramate (Topamax), and others;
a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or
HIV medicines such as amprenavir (Agenerase), atazanavir (Reyataz), indinavir (Crixivan), saquinavir (Invirase), fosamprenavir (Lexiva), ritonavir (Norvir), and others.
This list is not complete and there may be other drugs that can affect birth control pills. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
If you take too much
Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.
Additional information
Keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
