"The U.S. Food and Drug Administration today announced that it has approved an amended application submitted by Teva Women's Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years"...
- Clinician Information:
Tri-Sprintec Patient Information including How Should I Take
In this Article
- What is ethinyl estradiol and norgestimate (Tri-Sprintec)?
- What are the possible side effects of ethinyl estradiol and norgestimate?
- What is the most important information I should know about ethinyl estradiol and norgestimate?
- What should I discuss with my healthcare provider before taking ethinyl estradiol and norgestimate?
- How should I take ethinyl estradiol and norgestimate?
- What happens if I miss a dose?
- What happens if I overdose?
- What should I avoid while taking ethinyl estradiol and norgestimate?
- What other drugs will affect ethinyl estradiol and norgestimate?
- Where can I get more information?
What should I discuss with my healthcare provider before taking ethinyl estradiol and norgestimate?
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).
You should not take birth control pills if you have:
- coronary artery disease, a severe or uncontrolled heart valve disorder, untreated or uncontrolled high blood pressure;
- a history of a stroke, blood clot, or circulation problems;
- a hormone-related cancer such as breast or uterine cancer;
- unusual vaginal bleeding that has not been checked by a doctor;
- liver disease or liver cancer;
- severe migraine headaches; or
- a history of jaundice caused by pregnancy or birth control pills.
To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:
- high blood pressure, heart disease, congestive heart failure, angina (chest pain), or a history of heart attack;
- high cholesterol or triglycerides, or if you are overweight;
- a history of depression;
- gallbladder disease;
- 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.
How should I take ethinyl estradiol and norgestimate?
Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. 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 surgery or medical tests 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 check your progress on a regular basis. Do not miss any scheduled appointments.
Store at room temperature away from moisture and heat.
Additional Tri-Sprintec Information
- Tri-Sprintec Drug Interactions Center: norgestimate-ethinyl estradiol oral
- Tri-Sprintec Side Effects Center
- Tri-Sprintec FDA Approved Prescribing Information including Dosage
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.