"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"...
Mirena Patient Information including How Should I Take
In this Article
- What is levonorgestrel intrauterine system (Mirena)?
- What are the possible side effects of levonorgestrel intrauterine system (Mirena)?
- What is the most important information I should know about levonorgestrel intrauterine system (Mirena)?
- What should I discuss with my healthcare provider before taking levonorgestrel intrauterine system (Mirena)?
- How is levonorgestrel intrauterine system used (Mirena)?
- What happens if I miss a dose (Mirena)?
- What happens if I overdose (Mirena)?
- What should I avoid while using levonorgestrel intrauterine system (Mirena)?
- What other drugs will affect levonorgestrel intrauterine system (Mirena)?
- Where can I get more information?
What should I discuss with my healthcare provider before taking levonorgestrel intrauterine system (Mirena)?
An intrauterine device can increase your risk of developing a serious pelvic infection, which may threaten your life or your future ability to have children. Ask your doctor about your personal risk and about ways to help prevent a pelvic infection.
You should not use this medication if you are allergic to levonorgestrel, silicone, or polyethylene, or if you have:
- abnormal vaginal bleeding;
- an untreated or uncontrolled pelvic infection (vaginal, uterine, or bladder);
- a serious pelvic infection following a pregnancy or abortion within the past 3 months;
- a history of pelvic inflammatory disease (PID), unless you have had a normal pregnancy after the infection was treated and cleared;
- uterine fibroid tumors or other conditions that affect the shape of the uterus;
- past or present breast cancer;
- liver disease or liver tumor (benign or malignant);
- known or suspected cervical or uterine cancer;
- a recent abnormal Pap smear that has not yet been diagnosed or treated;
- a disease or condition that weakens your immune system, such as AIDS, leukemia, or IV drug abuse;
- if you have another intrauterine device (IUD) in place; or
- if you do not have an exclusive sexual partner.
You may need special tests to safely use a levonorgestrel intrauterine device if you have:
- a bleeding or blood-clotting disorder;
- a vaginal infection, pelvic infection, or sexually transmitted disease; or
- high blood pressure, heart disease or a heart valve disorder.
Your doctor may ask about your partner's medical and sexual history before prescribing a levonorgestrel intrauterine device for you.
The levonorgestrel intrauterine system should not be used during pregnancy. This device can cause severe infection, miscarriage, premature birth, or death of the mother if it is left in place during pregnancy. Tell your doctor right away if you become pregnant while using the intrauterine system.
If you choose to continue a pregnancy that occurs while using a levonorgestrel intrauterine system, watch for signs of infection such as fever, chills, flu symptoms, cramps, vaginal bleeding or discharge. Contact your doctor at once if you have any of these symptoms.
If you have recently had a baby and are breast-feeding, wait until your baby is at least 6 weeks old before you start using the intrauterine system.
How is levonorgestrel intrauterine system used (Mirena)?
Levonorgestrel is a T-shaped plastic device that is inserted through the vagina and placed into the uterus. You will receive the device in a clinic setting. Your doctor will place the device into your uterus using a thin plastic tube. The device is usually inserted within 7 days after the start of a menstrual period.
You may feel pain or dizziness during insertion of the intrauterine device. You may also have some vaginal bleeding. These symptoms should last only 30 minutes or less after the device is inserted, especially if you stay in a sitting or lying position during that time. Tell your doctor if you still have these symptoms after 30 minutes have passed.
A pair of strings is attached to the device for removal when you decide to discontinue using it. Your doctor will cut these strings short enough so they do not protrude from your vagina. Do not pull on the strings or attempt to remove the device.
After each menstrual period you should check to make sure you can still feel the removal strings. Wash your hands with soap and water, and insert your clean fingers into the vagina. You should be able to feel the strings deep inside the vagina, at the opening of your cervix. Call your doctor at once if you cannot feel the strings, or if you think the device has slipped lower in your uterus or out of your uterus. A sudden increase in menstrual flow may be a sign that the device has slipped out of place.
If you think the device is not properly in place, use a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy until your doctor is able to replace the levonorgestrel device.
Your doctor will need to see you within 4 and 12 weeks after insertion of the device to make sure it is still in place correctly. Be sure to also have regular annual pelvic exams and Pap smears while you are using the levonorgestrel intrauterine system.
The levonorgestrel intrauterine system should not interfere with sexual intercourse, wearing tampons, or using other vaginal medications recommended by your doctor.
You may have irregular periods during the first 3 to 6 months of using the intrauterine system. Your flow may be lighter or heavier, and you may eventually stop having periods after several months. Contact your doctor if you think you might be pregnant, or if you do not have a menstrual period for 6 weeks in a row.
The levonorgestrel intrauterine system must be removed at the end of the 5-year wearing time. Your doctor can insert a new device at that time if you wish to continue using this form of contraception. Only your doctor should remove the intrauterine system. Do not attempt to remove the device yourself.
Following removal of the levonorgestrel intrauterine device, you may become pregnant right away. Most women who choose to discontinue using the device in order to have a baby will become pregnant within the first year after removal.
Additional Mirena Information
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.
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