Generic Name: levonorgestrel (LEE-voe-nor-JES-trel)
Brand Name: Mirena
Mirena iud is used for:
Preventing pregnancy for up to 5 years in certain women. It is also used to treat heavy menstrual bleeding.
Mirena iud is a progestin intrauterine device (IUD). It may work in several ways. It may change cervical mucus to prevent the sperm from reaching the egg. It may also change the lining of the uterus to prevent implantation in the uterus if an egg is fertilized. This change in the lining of the uterus also helps to decrease heavy menstrual bleeding.
Do NOT use Mirena iud if:
- you are allergic to any ingredient in this product, including silicone or polyethylene
- you are pregnant or suspect that you are pregnant
- you have an abnormally shaped uterus or uterine fibroid tumors that change the shape of your uterus
- you currently have pelvic inflammatory disease (PID) or you have a history of PID and have not had a normal pregnancy since that time
- you have a history of ectopic pregnancy, endometritis, or a condition that puts you at risk of ectopic pregnancy or pelvic infections
- you have had an inflamed lining of the uterus after pregnancy or an infected abortion within the past 3 months
- you have an abnormal Pap smear of unknown cause; vaginal bleeding of unknown cause; inflammation of the cervix or vagina; an infection of the genitals, vagina, or cervix that has not been treated; or any sexually transmitted disease (STD) (eg, chlamydia, gonorrhea)
- you have a condition that makes it easier for you to get an infection (eg, leukemia, immune system problems, HIV infection)
- you have risk factors that increase your chance of getting an infection (eg, you or your sex partner have more than one sex partner, intravenous [IV] substance abuse)
- you have a previously inserted IUD that has not been removed
- you have a history of breast cancer or you know or suspect that you have breast cancer
- you know or suspect that you have cancer of the uterus or cervix
- you have liver disease or liver tumors
Contact your doctor or health care provider right away if any of these apply to you.
Before using Mirena iud:
Some medical conditions may interact with Mirena iud. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have recently had a baby or an abortion
- if you have ever had an ectopic pregnancy (pregnancy outside the uterus)
- if you have a history of PID or other pelvic problems (eg, persistent pelvic pain or infections), fallopian tube surgery, endometriosis, genital sores or lesions, painful sexual intercourse, or abnormal vaginal bleeding or discharge
- if you have a history of infections, diabetes, severe headache or migraine (with or without vision changes), heart disease or other heart problems (eg, heart attack, heart valve problems), heart surgery, blood pressure problems, blood vessel problems, stroke or bleeding in the brain, blood clotting problems, or anemia
- if you take anticoagulants (eg, warfarin), corticosteroids (eg, prednisone), or insulin
- if you have never given birth to a child or you have not yet started having a menstrual period
Some MEDICINES MAY INTERACT with Mirena iud. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Azole antifungals (eg, ketoconazole), barbiturates (eg, phenobarbital), bosentan, carbamazepine, felbamate, griseofulvin, protease inhibitors (eg, indinavir, boceprevir), hydantoins (eg, phenytoin), modafinil, nonnucleoside reverse transcriptase inhibitors (NNRTIs) (eg, nevirapine), oxcarbazepine, rifampin, St. John's wort, or topiramate because they may decrease the amount of levonorgestrel in the blood. Talk with your doctor if you have questions about whether these medicines may affect Mirena iud
- Anticoagulants (eg, warfarin) because the risk of their side effects may be increased or decreased by Mirena iud
- Troleandomycin because the risk of liver problems may be increased
- Lamotrigine because its effectiveness may be decreased. Blood levels and side effects of lamotrigine may be increased when Mirena iud is stopped
This may not be a complete list of all interactions that may occur. Ask your health care provider if Mirena iud may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Mirena iud:
Use Mirena iud as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Mirena iud. Talk to your pharmacist if you have questions about this information.
- Before using this product, read the patient insert and discuss the information, as well as other birth control methods, with your health care provider.
- This product will be inserted by a qualified health care provider in a medical setting.
- Your period may be irregular during the first 3 to 6 months of use.
- The IUD may be left in place for up to 5 years. If you wish to continue to use this method of birth control for longer than 5 years, your doctor will need to remove the old IUD and replace it with a new one.
- You may have your doctor remove the IUD at any time if you decide you no longer wish to use this method of birth control.
- If you are using this product and your current IUD has been in place for longer than 5 years, contact your doctor right away.
Ask your health care provider any questions you may have about how to use Mirena iud.
Important safety information:
- This product does not protect against HIV or other STDs.
- Contact your doctor immediately if either you or your partner develops HIV infection, an STD, or symptoms of an STD or genital infection (eg, genital sores). You may need to use a barrier method of birth control (eg, condoms). You will need to discuss with your doctor if this product is still right for you.
- Contact your doctor right away if you experience a change in your health while you use this product, especially if you develop severe or persistent headaches (eg, migraine), symptoms of liver problems (eg, yellowing of the eyes or skin; dark urine; pale stools; severe or persistent nausea, stomach pain, or loss of appetite), high blood pressure, or if you have a heart attack or stroke. You will need to discuss with your doctor if this product is still right for you.
- Diabetes patients - Mirena iud may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- If you experience severe pain, bleeding, or dizziness within hours after the device is inserted, contact your doctor right away.
- This medication device may sometimes come out by itself or move out of place. This may result in pregnancy or other problems. Check after each menstrual period to make sure you can locate the thread from the IUD that extends through the cervix. Do not pull on the thread. If the device comes out or you cannot feel its threads, call your doctor right away and use a backup birth control method (eg, condoms).
- Lab tests, including a complete physical exam, pelvic exam, Pap smear, uterine ultrasound, pregnancy tests, liver function tests, x-ray, and complete blood cell counts, may be performed while you use Mirena iud. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- PREGNANCY and BREAST-FEEDING: Do not use Mirena iud if you are pregnant. If you become pregnant or think you may be pregnant, contact your doctor right away. You may be at risk of serious complications. This may include an ectopic pregnancy (pregnancy outside the uterus), a serious and sometimes fatal condition. If you become pregnant and the pregnancy is inside the uterus, you may be at risk of serious complications, including severe infection, miscarriage, premature delivery, or death. Mirena iud is found in breast milk. If you are or will be breast-feeding while you use Mirena iud, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Mirena iud:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Acne; breast pain or tenderness; changes in menstrual bleeding (eg, spotting); dizziness, bleeding, or cramping during placement.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chills; fever; mental or mood changes (eg, depression); missed menstrual period; painful sexual intercourse; prolonged heavy menstrual bleeding; severe or persistent headache (eg, migraine); severe pain or tenderness in the abdomen or pelvis; unusual or odorous vaginal discharge; unusual vaginal swelling or bleeding.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Mirena iud:
Mirena iud is usually handled and stored by a health care provider. Keep Mirena iud out of the reach of children and away from pets.
- If you have any questions about Mirena iud, please talk with your doctor, pharmacist, or other health care provider.
- Mirena iud is to be used only by the patient for whom it is prescribed.
- If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Mirena iud. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.