Mirena

Generic Name: levonorgestrel intrauterine system (boe SUE tin ib)
Brand Name: Mirena, Skyla

What is Mirena?

Mirena contains levonorgestrel, a female hormone that can cause 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.

Mirena is a plastic device that contains this hormone. This device is placed in the uterus where it slowly releases the hormone to prevent pregnancy for 3 to 5 years. Mirena is for use in a woman who has have at least one child.

Mirena is also used in women who have heavy menstrual bleeding and choose to use an intrauterine form of birth control.

Levonorgestrel is a progestin hormone and does not contain estrogen. The Mirena intrauterine device releases levonorgestrel in the uterus, but only small amounts of the hormone reach the bloodstream.

Mirena may also be used for purposes not listed in this medication guide.

Important information about Mirena

Mirena should not be used during pregnancy.

You should not use Mirena if you have abnormal vaginal bleeding, uterine infection after a pregnancy, pelvic inflammatory disease (PID), uterine fibroid tumors, a vaginal or cervical infection, abnormal Pap smear, breast cancer, cervical or uterine cancer, liver disease, or liver tumor.

Slideshow: Can Prescription Drugs Lead to Weight Gain?

Call your doctor at once if you have symptoms of a stroke or heart attack, such as sudden numbness or weakness, severe headache, or chest pain.

Before using Mirena

Mirena 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 Mirena if you are allergic to levonorgestrel, silicone, silica, silver, barium, iron oxide, or polyethylene, or if you have:

• abnormal vaginal bleeding;

• an untreated or uncontrolled pelvic infection (vaginal, cervical 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; or

• if you have another intrauterine device (IUD) in place.

You may need special tests to safely use a Mirena intrauterine device if you have:

• diabetes;

• a bleeding or blood-clotting disorder;

• migraine headaches;

• 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 Mirena for you.

Mirena 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 Mirena 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 Mirena intrauterine system.

How is Mirena used?

Mirena 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 Mirena intrauterine device. You may also have minor vaginal bleeding. These symptoms should last only 30 minutes or less after the device is inserted. Tell your doctor if you still have these symptoms longer than 30 minutes.

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.

Mirena should not interfere with sexual intercourse, wearing tampons, or using other vaginal medications recommended by your doctor.

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 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 (condom, or diaphragm with spermicide) to prevent pregnancy until your doctor is able to replace the Mirena device.

Your doctor will need to see you within a few weeks after insertion of the device to make sure it is still in place correctly. You will also need regular annual pelvic exams and Pap smears.

If you need to have an MRI (magnetic resonance imaging), tell your caregivers ahead of time that you have a Mirena intrauterine system in place.

You may have irregular periods during the first 3 to 6 months of use. Your flow may be lighter or heavier, and you may eventually stop having periods after several months. Call your doctor if you miss a period or think you might be pregnant.

Your Mirena intrauterine device may be removed at any time you decide to stop using birth control. The Mirena 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 birth control. Only your doctor should remove the intrauterine system. Do not attempt to remove the device yourself.

Following removal of the Mirena intrauterine device, you may become pregnant right away.

What happens if I miss a dose?

Since the Mirena intrauterine device continuously releases a low dose of levonorgestrel, missing a dose does not occur when using this form of levonorgestrel.

What happens if I overdose?

An overdose of levonorgestrel released from the Mirena intrauterine system is very unlikely to occur.

What should I avoid while using Mirena?

Avoid having more than one sexual partner. Mirena can increase your risk of developing a serious pelvic infection, which is often caused by sexually transmitted disease.

Mirena will not protect you from sexually transmitted diseases, including HIV and AIDS. Using a condom is the only way to help protect yourself from these diseases. Contact your doctor if your sexual partner develops HIV or a sexually transmitted disease, or if you have any change in sexual relationships.

Mirena side effects

Get emergency medical help if you have severe pain in your lower stomach or side. This could be a sign of a tubal pregnancy (a pregnancy that implants in the fallopian tube instead of the uterus). A tubal pregnancy is a medical emergency.

The Mirena intrauterine device may become embedded into the wall of the uterus, or may perforate (form a hole) in the uterus. If this occurs, the device may no longer prevent pregnancy, or it may move outside the uterus and cause scarring, infection, or damage to other organs. Your doctor may need to surgically remove the device.

Call your doctor at once if you have:

• severe cramps or pelvic pain;

• extreme dizziness or light-headed feeling;

• heavy or ongoing vaginal bleeding, vaginal sores, vaginal discharge that is watery, foul-smelling discharge, or otherwise unusual;

• severe pain in your side or lower stomach;

• pale skin, weakness, easy bruising or bleeding;

• fever, chills, or other signs of infection;

• pain during sexual intercourse;

• sudden numbness or weakness, especially on one side of the body;

• sudden or severe headache, confusion, problems with vision, sensitivity to light;

• jaundice (yellowing of the skin or eyes); or

• signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Common Mirena side effects may include:

• vaginal itching, irregular menstrual periods, changes in bleeding patterns or flow;

• breakthrough bleeding, or heavier menstrual bleeding during the first few weeks after device insertion;

• mild stomach pain, nausea, bloating;

• back pain, breast tenderness or pain;

• weight gain, acne, changes in hair growth;

• mood changes, loss of interest in sex;

• puffiness in your face, hands, ankles, or feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Mirena side effects (in more detail)

What other drugs will affect Mirena?

Tell your doctor about all medicines you use, and those you start or stop using while your uterine device is in place, especially:

• bosentan;

• griseofulvin;

• insulin;

• rifabutin, rifampin, rifapentine;

• St. John's wort;

• topiramate;

• a barbiturate--butabarbital, phenobarbital, secobarbital, and others;

• a blood thinner such as warfarin, Coumadin;

• HIV/AIDS medication--efavirenz, nevirapine, ritonavir;

• seizure medication--carbamazepine, felbamate, oxcarbazepine, phenytoin, primidone; or

• steroids--prednisone, fluticasone, mometasone, dexamethasone, and others.

This list is not complete. Other drugs may interact with Mirena, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

• Your doctor or pharmacist can provide more information about Mirena.