Brand Name

Mirena {Bayer}

Generic Name

levonorgestrel intrauterine system, pronounced LEE voe nor JES trel

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Drug Guide

The information contained in the following drug guide is intended as an educational resource only. This guide is not exhaustive and does not contain all available information about this drug.This guide is not intended as medical advice for individual conditions or treatment.

The information provided in this guide does not replace the need for the advice and services of medical professionals or the need for medical examination. Always talk to your physician or pharmacist before taking any prescription medication or over the counter drugs (including any supplements) or before making any changes to your treatment. Only your doctor, nurse or pharmacist can provide you with safe and effective advice regarding your drug treatment.

The use of the information in this guide is at your sole risk. This information is provided "AS IS" with no warranties to accuracy or timeliness.

**All trademarks and registered trademarks are the property of their respective owners.

What is Mirena?

Mirena is a birth control device, in the form of a plastic device that contains the female hormone levonorgestrel. Mirena works because the hormone levonorgestrel causes changes in your cervical mucus and uterine lining, which makes it more difficult for the sperm to reach your uterus. The hormone levonorgestrel also makes it harder for a fertilized egg to attach to the uterus. The Mirena intrauterine device is placed in your uterus by a health care professional where it slowly releases the levonorgestrel hormone. This device can remain in your uterus to prevent pregnancy for up to 5 years.

Mirena may also be prescribed for women who have heavy menstrual bleeding and choose to use an intrauterine form of birth control to control this heavy flow.

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

Seek emergency help if you have severe pain in your lower stomach or side. This could be a sign of a tubal/ectopic pregnancy, which is a pregnancy that implants in the fallopian tube instead of the uterus.

Mirena may become embedded into the wall of the uterus, and can perforate or form a hole in the uterus. If this occurs, the device may no longer prevent pregnancy, and it may cause scarring, infection, or damage to other organs, especially if it moved outside of the uterus. Should this rare issue occur your doctor may need to surgically remove the device.

Key Facts About Mirena

Mirena is meant to be used in woman who has had at least one child, and is in a stable sexual relationship with someone who has no other sexual partners.

Your doctor may ask about your partner’s sexual and medical history before prescribing Mirena for you.

Mirena does not protect you from sexually transmitted diseases, including HIV and AIDS. The only way to prevent these diseases is to use a condom. If your sexual partner develops HIV or a sexually transmitted disease while you are using Mirena, or if you have any change in sexual relationships you should discuss additional forms of protection with your physician.

An intrauterine device like Mirena can increase your risk of developing a serious pelvic infection, which can threaten your life or ability to have children in the future. Ask your doctor about your personal risk for a pelvic infection and you may be able to prevent it from happening.

Before You Take Mirena

If you are allergic to levonorgestrel you should not take Mirena.

If you have a history of untreated or uncontrolled pelvic infection (vaginal, uterine, or bladder), or a serious pelvic infection following a pregnancy or abortion within the past 3 months or you should not use Mirena.

Do not use Mirena if you have a history of pelvic inflammatory disease, also known as PID, unless you have had a normal pregnancy since your infection, and if it has been treated and cleared.

If you have had any type of abnormal vaginal bleeding, uterine fibroid tumors or other conditions that affect the shape of the uterus, known or suspected cervical or uterine cancer or a recent abnormal Pap smear that has not yet been diagnosed or treated you may not be a candidate for Mirena.

Tell your doctor if you have liver disease, a benign or malignant liver tumor, past or present breast cancer, or a disease or condition that weakens your immune system, such as AIDS, leukemia, or IV drug abuse before using Mirena.

Tell your doctor before starting treatment with Mirena if you have another intrauterine device (IUD) in place or if you do not currently have an exclusive sexual partner.

If you have diabetes, a bleeding or blood-clotting disorder, a vaginal infection, a pelvic infection, a sexually transmitted disease, high blood pressure, heart disease or a heart valve disorder your doctor may need to evaluate if Mirena is right for you.

If you are pregnant, think you may be pregnant, or are breast-feeding you should not take Mirena. If used during pregnancy the Mirena device can cause a severe infection, miscarriage, premature birth, or death of the mother if it is left in place throughout the pregnancy duration. Tell your doctor immediately if you become pregnant while using Mirena.

It is important for you to know that if you choose to continue a pregnancy that occurs while you are using Mirena you need to watch for signs of an infection like fever, chills, flu symptoms, cramps, vaginal bleeding or discharge. Contact your doctor right away if you have any of these symptoms and are pregnant.

If you have recently had a baby and are breast-feeding, you should wait until your baby is 6 weeks or older before you start using Mirena.

Mirena may be inserted immediately after a first trimester abortion. Your doctor will let you know if this is an option for you.

Mirena Drug Interactions

You should inform your doctor if you are taking any of the following:

• dexamethasone (Decadron, Hexadrol)
• fluticasone (Advair)
• insulin
• mometasone (Asmanex, Nasonex)
• steroids (prednisone)
• warfarin (Coumadin)

Other drugs you take that are not listed may interact with Mirena. You should tell your doctor about all of the medications you use. This includes prescription drugs, vitamins, supplements and herbal products, and over the counter medications. You should not begin taking a new medication without telling your doctor first.

Directions for Using Mirena

Mirena is a T-shaped plastic device that is inserted through your vagina and placed in your uterus. Mirena should be inserted in a doctor’s office or clinic setting. Your doctor will use a thin plastic tube to place the device into your uterus. Mirena is usually inserted within the first 7 days after the start of your menstrual period.

When the Mirena intrauterine device is inserted you may feel slight pain or dizziness, and you may also experience minor vaginal bleeding. These symptoms typically last 30 minutes or less after Mirena is inserted, especially if you stay in a lying or sitting position after insertion. If 30 minutes have passed and you still have any of the aforementioned symptoms you should let your doctor know.

There is a pair of strings attached to the Mirena device for the removal of it when the time comes. If you decide to discontinue using Mirena your doctor will remove this device safely. Do not try to remove the device on your own. The strings will be cut short enough so they do not protrude from your vagina.

Never attempt to pull on the strings or remove the Mirena intrauterine device. Your doctor will do this in his or her office.

After each menstrual period has passed you should check to see that you can still feel the removal strings. Before doing so wash your hands with soap and water, and insert your clean fingers into your vagina. The strings should be easily felt deep inside your vagina, at the opening of your cervix. If for any reason you cannot feel the strings tell your doctor at once. In addition, if you have a sudden increase in menstrual flow it may be a sign that the device has slipped out of place. Let your doctor know if this occurs. If time passes until you can see your doctor and you are not certain that Mirena is properly in place, be sure to use a non-hormone method of birth control, such as a condom to prevent pregnancy, until your doctor is able to determine if you need a Mirena replacement.

Visit your doctor 4 weeks and 12 weeks after your Mirena insertion, as he or she will need to make sure that it is still in place correctly. Continue to have regular annual pelvic exams and pap smears while using Mirena.

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

During the first 3 to 6 months of using Mirena you may experience irregular periods. Your flow may be lighter or heavier, and you may stop having periods after several months. If this occurs and you think you may be pregnant you should contact your doctor, especially if more than 6 weeks passes without you have a menstrual period.

You must have Mirena removed at the end of the 5-year wearing time. You can ask your doctor to insert a new device at that time if you wish to continue using this form of contraception. Your ability to conceive is not affected by the removal of Mirena. In fact, many women become pregnant right away after having Mirena removed. Most women will conceive within the first year after stopping Mirena.

Mirena Side Effects

Seek immediate emergency medical assistance if you experience:

• severe pain in your side or lower stomach that is severe (this may be a sign of an ectopic/tubal pregnancy)
• allergic reaction including breathing difficulties, hives and swelling of your face, lips, throat or tongue
• bleeding or bruising easily
• cramping that is severe
• extreme dizziness
• faint feeling, like you may pass out
• fever and chills, or signs of an infection
• headache which is severe, along with confusion, problems with your vision and sensitivity to light
• heavy or ongoing vaginal bleeding
• jaundice, or a yellowing of your skin or eyes
• numbness and weakness that is sudden, or on one side of your body
• pale skin
• pain during intercourse
• pelvic pain
• weakness
• vaginal discharge that is watery, foul-smelling discharge, or unusual
• vaginal sores

Less serious side Mirena effects may include:

• acne
• back pain
• bloating
• breakthrough bleeding
• breast pain and tenderness
• decreased libido
• dizziness
• hair growth changes
• headache
• irregular menstrual periods, like changes in bleeding patterns or flow
• menstrual periods that are heavier than usual, especially the first few weeks after Mirena is inserted
• mood changes
• nausea
• nervousness
• puffiness in your hands and feet
• skin rash with itching that is mild
• vomiting
• weight gain

It should be noted that this is not a complete list of possible side effects of Mirena. You should contact your physician for a complete list and medical advice regarding these effects.

Mirena Description and Dosing

Mirena is available as an intrauterine device that is T-shaped with a polyethylene frame, and a steroid reservoir containing a total of 52 mg levonorgestrel.

Ingredients in Mirena

The main ingredient in Mirena is levonorgestrel.

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The information contained in this drug guide is intended as an educational resource only. This guide is not exhaustive and does not contain all available information about this drug.This guide is not intended as medical advice for individual conditions or treatment.

The information provided in this guide does not replace the need for the advice and services of medical professionals or the need for medical examination. Always talk to your physician or pharmacist before taking any prescription medication or over the counter drugs (including any supplements) or before making any changes to your treatment. Only your doctor, nurse or pharmacist can provide you with safe and effective advice regarding your drug treatment.

The use of the information in this guide is at your sole risk. This information is provided "AS IS" with no warranties to accuracy or timeliness.

**All trademarks and registered trademarks are the property of their respective owners.