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Generic Name: levonorgestrel intrauterine system (LEE voe nor JES trel IN tra UE ter ine SIS tem)
Brand Name: Liletta, Mirena, Skyla
What is levonorgestrel intrauterine system?
Levonorgestrel is 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. Levonorgestrel intrauterine system 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 meant for use in a woman who has had at least one child. Skyla or Liletta can be used whether you have children or not. 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 intrauterine device release levonorgestrel in the uterus, but only small amounts of the hormone reach the bloodstream. Levonorgestrel intrauterine system should not be used as emergency birth control.
Levonorgestrel intrauterine system may also be used for purposes not listed in this medication guide.
What is the most important information I should know about levonorgestrel intrauterine system?
You should not use this intrauterine device (IUD) if you have abnormal vaginal bleeding, a pelvic infection, certain other problems with your uterus or cervix, or if you have breast or uterine cancer, liver disease or liver tumor, or a weak immune system.
Do not use during pregnancy.
What should I discuss with my healthcare provider before taking levonorgestrel intrauterine system?
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 device if you are allergic to levonorgestrel, silicone, silica, silver, barium, iron oxide, or polyethylene, or if you have:
abnormal vaginal bleeding that has not been checked by a doctor;
an untreated or uncontrolled pelvic infection (vaginal, cervical uterine, or bladder);
endometriosis or 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, known or suspected cervical or uterine cancer;
liver disease or liver tumor (benign or malignant);
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 levonorgestrel intrauterine device if you have:
high blood pressure, heart disease or a heart valve disorder;
history of heart attack or stroke;
a bleeding or blood-clotting disorder;
a vaginal infection, pelvic infection, or sexually transmitted disease; or
Do not use levonorgestrel intrauterine system during pregnancy. This device can cause severe infection, miscarriage, premature birth, or death of the mother if left in place during pregnancy. Tell your doctor right away if you become pregnant. 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.
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?
Levonorgestrel intrauterine system is a T-shaped plastic device that is inserted through the vagina and placed into the uterus by a doctor. 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 minor vaginal bleeding. Tell your doctor if you still have these symptoms longer than 30 minutes.
The levonorgestrel device should not interfere with sexual intercourse, wearing tampons, or using other vaginal medications recommended by your doctor.
After each menstrual period, 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 levonorgestrel 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 an intrauterine device 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 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. The Skyla or Liletta device must be removed after 3 years. 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 device. Do not attempt to remove the device yourself.
Following removal of the levonorgestrel intrauterine device, you may become pregnant right away.
What happens if I miss a dose?
Since the 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 intrauterine system is very unlikely to occur.
What should I avoid while using levonorgestrel intrauterine system?
Avoid having more than one sexual partner. The intrauterine device can increase your risk of developing a serious pelvic infection, which is often caused by sexually transmitted disease. Levonorgestrel intrauterine system 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.
Levonorgestrel intrauterine system 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 levonorgestrel 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, pain during sexual intercourse;
extreme dizziness or light-headed feeling;
severe migraine headache;
heavy or ongoing vaginal bleeding, vaginal sores, vaginal discharge that is watery, foul-smelling discharge, or otherwise unusual;
pale skin, weakness, easy bruising or bleeding, fever, chills, or other signs of infection;
sudden numbness or weakness (especially on one side of the body), 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 side effects may include:
pelvic pain, vaginal itching or infection, irregular menstrual periods, changes in bleeding patterns or flow;
stomach pain, nausea, vomiting, bloating;
headache, depression, mood changes;
back pain, breast tenderness or pain;
weight gain, acne, changes in hair growth, loss of interest in sex; or
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.
Levonorgestrel dosing information
Usual Adult Dose for Contraception:
Mirena: One 52 mg intrauterine system inserted within seven days of the onset of menstruation or immediately after first-trimester abortion. One system is effective for 5 years.
Skyla: One 13.5 mg intrauterine system inserted during seven days of the menstrual cycle or immediately after a first trimester abortion. Postpone postpartum insertion and insertions following second trimester abortions a minimum of six weeks or until the uterus is fully involuted. One system is effective for 3 years.
Back up contraception not needed when Skyla is inserted as directed.
Mirena is also indicated for the treatment of heavy menstrual bleeding in women who choose to use intrauterine contraception as their method of contraception.
Emergency contraception after unprotected intercourse or after contraceptive failure:
one 0.75 mg tablet orally within 72 hours of unprotected intercourse followed by 0.75 mg orally 12 hours after the first dose.
one 1.5 mg tablet orally as soon as possible within 72 hours of unprotected intercourse.
Comment: Efficacy is better if the tablet(s) is taken as soon as possible after unprotected intercourse.
Usual Pediatric Dose for Contraception:
Emergency contraception after unprotected intercourse or after contraceptive failure:
For 15 years of age and older: one 1.5 mg tablet orally as soon as possible within 72 hours of unprotected intercourse.
Comment: Efficacy is better if the tablet is taken as soon as possible after unprotected intercourse.
What other drugs will affect levonorgestrel intrauterine system?
Other drugs may interact with levonorgestrel, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
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Where can I get more information?
- Your doctor or pharmacist can provide more information about the levonorgestrel intrauterine system.
- Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
- Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2012 Cerner Multum, Inc. Version: 6.01. Revision Date: 2015-04-29, 7:38:07 AM.