LEVONORGESTREL INTRAUTERINE SYSTEM

(LEE voe nor JES trel IN tra UE ter ine SIS tem) Brand: Mirena, Skyla

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What is the most significant information I must know about levonorgestrel intrauterine system?

The levonorgestrel intrauterine system must not be used during pregnancy.

• You must not use this medication if you have emergency vaginal bleeding, uterine infection after a pregnancy, pelvic inflammatory malady (PID), uterine fibroid tumors, a vaginal or cervical infection, emergency Pap smear, breast cancer, cervical or uterine cancer, liver malady, or liver tumor.

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

What is levonorgestrel intrauterine system?

• Levonorgestrel is a female hormone that can reason 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 baby. Skyla can be used whether you have children or not. Mirena is also used in women who have hard 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 little amounts of the hormone reach the bloodstream.

Levonorgestrel intrauterine system may also be used for purposes not listed in this medicine guide.

What must I discuss with my healthcare provider till taking levonorgestrel intrauterine system?

• An intrauterine device can magnify your risk of developing a serious pelvic infection, which may threaten your life or your future capacity to have children. Ask your doctor about your private risk and about ways to help prevent a pelvic infection.

• You must not use this device if you are allergic to levonorgestrel, silicone, silica, silver, barium, iron oxide, or polyethylene, or if you have:

· emergency vaginal bleeding;

· an untreated or uncontrolled pelvic infection (vaginal, cervical uterine, or bladder);

· a serious pelvic infection next a pregnancy or abortion within the past 3 months;

· a history of pelvic inflammatory malady (PID), unless you have had a usual pregnancy after the infection was treated and cleared;

· uterine fibroid tumors or another conditions that affect the shape of the uterus;

· past or gift breast cancer, known or suspected cervical or uterine cancer;

· liver malady or liver tumor (benign or malignant);

· a last emergency Pap smear that has not yet been diagnosed or treated;

· a malady or condition that weakens your immune system, such as AIDS, leukemia, or IV drug abuse; or

· if you have other intrauterine device (IUD) in place.

• You may need particular trials to safely use a levonorgestrel intrauterine device if you have:

· diabetes;

· a bleeding or blood-clotting disorder;

· migraine headaches;

· a vaginal infection, pelvic infection, or sexually transmitted malady; or

· tall blood pressure, heart malady or a heart valve disorder.

The levonorgestrel intrauterine system must not be used during pregnancy. This device can reason severe infection, miscarriage, premature birth, or death of the mother if it is left in seat 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.

• If you have recently had a child and are breast-feeding, wait before your child is at least 6 weeks old till you start using the intrauterine system.

How is levonorgestrel intrauterine system used?

• Levonorgestrel is a T-shaped plastic device that is inserted through the vagina and placed into the uterus. Your doctor will seat the device into your uterus using a thin plastic pipe. The device is generally 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. These symptoms must recent only 30 minutes or smaller. Tell your doctor if you still have these symptoms longer than 30 minutes.

• The levonorgestrel intrauterine system must not interfere with sexual intercourse, wearing tampons, or using another vaginal medications recommended by your doctor.

• After every menstrual period you must check to create certain you can still feel the removal strings. Wash your hands with soap and water, and insert your clean fingers into the vagina. You must be able to feel the strings at the opening of your cervix. Call your doctor at once if you can't feel the strings, or if you think the device has slipped lower in your uterus or out of your uterus. A sudden magnify in menstrual flow may be a sign that the device has slipped out of place.

• If you think the device is not properly in seat, use a non-hormone method of birth control (condom, or diaphragm with spermicide) to prevent pregnancy before your doctor is able to replace the levonorgestrel device.

• Your doctor will need to see you within a little weeks after insertion of the device to create certain it is still in seat correctly. You will also need regular annual pelvic exams and Pap smears.

If you need to have an MRI (magnetic resonance imaging), speak your caregivers onward of time that you have the levonorgestrel 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 different months. Call your doctor if you miss a period or think you might be pregnant.

• Your device may be removed at any time you solve to stop using birth control. The Mirena intrauterine system should be removed at the end of the 5-year wearing time. The Skyla device should 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 must remove the intrauterine system. Do not attempt to remove the device yourself.

• Next 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 doze of levonorgestrel, missing a doze 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 must I avoid while using levonorgestrel intrauterine system?

• Avoid having more than one sexual partner. Levonorgestrel intrauterine device can magnify your risk of developing a serious pelvic infection, which is often caused by sexually transmitted malady. Levonorgestrel intrauterine system will not protect you from sexually transmitted illness, including HIV and AIDS. Using a condom is the only way to help protect yourself from these illness. Contact your doctor if your sexual partner develops HIV or a sexually transmitted malady, or if you have any change in sexual relationships.

What are the possible side effects of levonorgestrel intrauterine system?

• Get abnormal 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 pipe 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 external the uterus and reason scarring, infection, or hurt to another 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;

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

· pale skin, weakness, light bruising or bleeding, fever, chills, or another 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 person, lips, tongue, or throat.

• General side effects may include:

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

· 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 person, 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 message side effects to FDA at 1-800-FDA-1088.

What another drugs will affect levonorgestrel intrauterine system?

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

· bosentan, griseofulvin, insulin, St. John's wort, topiramate; or

· a barbiturate--butabarbital, phenobarbital, secobarbital, and others; a blood thinner--warfarin, Coumadin; HIV/AIDS medication--efavirenz, nevirapine, ritonavir; seizure medication--carbamazepine, fosphenytoin, oxcarbazepine, phenobarbital, phenytoin, primidone; steroids--prednisone, fluticasone, mometasone, dexamethasone, and others; tuberculosis medication--rifabutin, rifampin, rifapentine.

• This list is not complete. Another drugs may interact with levonorgestrel, including prescription and over-the-counter medicines, vitamins, and herbal commodity. Not all possible interactions are listed in this medicine manual.

Where can I get more information?

• Your doctor or pharmacist can provide more information about the levonorgestrel intrauterine system.

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Disclaim: Each 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 external 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 must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help 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.

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