Norplant System

Generic Name: levonorgestrel intrauterine system (LEE voe nor JES trel)

What is Norplant System (levonorgestrel intrauterine system)?

Levonorgestrel is a female hormone. This hormone 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 the hormone levonorgestrel. This device is placed in the uterus where it slowly releases the hormone to prevent pregnancy for up to 5 years. Levonorgestrel intrauterine system is meant for use in a woman who has had at least one child and is in a stable sexual relationship with someone who has no other sexual partners.

Levonorgestrel is a progestin hormone and does not contain estrogen. The intrauterine device releases levonorgestrel into the uterus, but only small amounts of the hormone reach your blood stream.

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

What is the most important information I should know about Norplant System (levonorgestrel intrauterine system)?

You should not use this medication if you have abnormal vaginal bleeding, an uncontrolled pelvic infection, a condition that affects the shape of the uterus, past or present breast cancer, a liver problem, cervical or uterine cancer, a weak immune system, if you have recently had a serious pelvic infection following a pregnancy or abortion, or if you already have an intrauterine device (IUD) in place.

You also should not use this medication if you have a history of pelvic inflammatory disease (unless you have had a normal pregnancy after the infection was treated and cleared), a recent abnormal Pap smear that has not yet been diagnosed or treated, or if you do not have an exclusive sexual partner.

Before using the levonorgestrel intrauterine device, tell your doctor if you have diabetes, a bleeding or blood-clotting disorder, a vaginal infection, pelvic infection, or sexually transmitted disease, high blood pressure, heart disease, or a heart valve disorder.

Serious side effects of the intrauterine system include severe cramps or pelvic pain, heavy or ongoing vaginal bleeding, unusual vaginal discharge, pale skin, easy bruising or bleeding, fever, chills, sudden numbness or weakness, severe headaches, or jaundice (yellowing of the skin or eyes). Only your doctor should remove the levonorgestrel intrauterine system. Do not attempt to remove the device yourself.

What should I discuss with my healthcare provider before taking Norplant System (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 medication if you are allergic to levonorgestrel, silicone, or polyethylene, or if you have:

abnormal vaginal bleeding;

an untreated or uncontrolled pelvic infection (vaginal, 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;

if you have another intrauterine device (IUD) in place; or

if you do not have an exclusive sexual partner.

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

diabetes;

a bleeding or blood-clotting disorder;

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 a levonorgestrel intrauterine device for you.

The levonorgestrel intrauterine system 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 levonorgestrel 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 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. 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 intrauterine device. You may also have some vaginal bleeding. These symptoms should last only 30 minutes or less after the device is inserted, especially if you stay in a sitting or lying position during that time. Tell your doctor if you still have these symptoms after 30 minutes have passed.

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.

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 deep inside the vagina, 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 (such as a condom, diaphragm, spermicide) to prevent pregnancy until your doctor is able to replace the levonorgestrel device.

Your doctor will need to see you within 4 and 12 weeks after insertion of the device to make sure it is still in place correctly. Be sure to also have regular annual pelvic exams and Pap smears while you are using the levonorgestrel intrauterine system.

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

You may have irregular periods during the first 3 to 6 months of using the intrauterine system. Your flow may be lighter or heavier, and you may eventually stop having periods after several months. Contact your doctor if you think you might be pregnant, or if you do not have a menstrual period for 6 weeks in a row.

The levonorgestrel 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 contraception. Only your doctor should remove the intrauterine system. Do not attempt to remove the device yourself.

Following removal of the levonorgestrel intrauterine device, you may become pregnant right away. Most women who choose to discontinue using the device in order to have a baby will become pregnant within the first year after removal.

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 Norplant System (levonorgestrel intrauterine system)?

Avoid having sexual intercourse with more than one partner. Also avoid having sexual intercourse with a partner who has other sexual partners besides you. 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.

Norplant System (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. If the device embeds in or perforates the uterine wall, your doctor may need to surgically remove the device.

Call your doctor at once if you have a serious side effect such as:

severe cramps or pelvic pain;

extreme dizziness, feeling like you might pass out;

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.

Less serious side effects may include:

irregular menstrual periods, changes in bleeding patterns or flow;

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

back pain;

headache, nervousness, mild dizziness;

nausea, vomiting, bloating;

breast tenderness or pain;

weight gain, acne, changes in hair growth;

mood changes, loss of interest in sex;

mild itching, skin rash; or

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

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Norplant System (levonorgestrel intrauterine system)?

Tell your doctor about all other medications you use, especially:

insulin;

a blood thinner such as warfarin (Coumadin); or

steroids such as prednisone, fluticasone (Advair), mometasone (Asmanex, Nasonex), dexamethasone (Decadron, Hexadrol) and others.

This list is not complete and there may be other drugs that can interact with the levonorgestrel intrauterine system. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.