Available in:Device
Dosage:19.5MG, 52MG
Manufacturer:Bayer
Available in:Device
Dosage:19.5MG, 52MG
Manufacturer:Bayer
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This device is placed inside the uterus by your doctor within 7 days after the start of your period. Your doctor will most likely perform a gynecological examination before the device is inserted to examine your uterus for correct placement and to rule out pregnancy or other gynecological conditions that would make using levonorgestrel undesirable.
The device is inserted during a routine office visit with your doctor and only takes a few minutes. You may have to go back to your doctor's office about 4 to 12 weeks after the device is inserted to ensure it is in the right position, and then once a year thereafter or as directed by your doctor. The device can be left in place for up to 5 years, after which a decision must be made whether to replace the device with a new one or simply to remove the old device.
It is important to use this contraceptive device exactly as prescribed by your doctor.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
This device is placed inside the uterus by your doctor within 7 days after the start of your period. Your doctor will most likely perform a gynecological examination before the device is inserted to examine your uterus for correct placement and to rule out pregnancy or other gynecological conditions that would make using levonorgestrel undesirable.
The device is inserted during a routine office visit with your doctor and only takes a few minutes. You may have to go back to your doctor's office about 4 to 12 weeks after the device is inserted to ensure it is in the right position, and then once a year thereafter or as directed by your doctor. The device can be left in place for up to 5 years, after which you must decide whether to replace the device with a new one or simply to remove the old device.
It is important Kyleena (Levonorgestrel-intra-uterine) be used exactly as recommended by your doctor. If you miss an appointment to have a new levonorgestrel-releasing intrauterine device removed or inserted, contact your doctor as soon as possible to reschedule your appointment. After 5 years, this device may not prevent pregnancy.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes Mirena (Levonorgestrel-intra-uterine). If you are concerned about side effects, discuss the risks and benefits of Mirena (Levonorgestrel-intra-uterine) with your doctor.
The following side effects have been reported by at least 1% of people taking Mirena (Levonorgestrel-intra-uterine). Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
Stop taking the medication and seek immediate medical attention if any of the following occur:
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Mirena (Levonorgestrel-intra-uterine).
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes Kyleena (Levonorgestrel-intra-uterine). If you are concerned about side effects, discuss the risks and benefits of Kyleena (Levonorgestrel-intra-uterine) with your doctor.
The following side effects have been reported by at least 1% of people taking Kyleena (Levonorgestrel-intra-uterine). Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
Stop taking the medication and seek immediate medical attention if any of the following occur:
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Kyleena (Levonorgestrel-intra-uterine).
Mirena® is supplied as a soft, flexible, T-shaped device about the size of a quarter. It contains 52 mg of levonorgestrel in a cylindrical-shaped reservoir. The reservoir is mounted on a T-shaped frame and covered with a rate-controlling membrane of polydimethylsiloxane and silica. The T-frame is coloured with barium sulfate. The polyethylene removal threads attached to the T-frame are coloured with black iron oxide.
Kyleena® consists of a small, white, T-shaped body made from soft, flexible plastic. The vertical and horizontal arms of the T-body are about 3 cm long. The vertical arm is surrounded by a narrow, cylindrical drug reservoir that contains levonorgestrel. Nonmedicinal ingredients: barium sulphate, copper phthalocyanine, polydimethylsiloxane elastomer, polyethylene, polypropylene, silica colloidal anhydrous, and silver. Two fine blue plastic threads are attached to the tip of the vertical arm. In addition, the vertical stem contains a silver ring located close to the horizontal arms, which is visible under ultrasound.
The levonorgestrel IUD should not be used by anyone who:
Do not take Kyleena (Levonorgestrel-intra-uterine) if you:
There may be an interaction between the levonorgestrel IUD device and any of the following:
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than the ones listed above may interact with Mirena (Levonorgestrel-intra-uterine). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, Nicotine from cigarettes, and street drugs can affect the action of many medications, you should let your prescriber know if you use them.
There may be an interaction between levonorgestrel intrauterine system and any of the following:
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with Kyleena (Levonorgestrel-intra-uterine). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Mirena (Levonorgestrel-intra-uterine).
Blood pressure: Levonorgestrel can cause an increase in blood pressure. If you have high blood pressure, discuss with your doctor how Mirena (Levonorgestrel-intra-uterine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Mirena (Levonorgestrel-intra-uterine), and whether any special monitoring is needed.
If you experience an increase in your blood pressure after having this device inserted, contact your doctor.
Breast cancer: Cases of breast cancer have been reported by women using levonorgestrel-releasing IUDs. However, some studies have shown that progestin-only forms of birth control do not appear to increase the risk of breast cancer. Discuss any concerns you have with your doctor.
Depression: Hormones, such as progestins, are known to contribute to mood swings and symptoms of depression. If you have depression or a history of depression, discuss with your doctor how Mirena (Levonorgestrel-intra-uterine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Mirena (Levonorgestrel-intra-uterine), and whether any special monitoring is needed.
If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, or notice them in a family member who is taking Mirena (Levonorgestrel-intra-uterine), contact your doctor as soon as possible.
Diabetes: Low-dose contraceptives such as this device have very little effect on blood sugar control. However, people with diabetes or those with a family history of diabetes should monitor their blood sugar closely to detect any worsening of blood sugar control.
Ectopic Pregnancy: If you have a history of ectopic pregnancy (when a fertilized egg implants itself outside of the uterus), have had surgery on the fallopian tubes, or have had a pelvic infection, you should speak to your doctor or pharmacist before using this device. If you experience lower abdominal pain along with a missed period or unexpected bleeding while using Mirena (Levonorgestrel-intra-uterine), contact your doctor.
Expulsion of device: Bleeding or pain may indicate that the device has either moved out of position or has been expelled from the uterine cavity. A device that is out of position is less effective and should be removed and replaced by a new device.
Eye problems: Some women may experience a change in vision or contact lens tolerance. If this occurs, contact your eye doctor.
Headache: Levonorgestrel, like other hormones, may cause severe headache or migraine. If you have a history of migraines, discuss with your doctor how Mirena (Levonorgestrel-intra-uterine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Mirena (Levonorgestrel-intra-uterine), and whether any special monitoring is needed.
If you notice increasing numbers or severity of headaches after the device has been inserted, contact your doctor as soon as possible.
Heart disease: Levonorgestrel may increase the risk of developing Blood Clots, causing reduced blood flow to organs or the extremities. If you have a history of clotting you may be at increased risk of experiencing blood clot-related problems such as heart attack, stroke, or clots in the deep veins of your leg. Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels. Discuss with your doctor how Mirena (Levonorgestrel-intra-uterine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Mirena (Levonorgestrel-intra-uterine), and whether any special monitoring is needed.
If you experience symptoms such as sharp pain and swelling in the leg, difficulty breathing, chest pain, blurred vision, or difficulty speaking, contact your doctor immediately.
Heart valve disorders: Mirena (Levonorgestrel-intra-uterine) can increase your risk of getting an infection in your heart valves if you were born with or have acquired a heart valve defect. You may need to take antibiotics before the insertion and removal of Mirena (Levonorgestrel-intra-uterine) to prevent the infection.
Insertion and removal of the device: Some women may experience some pain and bleeding when the device is inserted or removed. The procedure may also cause fainting or a seizure for someone with a seizure disorder.
Liver disease: If you develop signs of a liver problem (yellow skin or eyes, dark urine, pale stools, abdominal pain, or itchy skin), talk to your doctor about whether you should have the device removed.
Menstrual bleeding: Some women may experience some pain and bleeding when the device is inserted or removed. Irregular menstrual bleeding is common for the first few months after the device is inserted. Over time, menstrual bleeding decreases and may stop completely while the device is inserted.
Ovarian cysts: Mirena (Levonorgestrel-intra-uterine) can cause the development of ovarian cysts. Most of these don't have any symptoms and disappear on their own within 2 to 3 months. However, if you experience pain in the pelvic area, contact your doctor.
Perforation: The chance of the device puncturing the cervix or uterus is very rare (between 1 in 1,000 and 1 in 10,000). If it were to occur, it would most likely be when the device is being inserted. If this happens, the device should be removed as soon as possible.
Removal of the device: If you experience any of the following, check with your doctor to see if you should have your device removed:
Return to fertility: Your usual level of fertility should return soon after the device is removed. Nearly 90% of women wishing to become pregnant conceive within 24 months after removal of the device.
Sexually transmitted infections (STIs): This device does not protect against STIs, including HIV/AIDS. For protection against STIs, use latex condoms.
Pregnancy: This device should not be used during pregnancy. You should have this device removed if you become pregnant. Any device in the uterus during pregnancy can result in an increased risk of miscarriage or early labour. There is no evidence of birth defects when the device remains in the uterus for the full term. However, there is no conclusive evidence of this because of limited experience.
Breast-feeding: Hormonal birth control, such as this device, is not the first choice of birth control for women who are breast-feeding. Mirena (Levonorgestrel-intra-uterine) passes into breast milk. If you are a breast-feeding mother and are using levonorgestrel, it may affect your baby. Some women using Mirena (Levonorgestrel-intra-uterine) have reported decreased milk production. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using Mirena (Levonorgestrel-intra-uterine) have not been established for children under 18 years of age. This contraceptive device is not the first option of contraception for women that have not been pregnant before.
Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Kyleena (Levonorgestrel-intra-uterine).
Blood Clots: Kyleena (Levonorgestrel-intra-uterine) may increase the chance of blood clot formation, causing reduction of blood flow to organs or the extremities.
If you have a history of clotting you may be at increased risk of experiencing blood clot-related problems such as Heart Attack, stroke, or clots in the deep veins of your leg. Discuss with your doctor how Kyleena (Levonorgestrel-intra-uterine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Kyleena (Levonorgestrel-intra-uterine), and whether any special monitoring is needed.
If you experience symptoms such as sharp pain and swelling in the leg, difficulty breathing, chest pain, blurred vision, or difficulty speaking, contact your doctor immediately.
Blood pressure: Levonorgestrel can cause an increase in blood pressure. If you have high blood pressure, discuss with your doctor how Kyleena (Levonorgestrel-intra-uterine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Kyleena (Levonorgestrel-intra-uterine), and whether any special monitoring is needed.
If you experience an increase in your blood pressure after having this device inserted, contact your doctor.
Depression: Hormones, such as progestins, are known to contribute to mood swings and symptoms of depression. If you have depression or a history of depression, discuss with your doctor how Kyleena (Levonorgestrel-intra-uterine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Kyleena (Levonorgestrel-intra-uterine), and whether any special monitoring is needed.
If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, or decreased interest in activities, or notice them in a family member who is taking Kyleena (Levonorgestrel-intra-uterine), contact your doctor as soon as possible.
Diabetes: While low-dose contraceptives, such as this device, often have very little effect on blood sugar control, women with diabetes or those with a family history of diabetes should monitor their blood sugar closely to detect any worsening of blood sugar control.
Ectopic pregnancy: If you have a history of ectopic pregnancy (when a fertilized egg implants itself outside of the uterus), have had surgery on the fallopian tubes, or have had a pelvic infection, you should speak to your doctor or pharmacist before using this device. If you experience lower abdominal pain along with a missed period or unexpected bleeding while using Kyleena (Levonorgestrel-intra-uterine), contact your doctor.
Expulsion of device: Bleeding or pain may indicate that the device has either moved out of position or been expelled from the uterine cavity. A device that is out of position is less effective and should be removed and replaced by a new device.
Eye problems: Some women may experience a change in vision or contact lens tolerance. If this occurs, contact your eye doctor.
Headache: Levonorgestrel, like other hormones, may cause severe headache or migraine. If you have a history of migraine, discuss with your doctor how Kyleena (Levonorgestrel-intra-uterine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Kyleena (Levonorgestrel-intra-uterine), and whether any special monitoring is needed.
If you notice increasing numbers or severity of Headaches after the device has been inserted, contact your doctor as soon as possible.
Heart disease: Levonorgestrel may increase the risk of developing blood clots, causing reduced blood flow to organs or the extremities. If you have a history of clotting, you may be at increased risk of experiencing blood-clot-related problems such as heart attack, stroke, or clots in the deep veins of your leg. Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels. Discuss with your doctor how Kyleena (Levonorgestrel-intra-uterine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Kyleena (Levonorgestrel-intra-uterine), and whether any special monitoring is needed.
If you experience symptoms such as sharp pain and swelling in the leg, difficulty breathing, chest pain, blurred vision, or difficulty speaking, contact your doctor immediately.
Heart valve disorders: Kyleena (Levonorgestrel-intra-uterine) can increase your risk of getting an infection in your heart valves if you were born with or have acquired a heart valve defect. You may need to take antibiotics before the insertion and removal of Kyleena (Levonorgestrel-intra-uterine) to prevent the infection.
Infections: In the first few weeks after this device is inserted, you may be at an increased risk of a serious infection known as pelvic inflammatory disease (PID). This infection can cause the development of pregnancy outside the uterus (ectopic pregnancy) or ongoing pelvic pain. If you experience heavy bleeding, unusual vaginal discharge, pain in the lower stomach area, pain during sexual activity, chills, or fever, contact your doctor as soon as possible.
Liver function: Women who have a history of liver problems, particularly during pregnancy, may also be at an increased risk of developing liver problems when using this device. Your doctor may want to test your liver function regularly with blood tests while you are taking Kyleena (Levonorgestrel-intra-uterine).
If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.
Menstrual bleeding: Some women may experience pain and bleeding when the device is inserted or removed. Irregular menstrual bleeding is common for the first few months after the device is inserted. Over time, menstrual bleeding decreases and may stop completely while the device is inserted.
If you develop unusual or unexpected menstrual bleeding after using Kyleena (Levonorgestrel-intra-uterine) for some time, contact your doctor.
Ovarian cysts: Kyleena (Levonorgestrel-intra-uterine) can cause the development of ovarian cysts. Most of these don't have any symptoms and disappear on their own within 2 to 3 months. However, if you experience pain in the pelvic area, contact your doctor.
Perforation: The chance of the device puncturing the cervix or uterus is very rare (between 1 in 1,000 and 1 in 10,000). If it were to occur, it would most likely be when the device is being inserted. If this happens, the device should be removed as soon as possible.
Removal of the device: If you experience any of the following, check with your doctor to see if you should have your device removed:
Sexually transmitted infections (STIs): This device does not protect against STIs, including HIV/AIDS. For protection against STIs, use latex condoms.
Pregnancy: This device should not be used during pregnancy. If you become pregnant, have this device removed as soon as possible. The effects of levonorgestrel on a developing infant are not well known, and the risk of harm to the baby cannot be completely ruled out. Removal of this device or probing of the uterus may result in spontaneous abortion, but an intrauterine system that is left in place during pregnancy increases chances of having a miscarriage or premature delivery. Talk to your doctor about the risks to you and your unborn child.
Breast-feeding: Hormonal birth control, such as this device, is not the first choice of birth control for women who are breast-feeding. Kyleena (Levonorgestrel-intra-uterine) passes into breast milk. If you are a breast-feeding mother and are using levonorgestrel, it may affect your baby. Some women using Kyleena (Levonorgestrel-intra-uterine) have reported decreased milk production. Talk to your doctor about whether you should continue breast-feeding.
Children: The levonorgestrel-releasing intrauterine system is not intended to be used by girls who have not had their first menstrual period. The safety and effectiveness of using Kyleena (Levonorgestrel-intra-uterine) have not been established for adolescents less than 18 years old.
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