Mirena

DRUG DESCRIPTION

Mirena (levonorgestrel-releasing intrauterine system) is intended to provide an initial release rate of 20 mcg/day of levonorgestrel

Levonorgestrel USP, (-)-13-Ethyl-17-hydroxy-18,19-dinor-17?-pregn-4-en-20-yn-3-one, the active ingredient in Mirena (levonorgestrel-releasing intrauterine system) , has a molecular weight of 312.4, a molecular formula of C21H28O2, and the following structural formula:

Mirena (levonorgestrel) Structural Formula Illustration

Mirena

Mirena (levonorgestrel-releasing intrauterine system) consists of a T-shaped polyethylene frame (T-body) with a steroid reservoir (hormone elastomer core) around the vertical stem. The reservoir consists of a white or almost white cylinder, made of a mixture of levonorgestrel and silicone (polydimethylsiloxane), containing a total of 52 mg levonorgestrel. The reservoir is covered by a semi-opaque silicone (polydimethylsiloxane) membrane. The T-body is 32 mm in both the horizontal and vertical directions. The polyethylene of the T-body is compounded with barium sulfate, which makes it radiopaque. A monofilament brown polyethylene removal thread is attached to a loop at the end of the vertical stem of the T-body.

Schematic drawing of Mirena (levonorgestrel-releasing intrauterine system)

Schematic drawing of Mirena - Illustration

Inserter

Mirena (levonorgestrel-releasing intrauterine system) is packaged sterile within an inserter. The inserter, which is used for insertion of Mirena (levonorgestrel-releasing intrauterine system) into the uterine cavity, consists of a symmetric two-sided body and slider that are integrated with flange, lock, pre-bent insertion tube and plunger. Once Mirena (levonorgestrel-releasing intrauterine system) is in place, the inserter is discarded.

Diagram of Inserter

Diagram of Inserter - Illustration

What are the possible side effects of levonorgestrel intrauterine system (Mirena)?

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...

Read All Potential Side Effects and See Pictures of Mirena

What are the precautions when taking levonorgestrel-releasing intrauterine system (Mirena)?

Before using this medication device, tell your doctor or pharmacist if you are allergic to levonorgestrel, or to any other progestins (e.g., norethindrone, desogestrel); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication device should not be used if you have certain medical conditions. Before using this product, consult your doctor or pharmacist if you have: current known or suspected pregnancy, previous ectopic pregnancy, uterus problems (e.g., cancer, endometriosis, fibroids, pelvic inflammatory disease-PID), other IUD (intrauterine device) still in place, vaginal problems (e.g., infection), breast cancer, liver disease/tumors, any...

Read All Potential Precautions of Mirena


Mirena Consumer (continued)

SIDE EFFECTS: Irregular vaginal bleeding (e.g., spotting), cramps, headache, nausea, breast pain, acne, rash, hair loss, weight gain, or decreased interest in sex may occur. If any of these effects persist or worsen, tell your doctor promptly.

Remember that your doctor has prescribed this medication device because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication device do not have serious side effects.

Tell your doctor immediately if any of these serious side effects occur: lack of menstrual period, unexplained fever, chills, trouble breathing, mental/mood changes (e.g., depression, nervousness), vaginal swelling/itching, painful intercourse.

Tell your doctor immediately if any of these unlikely but serious side effects occur: migraine/severe headache, vomiting, tiredness, fast/pounding heartbeat.

Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: prolonged or heavy vaginal bleeding, unusual vaginal discharge/odor, vaginal sores, abdominal/pelvic pain or tenderness, lumps in the breast, yellowing eyes/skin, dark urine, persistent nausea, trouble urinating.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this medication device, tell your doctor or pharmacist if you are allergic to levonorgestrel, or to any other progestins (e.g., norethindrone, desogestrel); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication device should not be used if you have certain medical conditions. Before using this product, consult your doctor or pharmacist if you have: current known or suspected pregnancy, previous ectopic pregnancy, uterus problems (e.g., cancer, endometriosis, fibroids, pelvic inflammatory disease-PID), other IUD (intrauterine device) still in place, vaginal problems (e.g., infection), breast cancer, liver disease/tumors, any condition that affects your immune system (e.g., AIDS, leukemia).

Before using this product, tell your doctor your medical history, especially of: bleeding problems (e.g., menstrual changes, clotting problems), heart problems (e.g., congenital valve conditions), high blood pressure, migraine headaches, stroke, diabetes.

If you have diabetes, this medication may make it harder to control your blood sugar levels. Monitor your blood sugar regularly as directed by your doctor. Tell your doctor the results and any symptoms such as increased thirst/urination. Your anti-diabetic medication or diet may need to be adjusted.

This medication device may sometimes come out by itself or move out of place. This may result in unwanted pregnancy or other problems. After each menstrual period, check to make sure it is in the right place. Talk to your doctor about how to check your device. If it comes out or you cannot feel its threads, call your doctor promptly, and use a backup birth control method such as condoms.

If you or partner has any other sexual partners, this medication device may no longer be a good choice for pregnancy prevention. If you or your partner becomes HIV positive, or if you think you may have been exposed to any sexually transmitted disease, contact your doctor immediately. You should consider having this device removed.

This medication device must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor immediately. If you have just given birth and are not breast-feeding, or if you have had a pregnancy loss or abortion after the 3 months of pregnancy, wait at least 6 weeks (or as directed by your doctor) before using this medication device. Consult your doctor about the problems that may occur during pregnancy while using this product.

Levonorgestrel passes into breast milk. Consult your doctor before breast-feeding.


Mirena Patient Information Including Side Effects

Brand Names: Mirena

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

  • What is levonorgestrel intrauterine system (Mirena)?
  • What are the possible side effects of levonorgestrel intrauterine system (Mirena)?
  • What is the most important information I should know about levonorgestrel intrauterine system (Mirena)?
  • What should I discuss with my healthcare provider before taking levonorgestrel intrauterine system (Mirena)?
  • How is levonorgestrel intrauterine system used (Mirena)?
  • What happens if I miss a dose (Mirena)?
  • What happens if I overdose (Mirena)?
  • What should I avoid while using levonorgestrel intrauterine system (Mirena)?
  • What other drugs will affect levonorgestrel intrauterine system (Mirena)?
  • Where can I get more information?

What is levonorgestrel intrauterine system (Mirena)?

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 intrauterine system 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 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 are the possible side effects of levonorgestrel intrauterine system (Mirena)?

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 is the most important information I should know about levonorgestrel intrauterine system (Mirena)?

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.

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