MIRENA

Mirena Information

Mirena is a popular progestin intrauterin device (IUD) that has proven itself to be highly efficient in preventing the patient (the woman) from becoming pregnant for a certain time period (in some cases, the effect lasts for 5 years). This device alters the uterus’ lining, therefore preventing implantation (in case the fertilization does occur).

Mirena Dosage and Administration

Mirena contains 52 mg of levonorgestrel. Initially, levonorgestrel is released at a rate of approximately 20 mcg/day. This rate decreases progressively to half that value after 5 years.

Mirena is packaged sterile within an inserter. Information regarding insertion instructions, patient counseling and record keeping, patient follow-up, removal of Mirena and continuation of contraception after removal is provided below.

. Insertion Instructions

• NOTE: Mirena should be inserted by a trained healthcare provider. Healthcare providers are advised to become thoroughly familiar with the insertion instructions before attempting insertion of Mirena.
• Mirena is inserted with the provided inserter (Figure 1a)  into the uterine cavity within seven days of the onset of menstruation or immediately after a first trimester abortion by carefully following the insertion instructions. It can be replaced by a new Mirena at any time during the menstrual cycle.
• 

  Figure 1a. Mirena and inserter

Preparation for insertion

• Ensure that the patient understands the contents of the Patient Information Booklet and obtain consent. A consent form that includes the lot number is on the last page of the Patient Information Booklet.
• Confirm that there are no contraindications to the use of Mirena.
• Perform a urine pregnancy test, if indicated.
• With the patient comfortably in lithotomy position, gently insert a speculum to visualize the cervix and rule out genital contraindications to the use of Mirena.
• Do a bimanual exam to establish the size and position of the uterus, to detect other genital contraindications, and to exclude pregnancy.
• Thoroughly cleanse the cervix and vagina with a suitable antiseptic solution. Perform a paracervical block, if needed.
• Prepare to sound the uterine cavity. Grasp the upper lip of the cervix with a tenaculum forceps and apply gentle traction to align the cervical canal with the uterine cavity. If the uterus is retroverted, it may be more appropriate to grasp the lower lip of the cervix. Note that the tenaculum forceps should remain in position throughout the insertion procedure to maintain gentle traction on the cervix.
• Gently insert a uterine sound to check the patency of the cervix, measure the depth of the uterine cavity, confirm its direction and exclude the presence of any uterine anomaly. If you encounter cervical stenosis, use dilatation, not force, to overcome resistance.
• The uterus should sound to a depth of 6 to 10 cm. Insertion of Mirena into a uterine cavity less than 6 cm by sounding may increase the incidence of expulsion, bleeding, pain, perforation, and possibly pregnancy.
• After ascertaining that the patient is appropriate for Mirena, open the carton containing Mirena.

Insertion Procedure

Ensure use of sterile technique throughout the entire procedure.

Step 1–Opening of the sterile package

• Open the sterile package completely (Figure 1b).
• Place sterile gloves on your hands.
• Pick up the handle of the inserter containing Mirena and carefully release the threads so that they hang freely.

Place your thumb or forefinger on the slider. Make sure that the slider is in the furthest position away from you, for example, at the top of the handle towards the insertion tube (Figure 1b).
NOTE: Keep your thumb or forefinger on the slider until insertion is complete.

• With the centimeter scale of the insertion tube facing up, check that the arms of Mirena are in a horizontal position. If they are not, align them on a flat, sterile surface, for example, the sterile package (Figures 1b and 1c).
• 

  Figure 1b. Aligning the arms with the slider in the furthest position

• 

  Figure 1c. Checking that the arms are horizontal and aligned with respect to the scale

Step 2–Load Mirena into the insertion tube

• Holding the slider in the furthest position, pull on both threads to load Mirena into the insertion tube (Figure 2a).
• Note that the knobs at the ends of the arms now meet to close the open end of the insertion tube (Figure 2b).

  If the knobs do not meet properly

If the knobs do not meet properly, release the arms by pulling the slider back to the mark (raised horizontal line on the handle) (Figure 6a) . Re-load Mirena by aligning the open arms on a sterile surface (Figure 1b). Return the slider to its furthermost position and pull on both threads. Check for proper loading (Figure 2b).

Step 3–Secure the threads

Secure the threads in the cleft at the bottom end of the handle to keep Mirena in the loaded position (Figure 3).

Step 4–Setting the flange

Set the upper edge of the flange to the depth measured during the uterine sounding (Figure 4). 

 

 Step 5–Mirena is now ready to be inserted

• Continue to hold the slider with the thumb or forefinger firmly in the furthermost position. Grasp the tenaculum forceps with your other hand and apply gentle traction to align the cervical canal with the uterine cavity.
• While maintaining traction on the cervix, gently advance the insertion tube through the cervical canal and into the uterine cavity until the flange is 1.5 to 2 cm from the external cervical os.
• CAUTION: do not advance flange to the cervix at this step. Maintaining the flange 1.5 to 2 cm from the cervical os allows sufficient space for the arms to open (when released) within the uterine cavity (Figures 5 and 6b).

  NOTE! Do not force the inserter. If necessary, dilate the cervical canal.

Step 6–Release the arms

• While holding the inserter steady, release the arms of Mirena by pulling the slider back until the top of the slider reaches the mark (raised horizontal line on the handle) (Figure 6a).
• Wait approximately 10 seconds to allow the horizontal arms of Mirena to open and regain its T-shape (Figure 6b).

Step 7–Advance to fundal position

Gently advance the inserter into the uterine cavity until the flange meets the cervix and you feel fundal resistance. Mirena should now be in the desired fundal position (Figure 7).

Step 8–Release Mirena and withdraw the inserter

• While holding the inserter steady, pull the slider all the way down to release Mirena from the insertion tube (Figure 8). The threads will release automatically from the cleft.
• Check that the threads are hanging freely and gently withdraw the inserter from the uterus. Be careful not to pull on the threads as this will displace Mirena.

Step 9–Cut the threads

• Cut the threads perpendicular to the thread length, for example, with sterile curved scissors, leaving about 3 cm visible outside the cervix (Figure 9).
  NOTE: Cutting threads at an angle may leave sharp ends.

Mirena insertion is now complete.

Important information to consider during or after insertion

• If you suspect that Mirena is not in the correct position, check placement (for example, with transvaginal ultrasound). Remove Mirena if it is not positioned completely within the uterus. A removed Mirena must not be reinserted.
• If there is clinical concern and/or exceptional pain or bleeding during or after insertion, appropriate and timely measures and assessments, for example ultrasound, should be performed to exclude perforation.

Patient Counseling and Record Keeping

• Keep a copy of the consent form and lot number for your records.
• Counsel the patient on what to expect following Mirena insertion. Give the patient the Follow-up Reminder Card that is provided with the product. Discuss expected bleeding patterns during the first months of Mirena use. [See Patient Counseling Information (17.1).]
• Prescribe analgesics, if indicated.

Patient Follow-up

• Patients should be reexamined and evaluated 4 to 12 weeks after insertion and once a year thereafter, or more frequently if clinically indicated.

Removal of Mirena

• Remove Mirena by applying gentle traction on the threads with forceps. The arms will fold upward as it is withdrawn from the uterus. Mirena should not remain in the uterus after 5 years.
• Removal may be associated with some pain and/or bleeding or neurovascular episodes.
• If the threads are not visible and Mirena is in the uterine cavity, it may be removed using a narrow forceps, such as an alligator forceps. This may require dilation of the cervical canal [see Warnings and Precautions (5.13)].
• After removal of Mirena, verify that the system is intact.
• During difficult removals, the hormone cylinder may slide over and cover the horizontal arms. This situation generally does not require further intervention once the system is verified to be intact.
• If Mirena is removed mid-cycle and the woman has had intercourse within the preceding week, she is at a risk of pregnancy unless a new Mirena is inserted immediately following removal.

Continuation of Contraception after Removal

• You may insert a new Mirena immediately following removal.
• If a patient with regular cycles wants to start a different birth control method, remove Mirena during the first 7 days of the menstrual cycle and start the new method.
• If a patient with irregular cycles or amenorrhea wants to start a different birth control method, or if you remove Mirena after the seventh day of the menstrual cycle, start the new method at least 7 days before removal.

Dosage Forms and Strengths

Mirena is a levonorgestrel-releasing intrauterine system consisting of a T-shaped polyethylene frame with a steroid reservoir containing a total of 52 mg levonorgestrel.

Mirena Indications

Mirena is a device that prevents women from becoming pregnant for a certain period of time. Ask your personal physician for further information regarding the uses of this IUD.

Mirena Warnings

Some medical conditions (disorders) are known to interact with this IUD device. Before you consider using this device, you should alert your personal physician if you are suffering from any medical disorders, especially if the following statements apply to you:

• if you are breastfeeding, are pregnant or are planning to become pregnant soon
• if you are following a treatment with any non prescription or prescription drugs, herbal products, vitamins, minerals or dietary supplements
• if you are suffering from known allergic reactions to foods, medicines, dyes, preservatives or any other substances
• if you have recently had an abortion or a baby
• if you are suffering from diabetes, heart disease, migraine headaches, or other heart disorders, blood vessel problems, blood pressure problems, or anemia
• if you are premenstrual or if you have never had a child
• if you are suffering from pelvic problems (such as persistent pelvic infections or pain), any other type of infections, Endometriosis, painful sexual intercourse, genital lesions, vaginal discharge, bleeding of the uterus, etc

You should not use Mirena if:

• you are suffering from known allergic reactions to this drug or to any of its ingredients
• you are pregnant
• you have uterine fibroids or an abnormally shaped uterus 
• you have a history of ectopic pregnancy, pelvic inflammatory disease (PID), or any other medical condition that increases the risk of an undesired ectopic pregnancy
• you have suffered from an infected abortion or an inflamed lining of the uterus during the past three months 
• you are suffering from an abnormal Pap smear, vaginal bleeding, inflammation of the vagina or cervix, an untreated vaginal infection, any sexually transmitted disorders (such as gonorrhea, chlamydia), suspected or known tumors of the cervix or of the uterus, or genital, cervical or vaginal infections
• you are suffering from a medical disorder that makes you more prone to severe infections (for example, leukemia), HIV infection, immune system problems
• you have inserted another IUD before, without removing it yet
• you suspect that you are suffering from or you are suffering from Breast Cancer
• you are currently taking troleandomycin, nevirapine, or St. John's Wort
• you are suffering from liver disorders or liver tumors, a history of brain bleeding, had a stroke, or blood clotting problems

If you do have any of these conditions, you may not be allowed to use Mirena. Ask your personal physician for more information.

Mirena ought to be stored at 25 degrees C (it is permitted that you store it for a brief period of time at temperatures between 15 and 30 degrees C). Keep it away from moisture, heat and direct sunlight (in a cool, dark place such as a closet). Keep Mirena away from the reach of pets and children in order to avoid unwanted accidents. Avoid keeping it in the bathroom or nest to the kitchen sink.

Mirena Intake Guidelines

Ask your physician how to use Mirena properly. Consult the IUD’s label for other information. If you have further questions, address a pharmacist, a doctor or a nurse. The product should be inserted in a medical setting by a doctor or by a qualified health care provider. During the first 6 months of using this product, you may experience irregular menstruations. After each of your menstrual periods, you should check to see if the Mirena thread does still protude from your cervix. You must not pull the thread. Alert your physician if you are unable to locate the thread. This product should be replaced every 5 years.

This product is not able to protect you against sexually transmitted disorders such as HIV. If you are suffering from diabetes, you should know that Mirena IUD is known to sometimes affect the patient’s blood sugar. You should regularly check your blood sugar levels. While you use this product, you may still have lab tests (this includes complete physical examinations, Pap smear, pelvic examination, x-ray, uterine ultrasound, liver function tests, pregnancy tests, and even blood counts.

Mirena Dosage

While using Mirena you do not have to worry about dosing.

Mirena Overdose

Mirena overdose is unlikely to occur.

Mirena Missed Dose

Mirena missed dose should not occur.

Mirena Side Effects

Alert your personal physician if you are experiencing any of these common side effects while using Mirena: acne; breast pain or tenderness; back pain; cramps; changes in sex drive; headache; depression; hair loss; lack of menstruation; irregular bleeding; sinus infection; nausea; nervousness; skin problems; stomach pain, etc.

You should seek medical care immediately if you experience any of these severe side effects: severe allergic reactions (hives; rash; itching; breathing difficulty; chest tightness; mouth, lips, face or tongue swelling); vision changes; breast lumps; fever; chills; dizziness; genital sores; mood or mental changes, etc.   Alert your personal physician if you experience anything abnormal while using Mirena.

Mirena Drug Reactions

You should ask your physician if you may take any other medicines while using Mirena.

Buy Mirena

Buy Mirena. It is available through our Online Pharmacy Escrow Service or at any Canada Pharmacy selling Online Prescriptions.

In some countries MIRENA may also be known as: Norgestrel Continuo, Microlut, Norgestrel Max, Ovulol, Postinor-2, Segurite, Microval, Mirena, Vikela, Norlevo, Minipil, Pilem, Pozato, Tace, Norplant, Ecee2, Glanique, Hispatrel, Post-Day, Silogin, Jadelle, Escapelle, Jadelle, Follistrel, Ovrette, Plan B

Although MIRENA may be available from different countries, the MIRENA you receive will be of the exact same quality regardless of where in the world the MIRENA is shipped from. The different MIRENA prices simply reflect what the manufacturers charge in that region of the world for the same medication. Each pharmacy ships MIRENA world wide so place your order today!