At what period of the menstrual cycle is Mirena placed? Women Health. Removing the intrauterine device

Compound

pharmachologic effect

In terms of its effectiveness as a contraceptive, Mirena is comparable “i to sterilizing a woman. It is as effective as today's most effective copper-containing intrauterine devices and oral contraceptives (birth control pills). Studies (clinical trials) have found that over the course of a year, for every 1,000 women using Mirena, there are only two pregnancies. In women with excessive menstrual bleeding, Mirena causes a significant reduction in its intensity within three months after insertion into the uterus. Some women stop bleeding altogether.

Indications for use

Mirena is used for contraception (prevention of pregnancy), treatment of idiopathic menorrhagia (excessive menstrual bleeding) and for the prevention of endometrial hyperplasia (excessive growth of the inner lining of the uterus) during estrogen replacement therapy.

Contraindications

Mirena should not be used for any of the following conditions.

Pregnancy or suspicion of it.

Existing or recurrent inflammatory diseases of the pelvic organs. Infections of the lower genitourinary tract.

Postpartum endometritis.

Septic abortion within the last three months.

Cervicitis.

Diseases accompanied by increased susceptibility to infections. Cervical dysplasia.

Malignant neoplasms of the uterus or cervix.

Progestogen-dependent tumors, including breast cancer.

Pathological uterine bleeding of unknown etiology.

Congenital or acquired anomalies of the uterus, including fibroids, leading to deformation of the uterine cavity.

Acute liver diseases or tumors.

Hypersensitivity to the components of the drug.

Mirena can be used with caution after consultation with a specialist, or your doctor may discuss the need to remove it if you have, or shortly after insertion of the system into the uterus, one of the following conditions:

Migraine, focal migraine with asymmetric vision loss or other symptoms suggestive of transient ischemia brain,

Unusually strong headache;

Jaundice;

Severe arterial hypertension;

Severe circulatory disorders, including stroke and myocardial infarction.

Pregnancy and lactation

Contraindicated.

Mirena is contraindicated during pregnancy or suspected pregnancy.

Pregnancy in women who have Mirena installed is extremely rare. But if

Mirena leaves the uterus, you are no longer protected from pregnancy and should

Use other methods of contraception until you talk to your doctor.

While using Mirena, some women experience no menstrual bleeding. The absence of menstruation does not necessarily indicate pregnancy.

If you are not menstruating and have other signs of pregnancy (nausea, fatigue, breast tenderness), you should see your doctor for an examination and a pregnancy test.

If you become pregnant while using Mirena, Mirena should be removed as soon as possible. Leaving Mirena in your uterus during pregnancy increases the risk of miscarriage, infection, or premature birth. You can also discuss the suitability of a medical abortion. The hormone contained in Mirena is released into the uterine cavity. This means that the fetus is exposed to a relatively high local concentration of the hormone, although the hormone enters it in small quantities through the blood and placenta. Currently, the effect of such amounts of the hormone on the fetus is unknown, since cases of pregnancy in women with Mirena in the uterus are very rare. Due to the intrauterine use and local action of the hormone, it is necessary to take into account the possibility of a virilizing effect on the fetus. However, to date there is no evidence of birth defects caused by the use of Mirena in cases where pregnancy was maintained until natural birth.

You can breastfeed your baby while using Mirena. Levonorgestrel has been found in trace amounts in the breast milk of nursing women. About 0.1% of the levonorgestrel dose may enter the child's body during breastfeeding. None dangerous influences Mirena was not observed to affect the growth and development of the child when used six weeks after birth. Mirena does not affect the quantity or quality of breast milk.

Check with your doctor before taking any medications while pregnant or breastfeeding.

Directions for use and doses

Before Mirena insertion

Before inserting Mirena, a vaginal smear may be taken, a mammary gland examination may be performed, and, if necessary, other studies may be carried out, for example, aimed at identifying infections, including sexually transmitted ones.

To determine the position and size of the uterus, a gynecological examination should be performed.

When should Mirena be installed?

Mirena can be inserted into the uterus no later than seven days after the start of menstrual bleeding. It can also be installed in the uterus immediately after a medical abortion; in this case, the doctor must be sure that there is no genital infection. Mirena should not be placed until six weeks after birth. Mirena can be replaced new system any day menstrual cycle. Mirena is not used as a contraceptive used after sexual intercourse. To protect the inner layer of the uterus during the Mirena can be installed at any time in women with preserved menstruation, the Mirena is installed in the last days of menstrual bleeding or “withdrawal” bleeding. amenorrhea (not having periods)

How to install Mirena After a gynecological examination, a special instrument, the so-called vaginal speculum, is inserted into the vagina and the cervix is ​​treated with an antiseptic solution. Mirena is then inserted into the uterus through a thin, flexible plastic tube. You may feel the insertion of the system, but it should not cause you much pain. Before insertion, if necessary, local anesthesia of the cervix can be applied.

Some women experience pain and dizziness after insertion of the system.

If, after staying in a quiet position for half an hour, these phenomena do not go away, it is possible that the intrauterine system is not positioned correctly. A gynecological examination must be performed; if necessary, the system is removed. In some women, the use of Mirena causes allergic skin reactions.

With correct installation of Mirena, carried out in accordance with the instructions for use, the Pearl index (an indicator reflecting the number of pregnancies in 100 women using a contraceptive for 1 year) is about 0.2%. The cumulative rate reflecting the number of pregnancies in 100 women using contraceptives for 5 years is 0.7%. After removing Mirena, you should check the system for integrity. When it was difficult to remove the IUD, there were isolated cases of the hormonal-elastomer core slipping onto the horizontal arms of the T-shaped body, as a result of which they were hidden inside the core. Once the integrity of the IUD is confirmed, this situation does not require additional intervention. Stoppers on the horizontal arms usually prevent the core from completely separating from the T-body.

Side effect

When using Mirena, like any other medicines, adverse reactions (HP) may occur, although their occurrence is not necessary in all patients. Listed below are the HPs that have been reported with Mirena for the indications “contraception (prevention of pregnancy)” and “treatment of idiopathic menorrhagia (excessive menstrual bleeding).”

Possible HP in women using Mirena for the indication “prevention of endometrial hyperplasia (excessive growth of the inner lining of the uterus) during estrogen replacement therapy” were observed with the same frequency, with the exception of cases indicated by footnotes (*,**).

Very frequent HP (>1/10):

Headache

Abdominal/pelvic pain

Changes in the nature of bleeding, including an increase and decrease in the intensity of bleeding, spotting bloody issues, oligomenorrhea and amenorrhea

Vulvovaginitis*

Discharge from the genital tract*

Frequent HP (more than 1/100 and less than 1/10):

Low mood/depression

Migraine

Nausea

Hirsutism

Backache**

Upper genital tract infections

Ovarian cysts

Dysmenorrhea

Pain in the mammary glands**

Expulsion of the IUD (full or partial)

Uncommon HP (more than 1/1000 and less than 1/100):

Alopecia

Rare HP (more than 1/10000 and less than 1/1000):

Perforation of the uterus

HP with unknown frequency:

Hypersensitivity including rash, urticaria and angioedema

High blood pressure

* “Often” for the indication “prevention of endometrial hyperplasia during estrogen replacement therapy.”

** “Very often” for the indication “prevention of endometrial hyperplasia during estrogen replacement therapy.”

Additional Information

The partner may feel the threads during intercourse.

If a woman diagnosed with Mirena becomes pregnant, the relative risk of ectopic pregnancy increases.

The risk of perforation increases in breastfeeding women.

Cases of sepsis (very severe systemic infections that can be fatal) have been reported following IUD insertion.

The risk of breast cancer when using Mirena for the indication “prevention of endometrial hyperplasia (excessive growth of the inner lining of the uterus) during estrogen replacement therapy” is unknown. Cases of breast cancer have been reported (frequency unknown).

The following adverse events or effects have been reported in connection with the installation or removal of Mirena:

Painfulness of the procedure, bleeding during the procedure, dizziness or syncope (fainting) associated with a vasovagal reaction during installation. The procedure may trigger seizures (convulsions) in patients with epilepsy.

If any of the above or others develop side effects you should consult a doctor.

Overdose

Interaction with other drugs

If you use any medications for a long time (for example, antiepileptic isoenzymes of cytochrome P450 involved in the metabolism medicines, such as anticonvulsants (eg, phenobarbital, phenytoin, carbamazepine) and drugs to treat infections (eg, rifampicin, rifabutin, nevirapine, efavirenz). The effect of these drugs on the effectiveness of Mirena is not known, but it is believed that it is not significant since Mirena has mainly local effects.

Features of application

The results of some recent studies indicate that women taking progestogen-only contraceptives may have a slight increase in the risk of venous thrombosis; however, these results are not well defined. However, if signs of thrombosis of veins and arteries appear, you should immediately consult a doctor. Symptoms of venous or arterial thrombosis include: unilateral pain and/or swelling in the leg; sudden severe pain in the chest, regardless of whether it radiates to the left arm; sudden severe breathing problems; sudden cough; unusually severe, prolonged headache; sudden partial or complete loss of vision; double vision; slurred or difficult speech; dizziness; collapse (sometimes with convulsive seizure); weakness or very significant loss of sensation that suddenly appears on one side or in one part of the body; movement disorders; sharp pain in the abdomen. Signs of a blood clot forming in the blood vessels of the eye include unexplained partial or complete loss of vision and any other unexplained visual disturbances.

It has not yet been established whether there is a connection between varicose veins or superficial thrombophlebitis (inflammation of the veins with the formation of a blood clot) with the phenomenon of venous thromboembolism.

nulliparous women

Mirena is not the first choice for young women who have never been pregnant or for postmenopausal women with age-related shrinkage of the uterus.

Infections

The guide tube helps protect the Mirena from contamination by microorganisms during insertion into the uterus, and the Mirena guide tube is designed to minimize the risk of infection. Despite this, the risk of pelvic infection immediately after insertion of the system into the uterus and for the next four months is increased. Infections of the pelvic organs in patients using intrauterine systems are often classified as sexually transmitted diseases. The risk of infection increases if a woman or her partner has multiple sexual partners. If a pelvic infection is detected, it should be treated immediately. These infections can impair fertility and increase your risk in the future. ectopic pregnancy.

In extremely rare cases, severe infection or sepsis (a very serious infection that can be fatal) may occur soon after insertion of an IUD. If there is a recurrent infection of the pelvic organs or an acute infection that is resistant to treatment for several days, Mirena should be removed. If you have persistent pain in the lower abdomen, fever, pain associated with sexual intercourse, or unusual bleeding, consult your doctor immediately.

If severe pain or fever continues to develop shortly after insertion, you may have a serious infection that should be treated immediately.

Oligo- and amenorrhea

Oligo- and amenorrhea in women of childbearing age develops gradually in 57% and 16%

cases by the end of the first year of Mirena use, respectively. If menstruation is absent within six weeks of the start of the last menstrual period, pregnancy should be ruled out. Repeated pregnancy tests for amenorrhea are not necessary unless there are other signs of pregnancy. When Mirena is used in combination with continuous estrogen replacement therapy, most women gradually develop amenorrhea during the first year of Mirena use.

Expulsion (loss of intrauterine system)

Contractions of the uterine muscles during menstruation sometimes lead to the displacement of the intrauterine system or even to its expulsion from the uterus, which leads to the cessation of contraceptive action. TO possible symptoms prolapse includes pain and bleeding that is unusual for you. If Mirena has moved into the uterine cavity, its effectiveness is reduced. It is recommended to check the threads with your fingers, for example when you take a shower. If you notice signs of displacement or prolapse of the intrauterine system or cannot feel the threads, you should avoid sexual intercourse or use other methods of contraception, and consult a doctor as soon as possible. Mirena reduces the intensity of menstrual bleeding; an increase in their intensity may indicate a loss of the system.

Perforation and penetrapy

Perforation or penetration of the body or cervix by the intrauterine contraceptive device occurs rarely, mainly during insertion, and may reduce the effectiveness of Mirena. In these cases, the system should be removed. The risk of perforation increases in breastfeeding women and may occur if inserted during the postpartum period or in women with a fixed posterior flexion of the uterus (towards the intestine).

The risk of perforation is increased in women who are breastfeeding and may also be increased if Mirena is administered soon after delivery.

Ectopic pregnancy

Pregnancy occurs extremely rarely when using Mirena. The incidence of ectopic pregnancy with Mirena is approximately 0.1% per year. If you become pregnant while using Mirena, the fetus may be outside the uterus (ectopic pregnancy). Ectopic pregnancy - severe pathological condition, requiring immediate medical intervention. The risk of ectopic pregnancy is increased in women who have previously had an ectopic pregnancy, or who have had surgery to fallopian tubes or pelvic infections. The following symptoms may indicate that you have an ectopic pregnancy and you need to see a doctor immediately.

Disappearance of menstrual cycles, followed by constant bleeding or pain.

Wandering or very severe pain in the lower abdomen.

Signs of a normal pregnancy combined with bleeding and a feeling of dizziness.

Weakness

Some women experience dizziness after Mirena insertion. This is a normal physiological reaction. Doctors suggest that women rest for some time after Mirena insertion.

Ovarian cysts

Since the contraceptive effect of Mirena is due to its main action, women of childbearing age usually experience ovulatory cycles with rupture of follicles. Sometimes follicular atresia is delayed and follicular development may continue. Such enlarged follicles cannot be clinically distinguished from ovarian cysts. Ovarian cysts were reported as an adverse reaction in approximately 7% of women using Mirena. In most cases, these follicles do not cause any symptoms, although sometimes they are accompanied by pain in the lower abdomen or pain during sexual intercourse.

In most cases, ovarian cysts disappear on their own within two to three months of observation. If this does not happen, it is recommended to continue monitoring with ultrasound, as well as therapeutic and diagnostic measures. In rare cases, it is necessary to resort to surgical intervention.

By rocks of the heart

Mirena should be used with caution in women with congenital or acquired heart defects due to the risk of infectious inflammation of the heart muscle. Such patients should undergo a prophylactic course of antibiotic treatment when installing or removing Mirena.

Diabetes

Women with diabetes and using Mirena need to regularly determine their blood glucose levels. However, as a rule, there is no need to change therapeutic prescriptions in women with diabetes using Mirena.

Mirena is not used for postcoital contraception.

Available evidence suggests that Mirena use does not increase the risk of developing breast cancer in postmenopausal women under 50 years of age. Due to the limited data obtained from the Mirena study for the indication “prevention of endometrial hyperplasia during estrogen replacement therapy,” the risk of breast cancer when using Mirena for this indication cannot be confirmed or refuted.

Excipients contained in Mirena

The T-shaped base of Mirena contains barium sulfate, which becomes visible during X-ray examination.

Speed-release intrauterine therapy system (IUD) active substance 20 mcg/24 hours consists of a white or off-white hormonal elastomeric core placed on a T-shaped body and covered with an opaque membrane that regulates the release of levonorgestrel. The T-shaped body has a loop at one end and two arms at the other; threads are attached to the loop to remove the system. The IUD is placed in a guide tube. The system and conductor are free of visible impurities.

1 IUD contains levonorgestrel 52 mg. Excipients: polydimethylsiloxane elastomer.

pharmachologic effect

The levonorgestrel-releasing intrauterine system (IUD) has a primarily local progestational effect. Progestin (levonorgestrel) is released directly into the uterine cavity, which allows it to be used in an extremely low daily dose. High concentrations of levonorgestrel in the endometrium help to reduce the sensitivity of its estrogen and progesterone receptors, making the endometrium resistant to estradiol and having a strong antiproliferative effect. When using Mirena, morphological changes in the endometrium and a weak local reaction to the presence of a foreign body in the uterus are observed. Thickening of the mucous membrane of the cervical canal prevents the penetration of sperm into the uterus. Mirena® prevents fertilization due to inhibition of sperm motility and function in the uterus and fallopian tubes. In some women, ovulation is also suppressed.

Previous use of Mirena does not affect reproductive function. Approximately 80% of women who want to have a child become pregnant within 12 months after removal of the IUD.

In the first months of using Mirena, due to the process of suppressing endometrial proliferation, an initial increase in spotting may be observed. Following this, pronounced suppression of the endometrium leads to a decrease in the duration and volume of menstrual bleeding in women using Mirena. Scanty bleeding often transforms into oligo- or amenorrhea. At the same time, ovarian function and the concentration of estradiol in the blood remain normal.

Mirena can be successfully used to treat idiopathic menorrhagia, i.e. menorrhagia in the absence of genital diseases (for example, endometrial cancer, metastatic lesions of the uterus, submucosal or large interstitial node of uterine fibroids leading to deformation of the uterine cavity, adenomyosis, endometrial hyperplastic processes, endometritis), extragenital diseases and conditions accompanied by severe hypocoagulation (for example , von Willebrand disease, severe thrombocytopenia), the symptoms of which are menorrhagia.

By the end of the third month after Mirena installation, in women with menorrhagia, the volume of menstrual bleeding decreased by 88%. Reducing menstrual blood loss reduces the risk of iron deficiency anemia. Mirena® also reduces the severity of dysmenorrhea.

The effectiveness of Mirena in preventing endometrial hyperplasia during chronic estrogen therapy was equally high with both oral and transdermal estrogen administration.

Indications for use

• contraception;
• idiopathic menorrhagia;
• prevention of endometrial hyperplasia during estrogen replacement therapy.

Mode of application

Mirena is inserted into the uterine cavity and remains effective for 5 years. The in vivo release rate of levonorgestrel is initially approximately 20 mcg/day and decreases after 5 years to approximately 10 mcg/day. average speed levonorgestrel release - approximately 14 mcg/day for up to 5 years. Mirena can be used in women receiving hormone replacement therapy in combination with oral or transdermal estrogen preparations that do not contain progestogens.

With correct installation of Mirena, carried out in accordance with the instructions for medical use, the Pearl index (an indicator reflecting the number of pregnancies in 100 women using a contraceptive during the year) is approximately 0.2% within 1 year. The cumulative rate reflecting the number of pregnancies in 100 women using contraception for 5 years is 0.7%.

• For the purpose of contraception For women of childbearing age, Mirena should be inserted into the uterine cavity within 7 days from the start of menstruation. Mirena can be replaced with a new IUD on any day of the menstrual cycle. An IUD can also be inserted immediately after an abortion in the first trimester of pregnancy.
• After childbirth installation of the IUD should be carried out when uterine involution occurs, but not earlier than 6 weeks after birth. With prolonged subinvolution, it is necessary to exclude postpartum endometritis and postpone the decision to introduce Mirena until the involution is completed. If there is difficulty inserting the IUD and/or very severe pain or bleeding during or after the procedure, a physical and ultrasound examination should be performed immediately to rule out perforation.
• To protect the endometrium during estrogen replacement therapy in women with amenorrhea, Mirena can be installed at any time; in women with preserved menstruation, installation is carried out during menstrual bleeding or withdrawal bleeding.

Mirena should not be used for postcoital contraception.

Rules for using the IUD

Mirena is supplied in sterile packaging, which is opened only immediately before insertion of the IUD. It is necessary to observe aseptic rules when handling an opened system. If the sterility of the packaging appears to be compromised, the IUD should be disposed of as medical waste. The IUD removed from the uterus should also be handled as it contains hormone residues.

Installation, removal and replacement of the IUD

Removing Mirena

Mirena is removed by carefully pulling the threads grasped with forceps.

Special instructions

If further contraception is necessary in women of childbearing age, the system should be removed during menstruation, subject to a monthly menstrual cycle. Otherwise, you should use other methods of contraception (for example, a condom) for at least 7 days before removal. If a woman is amenorrheic, she should start using barrier contraception 7 days before removal of the system and continue until menstruation returns.

A new Mirena can also be introduced immediately after the old one is removed, in which case there is no need for additional contraception.

After removing Mirena, you should check the system for integrity. When it was difficult to remove the IUD, there were isolated cases of the hormonal-elastomer core slipping onto the horizontal arms of the T-shaped body, as a result of which they were hidden inside the core. Once the integrity of the IUD is confirmed, this situation does not require additional intervention. Stoppers on the horizontal arms usually prevent the core from completely separating from the T-body.

Side effect

Side effects usually do not require additional therapy and disappear within a few months.

Expulsion of the intrauterine system, uterine perforation, and ectopic pregnancy, described with the use of other intrauterine contraceptives, may develop.

Side effects most often develop in the first months after Mirena is inserted into the uterus; With prolonged use of the IUD, they gradually disappear.

Very common (more than 10%): uterine/vaginal bleeding, spotting, oligo- and amenorrhea, benign ovarian cysts. The average number of days of spotting in women of childbearing age gradually decreases from 9 to 4 days per month during the first 6 months after IUD insertion. The number of women with prolonged (more than 8 days) bleeding decreases from 20% to 3% in the first 3 months of using Mirena. Clinical studies found that in the first year of Mirena use, 17% of women experienced amenorrhea lasting at least 3 months. When Mirena is used in combination with estrogen replacement therapy, most peri- and postmenopausal women experience spotting and irregular bleeding in the first months of treatment. Subsequently, their frequency decreases, and in approximately 40% of women receiving this therapy, bleeding disappears altogether in the last 3 months of the first year of treatment. Changes in bleeding patterns are more common in the perimenopausal period than in the postmenopausal period. The frequency of detection of benign ovarian cysts depends on the diagnostic method used. According to clinical trials, enlarged follicles were diagnosed in 12% of women who used Mirena. In most cases, the enlargement of follicles was asymptomatic and disappeared within 3 months.

The table shows side effects, the frequency of which corresponds to data from clinical studies.

Organs and systems	Side effects
From the central nervous system and peripheral nervous system	decreased mood, nervousness, decreased libido, headache, mood changes, migraine
From the digestive system	abdominal pain, nausea, bloating
Dermatological reactions	acne, alopecia, hirsutism, itching, eczema, rash, urticaria
From the musculoskeletal system	backache
From the outside reproductive system and mammary glands	pelvic pain, dysmenorrhea, vaginal discharge, vulvovaginitis, breast tension, breast tenderness, pelvic inflammatory disease, endometritis, cervicitis, uterine perforation
Metabolism	weight gain
From the body as a whole	swelling
General disorders and pathological conditions in the area of ​​IUD installation	IUD expulsion

If a woman with Mirena installed becomes pregnant, the relative risk of ectopic pregnancy increases.

Cases of breast cancer have been reported (frequency unknown).

Contraindications to the use of Mirena

• pregnancy or suspicion of it;
• inflammatory diseases of the pelvic organs (including recurrent);
• infections of the lower genitourinary tract;
• malignant neoplasms of the uterus or cervix;
• postpartum endometritis;
• septic abortion within the last three months;
• cervicitis;
• cervical dysplasia;
• pathological uterine bleeding of unknown etiology;
• progestogen-dependent tumors, incl. mammary cancer;
• diseases accompanied by increased susceptibility to infections;
• congenital and acquired anomalies of the uterus, incl. fibroids leading to deformation of the uterine cavity;
• acute liver diseases, liver tumors;
• hypersensitivity to the components of the drug.

Use of Mirena during pregnancy and breastfeeding

Mirena should not be used if you are pregnant or suspected of being pregnant. If a woman becomes pregnant while using Mirena, it is recommended to remove the IUD, because Any intrauterine contraceptive device left in situ increases the risk of spontaneous abortion and premature birth. Removing Mirena or probing the uterus may lead to spontaneous abortion. If it is not possible to carefully remove the intrauterine contraceptive device, the advisability of induced termination of pregnancy should be discussed. If a woman wants to continue her pregnancy and the IUD cannot be removed, the patient should be informed about the risks and possible consequences premature birth for the baby. In such cases, the course of pregnancy should be carefully monitored. It is necessary to exclude ectopic pregnancy.

The woman should be advised that she should report all symptoms that suggest pregnancy complications, in particular colicky abdominal pain accompanied by fever.

Due to the intrauterine use and local action of the hormone, it is necessary to take into account the possibility of a virilizing effect on the fetus. Due to the high contraceptive effectiveness of Mirena, clinical experience regarding pregnancy outcomes with its use is limited. However, the woman should be advised that there is currently no evidence of birth defects caused by the use of Mirena in cases of pregnancy continuing until childbirth without removal of the IUD.

About 0.1% of the dose of levonorgestrel can enter the newborn's body during breastfeeding. However, it is unlikely to pose a risk to the baby at doses released by Mirena in the uterus.

It is believed that the use of Mirena 6 weeks after birth does not have a harmful effect on the growth and development of the child. Monotherapy with gestagens does not affect the quantity and quality of breast milk. Rare cases of uterine bleeding have been reported in women using Mirena during lactation.

Use for liver dysfunction

Contraindicated in acute liver diseases, liver tumors.

special instructions

The results of some recent studies indicate that women taking progestogen-only contraceptives may have a slight increase in the risk of venous thrombosis; however, these results are not statistically significant. However, if symptoms of venous thrombosis appear, appropriate diagnostic and treatment measures should be taken immediately.

It has not yet been established whether there is a connection between varicose veins or superficial thrombophlebitis with the phenomenon of venous thromboembolism. Mirena should be used with caution in women with congenital or acquired valvular heart disease, keeping in mind the risk of septic endocarditis. When inserting or removing an IUD, these patients should be given prophylactic antibiotics.

Levonorgestrel in low doses can affect glucose tolerance, and therefore blood glucose levels should be regularly monitored in women with diabetes using Mirena. However, as a rule, there is no need to change therapeutic prescriptions in women with diabetes using Mirena.

Some manifestations of polyposis or endometrial cancer may be masked by irregular bleeding. In such cases it is necessary additional examination to clarify the diagnosis.

Mirena is not the first choice method for young women who have never become pregnant or for postmenopausal women with severe uterine atrophy.

With estrogen monotherapy, the incidence of endometrial hyperplasia can reach 20%. In a clinical study of the use of Mirena (201 perimenopausal women and 259 postmenopausal women) during a 5-year observation period in a group of postmenopausal women, there were no cases of endometrial hyperplasia.

Oligo- and amenorrhea

Oligo- and amenorrhea in women of childbearing age develops gradually, in approximately 20% of cases of Mirena use. If menstruation is absent within 6 weeks after the start of the last menstrual period, pregnancy should be ruled out. Repeated pregnancy tests for amenorrhea are not necessary unless there are other signs of pregnancy.

When Mirena is used in combination with continuous estrogen replacement therapy, most women gradually develop amenorrhea over the first year.

Pelvic organ infections

The guide tube helps protect Mirena from microbial contamination during insertion, and the Mirena insertion device is specially designed to minimize the risk of infection. Having multiple sexual partners has been found to be a risk factor for pelvic infections. Infections of the pelvic organs can have serious consequences: they can impair fertility and increase the risk of ectopic pregnancy.

For recurrent endometritis or pelvic infections, as well as for severe or acute infections that are resistant to treatment for several days, Mirena should be removed.

Even in cases where only individual symptoms indicate the possibility of infection, bacteriological examination and monitoring are indicated.

Expulsion

Possible signs of partial or complete expulsion of any IUD are bleeding and pain. However, the system can be expelled from the uterine cavity unnoticed by the woman, which leads to the cessation of the contraceptive effect. Partial expulsion may reduce the effectiveness of Mirena. Since Mirena reduces menstrual blood loss, an increase in blood loss may indicate expulsion of the IUD.

If the position is incorrect, Mirena must be removed. A new system may be installed at this time.

It is necessary to explain to the woman how to check the Mirena threads.

Perforation and penetration

Perforation or penetration of the body or cervix by the intrauterine contraceptive device occurs rarely, mainly during insertion, and may reduce the effectiveness of Mirena. In these cases, the system should be removed. There may be an increased risk of perforation when installing an IUD after childbirth, during lactation, and in women with a fixed uterine flexion.

Ectopic pregnancy

Women with a history of ectopic pregnancy, tubal surgery or pelvic infection are at higher risk of ectopic pregnancy. The possibility of ectopic pregnancy should be considered in the case of lower abdominal pain, especially if it is combined with cessation of menstruation, or when a woman with amenorrhea begins to bleed. The incidence of ectopic pregnancy with Mirena is approximately 0.1% per year. The absolute risk of ectopic pregnancy in women using Mirena is low. However, if a woman with Mirena installed becomes pregnant, the relative likelihood of an ectopic pregnancy is higher.

Lost threads

If, during a gynecological examination, the threads for removing the IUD cannot be detected in the cervical area, it is necessary to exclude pregnancy. The threads can be drawn into the uterine cavity or cervical canal and become visible again after the next menstruation. If pregnancy is ruled out, the location of the threads can usually be determined by careful probing with an appropriate instrument. If the threads cannot be detected, it is possible that the IUD has been expelled from the uterine cavity. Ultrasound can be used to determine the correct placement of the system. If it is unavailable or unsuccessful, X-ray examination is used to determine the location of Mirena.

Delayed follicular atresia

Since the contraceptive effect of Mirena is due mainly to its local action, women of childbearing age usually experience ovulatory cycles with rupture of follicles. Sometimes follicular atresia is delayed and follicular development may continue. Such enlarged follicles cannot be clinically distinguished from ovarian cysts. Enlarged follicles were found in 12% of women using Mirena. In most cases, these follicles do not cause any symptoms, although sometimes they are accompanied by pain in the lower abdomen or pain during sexual intercourse.

In most cases, enlarged follicles disappear on their own within two to three months of observation. If this does not happen, it is recommended to continue monitoring with ultrasound, as well as therapeutic and diagnostic measures. In rare cases, it is necessary to resort to surgical intervention.

Impact on the ability to drive vehicles and operate machinery

Not observed.

Drug interactions

It is possible to increase the metabolism of gestagens with simultaneous use substances that are inducers of enzymes, especially isoenzymes of the cytochrome P450 system, involved in the metabolism of drugs, such as anticonvulsants (for example, phenobarbital, phenytoin, carbamazepine) and drugs for the treatment of infections (for example, rifampicin, rifabutin, nevirapine, efavirenz). The effect of these drugs on the effectiveness of Mirena is unknown, but it is assumed that it is insignificant since Mirena has mainly local effects.

Childbirth is one of the most pleasant and joyful events that can happen in the life of a spouse. However, you should carefully prepare for it mentally, physically and financially.

It is very good that every married couple can decide for themselves how many children to have and when. To do this, spouses use different contraceptives, one of which is the hormonal IUD. The pros and cons of this method of contraception, the subtleties of installation and use, reviews and frequently asked questions - you will find all this in our article.

Now let's look at the principle of operation of the spiral and give its description.

Description of the spiral

The hormonal intrauterine device is one of the most effective contraceptives. It is made of plastic and has the shape of the letter “T”. On the spiral, the size of which varies from three to five centimeters, there is a small compartment containing the necessary hormone. The essence of this device The idea is that the drug is introduced into the body gradually, in equal doses. What is its effect?

The hormone affects the uterus in such a way that its ability to close is lost. This occurs due to inhibition of the growth of the uterine epithelium, weakening of the function of the glands and self-compaction of cervical mucus. As a result, the fertilized egg cannot reach the uterine cavity, which means pregnancy does not occur.

As you can see, many types of hormonal IUDs are abortifacients, since their task is not to prevent the egg from being fertilized, but to limit its access to the uterus. That is, pregnancy occurs, but the development of the fertilized egg stops.

What are the positive and negative aspects of installing a hormonal IUD? Let's find out.

Pros and cons of using a spiral

Before deciding which contraceptive to use, a woman should weigh all the pros and cons of a particular method. Let's discuss them in more detail in the light of our topic.

Positive points of the hormonal contraceptive device:

• Almost one hundred percent guarantee of preventing unwanted pregnancy.
• Comfortable to use.
• Local action of the drug.
• Duration of use.
• No discomfort during sexual intercourse.
• Therapeutic effect for certain diseases.

To the main negative Aspects of the hormonal spiral include:

• Expensive installation.
• Existence of side effects.
• Fertility is fully restored only six to twelve months after removal of the device.
• The possibility of installing the IUD is only for those who have children (nulliminating women can be prescribed a contraceptive only for medical reasons).
• The use of hormonal drugs during the treatment of diseases is carried out only after consultation with a specialist.
• Takes some getting used to (some women may experience discomfort at first).
• Lack of protection against sexually transmitted infections.
• Inability to use for certain diseases.

What side effects does the hormonal IUD have?

Negative consequences

Side effects of the hormonal IUD are:

1. The likelihood of bleeding.
2. The appearance of benign cysts on the ovaries (which may go away on their own).
3. Possibility of ectopic pregnancy.
4. Painful sensations in the mammary glands.
5. Various pathological changes in the organs of the reproductive system.
6. Irritability, bad mood, depression.
7. Pain in the pelvic organs.
8. Frequent headaches.

According to various studies, many of the above symptoms occur during the initial period of action of the hormone and disappear immediately after the body gets used to it.

What about birth control pills? Are they effective in the fight against unwanted pregnancy? Do they have bad influence? And what is better to choose: pills or spirals?

Hormonal drugs

The age-old question: “Intrauterine device or hormonal pills - which is better?” - should be decided based on your views and preferences. What can be taken into account?

First of all, you should know that hormonal contraceptives are very different both in composition and in their principle of action. Some of them have an abortifacient effect (they make the lining of the uterus so thin that a newly formed embryo cannot attach to it), while others thicken the uterine mucus so that it does not allow the sperm to be fertilized.

Are there positives and negatives to the birth control “pill”? Of course, and here are some of them.

Flaws. These include an inconvenient dosage schedule, which can be missed or forgotten, and then the likelihood of pregnancy will increase. As well as a number of side effects similar to side effects spirals.

Advantages. This advantage of medicines includes the formation hormonal levels women, including stabilization of the menstrual cycle, which relieves the “weaker sex” of pain during “critical days”, and can also have a beneficial effect on appearance (the condition of the skin and hair).

Another important positive feature The use of tablets is that their use prevents the development of tumors in the female genital organs and prevents the occurrence of ectopic pregnancy. Moreover, hormones in the form of medications do not affect basic reproductive functions - the likelihood of conception is restored almost immediately after stopping contraception.

So, the advantages, disadvantages and negative consequences of hormonal IUDs have been determined, and the decision to install this type of contraception has been accepted and approved. What should you do next?

Installation of a contraceptive

The installation of the hormonal IUD must take place under sterile conditions. The manipulation is carried out by an experienced doctor. If these conditions are met, the intrauterine device will not cause pain, and the risk of infection of the uterine cavity will be minimized.

Is it necessary to undergo any procedures or examinations before installing the IUD? Certainly.

First of all, the possibility of pregnancy should be excluded (for this there is a specialized test or a specific blood and urine test). You will also need to undergo universal tests: general blood/urinalysis, vaginal smear and gynecological ultrasound. If a woman is sick with any chronic diseases, consultations with specialists will be required.

Now let's move on to the next question: what types of hormonal IUDs are there and how do they differ from each other?

Types of intrauterine contraceptives

Greatest demand in Russian Federation The following types of hormonal intrauterine devices are used:

1. "Mirena" (manufactured in Germany).
2. "Levonova" (produced in Finland).

Both protection devices have almost identical design and characteristics.

But since the most common method of contraception is the Mirena intrauterine device (IUD), then we will talk about it further.

What is Mirena

This type of contraceptive is securely fixed in the woman’s uterus due to its “T”-shaped design. A thread loop is placed on the lower edge of the product to make it easy to remove the system from the body.

At the center of the Mirena IUD is a device with fifty-two milligrams of the hormone white(levonorgestrel), which slowly penetrates the body through a special membrane.

The contraceptive begins to act immediately after installation. Released directly into the uterine cavity, the gestagen acts predominantly locally. In this case, a fairly high concentration of levonorgestrel is achieved directly in the endometrium.

Like other hormonal IUDs, Mirena suppresses the activity of the uterine epithelium and reduces sperm mobility. Over the course of several months, transformation occurs in the endometrium, which leads to infrequent bleeding and ultimately to a shortening of the menstrual cycle or its complete cancellation.

Are there any contraindications to the use of this method of contraception? Yes, and we’ll talk about this below.

When should you not install Mirena?

The Mirena hormonal device should not be used if:

1. There is a possibility of pregnancy.
2. There are inflammatory processes in the pelvic organs or in the urinary system.
3. Chronic sexually transmitted infections appear.
4. Oncological, precancerous conditions of the uterus or mammary glands are noted.
5. There is a history of thrombosis.
6. There are serious liver diseases.
7. Present allergic reaction onto the spiral components.

Indications for use

Sometimes Mirena is recommended for use as an auxiliary treatment for certain diseases. For example, uterine fibroids, accompanied by severe pain and bleeding. In this case, an intrauterine device will alleviate such symptoms. It will also relieve pain during monthly menstruation and can significantly reduce or stop the increase in fibroid nodes.

How to install Mirena

As noted above, an IUD should be installed by a gynecologist. After a careful examination and examinations, the doctor will install Mirena in his office, and will do it quickly and painlessly. If a woman has a low pain threshold, she may be given a local anesthetic.

When is the best time to carry out this manipulation? During the first week after the start of the critical days, when the likelihood of getting pregnant was reduced to zero.

Does Mirena have side effects? Of course, like other hormonal IUDs.

Bad influence

What undesirable consequences can this hormonal IUD have? The harm to the body caused by Mirena is usually temporary and minimal. First of all this:

• acne;
• nausea;
• weight gain;
• headache;
• sudden mood swings;
• absence of menstruation, minimization of discharge;
• decreased sexual activity;
• pain in the spine.

Such symptoms are rare and disappear soon. If the discomfort and accompanying unpleasant sensations do not go away, you should consult a doctor.

Is it possible to place the Mirena hormonal device immediately after childbirth?

Childbirth and breastfeeding

It is not recommended to install an intrauterine contraceptive immediately after delivery. This is due to an increase in the volume of the uterus, which can provoke rapid prolapse of the device. According to the instructions, it should take about two months (and in some cases more) before the uterus returns to its original size and the gynecologist allows the introduction of Mirena.

If a woman is breastfeeding, this is not a reason to refuse contraception. The fact is that the hormone acting in a spiral will in no case spread through the blood vessels and be absorbed into the milk. As mentioned above, the principle of action of Mirena is the local distribution of the main substance.

Is it possible to install an IUD after a miscarriage or abortion? Sometimes this can be done on the same day, sometimes a week later. Be that as it may, the decision is made by the attending gynecologist after a detailed examination of the patient.

Spiral falling out

Although Mirena is installed for at least five years, sometimes there are cases of it being dropped without permission. How can this be determined?

For example, during menstruation, you should carefully examine pads and tampons in order to notice a fallen device. In addition, any change in the position of the spiral will be indicated by poor health or pain experienced by the woman.

Why can a helix self-remove? This happens quite rarely, often during the first stages of installation of the intrauterine system and most often in nulliparous women. The reasons for this phenomenon have not been scientifically determined or substantiated.

It has been precisely proven that neither vomiting, nor diarrhea, nor playing sports, nor drinking alcohol affect the partial or complete slipping of the Mirena from the uterine cavity.

Yes, the hormonal IUD is effective remedy against pregnancy. But what to do if fertilization does occur?

Pregnancy and Mirena

It is worth mentioning here that pregnancy occurs extremely rarely when using an intrauterine contraceptive. However, if this happens, it is recommended to do an ultrasound as soon as possible to determine the place where the fetus is attached.

If the fertilized egg is implanted in the uterus, the IUD should be removed. This will prevent the development of a threat to the child's development.

If Mirena is deeply embedded in the placenta, then it is not recommended to remove it so as not to harm the fetus.

For birth healthy child It has virtually no effect on whether the hormonal IUD remains in the uterus or not. In such incidents, a pattern is impossible: cases of the birth of both healthy children and those with pathologies were observed. It is still difficult to determine whether abnormalities in fetal development are a consequence of the presence of the contraceptive in the uterus or whether it was influenced by other, more objective factors.

Removal of the IUD

Since the validity period of Mirena is limited to five years, after this period the system is removed and, at the woman’s request, a new one is installed. If necessary, the spiral can be removed earlier.

This is very easy to do. On any day of the menstrual cycle, you should contact your treating gynecologist, who will carefully pull out the Mirena, grasping its threads with special forceps.

After such a procedure, the doctor is obliged to check the integrity and integrity of the system. If some element is missing (for example, the core containing the hormone has slipped out), the specialist will carry out the necessary manipulations to remove them from the body.

Is it possible to get pregnant immediately after taking off the contraceptive? In some cases, this may happen as early as the next month. Often, the body will need some time to adapt to the function of childbearing. Sometimes this period can last a whole year.

On practice

What are the real opinions regarding the use of hormonal IUDs? Reviews about this are quite ambiguous and contradictory.

First of all, many patients are not satisfied with the abortifacient effect of some types of hormonal IUDs, as well as their negative effect on the skin and weight. However, the last negative effect can be easily eliminated - experts recommend that women with IUDs move more and give up sweets, flour and fatty foods.

Others are very satisfied with the chosen contraceptive method and are happy to note the absence or minimization of menstruation, ease of use and favorable cost (if you calculate the total price over a five-year period birth control pills, then installing a spiral no longer looks so expensive).

Gynecologists also cannot clearly agree on the use of an IUD. They confirm a fairly high level of protection and some medicinal properties spirals, however, they note that it should be installed carefully, after a thorough diagnosis.

The Mirena intrauterine device is one of the modern contraceptives that also has a therapeutic effect. The spiral manufacturer is Bayer, located in Finland. Like any medical drug, Mirena has its advantages and disadvantages.

What is this product

The hormonal coil consists of a core, which is filled with hormonal-elastomer content. It is located on the T-shaped body. On top of the hormone there is a membrane that promotes the gradual release of the contraceptive in an amount of 20 mcg over 24 hours. After five years of using the IUD, the amount of hormone released decreases to 10 mcg. There is a loop at the end of the T-shaped body to which threads are attached to remove the IUD from the uterus. This structure is placed in a guide tube and has a length of about 30 cm. But do not be alarmed by such large sizes: it is only used to insert a T-shaped body into the uterus.

What effect does it have on the body?

The Mirena IUD slowly releases the hormone levonorgestrel into the uterine cavity. It does not affect blood clotting, level blood pressure and blood sugar. That is why the use of the IUD for healthy women is practically safe.

When installed, the IUD provides local gestagenic effect. The hormone reduces the sensitivity of the genital receptors of the uterus, which leads to the cessation of growth and rejection of the inner layer of the organ, in other words, menstruation disappears in women without suppressing ovulation. The presence of a foreign body prevents the fertilized egg from attaching. The cervix also reacts to the spiral: its mucus becomes dense, which makes it difficult for sperm to move.

Mirena has an analogue - Jaydess. This is a levonorgestrel-based IUD, but it contains less of the hormone and only lasts for three years.

Pharmaceutical manufacturers have also created a combination drug based on levonorgestrel and estrogen for oral administration. This remedy is often used as emergency contraception after unprotected intercourse.

Indications

The hormonal IUD is used not only as a method of protection. The drug is prescribed in the presence of the following pathologies:

• endometriosis;
• uterine fibroids;
• idiopathic hemorrhage;
• endometrial hyperplasia.

Restrictions

1. Pregnancy.
2. Acute and chronic infectious diseases of the genital tract, urethra and bladder.
3. Various pathologies of the cervix.
4. Malignant neoplasm of the breast.
5. Endometritis after childbirth or abortion.
6. Anomalies in the structure of the organ: bicornuate uterus, presence of septa.

Interaction with other drugs

Anticonvulsants and antibiotics can affect hormonal contraceptives, but when using the Mirena spiral you don’t have to worry about this. It has a main effect on the inner layer of the uterus, and practically does not affect the body.

Storage conditions and shelf life

The drug should be kept in tightly closed sterile packaging. Removal of the IUD should be carried out immediately before its insertion into the uterine cavity. If all storage rules are followed, the shelf life of the IUD is 36 months.

Benefits of use

Unlike hormonal contraceptives or simple spirals, Mirena has many advantages:

1. IUD prolapse is extremely rare., because the hormone relaxes the uterus, and it does not push out the foreign body.
2. Stopping menstrual bleeding.
3. Using Mirena prevents development inflammatory diseases .
4. The contraceptive effect is almost 100%. After five years of use, only seven women out of a thousand become pregnant.
5. Has a local therapeutic effect: prevents the growth and development of endometrioid cysts and fibroids.
6. Pregnancy after removal of the IUD occurs within the first year.
7. Used by women of different ages: nulliparous, during lactation and during menopause.

Disadvantages of Mirena

Like any medication, the hormonal IUD has its side effects. These include:

• swelling;
• pain in the lower abdomen;
• increased blood pressure;
• the appearance of acne;
• weight gain;
• Bad mood;
• irritability;
• headache;
• leucorrhoea;
• hair loss;
• painful tension in the mammary glands;
• decreased libido;
• hives;
• eczema.

In addition to side effects, the disadvantages of the hormonal IUD include:

1. Price. The cost is about 12 thousand rubles.

However, it must be taken into account that by installing this IUD, you can forget about contraception for five years. Consequently, only 200 rubles are spent monthly on protection against unwanted pregnancy.

1. For installation of an IUD a visit to a gynecologist is necessary.
2. Does not protect against infections sexually transmitted diseases.
3. The likelihood of an ectopic pregnancy.
4. May affect menstruation: irregular cycle, prolonged spotting or spotting in the first months after installation; development of amenorrhea - complete absence of menstrual periods.

Complications

The main difficulties of inserting an IUD include:

1. Perforation of the uterus. This problem is extremely rare. An organ rupture occurs, which the doctor will immediately notice. At the same time, he must remove the spiral and refer the woman for an emergency operation to stitch the organ. If the gynecologist did not notice the perforation during installation, the spiral may continue its movement in the pelvis and disrupt the integrity of other organs. All this leads to serious consequences.
2. Spiral falling out. This can happen if the doctor installed the product incorrectly or the woman did not listen to the gynecologist’s recommendations and had sexual intercourse during the first week after installation.
3. Infections. Inflammation of the pelvic organs occurs when aseptic rules are violated and bacteria enter the uterine cavity during the installation of an IUD. If the infection appears 20 days after the insertion of the IUD, this means that the bacteria entered the uterus in another way, for example, during sexual intercourse.

Removing the spiral

In a normal cycle, the IUD is removed on any day of menstruation. If a woman is not planning a pregnancy and is interested in further contraception, the doctor can immediately introduce a new method.

It has been proven that using several IUDs in a row does not affect women's health.

If for some reason it is impossible to install a new IUD, you must start taking oral contraceptives a week before removing Mirena.

After removing the IUD from the uterine cavity, the doctor examines it for integrity. To avoid negative consequences you need to make sure that the tendrils or core do not remain in the organ cavity.

Conclusion

The hormonal intrauterine device Mirena is one of the most the best means contraception at present. When choosing this method of protection against unwanted pregnancy, a mandatory consultation with a gynecologist and endocrinologist is necessary. The presence of infections of the pelvic organs may cause refusal to install the IUD. In addition, before inserting an IUD, you must undergo a number of tests. The cost of Mirena is quite high, but if the body adapts to it, the woman will forget about other methods of contraception for a long time.

The Mirena intrauterine therapeutic system is a white or almost white hormonal-elastomer core located on a T-shaped body and covered with an opaque membrane, which serves as a kind of regulator for the release of the active ingredient. The T-shaped body has a loop at one end with an attached thread to remove the coil and two arms. The Mirena system is placed in a guide tube and is free of visible impurities. The drug is supplied in sterile blisters made of polyester or TYVEK material in the amount of 1 piece.

pharmachologic effect

The intrauterine system, or simply the Mirena IUD, is a pharmaceutical drug based on levonorgestrel , which, gradually released into the uterine cavity, has local gestagenic effect . Thanks to the active component of the therapeutic agent, the sensitivity of estrogen and progesterone receptors of the endometrium is reduced, which is manifested in a strong antiproliferative effect.

There are morphological changes in the inner lining of the uterus and a weak local reaction to a foreign body in its cavity. The mucous membrane of the cervical canal becomes significantly denser, which prevents the penetration of sperm into the uterus and inhibits the motor abilities of individual sperm. In some cases, suppression of ovulation is also noted.

The use of Mirena gradually changes the character menstrual bleeding . In the first months of use intrauterine device, due to the suppression of endometrial proliferation, an increase in spotting and bloody discharge from the vagina may be observed. As the pharmacological effect of the therapeutic agent develops, when the pronounced suppression of proliferative processes reaches a maximum, a period of scanty bleeding begins, which often transforms into oligo- And amenorrhea .

3 months after starting to use Mirena, menstrual blood loss in women is reduced by 62-94%, and after 6 months - by 71-95%. This pharmacological ability to change the character uterine bleeding used for treatment idiopathic menorrhagia in the absence of hyperplastic processes in the membranes of the female genital organs or extra genital conditions, an integral part of the pathogenesis of which is a pronounced hypocoagulation , since the effectiveness of the drug is comparable to surgical treatment methods.

Pharmacodynamics and pharmacokinetics

Once the intrauterine system is installed, the pharmaceutical drug begins to act immediately, which is manifested in the gradual release levonorgestrel and its active absorption, which can be judged by changes in its concentration in the blood plasma. Speed The release of the active component is initially 20 mcg per day and gradually decreases, reaching 10 mcg per day after 5 years. Hormonal IUD Mirena installs high local exposure , which provides a concentration gradient of the active substance in the direction from the endometrium to the myometrium (the concentration in the walls of the uterus varies more than 100 times).

Entering the systemic circulation, levonorgestrel contacts whey proteins blood: 40-60% of the active component nonspecifically combines with , and 42-62% of the active component – ​​specifically with selective sex hormone carrier SHBG . About 1-2% of the dosage is present in the circulating blood as free steroid. During use of a therapeutic agent, the concentration of SHBG decreases and the free fraction increases, which indicates the nonlinearity of the pharmacokinetic ability of the drug.

After insertion of the Mirena IUD into the uterine cavity, levonorgestrel in blood plasma is detected after 1 hour, and the maximum concentration is reached after 2 weeks. In clinical studies, it was proven that the concentration of the active component depends on the woman’s body weight - with low weight and/or with a high concentration of SHBG, the amount of the main component in the plasma is higher.

Levonorgestrel metabolized with the participation isoenzyme CYP3A4 to the final metabolic products in the form of conjugated and non-conjugated 3-alpha and 5-beta tetrahydrolevonorgestrel , after which it is excreted through the intestines and through the kidneys with an excretion coefficient of 1.77. In its unchanged form, the active component is eliminated only in trace amounts. The total clearance of the biological substance Mirena from blood plasma is 1 ml per minute per kilogram of weight. The half-life is about 1 day.

Indications for use

• contraception;
• idiopathic menorrhagia;
• preventive treatment endometrial hyperplasia during hormone replacement therapy.

Mirena spiral - contraindications

Absolute contraindications for the use of hormonal IUDs:

• pregnancy ;
• inflammatory diseases of the pelvic organs;
• postpartum ;
• infectious process in the lower parts of the genitourinary system;
• history of septic abortion over the past three months;
• malignant neoplasms uterus or cervix;
• female reproductive system;
• uterine bleeding of unknown origin;
• hormone-dependent tumor neoplasms;
• congenital or acquired anomalies of the anatomical and histological structure of the uterus;
• acute liver diseases;
• increased sensitivity to the pharmacological components of the intrauterine device.

Pathological conditions that may complicate the use of an intrauterine device with levonorgestrel :

• postpartum period from 48 hours to 4 weeks;
• deep vein thrombosis;
• benign trophoblastic disease ;
• breast cancer present or in history within the last 5 years;
• high probability of sexually transmitted infectious diseases;
• active liver disease (eg spicy , decompensated and so on).

Side effects of Mirena

Menstrual cycle changes

Side effects of the IUD should start with changes in the nature and cyclicity of menstrual bleeding , because they occur much more often than other adverse consequences therapeutic measures. Thus, the duration of bleeding increases in 22% of women, and irregular uterine hemorrhages observed in 67%, when considering the first 90 days after installation of the Mirena drug. The frequency of these phenomena gradually decreases, since the hormonal spiral releases less biologically active substance over time and by the end of the first year it is 3% and 19%, respectively. However, the number of manifestations of other menstrual cycle disorders increases - by the end of the first year develops in 16%, and rare bleeding in 57% of patients.

Other side effects

• From the outside immune system: skin rash and , , .
• From the outside nervous system: headache, , depressed mood up to .
• Side effects from the reproductive system and mammary glands: vulvovaginitis , discharge from the genital tract, pelvic infections, , pain in the mammary glands, expulsion intrauterine device, , perforation of the uterus.
• From the outside gastrointestinal tract : abdominal pain, nausea.
• Dermatological disorders: , , .
• From the outside of cardio-vascular system: increased blood pressure.

Mirena intrauterine device: instructions for use (Method and dosage)

General provisions for using the drug

The contraceptive Mirena is injected directly into the uterine cavity, where it exerts its pharmacological effects for 5 years. Release speed the active hormonal component is 20 mcg per day at the beginning of the use of the intrauterine device and gradually decreases to a level of 10 mcg per day after 5 years. Average elimination rate levonorgestrel throughout the entire therapeutic course is about 14 mcg per day.

There is a special contraceptive effectiveness indicator , which reflects the number of pregnancies in 100 women while using a contraceptive. If installed correctly and all rules for using the intrauterine device are followed, Pearl index for Mirena is about 0.2% for 1 year, and the same figure for 5 years is 0.7%, which expresses the incredibly high effectiveness of this method of contraception (for comparison: condoms have a Pearl index of 3.5% to 11 %, and y chemicals type of spermicides – from 5% to 11%).

Installation and removal of the intrauterine system may be accompanied by pain in the lower abdomen and moderate bleeding. Also, manipulation can cause fainting due to a vascular-vagal reaction or a convulsive seizure in patients , therefore, the use of local anesthesia of the female genital organs may be required.

Before installing the drug

It is recommended that the IUD be placed only doctor , who has experience with this type of contraception, since mandatory aseptic conditions and appropriate medical knowledge of female anatomy and the operation of the pharmaceutical drug are required. Immediately before installation it is necessary to carry out general and gynecological examination , in order to eliminate the risks of further use of contraception, the presence pregnancy and diseases that act as contraindications.

The doctor must determine the position of the uterus and the size of its cavity, since correct location The Mirena system ensures a uniform effect of the active ingredient on endometrium , which creates conditions for its maximum efficiency.

Instructions for Mirena for medical personnel

Visualize the cervix using gynecological mirrors, treat it and the vagina with antiseptic solutions. Grasp the upper lip of the cervix with forceps and, using gentle traction, straighten the cervical canal, secure this position of the medical instruments until the end of the procedure for installing the intrauterine device. Slowly moving the uterine probe through the organ cavity to the fundus of the uterus, determine the direction of the cervical canal and the exact depth of the cavity, in parallel, excluding possible anatomical septa, synechiae, submucosal fibroma or other obstacles. If the cervical canal is narrow, it is recommended to use local or conduction anesthesia to widen it.

Check the sterile packaging with the drug for integrity, then open it and remove the intrauterine device. Move the slider to the farthest position so that the system is pulled inside the conductor tube and takes on the appearance of a small stick. Holding the slider in the same position, set the upper edge of the index ring in accordance with the previously measured distance to the fundus of the uterus. Carefully advance the guidewire through the cervical canal until the ring is approximately 1.5-2 cm from the cervix.

After reaching the required position of the spiral, slowly move the slider until the horizontal arms are fully opened and wait 5-10 seconds until the system acquires a T-shape. Advance the guidewire to the fundal position, as evidenced by complete contact of the index ring with the cervix. While holding the conductor in this position, release the drug using the lowest position of the slider. Carefully remove the conductor. Cut the threads to a length of 2-3 cm, starting from the external os of the uterus.

It is recommended to confirm the correct position of the intrauterine device using ultrasound immediately after the procedure for installing Mirena. Repeated examination is performed after 4-12 weeks, and then once a year. If there are clinical indications, a gynecological examination and verification of the correct position of the spiral using functional laboratory diagnostic methods should be carried out regularly.

Removing the intrauterine device

Mirena should be removed after 5 years after installation, since the effectiveness of the therapeutic agent is significantly reduced after this period. The medical literature even describes cases of the adverse effects of an intrauterine device not removed in a timely manner with the development of inflammatory diseases of the pelvic organs and some other pathological conditions.

To extract the drug requires strict adherence to aseptic conditions. Removing Mirena involves carefully pulling the threads grasped with special gynecological forceps. If the threads are not visible and the intrauterine device is located deep in the organ cavity, then a traction hook can be used. It may also be necessary to dilate the cervical canal.

After removal Mirena preparation should inspect the system for its integrity, since in some situations the hormonal-elastomer core may separate or slip onto the shoulders of the T-shaped body. Pathological cases have been described in which such complications of intrauterine device removal required additional gynecological intervention.

Overdose

When used correctly and following all the rules for placing an intrauterine device, an overdose of a pharmaceutical drug impossible .

Interaction

Pharmaceutical enzyme inducers, especially biological catalysts from the system cytochrome P 450 , which are involved in the metabolic degeneration of drugs such as anticonvulsants ( , Phenytoin , ) And ( and others), enhance biochemical transformation gestagens . However, their influence on the effectiveness of Mirena is insignificant, since the main point of application of the therapeutic abilities of the intrauterine device is the local effect on the endometrium.

Terms of sale

Available in pharmacy kiosks with a prescription.

Storage conditions

The intrauterine hormonal device should be stored in sterile packaging out of the reach of children. younger age a place that is protected from direct sun rays. The proper temperature should not exceed 30 degrees Celsius.

Best before date

special instructions

Mirena hormonal device for uterine fibroids

(other names - fibroids or leiomyoma ) is a benign tumor that grows from the muscular layer of the uterus (myometrium) and is one of the most common gynecological diseases. Pathological focus is a knot of chaotically woven smooth muscle fibers from several millimeters to several centimeters. To treat this nosological entity, surgical intervention is usually used, but a conservative therapy regimen has now been developed.

The drug of choice is hormonal agents with a preferred local type of interaction, therefore the Mirena intrauterine device is a kind of gold standard for the sanitation of uterine fibroids.

Antiestrogenic effect is implemented in reducing the size of pathological nodes, preventing possible complications and reducing the volume of surgical intervention in order to preserve the maximum physiological structure of the uterus and make future pregnancies possible.

Mirena spiral for endometriosis

– a pathological condition when the cells of the inner layer of the uterus grow outside it. Histological structures have receptors for female sex hormones, which causes the same changes as in the normal endometrium, manifested by monthly bleeding, in response to which an inflammatory reaction develops.

Gynecological disease is common in women of reproductive age and, in addition to painful sensations, can lead to a frequent complication of endometriosis, which is why it is so important to diagnose the pathological condition in a timely manner and correctly approach it. Of course, treatment for endometriosis can be a surgical intervention with minimally invasive access and a small number of side effects, but it is much preferable to choose conservative treatment methods.

The Mirena intrauterine device is an effective remedy for eliminating endometriosis for several reasons:

• the effect of the drug, proven by practical research, is manifested by inhibition of the growth of pathological foci, a decrease in their size and gradual resorption;
• fewer side effects compared to other pharmaceuticals;
• relief of pain that inherently accompanies the problem of endometriosis;
• there is no need to take daily oral tablets or injections;
• normalization of the menstrual cycle;
• there is no need for contraception.

Intrauterine device for endometrial hyperplasia

Endometrial hyperplasia – this pathological condition is extremely similar to endometriosis, as it represents excessive growth and thickening of the mucous membrane of the female genital organs. The difference lies in the correct anatomical location of histological structures, which only changes the symptoms and possible complications, but does not get rid of them.

The nosological unit can be recognized by heavy and prolonged bleeding during menstruation or uterine hemorrhages not related to the cycle, absent ovulation and the inability to implant the embryo into the altered endometrium, which is a manifestation higher level estrogen in the body. The etiological treatment of this problem, aimed at eliminating the immediate cause, is hormonal agents with a pronounced antiestrogenic effect.

Most gynecologists prefer to use the Mirena intrauterine system because of the reliability of its pharmacological action, ease of daily use, which does not require additional medical knowledge and relative cheapness compared to other therapeutic agents, because the use of Mirena does not involve everyday expenses for oral tablets or injections.

Pregnancy after using the Mirena intrauterine device

Since the contraceptive has predominantly local pharmacological effects, complete restoration of all physiological indicators after removal of the drug it occurs quite quickly. Within a year after the evacuation of the system, the frequency of planned pregnancies reaches 79.1-96.4%. The histological state of the endometrium is restored after 1-3 months, and the menstrual cycle is completely rebuilt and normalized within 30 days.

Analogs

There are several pharmaceutical drugs with the same ATC code and a similar composition of active ingredients: Jaydess , , Evadir , however, only Jaydess can rightfully be called an analogue, since medicine represented by an intrauterine system based levonorgestrel with a lower dosage, and therefore designed for only three years of constant use.

With alcohol

The pharmaceutical drug has a pronounced local therapeutic effect and enters the systemic circulation in small quantities. female body, therefore does not interact with the components of alcoholic beverages, however, their dosed use is recommended so as not to cause other side effects or adverse consequences.

During pregnancy and lactation

The use of the Mirena intrauterine device is contraindicated in pregnancy or suspicion of it, since any intrauterine contraceptive increases the risk spontaneous abortion And premature birth. Removal or probing of the system can also lead to unplanned evacuation of the fetus from the uterine cavity. If careful removal of the contraceptive is not possible, the appropriateness of medical abortion should be discussed if indicated.

If a woman wants to continue her pregnancy, then, first of all, the patient should be fully informed about the possible risks and adverse consequences for both her body and the child. In the future, you should carefully monitor the course of pregnancy and be sure to exclude ectopic implantation using reliable diagnostic methods.

Due to topical use of hormonal contraceptives, there is a possibility virilizing effect on the fetus However, due to the high effectiveness of the pharmaceutical drug Mirena, clinical experience regarding pregnancy outcomes with simultaneous use of an intrauterine device is very limited. A woman who wishes to continue her pregnancy should also be informed about this.

Breast-feeding is not a contraindication for the use of the intrauterine system, although small amounts of the active component (about 0.1% of the dose) may pass into milk during lactation. It is unlikely that such minute amounts of levonorgestrel will have any pharmacological effects on the child. The medical community overwhelmingly agrees that the use of the drug in 6 weeks after childbirth it does not have adverse effects on the growth and development of the young body.