Spiral intrauterine Mirena №1

Active ingredient

with a release rate of the active substance of 20 mcg / 24 h (in the initial period)
contains levonorgestrel 52 mg
in a vacuum paper-plastic package 1 pc.; in the box 1 pack.

The product consists of a conductor and an intrauterine system (IUD), releasing the levonorgestrel. The Navy is placed in a conduit tube. The system consists of a white or almost white hormone-elastomer core, placed on a T-shaped case and covered with an opaque membrane that regulates the release of levonorgestrel. The T-shaped body is provided with a loop at one end and two shoulders at the other. Threads are attached to the loop to remove the system. The system is free from visible impurities.

Mechanism of action

Mirena is an intrauterine contraceptive. It is a T-shaped elastomer system (device), the vertical rod of which consists of a levonorgestrel containing container covered with a special membrane through which controlled diffusion of levonorgestrel at 20 mcg / day (during the initial period) occurs continuously.
Levonorgestrel, entering directly into the uterine cavity, has a direct local effect on the endometrium,preventing proliferative changes in it and thereby reducing its implantation function, and also increases the viscosity of the mucus of the cervical canal, which prevents the penetration of spermatozoa into the uterus.
Levonorgestrel also has a minor systemic effect, manifested by the inhibition of ovulation in a certain number of cycles.
Mirena reduces the amount of menstrual bleeding, reduces pre- and menstrual pain. In women with menorrhagia, after 2-3 months of using Mirena, the volume of menstrual bleeding decreases by 88%. Reducing menstrual blood loss reduces the risk of iron deficiency anemia.
Mirena's efficacy in preventing endometrial hyperplasia during continuous estrogen therapy was equally high with both oral and percutaneous estrogen use.

Indications and usage

 
- contraception;
- idiopathic menorrhagia;
- protection of the endometrium from hyperplasia during estrogen replacement therapy.

Contraindications

 
- pregnancy or suspicion of it;
- Malignant neoplasms of the uterus or cervix;
- inflammatory diseases of the pelvic organs;
- cervicitis;
- cervical dysplasia;
- congenital and acquired uterine anomalies that prevent the introduction of intrauterine contraceptives;
- abnormal uterine bleeding;
- infections of the lower urinary tract;
- postpartum endometritis;
- septic miscarriage in the last three months;
- acute liver disease, liver tumors;
- Diseases accompanied by increased susceptibility to infections;
- hypersensitivity to the drug.

Mirenfollows use with caution, after consulting with a specialist, or you should discuss the feasibility of deleting the system in the presence or first occurrence of any of the following conditions:
- migraine, focal migraine with asymmetric loss of vision or other symptoms indicating cerebral ischemia;
- unusually severe headache;
- jaundice;
- pronounced increase in blood pressure;
- confirmed or presumptive diagnosis of a hormone-dependent neoplasm, incl. mammary cancer;
- severe diseases of the arteries, incl. stroke and myocardial infarction.

Dosage and administration

Women of childbearing age the intrauterine system is recommended to enter into the uterine cavity for 1-7 day of the menstrual cycle; after induced abortion in the first trimester of pregnancy - immediately after the next menstruation; after uncomplicated spontaneous labor - no earlier than after 6 weeks.
Mirena should be removed after 5 years. At the same time it is possible to make the introduction of a new intrauterine system.
When conducting estrogen replacement therapy Miren can be administered during the last days of menstruation or withdrawal bleeding, in women with amenorrhea - at any time.

Adverse reactions

Side effects more often develop in the first months after Mirena is introduced into the uterus; with prolonged use, they gradually disappear. The following adverse effects have been described in women using Mirena, but their relationship with the use of the drug was not confirmed in all cases.
Common side effects (noted by more than 10% of women using Mirena) include changes in the nature of uterine bleeding and benign ovarian cysts.
Various types of changes in the nature of bleeding (frequent, prolonged or severe bleeding, spotting, oligo- and amenorrhea) are observed in all women using Mirena. The average number of days and months when spotting is noted in women of childbearing age gradually decreases from 9 to 4 days during the first 6 months after the installation of the IUD. The proportion of women with prolonged (more than 8 days) bleeding decreases from 20 to 3% in the first 3 months of using Mirena. In clinical studies, it was found that in the first year of Mirena use, 17% of women had amenorrhea for at least 3 months.
When Miren is used in combination with estrogen replacement therapy, in the first months of treatment, most women in the peri-and post-menopausal period have spotting and irregular bleeding. In the future, their frequency decreases, and approximately 40% of women receiving this therapy in the last 3 months of the first year of treatment completely disappear. Bleeding disorders 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 using Mirena. In most cases, an increase in follicles was asymptomatic and disappeared within 3 months.

Pregnancy and Breastfeeding

Miren cannot be used during pregnancy or suspected her. If pregnancy occurs in a woman while using Mirena, it is recommended to remove the IUD, since any contraceptive left in situ, increases the risk of miscarriage and premature birth. Removing Mirena or probing the uterus can also cause miscarriage. If it is impossible to remove the intrauterine contraceptive carefully, you need to think about the feasibility of abortion. If a woman wants to preserve a pregnancy, she should be informed about the risk and possible consequences of premature birth for the child. In such cases, the course of pregnancy should be carefully monitored. It is necessary to exclude an ectopic pregnancy. The woman should be explained that she should report all the symptoms suggesting pregnancy complications, in particular, pain such as colic in the lower abdomen, accompanied by fever.
Despite the intrauterine use and local action of the hormone, its teratogenic effect cannot be completely excluded (especially virilization).Due to Mirena's high contraceptive effectiveness, clinical experience related to pregnancy outcomes in her application is limited. However, a woman should be informed that today there is no evidence of birth defects caused by Mirena's use in cases of continuing pregnancy before giving birth without removing an IUD.
Levonorgestrel was found in breast milk, but it is unlikely that it would increase the risk to the baby at doses released by Mirena in the uterus.
It is assumed that the use of any progestin-only method of contraception 6 weeks after birth does not have a serious impact on the growth and development of the child. Only progestin methods do not affect the quantity and quality of breast milk. Rare cases of uterine bleeding have been reported in women using Mirena during lactation.

Before the introduction of the Mirena intrauterine system, a woman is recommended to undergo a thorough general medical and gynecological examination (including the examination of the mammary glands), to exclude pregnancy. In addition, sexually transmitted diseases should be excluded. Preventive control examinations should be carried out at least 1 time per year.
In some women, when applying Mirena, oligomenorrhea or amenorrhea develops, which in menorrhagia has a healing effect. After removal of the intrauterine system, the menstrual function is restored.
The intrauterine system Mirena is effective for 5 years. The ability to bear children is restored in 80% of women 12 months after the removal of the contraceptive.

With this method of use overdose is impossible.

 
The effectiveness of hormonal contraceptives may decrease when taking drugs that alter the work of liver enzymes, in particular primidone, barbiturates, difenina, Carbamazepine , rifampicin, oxcarbazepine; suggest that Griseofulvin also acts. The effect of these drugs on contraceptive activity of Mirenanot studied, probably not essential, since Mirena has mainly local action.

Recently conducted epidemiological studies show that women receiving mini-pillies containing only gestagen may have a slight increase in the risk of venous thromboembolism, but the results of these studies were not statistically significant. However, when detecting symptoms of thrombosis, appropriate diagnostic and therapeutic measures should be taken immediately.
A woman should seek medical attention if symptoms of venous or arterial thrombosis develop, which may include: one-sided leg pain and / or edema; sudden severe chest pain,with or without radiation in the left hand; sudden shortness of breath; sudden coughing up any unusual, severe, prolonged headache; sudden partial or complete loss of vision; diplopia; inarticulate speech or aphasia; dizziness; loss of consciousness with / or without convulsive seizure; weakness or a very significant loss of sensitivity, suddenly appearing on one side or in one part of the body; motor disorders; "Sharp belly".
Symptoms that indicate retinal vascular thrombosis include unexplained partial or complete loss of vision, ptosis of the eyelid or diplopia, swelling of the nipple of the optic nerve, or vascular lesions of the retina.
There is no consensus on the possible role of varicose veins or thrombophlebitis of the superficial veins in the occurrence of venous thromboembolism.
Miren should be used with caution in women with congenital or acquired valvular heart disease, bearing in mind the risk of septic endocarditis. When installing or removing an IUD in these patients, antibiotic prophylaxis should be performed.
Levonorgestrel in low doses can affect glucose tolerance, and therefore its blood levels should be regularly checked in women with diabetes and using Miren.
Some manifestations of polyposis or endometrial cancer may be masked by irregular bleeding. For prolonged and persistent intermenstrual bleeding, additional examination is necessary to clarify the diagnosis.
Mirena does not belong to the first choice methods either for young, never pregnant women, women, or for women in the postmenopausal period with severe uterus atrophy.
Oligo- and amenorrhea
Oligo- and amenorrhea in women of childbearing age develops gradually, in about 20% of cases of use of Mirena. If menstruation is absent within 6 weeks after the start of the last menstruation, pregnancy should be excluded. Repeated pregnancy tests for amenorrhea are optional, unless there are no other signs of pregnancy.
When Mirena is used in combination with permanent estrogen replacement therapy, most women gradually develop amenorrhea within 5 years.
Pelvic Infections
The conductor tube helps protect the Miren from contamination by microorganisms during installation, and the conductor Mirena is specially designed to minimize the risk of infection. When using copper-containing IUDs, the maximum risk of infection of the pelvic organs occurs in the first month after the installation of the system; further the risk decreases. A number of studies have shown that the incidence of pelvic organs in women with Mirena is lower than with copper-containing IUDs. It has been established that the presence of several sexual partners is a risk factor for infections of the organs of the small pelvis. Infections of the pelvic organs can have serious consequences: they can disrupt fertility and increase the risk of ectopic pregnancy.
For recurrent endometritis or pelvic infection, as well as for acute infections that are severe or 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 is indicated.
Expulsion
Possible signs of expulsion of any IUD are bleeding and pain. However, the system may be expelled from the uterus without being noticed by a woman. Partial expulsion may decrease Mirena's effectiveness. Since Mirena reduces menstrual blood loss, an increase in it may indicate an expulsion of the IUD.
If the position is incorrect, the IUD should be removed. Immediately following the removal, a new system can be installed.
A woman needs to be explained how to check Mirena's threads.
Perforation
Perforation or penetration of the body or cervix with an intrauterine contraceptive occurs rarely, mainly during installation. In these cases, the system should be removed.
Ectopic pregnancy
Women with a history of ectopic pregnancy who have undergone tubal surgery or pelvic infection are at high risk of ectopic pregnancy. The possibility of ectopic pregnancy should be considered in case of pain in the abdomen, especially if they are combined with the cessation of menstruation, or when a patient begins to bleed with amenorrhea.The frequency of ectopic pregnancy in women using Miren was 0.06 per 100 women per year. This figure is lower than that of women who did not use contraceptives (0.3–0.5 per 100 women per year).
Thread loss
If the threads to remove the IUD during a study during a long-term observation cannot be detected in the cervical area, it is necessary to exclude pregnancy. The filaments can be drawn into the uterine cavity or the cervical canal and become visible again after the next menstruation. If pregnancy is excluded, the filament can usually be localized by careful sensing. If it is not possible to detect the filament, it is possible that the IUD was pushed out of the uterus. To determine the correct location of the system, you can use ultrasound diagnostics. If it is unavailable or unsuccessful, Mirena uses an x-ray to locate it.
Delayed atresia of follicles
Since the contraceptive effect of Mirena is mainly due to its local effect, ovulatory cycles with rupture of follicles are usually observed in women of childbearing age. Sometimes atresia of the follicles is delayed and their development may continue. Such enlarged follicles are clinically impossible to distinguish 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 lower abdominal pain or pain during sexual intercourse.
In most cases, enlarged follicles disappear on their own within 2–3 months of observation.If this does not happen, continue ultrasound monitoring, as well as conducting therapeutic and diagnostic measures and the implementation of relevant recommendations. In rare cases, it is necessary to resort to surgical intervention.

The drug should be stored in a dry place protected from direct sunlight at a temperature of 15 ° to 30 ° C.

- 3 years.