Mirena is an intrauterine contraceptive.
Release form and composition
The mienna is produced in the form of an intrauterine therapy system (IUD), consisting of an almost white or white hormone-elastomer core placed on a T-shaped body and covered with an opaque membrane that regulates the release of levonorgestrel, with a release rate of the active substance of 0.02 mg per day . At one end of the T-shaped body is equipped with a loop, on the other - with two shoulders; threads are attached to the loop to remove the system. The Navy is located in the conduit tube. Conductor and system free from visible impurities. Available in 1 pc. in sterile blisters of TYVEK material and polyester (APET or PETG), 1 blister in a carton box.
The structure of 1 Navy includes:
- Active ingredient: levonorgestrel - 52 mg;
- Auxiliary component: polydimethylsiloxane elastomer - 52 mg.
Indications for use
- Idiopathic menorrhagia;
- Endometrial hyperplasia during estrogen replacement therapy (prophylaxis).
- Inflammatory diseases of the pelvic organs, including recurrent;
- Postpartum endometritis;
- Infections of the lower urinary tract;
- Septic abortion in the last three months;
- Cervical dysplasia;
- Diseases that are associated with increased susceptibility to infections;
- Malignant neoplasms of the cervix or uterus;
- Pathological uterine bleeding of unknown etiology;
- Progestogen-dependent tumors, including breast cancer;
- Abnormalities of the uterus (acquired and congenital), including fibroids, leading to deformation of the uterus;
- Liver tumors, acute liver disease;
- Pregnancy or suspicion of her;
- Age from 65 years;
- Hypersensitivity to the drug.
Miren should be installed with caution and only after consulting a doctor if you have the following diseases / conditions:
- Unusually severe headache;
- Migraine, focal migraine with asymmetric loss of vision or other signs indicating transient cerebral ischemia;
- Severe arterial hypertension;
- Severe circulatory disorders, including myocardial infarction and stroke;
- Valvular disease or congenital heart disease (due to the risk of septic endocarditis).
Dosing and Administration
Miren is introduced into the uterine cavity. The effectiveness of the drug lasts for 5 years.
At the beginning of the application of IUD, the rate of release of levonorgestrel is about 0.02 mg per day, it gradually decreases to 0.01 mg per day (the average rate over 5 years is 0.014 mg per day).
Mirena can be used in women receiving hormone replacement therapy in combination with transdermal or oral estrogen-free estrogen preparations.
With the correct installation of Mirena, carried out in accordance with the instructions, the Pearl Index (an indicator that reflects the number of pregnancies in 100 women using a contraceptive during the year) is approximately 0.2% for 1 year. The cumulative figure, which reflects the number of pregnancies in 100 women using a contraceptive over 5 years, is 0.7%.
Women of childbearing age for contraception Miren needs to be installed in the uterine cavity within 7 days from the start of menstruation. The drug can be replaced with a new IUD on any day of the menstrual cycle. The system can be installed immediately after an abortion in the first trimester of pregnancy, provided that there are no inflammatory diseases of the genital organs.
The installation of the IUD after birth can be performed when uterine involution occurs, but not earlier than 6 weeks after delivery. With prolonged subinvolution, it is necessary to exclude postpartum endometritis. The decision on the introduction of the Navy should be postponed until the completion of the involution. In the event of difficulty installing Mirena and / or bleeding, or very severe pain during or after the procedure, it is necessary to immediately conduct physical and ultrasound examination in order to exclude perforation.
In women with amenorrhea to protect the endometrium during estrogen replacement therapy, Mirena can be placed at any time; when menstruation is preserved, installation is performed in the last days of withdrawal bleeding or menstrual bleeding.
Open the sterile packaging Mirena should be immediately before installation, following the rules of asepsis when handling the opened system. If you suspect a violation of the sterility of the IUD packaging should be destroyed.
The system should be installed by a physician who is well trained in this procedure or has experience with this IUD.
Before installation, it is necessary to evaluate the effectiveness, risk and side effects of Mirena, as well as conduct a general and gynecological examination, which includes examination of the mammary glands and organs of the small pelvis, as well as a smear from the cervix. Before installing it is necessary to exclude pregnancy and the presence of sexually transmitted diseases, as well as the presence of inflammatory diseases of the genital organs. After that, determine the position of the uterus and the size of its cavity. If it is necessary to visualize the uterus, before the introduction of the system, an ultrasound of the pelvic organs is performed.
After a gynecological examination, a special instrument (vaginal speculum) should be inserted into the vagina and the cervix should be treated with an antiseptic solution. Miren is introduced into the uterus through a flexible thin plastic tube. The correct positioning of the IUD in the bottom of the uterus is especially important because it ensures a uniform effect of the progestogen on the endometrium, prevents the expulsion of the system and creates conditions for its maximum effective action.
The introduction of the system a woman can feel, but the procedure should not cause severe pain. If required, prior to the introduction of Mirena, local cervical anesthesia can be performed.
When stenosis of the cervical canal to apply excessive force with the introduction of the system should not be.
Sometimes after the introduction of Mirena, dizziness, pain, pallor of the skin and increased sweating may occur. For some time after administration of the drug, a woman is recommended to rest. If these phenomena do not disappear 30 minutes after being in a quiet position, it can be assumed that the system is located incorrectly. In these cases, conduct a gynecological examination; if necessary, an improperly installed system is removed.
After installing the IUD after 1-3 months, the woman must be re-examined. In the future, repeated examinations are carried out 1 time per year or, in the presence of clinical indications, more often.
Miren is removed by gently pulling the threads caught by the tongs. If the filaments are not visible, and the system is in the uterine cavity, it can be removed using a traction hook to extract the IUD, which may require dilation of the cervical canal.
The system is removed 5 years after installation. New Navy can be installed immediately after removing the previous one.
In women of childbearing age, if further contraception is necessary, removal of Mirena should be performed during menstruation, provided that the menstrual cycle is preserved. If the system is removed in the middle of a cycle, if a woman has had sexual intercourse during the previous week, there is a risk of becoming pregnant, unless the new system was installed immediately after removing the old one.
The procedure for installing and removing Mirena can be accompanied by bleeding and certain painful sensations. In addition, fainting may develop due to a vasovagal reaction, in patients with epilepsy, bradycardia or convulsive seizures may occur, especially if there is a predisposition to these conditions or with cervical stenosis.
After removing Mirana, you need to check the system for integrity. In case of difficulties with the removal of the system, isolated cases of slipping of the hormone-elastomer core on the horizontal shoulders of the T-shaped hull were noted, because of which they hid inside the core. After confirming the integrity of the Navy, this situation does not require additional intervention. Limiters located on horizontal arms, as a rule, prevent complete separation of the core from the T-shaped case.
Miren adolescents can be installed only after the onset of menarche.
The efficacy and safety of the drug in women over 65 years old has not been studied, so it is not recommended for use in this age group. There is also no experience with the use of the system for functional disorders of the kidneys.
IUD is contraindicated in the presence of acute diseases or tumors of the liver.
In women older than 65 years in the postmenopausal period with severe uterine atrophy, Mirena is not a first choice drug.
In most cases, after installing Mirena, a change in the nature of cyclical bleeding occurs. During the first 90 days of use of the system, an increase in the duration of bleeding was observed in 22% of women, irregular bleeding in 67% of women. By the end of the first year of use of the drug, the frequency of these phenomena decreases, respectively, to 3% and 19%. At the same time during the first 90 days of use, amenorrhea develops in 0%, rare bleeding in 11% of women. The frequency of these phenomena by the end of the first year of application of the Navy increases, respectively, to 16% and 57%.
In most cases, when Mirena is applied simultaneously with long-term estrogen replacement therapy, during the first year of use, cyclic bleeding gradually stops.
The following side effects may occur during use of the system (≥1 / 10 - very often; from ≥1 / 100 to <1/10 - often; from ≥1 / 1000 to <1/100 - infrequently; from ≥1 / 10 000 up to <1/1000 - rarely; with unknown frequency):
- Cardiovascular system: with unknown frequency - increase in blood pressure;
- Nervous system: very often - headache; often - migraine;
- Immune system: with an unknown frequency - hypersensitivity to the components of the drug, including urticaria, rash and angioedema;
- Reproductive system and mammary glands: very often - spotting bleeding, change in blood loss (decrease and increase in the intensity of bleeding), oligomenorrhea, vulvovaginitis, discharge from the genital tract, amenorrhea; often - ovarian cysts, pelvic infection, dysmenorrhea, breast engorgement, pain in the mammary glands, expulsion of the IUD (partial or complete); rarely, uterine perforation, including penetration;
- The digestive system: very often - pain in the abdomen and / or pelvic area; often nausea;
- Musculoskeletal system: often - back pain;
- Skin and subcutaneous tissue: often - hirsutism, acne; infrequently - itching, alopecia, eczema;
- Mind: often - depression, depressed mood.
If a woman with an established system becomes pregnant, the relative risk of ectopic pregnancy increases.
During intercourse partner can feel the thread.
During post-registration studies, an increased risk of uterine perforation in nursing women was noted.
After installing Mirena, cases of sepsis (including streptococcal sepsis of group A) have been reported.
Before installing the IUD, it is necessary to eliminate pathological processes in the endometrium, since in the first months of use of the system, spotting and / or irregular bleeding is often noted. You also need to exclude pathological processes in the endometrium with the development of bleeding after the start of replacement therapy with estrogen in women who continue to use Mirena, previously established for contraception. During prolonged therapy with the appearance of irregular bleeding, it is also necessary to take appropriate diagnostic measures.
IUDs should not be used for post-coital contraception.
Because of the risk of septic endocarditis, Miren should be used with caution in women with congenital or acquired valvular heart disease. For prophylaxis when installing or removing the system, these patients are prescribed antibiotic drugs.
Levonorgestrel in low doses may affect glucose tolerance, which is why women with diabetes need to regularly monitor their plasma concentration. As a rule, dose adjustment of hypoglycemic drugs is not required.
Some manifestations of endometrial cancer or polyposis may be masked by irregular bleeding. In these cases, to clarify the diagnosis you need to conduct an additional examination.
Mirena is not a first-choice drug for either young, not previously pregnant women, nor for postmenopausal women with severe uterine atrophy.
In women of fertile age, amenorrhea and oligomenorrhea develop gradually, in about 57% and 16% of cases by the end of the first year of application of the IUD, respectively. In the absence of menstruation for 1.5 months after the start of the last menstruation, pregnancy should be excluded. With amenorrhea, repeated pregnancy tests are not necessary only in the absence of other signs of pregnancy.
With the simultaneous use of Mirena with constant estrogen replacement therapy, amenorrhea in most women develops gradually over the first year.
With the development of recurrent endometritis or inflammatory diseases of the pelvic organs, as well as in acute or severe infections resistant to therapy for several days, the IUD must be removed. If you experience persistent pain in the lower abdomen, chills, fever, pain associated with sexual intercourse (dyspareunia), prolonged or heavy bleeding / bleeding from the vagina, changes in the nature of vaginal discharge, you should immediately consult with your doctor. An increase in temperature or severe pain, which appears soon after the installation of Mirena, may indicate a serious infection that should be treated immediately. Even if only individual symptoms indicate the possibility of infection, monitoring and bacteriological examination are indicated.
Possible signs of complete or partial expulsion of any IUD are pain and bleeding. During menstruation, contractions of the uterus muscles sometimes lead to a displacement of the system or even to pushing it out of the uterus, which means the cessation of the contraceptive effect. Partial expulsion may reduce the effectiveness of the IUD. Since Mirena reduces menstrual blood loss, its increase may be a sign of expulsion of the system. During a shower, a woman is recommended to check the threads with her fingers. If signs of bias or loss of Mirena are detected, or in cases where it is impossible to grope, you should avoid sexual intercourse or use other methods of contraception. You also need to see a doctor as soon as possible.
Penetration or perforation of the cervix or the body of the uterus of the system is rare, mainly during installation, and may reduce the effectiveness of the drug. In these cases, the Miren is removed. In case of delayed diagnosis of migration and perforation of the IUD, complications such as peritonitis, adhesions, intestinal perforation, intestinal obstruction, erosion, or abscesses of adjacent internal organs can be observed. The risk of uterine perforation is higher in lactating women. An increase in the risk of perforation during the installation of the system is possible in women with a fixed bend of the uterus and in the postpartum period.
In women with a history of ectopic pregnancy who have undergone surgery on the fallopian tubes or an infection of the pelvic organs, the risk of ectopic pregnancy is higher. The possibility of developing an ectopic pregnancy should be considered for pain in the lower abdomen, especially if they are combined with the cessation of menstruation, or in cases when women with amenorrhea start bleeding.
If during the gynecological examination of the thread to remove Mirena to detect in the area of the cervix fails, pregnancy should be excluded. Threads can be drawn into the cervical canal or uterine cavity and after the next menstruation they become visible again. After pregnancy is excluded, the location of the filaments is determined by careful sensing with an appropriate tool. To determine the correct location of Mirena, you can conduct an ultrasound.
Due to the fact that Mirena’s contraceptive effect is mainly due to local effects, ovulatory cycles with follicle rupture are usually observed in women of fertile age. Clinically enlarged follicles cannot be distinguished from ovarian cysts. As a rule, ovarian cysts pass independently during several months of observation.
The structure of the T-shaped Mirena includes barium sulfate, which becomes visible during X-ray examination.
It should be borne in mind that the drug from HIV infection and other sexually transmitted diseases does not protect.
With simultaneous application Mirena with substances which are inducers of enzymes, in particular isozymes of cytochrome P450 involved in the metabolism of drugs such as anticonvulsants (phenytoin, phenobarbital, carbamazepine) and drugs for the treatment of infections (rifabutin, rifampicin, efavirenz, nevirapine) may increased metabolism of gestagen. The effect of these drugs on the effectiveness of Mirena is unknown, but it is believed that it is irrelevant, since the system mainly has a local effect.
When applying Mirena with estrogen, you must additionally take into account the information specified in the instructions for the corresponding estrogen.
Terms and conditions of storage
Store in a dark, out of reach of children at a temperature up to 30 ° C.
Shelf life - 3 years.