Mirena #1

Mirena instruction

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Composition

I intrauterine device contains:
    levonorgestrel 52 mg;
    polydimethylsiloxane elastomer - 52 mg.

Form of issue

Mirena's intrauterine therapeutic system is a white or almost white hormonal-elastomeric core located on a T-shaped body and covered with an opaque membrane that serves as a regulator of the output of the active active ingredient. The T-shaped body is provided with a loop at one end with an attached thread to remove the spiral and two shoulders. The Mirena system is placed in the conductor tube and is free of visible impurities. The drug is delivered in sterile blisters of polyester or TYVEK material in an amount of 1 piece.

pharmachologic effect

The intrauterine system or simply the Navy Mirena is a pharmaceutical drug based on levonorgestrel, which, gradually released into the uterine cavity, exerts a local progestational effect. Due to the active component of the therapeutic agent, the sensitivity of estrogen and progesterone receptors of the endometrium decreases, which is manifested in a strong antiproliferative effect.
Morphological changes in the inner shell of the uterus and a weak local reaction to the foreign body in its cavity are observed. The mucous membrane of the cervical canal is heavily compacted, which prevents penetration of the sperm into the uterus and inhibits the motor abilities of individual spermatozoa. In some cases, oppression of ovulation is also noted.
The use of Mirena gradually changes the character of menstrual bleeding. In the first months of use of the intrauterine device, due to the inhibition of proliferation of the endometrium, there may be an increase in spotting discharge from the vagina bloody. As the pharmacological effect of the therapeutic agent develops, when the expressed inhibition of proliferative processes reaches a maximum, a period of megacious bleeding occurs, which often transforms into oligo- and amenorrhea.

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

Pharmacodynamics and pharmacokinetics

After the establishment of the intrauterine system, the pharmaceutical preparation begins to act immediately, which is manifested in the gradual release of levonorgestrel and its active absorption, which can be judged by the change in its concentration in the blood plasma. The release rate of the active ingredient is initially 20 μg per day and gradually decreases, reaching 10 μg per day after 5 years. Hormonal spiral Mirena sets a high local exposure, which provides a gradient of the concentration of the active substance in the direction from the endometrium to the myometrium (the concentration in the walls of the uterus varies by more than 100 times).
Getting into the systemic bloodstream, levonorgestrel binds to blood serum proteins: 40-60% of the active ingredient unintentionally combines with albumin, and 42-62% of the active component - specifically with a selective carrier of sex hormones SHGG. About 1-2% of the dosage is present in the circulating blood as a free steroid. During the use of the therapeutic agent, the concentration of SHBG decreases and the free fraction increases, which indicates the non-linearity of the pharmacokinetic ability of the drug.
After the introduction of the Mirena IUS into the uterus, levonorgestrel in the blood plasma is detected after 1 hour, and the maximum concentration is achieved after 2 weeks. In clinical trials, it has been proven that the concentration of the active component depends on the body weight of the woman - at a low weight and / or at a high concentration of SHBG, the amount of the main component in the plasma is higher.
Levonorgestrel is metabolized with the participation of the CYP3A4 isoenzyme to the final products of metabolism in the form of conjugated and non-conjugated 3-alpha and 5-beta-tetrahydrolunorgestrel after which it is excreted through the intestine and through the kidneys with an excretion coefficient of 1.77. In the unchanged form, the active component is eliminated only in trace amounts. The total clearance of the biological substance Mirena from the blood plasma is 1ml per minute per kilogram of weight. Half-life is about 1 day.

Indications for use

    contraception;
    idiopathic menorrhagia;
    endometriosis;
    uterine myoma;
    preventive treatment of endometrial hyperplasia during hormone replacement therapy.

Spiral Mirena - contraindications

Absolute contraindications for the use of hormonal spiral:
    pregnancy;
    inflammatory diseases of the pelvic organs;
    postpartum endometritis;
    infectious process in the lower parts of the genitourinary system;
    septic abortion in the history of the past three months;
    malignant neoplasms of the uterus or its cervix;
    cervicitis;
    tuberculosis of the female reproductive system;
    uterine bleeding of unknown origin;
    dysplasia of the cervix;
    hormone-dependent tumor neoplasms;
    congenital or acquired anomalies of the anatomical and histological structure of the uterus;
    acute liver disease;
    hypersensitivity to the pharmacological components of the intrauterine device.

Pathological conditions that can 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 in the presence or in the anamnesis for the last 5 years;
    pulmonary embolism;
    Acquired Immunodeficiency Syndrome;
    high probability of sexually transmitted infections;
    active liver pathology (eg, acute viral hepatitis, decompensated cirrhosis, and so on).

Side Effects of Mirena

Changes in the menstrual cycle
Side effects of the IUD should start with a change in the nature and cycle of menstrual bleeding, because they manifest themselves more often than other adverse effects of therapeutic measures. Thus, the duration of bleeding increases in 22% of women, and irregular uterine hemorrhages are noted in 67%, when examining the first 90 days after the installation of Mirena. The frequency of these phenomena gradually decreases, since the hormonal helix with time releases less active substance and by the end of the first year, respectively, is 3% and 19%. However, the number of manifestations of other disorders of the menstrual cycle increases - by the end of the first year amenorrhea develops in 16%, and rare bleeding in 57% of patients.

Other side effects

    From the immune system: skin rash and itching, hives, angioedema.
    From the nervous system: headache, migraines, depressed mood right up to depression.
    Side effects from the reproductive system and mammary glands: vulvovaginitis, discharge from the genital tract, infection of the pelvic organs, dysmenorrhea, pain in the mammary glands, expulsion of the intrauterine device, ovarian cysts, uterine perforation.
    From the gastrointestinal tract: abdominal pain, nausea.
    Dermatological disorders: acne, hirsutism, alopecia.
    From the cardiovascular system: increased blood pressure.
Intrauterine spiral Mirena: instructions for use (Method and dosage)

General provisions for drug use

Contraceptive Mirena is injected directly into the uterine cavity, where it exerts its pharmacological effects for 5 years. The release rate of the active hormonal component is 20 μg per day at the beginning of the use of the intrauterine device and gradually decreases to a level of 10 μg per day after 5 years. The average rate of elimination of levonorgestrel throughout the therapeutic course is about 14 μg per day.
There is a special indicator of the effectiveness of contraceptives, which reflects the number of pregnancies in 100 women during the use of the contraceptive. With the correct installation and compliance with all rules for using the intrauterine device, the 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, the Perl index is 3.5% to 11% for condoms, and for chemicals such as spermicides, from 5% to 11%).
Installation and removal of the intrauterine system may be accompanied by pain in the lower abdomen, moderate bleeding. Also, manipulation can cause syncope due to vascular-vagal reaction or convulsive seizure in epileptic patients, therefore, local anesthesia of female genital organs may be required.

Before installing the drug

It is recommended that the intrauterine device is installed only by a doctor who has experience with this type of contraception, since mandatory aseptic conditions and appropriate medical knowledge of female anatomy and the work of the pharmaceutical preparation are required. Immediate before the installation is necessary to conduct a general and gynecological examination in order to exclude the risks of continued use of the contraceptive, the presence of pregnancy and disease, which act as contraindications.
The doctor must determine the position of the uterus and the size of its cavity, since the correct arrangement of the Mirena system ensures a uniform influence of the active ingredient on the endometrium, which creates the conditions for its maximum effectiveness.

Instruction on the Mirena for medical personnel

Visualize the cervix with the help of gynecological mirrors, treat it and the vagina with antiseptic solutions. To grasp the upper lip of the cervix with forceps and with careful traction straighten the cervical canal, fix this position of the medical instrument until the end of manipulation of the installation of the intrauterine device. Slowly pushing the mother tube through the body cavity of the uterus to the bottom, to determine the direction of the cervical canal and the exact depth of the cavity, parallel, excluding the possible anatomical walls, adhesions, submucosal fibroids or other obstacles. If the cervical canal is narrow, it is recommended to use a local or conductive type of anesthesia to expand it.
Check the sterile packaging with the drug for integrity, then open it and get an intrauterine device. Push the slider to the furthest position so that the system is drawn into the conductor tube and becomes the shape of a small stick. While holding the slider in the same position, place the upper edge of the index ring in accordance with the previously measured distance to the bottom of the uterus. Carefully push the conductor through the cervical canal until the ring is about 1.5-2 cm from the cervix.

After reaching the desired position of the spiral, slowly push the slider to the mark of full opening of the horizontal hangers and wait 5-10 seconds until the system becomes T-shaped. Advance the conductor to the base position, as indicated by the full contact of the index ring with the cervix. While holding the conductor in this position, release the drug with the lowest possible position of the slider. Carefully remove the conductor. Cut the threads to a length of 2-3 cm, starting from the outer throat of the uterus.
It is recommended to confirm the correct position of the intrauterine device with ultrasound immediately after the manipulation of the Mirren preparation. Re-examination is performed after 4-12 weeks, and then once a year. In the presence of clinical indications, gynecological examination and verification of the correct position of the spiral by functional methods of laboratory diagnosis should be carried out regularly.

Removal of the intrauterine device

The drug Mirena should be removed after 5 years after installation, as the effectiveness of the therapeutic agent is significantly reduced after this period. In the medical literature, even cases of adverse effect of a timely not-removed intrauterine device with development of inflammatory diseases of the pelvic organs and some other pathological conditions are described.
For the extraction of the drug, strict adherence to aseptic conditions is necessary. The removal of the Mirena is a neat stretch for the threads captured by special gynecological forceps. If the filaments are not visible, and the intrauterine device is deep in the body cavity, a traction hook can be used. It may also require an extension of the cervical canal.
After removing the Mirena preparation, the system should be inspected for its integrity, since in some situations, separation of the hormone-elastomeric core or its slipping onto the shoulders of the T-shaped body can be observed. There are described pathological cases when such complications of intrauterine device removal required an additional gynecological intervention.

Overdose

With proper use and compliance with all rules for setting an intrauterine device, an overdose of a pharmaceutical preparation is not possible.

Interaction

Pharmaceutical inducers of enzymes, especially biological catalysts from the cytochrome P 450 system, which participate in the metabolic degeneration of drugs such as anti-convulsants (phenobarbital, phenytoin, carbamazepine) and antibiotics (Rifampicin and others), enhance the biochemical conversion of progestins. However, their effect on the effectiveness of Mirren's preparation is unimportant, since the main point of application of the therapeutic abilities of the intrauterine device is the local action on the endometrium.

Storage conditions

Intrauterine hormonal spiral should be stored in sterile packaging in a place inaccessible to young children, which is protected from direct sunlight. The proper temperature regime should not exceed 30 degrees Celsius.
Shelf life - 3 years

special instructions

Hormonal spiral Mirena with uterine myoma

Myoma of the uterus (other names - fibromyoma 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. The pathological focus is a bundle of chaotically woven smooth muscle fibers from a few millimeters to several centimeters. To treat this nosological unit, surgery is usually used, but a conservative therapy regimen has now been developed.
The drug of choice are the hormonal agents with the preferred local type of interaction, therefore the myrrh, an intrauterine device, is a kind of gold standard for the sanation of the uterine myoma.
The antiestrogenic effect is realized 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 to make possible future pregnancies.

Spiral Mirena in endometriosis

Endometriosis is a pathological condition when the cells of the inner layer of the uterus grow outside of it. Histological structures have receptors for female sex hormones, which causes the same changes as in normal endometrium, manifested by monthly bleeding, in response to which an inflammatory reaction develops.
Gynecological disease is inherent in women of reproductive age and, in addition to painful sensations, can lead to infertility - a frequent complication in endometriosis, so it is so important to diagnose and correctly treat a pathological condition in a timely manner. Of course, endometriosis therapy may represent a surgical intervention with mini-invasive access and a few side effects, but it is much more preferable to choose conservative methods of treatment.

Intrauterine spiral Mirena is an effective remedy for the elimination of endometriosis for several reasons:
    The effect of a drug demonstrated by practical studies, manifested by inhibition of growth of pathological foci, a decrease in their size and gradual resorption;
    fewer side effects than other pharmaceuticals;
    alleviation of pain syndrome, inherently associated with the problem of endometriosis;
    there is no need for daily intake of oral tablets or injections;
    normalization of the menstrual cycle;
    there is no need for contraception.

Intrauterine device for endometrial hyperplasia

Hyperplasia of the endometrium is a pathological condition extremely similar to endometriosis, since it represents an overgrowth and thickening of the mucous membrane of the female genital organs. The difference lies in the correct anatomical location of the histological structures, which only alters the symptoms and possible complications, but does not relieve them.
To recognize the nosological unit allow abundant and prolonged bloody discharge during menstruation or uterine hemorrhage not associated with the cycle, the absence of ovulation and the impossibility of implantation of the embryo into the altered endometrium, which is a manifestation of an elevated level of estrogens in the body. Etiological treatment of this problem, aimed at the elimination of the immediate cause, is a hormonal drug with a pronounced anti-estrogenic effect.
Most gynecologists prefer using the Mirena intrauterine system because of the reliability of its pharmacological action, convenience of daily operation, which does not require additional medical knowledge and is relatively inexpensive compared to other therapeutic agents, since the use of Mirena does not imply routine expenditure on oral tablets or injections.

Pregnancy after using the intrauterine device Mirena

Since the contraceptive has mainly local pharmacological effects, the complete recovery of all physiological parameters after removal of the drug occurs quickly enough. Within a year after system evacuation, the frequency of planned pregnancies reaches 79.1-96.4%. The histological condition of the endometrium is restored in 1-3 months, and the menstrual cycle is completely reconstructed and normalized within 30 days.

With alcohol

Pharmaceutical preparation has a pronounced local therapeutic effect and in small amounts falls into the systemic bloodstream of the female body, therefore it 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.

In pregnancy and lactation

Use of the intrauterine device Myrist is contraindicated in pregnancy or suspected of it, since any intrauterine contraceptive increases the risk of spontaneous abortion and premature birth. Removing or probing the system can also lead to unplanned evacuation of the fetus from the uterine cavity. If you carefully remove the contraceptive is not possible, you should discuss the advisability of medical abortion according to the indications.
In case the woman wants to keep the pregnancy, then, first of all, the patient should be fully informed about the possible risks and adverse consequences, both for her body and for the child. In the future, it is necessary to carefully monitor the course of pregnancy and must exclude ectopic implantation with reliable diagnostic methods.
Because of the local application of the hormonal contraceptive, there is the possibility of virilizing action on the fetus, however, due to the high effectiveness of the Mirena pharmaceutical preparation, the clinical experience regarding pregnancy outcomes with simultaneous use of the intrauterine device is severely limited. This should also inform the woman who wants to save the pregnancy.
Breastfeeding is not a contraindication for the use of the intrauterine system, although small amounts of the active ingredient (about 0.1% of the dose) can enter the milk during lactation. It is unlikely that such meager quantities of levonorgestrel have any pharmacological effects on the baby. The medical community in its overwhelming majority agrees that the use of the drug at 6 weeks after delivery does not have adverse effects on the growth and development of the young organism.

Reviews on Mirena

The pharmaceutical drug is very popular among women of reproductive age, because the Irenaeum spiral Mirena reviews has the following:
    the contraceptive is convenient to use, as it is not necessary to adhere to a regular intake scheme, as in the case of oral hormonal contraceptives, or special dietary rules, because the active ingredient has a local effect;
    the Pearl index generates a sufficiently large credit of trust in a pharmaceutical product, which is confirmed by reviews and recommendations on the Internet;
    the frequency of manifestation of the most formidable side effects is incredibly small, which makes it possible not even to think about the methods of elimination during the decision to use the Mirena contraceptive.
Councils and reviews of doctors are based not only on the effectiveness of the contraceptive pharmacological effects of the intrauterine system, but also on the therapeutic properties of the drug. The results of clinical studies allow the use of the Mirena spiral in endometriosis, hyperplasia of the uterine mucosa and benign neoplasms of its muscular layer. Qualified specialists-gynecologists consider the conservative scheme of treatment of this contraceptive - the drug of choice with the above nosological units.
Reviews about the Navy Mirena from women who used it for therapeutic purposes, also filled with positive emotions. Such treatment not only at times allows to avoid surgical intervention, inevitably leaving disfiguring scars or other defects of skin, but also completely eliminates pathological foci of the disease. Almost any thematic forum or Internet resource recommends discussing this scheme of conservative treatment with a personal physician.