Index of drugs

Contraception. Idiopathic excessive menstrual bleeding.

The intrauterine therapy system contains 52 mg of levonorgestrel. The dose initially released is 20 μg per day.

Intrauterine system with contraceptive effect. Levonorgestrel reduces the number of estrogen and Progesterone receptors, resulting in the endometrium becoming insensitive to circulating estradiol and inhibiting its growth. The thickening of the cervical mucus prevents the passage of sperm through the cervical canal. The local environment in the uterus and fallopian tubes inhibits sperm motility and function, preventing fertilization. In some women, ovulation is halted. With a well-established system, the failure rate is about 0.2% after one year and the accumulated failure rate is 0.7% after 5 years. C_max Levonorgestrel is achieved within 2 weeks of starting the system. The rate of release of levonorgestrel in the uterine cavityin vivo it is initially 20 μg / 24 h and decreases after 5 years to 10 μg / 24 h. The mean release rate of levonorgestrel within 5 years of use is 14 μg / 24 h. Levonorgestrel concentration in the blood depends on body weight and steroid hormone-binding globulin ( SHBG) - low body mass and high concentration of SHBG increase its concentration. Levonorgestrel is extensively metabolised and excreted mainly as metabolites in urine and faeces. T_0,5 is about 24 hours. The system has the shape of the letter "T". The vertical part of the system is a white cylinder containing levonorgestrel.

Hypersensitivity to system components. Pregnancy or its suspicion. Existing or recurrent inflammation of the pelvic organs. Infections of the lower part of the genital tract. Postpartum endometritis. Uterine infections after miscarriage in the last 3 months. Inflammation of the cervix. Dysplasia of the cervical epithelium. Malignant neoplasm of the cervix or the endometrium. Progestag-dependent tumors. Undiagnosed bleeding from the genital tract. Congenital or acquired changes in the cervix or uterine cavity, e.g. fibroids that distort the uterine cavity. Conditions conducive to the development of infection. Severe liver disease or liver cancer.

If you experience any of the following symptoms for the first time, you should consider removing the system: migraine (including focal migraine with asymmetric visual field defects or with other symptoms indicative of transient cerebral ischemia), severe headache, jaundice, marked elevation of blood pressure , severe arterial disease (such as stroke or heart attack). The system should be removed when recurrent infections of the endometrium, pelvic organs and acute inflammation occur, which do not subside after several days of treatment. Use with caution in women with congenital heart disease or heart valve defects that increase the risk of endocarditis - an antibiotic should be given when putting or removing the system. It should be taken into account that patients using contraceptive pills containing progestogen only have an increased risk of venous thromboembolism, and the risk of diagnosed breast cancer in women using only progestogen-only tablets may be close to the risks associated with the use of combined contraceptives. If you experience: one-sided pain or swelling of the leg, sudden severe chest pain, sudden shortness of breath, sudden coughing attacks, unusual, severe and prolonged headaches, sudden partial or complete loss of vision, double vision, speech or speech loss, dizziness , collapse that can be combined with seizure, paresis or severe numbness involving one side or part of the body, movement disorders, acute abdomen, consideration should be given to the possibility of developing thrombosis. The system is not an appropriate means of contraception after intercourse without effective protection. Irregular bleeding may mask the symptoms associated with the presence of polyps or endometrial cancer, therefore, if bleeding occurs, diagnostic tests should be performed.In women with a history of ectopic pregnancy, after surgery on the fallopian tubes or with infection of the pelvic organs, the risk of ectopic pregnancy increases. The system reduces the abundance of menstrual bleeding, the severity of these bleeding may be a symptom of system prolapse or dislocation. If the system moves, remove it and create a new one. The safety and effectiveness of the system was established in women of childbearing age. There is no indication to use the system before starting menstruation. The preparation has not been studied in women with renal insufficiency and in women over 65 years. It is not recommended to use the system as a method of contraception of the first choice in young women who have not given birth so far.

The system is contraindicated during pregnancy or if pregnancy is suspected. If the patient becomes pregnant despite using the system, it should be removed. If the system can not be removed, the possibility of abortion should be considered. A patient who decides to maintain a pregnancy should be informed about the risks and consequences of premature birth and the possibility of virilization effects in the fetus. So far, no birth defects have been found, if the pregnancy developed with the system in place. About 0.1% of the dose of levonogestrel can penetrate into the baby's body with breast milk. The system does not have a detrimental effect on the growth and development of a child if it is used 6 weeks after delivery. It was not stated that preparations containing only progestin affect the quantity or quality of food. When breastfeeding, contraceptives containing only progestagens are the second choice methods. Removal of the system restores fertility.

They occur mainly during the first months since the system was founded. Very common: abnormal bleeding from the vagina or uterus (such as spotting, skimpy bleeding or lack of it) and benign ovarian cysts. Common: depressive moods, nervousness, decreased libido, headache, abdominal pain, nausea, acne, back pain, pelvic pain, dysmenorrhea, vaginal discharge, vulvovaginal inflammation, tenderness and breast pain, system prolapse (also without knowledge patient), weight gain. Uncommon: mood deterioration, migraine, bloating, alopecia, hirsutism, pruritus, eczema, pelvic inflammation, edema. Rare: rash, urticaria, uterine perforation (especially in the case of postnatal assumptions, in breastfeeding women and in patients with permanently uterine uterus). In 12% of the patients, enlarged ovarian follicles were observed, which may sometimes cause pelvic pain or pain during intercourse. Insertion, removal, prolapse or displacement of the system may result in genital bleeding and pain. The treatment may cause fainting or epileptic seizure in patients with epilepsy.

The system should only be set up by doctors who have been trained in setting up the system and have experience in setting up the system. In women of childbearing age, the system is inserted into the uterine cavity within 7 days of menstrual bleeding. The system can be replaced with a new one on any day of the cycle. In the event of a miscarriage in the first trimester of pregnancy, the system can be set up immediately. Do not use the system after the birth of the uterus, but not earlier than 6 weeks. If the uterine contraction is significantly delayed, wait until 12 weeks after giving birth. In case of difficulties in establishing the system and / or severe pain or bleeding, during implantation or after placement, an immediate medical examination and ultrasound should be performed to prevent perforation. The system should be removed after 5 years from the time of menstrual bleeding (if there is a menstrual cycle); the new system can be installed right away. If the system is removed in the middle of the cycle and the patient has had sexual intercourse during the week, it is possible to become pregnant unless a new one is immediately established after the system is removed.