Livial - anti-menopausal estrogen drug.
Release form and composition
Livial is produced in the form of tablets: almost white or white, round, flat, with beveled edges, with extruded “MK” inscription above “2” on one side and “ORGANON” with a five-pointed star on the other side (28 pcs. Per blisters, 1 or 3 blisters in a carton box).
The composition of 1 tablet includes:
- Active ingredient: Tibolone - 2.5 mg;
- Auxiliary components: magnesium stearate - 0.5 mg; potato starch - 10 mg; lactose - up to 100 mg; ascorbyl palmitate - 0.2 mg; purified water - traces (removed during production).
Indications for use
- Treatment: symptoms of estrogen deficiency in postmenopausal women;
- Prevention: osteoporosis in postmenopausal women with a high risk of developing fractures, as well as intolerance to other groups of drugs used to prevent the disease.
- The period is less than a year after the last menstruation;
- Thrombosis (arterial or venous) and thromboembolism at present or in history (including thrombophlebitis and deep vein thrombosis, pulmonary thromboembolism, hemorrhagic or ischemic cerebrovascular disorders, myocardial infarction);
- Diagnosed (including in the anamnesis) malignant estrogen-dependent tumors (for example, endometrial cancer) or suspicion of them;
- Diagnosed (including a history of) breast cancer or suspicion of it;
- Diagnosed thrombophilic conditions (eg, deficiency of protein S, protein C or antithrombin);
- Untreated endometrial hyperplasia;
- Bleeding from the vagina of unknown etiology;
- Pre-thrombosis conditions (including angina pectoris and transient ischemic attacks), currently or in history;
- Cardiovascular failure in the stage of decompensation;
- Numerous or pronounced risk factors for arterial or venous thrombosis (including atrial fibrillation, subacute bacterial endocarditis and complicated valvular heart disease, uncontrolled arterial hypertension, prolonged immobilization, extended surgical intervention, extensive injuries, obesity (with body mass index, if given by human weight index, if given by weight index,). );
- Liver failure;
- Acute liver disease or liver disease in history, after which the indicators of liver function to normal did not return;
- Benign or malignant liver tumors (including liver adenoma) now or in history;
- Otosclerosis, developed with the use of hormonal contraceptive drugs in history or during a previous pregnancy;
- Rare hereditary diseases: galactose intolerance, glucose-galactose malabsorption or lactase deficiency;
- Pregnancy and lactation (breastfeeding);
- Established hypersensitivity to the drug.
Livial should be taken with caution if any of the diseases / conditions listed below are present, occurred earlier and / or exacerbated during the previous hormone therapy or pregnancy were observed:
- Cardiovascular insufficiency with no signs of decompensation;
- Endometriosis and / or leiomyoma (uterine fibroids);
- The presence of risk factors for estrogen-dependent tumors (for example, genetic predisposition);
- Increasing the concentration of cholesterol in the blood;
- Controlled arterial hypertension;
- Severe headache or migraine;
- Diabetes mellitus, disorders of carbohydrate metabolism (regardless of the presence or absence of complications);
- Endometrial hyperplasia in history;
- Systemic lupus erythematosus;
- Renal failure;
- Bronchial asthma;
- Not associated with previous use of hormonal contraceptive drugs or pregnancy otosclerosis.
When applying Livial in these cases, the woman should be under close medical supervision. It should be borne in mind that when taking the drug, these diseases / conditions may worsen or recur.
Dosing and Administration
Livial can be started to be taken 12 months after the last natural menstruation. When you take the drug before this period increases the likelihood of irregular bloody bleeding / vaginal discharge.
Before starting Livial's administration and when bloody discharge from the genital tract occurs in a woman taking other hormone replacement therapy (HRT) drugs or not taking them, it is necessary to exclude malignant neoplasms of the reproductive organs
Livial should be taken orally on 1 tablet per day. Tablets should be swallowed whole with water, preferably at the same time every day. The daily dose does not depend on the age of the woman.
Blisters with pills are marked with days of the week. You should start taking Livial from taking the pill marked the current day. For example, on Monday you need to take a pill from the top row, marked Monday. In the future, tablets are taken according to the days of the week. At the end of the blister, the drug is continued from the next one without interruption.
Assign a separate progestogen in the treatment of Livialom should not be.
The missed pill must be taken no later than 12 hours after the pass. If the break was longer than this period, you must take the next pill at the usual time. A double dose of Livial should not be taken.
During the transition from the cyclic regimen of drugs for HRT, Livial should be started after the previous treatment regimen is completed the next day. When switching from a continuous mode of administration of the combined drug for HRT, therapy can be started at any time.
During therapy, the following side effects may develop:
- Reproductive system and mammary glands: often - vaginal discharge, cervical dysplasia, endometrial thickening, bleeding or vaginal bleeding, genital itching, pain in the pelvic region, vulvovaginal candidiasis, vulvovaginitis, pain in the mammary glands; infrequently - breast engorgement, mycosis, nipple soreness;
- Skin and subcutaneous tissue: often - increased hair growth (including on the face); rarely - acne;
- Gastrointestinal tract: often - pain in the lower abdomen;
- Laboratory and instrumental data: often - deviations results smear from the cervix (from the normal values of the cytological characteristics of the cervical epithelium), weight gain.
As a rule, these side effects are mild.
Also, when taking Livial may develop such side effects as:
- Gastrointestinal disorders (diarrhea, flatulence);
- Headache, dizziness, migraine;
- Itching of the skin, skin rash, seborrheic dermatitis;
- Visual impairment (including its vagueness);
- Joint and muscle pain;
- Liver dysfunction (including increased transaminase activity);
- Peripheral edema, fluid retention in the body.
The risk of developing breast cancer in women who receive only estrogen or tibolone is significantly lower than the risk that women who take combined (estrogen / gestagen) drugs.
Before taking the drug, it is necessary to find out the existing risk of developing breast cancer that occurs with prolonged use of Livial, as well as the likelihood of endometrial cancer and ischemic stroke during treatment.
While taking drugs for hormone replacement therapy (monopreparations with estrogen or combined (estrogen / gestagen) drugs), other undesirable effects were noted:
- Prolonged use of mono- or combination drugs slightly increases the risk of ovarian cancer;
- Admission Liviala relatively increases the risk of venous thromboembolism (1.3-3 times), which is more often observed during the first year of administration;
- Taking combination medications for hormone replacement therapy in women over 60 years of age can lead to a slight increase in the risk of developing coronary heart disease;
- The use of mono- or combined drugs can cause the development of gallbladder diseases (cholecystitis, cholelithiasis) and skin diseases (chloasma, erythema multiforme, erythema nodosum, vascular purpura). In women over 65 at the beginning of therapy, there is the likelihood of dementia.
Livial is not intended for use as a contraceptive drug, and it does not protect against unwanted pregnancy.
The decision to start taking Livial should be made on the basis of an assessment of the “benefit / risk” ratio, taking into account individual risk factors. Women over 60 need to take into account the increased risk of stroke.
For the treatment of postmenopausal symptoms, Livial should be prescribed only in relation to symptoms that adversely affect the quality of life. In all cases, it is necessary at least once a year to assess the risk and benefit of therapy.
Given all the individual risk factors, you should carefully evaluate the risk of developing breast cancer and endometrial cancer, as well as stroke.
Before starting or resuming therapy, a family and individual medical history should be collected. Preventive follow-up examinations should be carried out at least 1 time in 6 months.
The reasons for the immediate cancellation of Livial are:
- Sudden increase in blood pressure;
- Jaundice or impaired liver function;
- The appearance of a migraine headache.
Also during therapy it is necessary to consider the following data:
- The risk of developing endometrial cancer increases with increasing duration of Livial. The appearance of bleeding / bleeding, which lasts more than 6 months from the start of the drug or starts 6 months after the start of therapy and continues even after the end of Livial, can indicate the development of endometrial hyperplasia;
- Data on the increased risk of developing breast cancer during the use of the drug are contradictory. The risk increases with the increase in the length of the Liviala intake period and returns to the initial level several years after discontinuation;
- The use of Livial and combined drugs for hormone therapy containing estrogen and progestogen may increase the risk of venous thromboembolism. Risk factors for the development of the disease are: old age, estrogen use, prolonged immobilization, extensive surgery, obesity, pregnancy and the postpartum period, cancer and systemic lupus erythematosus. The main symptoms of potential thromboembolism include pain and unilateral edema of the lower limb, shortness of breath, sudden chest pain. If venous thromboembolism develops at the beginning of therapy, the drug should be discontinued;
- Taking Livial increases the risk of ischemic stroke. If unexplained migraine-like headaches appear with or without visual impairment, consult a doctor as soon as possible. It is impossible to continue therapy without a doctor’s confirmation of its safety (due to the risk of stroke);
- During therapy, a significant dose-dependent decrease in cholesterol is possible - high-density lipoprotein.
Estrogens can cause fluid retention, so women with renal or heart failure need to be under close medical supervision.
Livial can enhance blood fibrinolytic activity, which increases the risk of increased anticoagulant action of anticoagulants, in particular warfarin. In this regard, the dose of warfarin should be adjusted accordingly. Simultaneous use of Livial with anticoagulants should be under medical supervision.
Medicinal products - inducers of CYP3A4 (carbamazepine, barbiturates, rifampicin and hydantoins), can increase the metabolism of tibolone, affecting its therapeutic effect.
Strengthening the metabolism of estrogen and progestin can drugs with the content of Hypericum perforatum (Hypericum perforatum), because of which it is possible to reduce their clinical effect and change the profile of uterine bleeding.
Terms and conditions of storage
Store in a dark, out of reach of children at a temperature of 2-25 ° C.
Shelf life - 2 years.