Hormone replacement therapy (HRT) - treatment of symptoms caused by estrogen deficiency in postmenopausal women. The product is intended for use mainly in women with a removed womb and therefore no complex estrogen-progestagen treatment is required. The experience in treating women> 65 years of age is limited.
Composition:
1 tabl powl. contains 2 mg estradiol (as a hemihydrate); 1 tabl powl. mite contains 1 mg estradiol (in the form of hemihydrate).
Action:
A preparation containing 17β-estradiol - identical to human endogenous estradiol, intended for oral use. Supplements estrogen deficiency in postmenopausal women and relieves post-menopausal symptoms. Endogenous estradiol affects the development and growth of primary and secondary female sexual characteristics. It works via a number of estrogen receptors, the steroid hormone receptor complex joins cellular DNA and induces the synthesis of specific proteins. Micronized estradiol is well absorbed from the gastrointestinal tract. The maximum concentration in the blood appears after 4-6 h. It is more than 90% bound to plasma proteins. It is metabolized mainly in the liver through the first pass, is partially secreted in the bile, hydrolysed and reabsorbed (enterohepatic circulation) and mostly excreted in the urine in inactive form, T0,5 is 14-16 hours.
Contraindications:
Hypersensitivity to the components of the preparation. Breast cancer - diagnosed, suspected or in an interview. Estrogen-dependent tumors - diagnosed or suspected, eg endometrial cancer. Undiagnosed bleeding from the genital tract. Untreated endometrial hyperplasia. I have an idiopathic or currently diagnosed venous thromboembolism, for example deep vein thrombosis, pulmonary embolism. Active or recent history of arterial thromboembolism (eg ischemic heart disease, myocardial infarction). acute liver disease or a history of liver disease until the liver test results return to normal. Porphyria.
Precautions:
The experience in treating women over 65 is limited. Hormone replacement therapy (HRT) should be started when the patient has menopausal symptoms that adversely affect her quality of life. In all cases, the benefit / risk should be evaluated at least once a year and HRT continued, as long as the benefits of treatment outweigh the risks of using it. Particularly cautiously use in patients with: myoma or endometriosis, previous embolic-thrombotic disorders or the presence of factors that increase the risk of their occurrence, risk factors for estrogen-dependent cancers such as breast cancer in first-degree relatives, hypertension, liver disease, e.g. hepatic adenoma , diabetes with vascular complications or without vascular complications, cholelithiasis, migraine or severe headaches, systemic lupus erythematosus, endometrial hyperplasia, epilepsy, bronchial asthma and otosclerosis. It is recommended to stop the treatment immediately in the following cases: jaundice and hepatic impairment, significant increase in blood pressure, migraine headaches, pregnancy and venous thromboembolism. In women after hysterectomy who have previously had endometriosis or who have had persistent outbreaks of endometriosis, the addition of progestogen during HRT should be considered. Special attention is required for patients with circulatory failure or renal insufficiency because estrogens increase fluid retention in the body. The use of systemic HRT is associated with an increased relative risk of developing venous thromboembolism. It should be considered to stop using the product for 4-6 weeks before planned long-term immobilisation after surgery, especially abdominal surgery or orthopedic surgery on the lower limbs. The HRT should be restarted after the patient regains her mobility.Women with pre-existing hypertriglyceridemia should be closely monitored during the use of estrogens or products complexed in HRT due to the rare cases of significantly increased plasma triglyceride levels leading to pancreatitis. Due to the lactose content, the preparation should not be used in patients with galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose.
Pregnancy and lactation:
The preparation is not indicated for use during pregnancy and during breastfeeding. If pregnancy is detected during treatment, treatment should be discontinued immediately.
Side effects:
Common: depression; Headache; abdominal pain, nausea; lower extremity muscle spasms; breast enlargement, pain and tenderness; swelling; weight gain. Uncommon: visual impairment; venous blockages; indigestion, vomiting, flatulence, bloating with the passing of winds; cholelithiasis; rash, urticaria. In addition, there may be: irregular bleeding from the genital tract (in women with a preserved uterus), severity of migraine, stroke, dizziness, diarrhea, alopecia, increased blood pressure, myocardial infarction, congestive heart disease, stroke, venous thromboembolism, e.g. deep vein or pelvic vein thrombosis, pulmonary embolism, gall bladder disease, chloasma, erythema multiforme, nodular erythema, haemorrhagic rash, vascular purpura, vaginal candidiasis, malignant development risk, estrogen-dependent endometrial cancer, endometrial hyperplasia or enlargement of the uterine fibroids, insomnia, epilepsy, libido disorders, asthma severity, dementia. In women with a preserved uterus, the risk of hyperplasia and endometrial cancer increases with the time of estrogen administration, adding progestin to treatment reduces this risk. The risk of breast cancer increases with the prolongation of the use of HRT.
Dosage:
Orally. Patients with a removed womb: 1-2 mg once a day, depending on individual needs. Consider increasing or reducing the daily dose when the clinical effect is unsatisfactory after three months of treatment or when the drug is not well tolerated. In women who are non-penetrating and do not use HRT or women who have previously used other estrogen preparations or who use continuous combined HRT, treatment starts on any day. In women who change from sequential therapy to continuous treatment, start on the 5th day of bleeding. In women with preserved uterus, the preparation is used together with progestogen (administered for at least 12-14 days in a month). If the dose has been missed, take it as soon as possible within the Next 12 hours. Otherwise, discard the unopened tablet and continue treatment with the next tablet the next day. Skipping the dose in women with a preserved uterus may increase the likelihood of bleeding or spotting. The lowest effective dose should be used for the shortest possible time.