Hormone replacement therapy (HRT) in the treatment of estrogen deficiency in postmenopausal women. The experience in treating women over 65 is limited.
Composition:
1 g of gel contains 1.0325 mg estradiol hemihydrate corresponding to 1 mg anhydrous estradiol (1 dose contains 0.5 mg estradiol).
Action:
A natural female sex hormone in the form of a gel for percutaneous administration. Supplements estrogen deficiency, reducing symptoms associated with menopause: vasomotor hot flushes, sweating, atrophic changes of the genitourinary system, sudden changes in mood. When estrogen is administered through the skin, there is no first-pass effect in the liver following oral administration. Disposable administration of 1.5 g of the preparation (corresponding to 1.5 g estradiol) to a surface of 400 cm2 abdominal skin causes a rapid increase in the concentration of estradiol in the blood. Steady-state concentrations occur after 4 days of the 1.5 g dose.
Contraindications:
Hypersensitivity to the components of the preparation. Breast cancer and estrogen-dependent tumors (diagnosed, suspected or history). Undiagnosed bleeding from the genital tract. Untreated endometrial hyperplasia. Idiopathic or active venous thromboembolic disease (eg deep vein thrombosis, pulmonary embolism). Active or recent history of arterial thromboembolism (eg angina pectoris, myocardial infarction). acute or past liver disease until the liver function test results return to normal. Porphyria.
Precautions:
Particularly cautiously use in patients with: myoma or endometriosis, history of thromboembolism or risk factors for thromboembolic events (eg positive personal or family history, significant obesity - body mass index over 30 kg / m2, systemic lupus erythematosus, varicose veins; long-term immobilization, extensive injuries or surgical procedures - it is recommended to discontinue the preparation at least 4-6 weeks before the planned operation and re-apply only after the patient returns to full mobility), risk factors for the development of estrogen-dependent tumors (eg breast cancer in first-degree relatives) , hypertension, liver diseases (eg liver adenoma), diabetes with or without vascular complications, cholelithiasis, migraine or (severe) headaches, systemic lupus erythematosus, endometrial hyperplasia, epilepsy, bronchial asthma, otosclerosis, cardiac dysfunction or kidneys, hypertriglyceridemia. Treatment should be discontinued immediately if: jaundice or hepatic dysfunction, significant increase in blood pressure, migraine headache, venous thromboembolism or if the patient becomes pregnant. In women after hysterectomy who have previously had endometriosis or who have had persistent outbreaks of endometriosis, estrogen stimulation may lead to pre-cancer or cancer in persistent endometriosis - the addition of progestagen to therapy should be considered.
Pregnancy and lactation:
Do not use during pregnancy and breast-feeding.
Side effects:
Common: spotting, uterine bleeding, breast pain, nausea, bloating, headache, legs heaviness. Uncommon: benign breast tumors, galactorrhea, vomiting, arthralgia, phlebitis, pulmonary embolism, weight gain, peripheral edema, fatigue, pruritus. The preparation contains propylene glycol, which can cause skin irritation. In addition, when estrogen-progestogen therapy is used, there may be: benign and malignant estrogen-dependent tumors (eg endometrial cancer, ovarian cancer, breast cancer), venous thromboembolism, cardiovascular disease, myocardial infarction, stroke, cholecystitis, chloasma, erythema multiforme, erythema nodosum, haemorrhagic rash, dementia, increased triglyceride concentration in the blood sometimes leading to pancreatitis. The risk of breast cancer increases with the duration of the use of HRT.The use of estrogen-progestagen combined therapy is associated with a higher risk of breast cancer than the use of estrogen alone. 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.
Dosage:
The usual dose is 1.5 g (3 doses) of gel a day for 24-28 days. The dose should be adjusted to the effectiveness of the preparation in a given patient. For maintenance therapy, the lowest effective dose should be used. The minimum gel dose is 0.5 g per day, while the maximum dose is 3 g per day. Two administration schedules can be used: 1. cyclic - administration of the preparation for 24-28 days, followed by a 2-7 day break; 2. continuous - treatment without interruption in administration - usually used when during the cyclic treatment the symptoms of estrogen deficiency occurred while the estrogens were not administered. Both in the 1st and 2nd regimen in women with a preserved uterus, the progestin should be administered together with the preparation for 12-14 days of each cycle in order to prevent estrogen-induced proliferation of the uterine mucosa. The product should be applied on the skin surface corresponding approximately to the area of two hands. The gel should be used on dry, healthy and intact skin of the abdomen, thighs, arms or shoulders, preferably after morning or evening washing. Do not use gel on the chest and mucous membranes.
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