the product in the database has an inactive status
indications:
Treatment of symptoms of estrogen deficiency occurring following natural or surgical menopause in women with a preserved uterus. Prophylaxis of osteoporosis in postmenopausal women who have an increased risk of fractures and who can not take other medicines for the prevention of osteoporosis.
Composition:
The preparation consists of two transdermal patches: Estraderm TTS, containing 4 mg estradiol, which is released at a rate of 50 μg / 24 h from a surface of 10 cm2 and Estragest TTS patches containing 10 mg of estradiol and 30 mg of norethisterone acetate, which are released at a rate of 50 μg / 24 h and 250 μg / 24 h from a surface of 20 cm, respectively2.
Action:
Combined preparation containing a natural female hormone - estradiol and a gestagen derivative of 19-nortestosterone - norethisterone acetate, in the form of transdermal patches. Supplements estrogen deficiency, reducing symptoms associated with menopause, has a positive effect on the lipid profile, and estrogens also prevent postmenopausal loss of bone mass. The progestogen content prevents the estrogen-dependent proliferation of the uterine mucosa. Percutaneous administration, compared to the oral route, allows the use of many times lower doses (the drug is not metabolized during the "first pass" through the liver). The estradiol concentration in the blood at steady-state is reached within 8 hours after patch application and last for 4 days. After removal of the patch, the concentration returns to baseline values within 24 hours. The norethisterone acetate released from the patch is extensively hydrolyzed during diffusion through the skin to the active metabolite - norethisterone. The concentration of norethisterone reaches steady state within 2 days and returns to baseline values 2 days after the patch has been removed.
Contraindications:
Hypersensitivity to the components of the preparation. Breast cancer and estrogen-dependent tumors (diagnosed, suspected or history). Abnormal, with unknown aetiology of genital tract bleeding. Untreated endometrial hyperplasia. acute or past liver disease until the liver function test results return to normal. Porphyria. Idiopathic or active venous thromboembolic disease (eg deep vein thrombosis, pulmonary embolism). Active or recent history of arterial thromboembolism (eg angina pectoris, myocardial infarction). Pregnancy or suspected pregnancy. Breastfeeding period.
Precautions:
Particularly cautiously use in patients with: myoma or endometriosis, history of thromboembolism or risk factors for thromboembolic disorders (eg positive personal or family history, significant obesity - body mass index over 30 kg / m2, systemic lupus erythematosus, age, 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. The experience in treating women over 65 is limited.
Pregnancy and lactation:
Do not use during pregnancy and breast-feeding.
Side effects:
Very common: transient erythema, irritation with or without pruritus, sticking to the patch, increased tension and soreness of the breast, spotting.Common: headache, nausea, painful intestinal spasms, bloating, change in the intensity and length of menstrual bleeding, dysmenorrhea, premenstrual syndrome, endometrial hyperplasia. Uncommon: breast cancer. Rarely: dizziness, swelling, weight gain or loss, lower extremity pain. Very rare: thromboembolism, exacerbation of varicose veins, increased blood pressure, abnormal liver function tests, cholestatic jaundice, contact dermatitis, transient post-inflammatory pigmented lesions, generalized skin pruritus and rash, anaphylactoid reactions. In addition, when taking HRT, you may experience: benign and malignant estrogen-dependent tumors (eg endometrial cancer, ovarian cancer, breast cancer), myocardial infarction, stroke, cholecystitis, chloasma, erythema multiforme, erythema nodosum, vascular purpura, dementia. Vein thromboembolic conditions (deep vein thrombosis and pulmonary embolism) are more common in women using HRT compared to women who have not received such treatment. 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 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.
Dosage:
Outwardly. After removing the protective film, the patch is applied to the clean, dry, healthy and intact torso (not used on the breast). The patches should be changed every 3-4 days. The Next patches should be glued to different places. For the first 2 weeks, Estraderm TTS patches (single patches) are used for the next 2 weeks - Estragest TTS (double patches). The next treatment cycle begins immediately after the last Estragest TTS has been removed, regardless of the menstrual bleeding.
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