the product in the database has an inactive status
indications:
Treatment of advanced breast cancer in postmenopausal women (the efficacy of anastrozole in patients without an estrogen receptor in the tumor has not been demonstrated unless there is a positive clinical response to previous Tamoxifen therapy). Supplementary treatment of early invasive breast cancer with hormone receptor in postmenopausal women. Supplementary treatment of early hormone receptor breast cancer in postmenopausal women who received supplementary treatment with tamoxifen for 2 to 3 years.
Composition:
1 tabl powl. contains 1 mg of anastrozole. The preparation contains lactose.
Action:
A strong and selective non-steroidal aromatase inhibitor involved in the conversion of androstenedione to oestrone in peripheral tissues (subsequently transformed into estradiol). It has been shown that in post-menopausal women, the use of anastrozole 1 mg daily causes suppression of oestradiol production by over 80%. Anastrozole has no progestagen, androgenic and estrogenic activity. Anastrozole administered at a dose of up to 10 mg daily does not affect the secretion of cortisol and aldosterone both without and after the stimulation of excretion by ACTH (therefore, during treatment, no corticosteroid supplementation is required). Following oral administration, anastrozole is rapidly absorbed from the gastrointestinal tract. The maximum concentration in the blood usually occurs within 2 hours of admission (fasting). The presence of food reduces the rate of absorption to a small extent, but does not affect the extent of absorption. In postmenopausal women the pharmacokinetics of anastrozole is not age dependent. The drug binds to 40% of plasma proteins. In postmenopausal women, anastrozole is extensively metabolised, less than 10% of the dose is excreted in urine unchanged within 72 hours of admission. Anastrozole is metabolized by N-dealkylation, hydroxylation and glucuronidation. Metabolites are mainly excreted in the urine. T0,5 is 40-50 h.
Contraindications:
Hypersensitivity to anastrozole or other ingredients. Pre-menopausal patients. Pregnancy and breastfeeding. Simultaneous treatment with tamoxifen. During treatment with anastrozole, estrogen-containing medicines should not be given.
Precautions:
The product is not recommended for use in children because the safety and efficacy of this medicine has not been established in this patient group. In case of doubts regarding the hormonal status of the patient, biochemically confirmed menopause should be confirmed. There are no data to support the safety of anastrozole in patients with moderate or severe hepatic impairment or in patients with severe renal impairment. Women with osteoporosis or the risk of osteoporosis should have a formal examination to assess bone mineral density, eg by the DEXA method, at the beginning of treatment and then at regular intervals. If there are indications, treatment or prevention of osteoporosis should be started and regular monitoring of the effectiveness of these activities. There are no data on the concomitant use of anastrozole and LHRH analogues - these drugs should not be used at the same time, except in clinical trials. Anastrozole reduces estrogen levels in the blood and may cause a reduction in bone mineral density; there is no data on the effect of bisphosphonates used prophylactically or in the case of reduction of bone mineral density caused by the use of anastrozole. 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 drug is contraindicated in pregnant women and during breastfeeding.
Side effects:
Very often: hot flashes. Common: headache, carpal tunnel syndrome; nausea, diarrhea; hair thinning, rash; joint pain / stiffness; weakness; increase of alkaline phosphatase, ALAT, AST; dryness of the vagina. Uncommon: drowsiness; vomiting; anorexia, hypercholesterolemia; increased γ-glutamyltransferase and bilirubin, hepatitis; vaginal bleeding.Very rare: erythema multiforme, Stevens-Johnson syndrome and allergic reactions, including angioneurotic edema, urticaria and anaphylaxis. Anastrozole reduces the estrogen concentration in the body, so it can cause a decrease in bone mineral density, increasing the risk of fractures. In clinical trials, mood disorders, spine fractures, hip fractures and wrist fractures, cataracts, ischemic cardiovascular disease, angina pectoris, myocardial infarction, coronary artery ischemia, vaginal discharge, vaginal discharge, thromboembolic events of the veins were also observed. deep vein thrombosis including pulmonary embolism, ischemic cerebrovascular events, endometrial cancer.
Dosage:
Orally. Adult patients, including the elderly: 1 mg once a day. In patients at an early stage of the disease, treatment is recommended for 5 years. No dose adjustment is required in patients with mild to moderate renal impairment and mild hepatic impairment.
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