the product in the database has an inactive status
indications:
Treatment of advanced breast cancer in postmenopausal women. The efficacy of anastrozole in patients with tumor cells without an estrogen receptor has not been demonstrated unless there is a clinical response to prior Tamoxifen therapy. Supportive treatment of early invasive breast cancer with hormonal receptor in postmenopausal women. Supportive treatment of early hormonal receptor breast cancer in postmenopausal women who received supplementary treatment with tamoxifen for 2-3 years.
Composition:
1 tabl powl. contains 1 mg of anastrozole.
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:
It is not indicated in children and adolescents because the safety and efficacy of this medicine has not been established in this age group. Women diagnosed with osteoporosis or at risk for osteoporosis should have a bone densitometry test prior to treatment and regularly repeated during treatment. 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 the concentration of estrogens in the blood and may reduce the 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. Because the preparation contains lactose, this medicine should not be used in patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose. Each tablet contains sodium in the range of 0.084-0.126 mg.
Pregnancy and lactation:
The drug is contraindicated in pregnant women and breastfeeding.
Side effects:
Very common: hot flashes (usually of low or moderate intensity). Common: headache (usually of mild to moderate intensity), carpal tunnel syndrome, nausea (usually of mild to moderate intensity), diarrhea (usually of mild to moderate intensity), weakness of the hair (usually of mild to moderate intensity), skin rash (usually mild to moderate), joint pain and stiffness (usually of mild or moderate intensity), weakness (usually of mild to moderate intensity), vaginal dryness (usually of mild to moderate intensity). Uncommon: vomiting (usually mild or moderate), drowsiness (usually mild to moderate), lack of appetite (usually of mild to moderate intensity), hypercholesterolaemia (usually mild to moderate), vaginal bleeding (usually moderate or moderate severity, mainly in the first weeks of treatment of patients with advanced breast cancer who have changed their previous hormonal therapy to anastrozole treatment. Very rare: erythema multiforme, Stevens-Johnson syndrome and allergic reactions (including angioneurotic edema, urticaria and anaphylactic reactions).It reduces the level of estrogen in the blood and may reduce the bone mineral density, which may increase the risk of bone fractures in some patients. Uncommon increases in gamma-glutamyltransferase and alkaline phosphatase were observed (no causal relationship between the use of anastrozole and these changes was established).
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 insufficiency.
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