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indications:
Treatment of advanced breast cancer in postmenopausal women (the efficacy of anastrozole in patients with non-estrogen receptor tumors has not been demonstrated unless there is a clinical response to prior Tamoxifen therapy). Supplementary treatment of early invasive breast cancer in postmenopausal women who have been found to have a hormone receptor in the tumor. Supplementary treatment of early breast cancer in postmenopausal women who have been found to have a hormone receptor in the tumor, who received supplemental 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 post-menopausal women, anastrozole is extensively metabolised, less than 10% of the dose is excreted in the urine in unchanged form 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. Severe renal failure (creatinine clearance <20 ml / min). Moderate or severe liver failure. Simultaneous treatment with tamoxifen. During treatment with anastrozole, estrogen-containing medicines should not be given. Do not use in children. Due to the lactose content, the drug should not be used in patients with rare inherited diseases of galactose intolerance, Lapp lactose deficiency or malabsorption of Glucose and galactose.
Precautions:
It is not indicated in children because the safety and efficacy of this medicine has not been established in this age group. 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. In women with or with the risk of osteoporosis, the bone mineral density should be examined by densitometric examination before starting treatment and then at regular intervals. If there are indications, initiate treatment or prophylaxis of osteoporosis and carefully monitor their effectiveness. 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. There are no data on the safety of the medicine in patients with severe or moderate hepatic impairment or with severe renal impairment (creatinine clearance less than 20 ml / min).
Pregnancy and lactation:
The drug is contraindicated in pregnant women and breastfeeding.
Side effects:
Very common (≥1 / 10): hot flashes (usually of low or moderate intensity). Common (<1/10 and ≥1 / 100): weakness (usually of mild or moderate intensity), joint pain and stiffness (usually of mild to moderate intensity), vaginal dryness (usually of mild to moderate intensity), thinning and thinning hair loss, skin rash (usually of mild to moderate intensity), nausea, diarrhea (usually of mild to moderate intensity), headache (usually of mild to moderate intensity).Uncommon (<1/100 and ≥1 / 1000): vaginal bleeding (usually of mild to moderate intensity, mainly observed in the first weeks of treatment of patients with advanced breast cancer who have had previous hormone replacement therapy for anastrozole), no appetite, hypercholesterolaemia (usually moderate or severe), vomiting (usually mild to moderate), drowsiness (usually mild to moderate). Very rare (<1 / 10,000): 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 with early breast cancer, treatment is recommended for 5 years. No dose adjustment is required in patients with mild to moderate renal impairment and mild hepatic insufficiency.
(C)
