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 tumors without the presence of an estrogen receptor has not been demonstrated unless there is a clinical response to prior Tamoxifen therapy.
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. Severe renal impairment (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.
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 to support the safety of the medicine in patients with moderate or severe hepatic impairment or in patients with severe renal impairment (creatinine clearance <20 ml / min). Women with known osteoporosis or with the risk of osteoporosis should have a bone densitometry performed before 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 estrogen levels in the blood and may cause a reduction in bone mineral density; there are no data on the effects of bisphosphonates used prophylactically or in the case of a decrease in bone mineral density caused by the use of anastrozole. Due to the lactose content, the preparation should not be used in patients with rare hereditary 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 common: hot flashes (usually of low or moderate intensity). Common: weakness (usually of mild to moderate intensity), joint pain and stiffness (usually of mild to moderate intensity), vaginal dryness (usually of mild or moderate intensity), weakness of the hair (usually of mild to moderate intensity), skin rash ( usually low to moderate), nausea (usually mild to moderate), diarrhea (usually mild to moderate), headache (usually mild to moderate), carpal tunnel syndrome, increased alkaline phosphatase, alanine aminotransferase and aspartate.Uncommon: vaginal bleeding (usually of mild or moderate intensity, mainly observed in the first weeks of treatment of patients with advanced breast cancer that have been altered to previous treatment with anastrozole), anorexia (usually not severe), hypercholesterolemia (usually slight or moderate intensity), vomiting (usually mild to moderate), drowsiness (usually mild to moderate), increased gamma-glutamyltransferase and bilirubin, hepatitis. 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 cause a decrease in bone mineral density, which is why some patients may increase the risk of bone fractures.
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.
(C)
