Description
Release form
Tablets.
Packing
In the package 30 pcs.
Pharmacological action
Antitumor agent.
It is a non-steroidal inhibitor of aromatase, an enzyme with the participation of which the synthesis of estrogen in women in the postmenopausal period occurs.
Aromatase promotes the conversion of androgens synthesized in the adrenal glands (primarily androstenedione and testosterone), in estrone and estradiol.
Inhibition of aromatase activity is realized by competitive binding to the subunit of this enzyme, the cytochrome P450 heme, which leads to a decrease in estrogen biosynthesis in all tissues, including in tissues of estrogen-dependent tumors.
Indications
Common breast cancer, mainly in postmenopausal women, including with resistance to antiestrogen therapy.
Contraindications
Hypersensitivity, premenopausal period, severe renal dysfunction (Cl creatinine <10 ml / min), pregnancy, breast-feeding (discontinue). Composition Coated tablets 1 tablet vitamin A (retinol acetate) 800 μg (corresponding to approximately 2666 IU) vitamin D (colecalciferol) 5 μg (corresponding to approximately 200 IU) vitamin E (D-alpha tocopherol acetate) 10 mg (corresponding to approximately 14, 9 IU) vitamin B1 (thiamine nitrate) 2.1 mg vitamin B2 (riboflavin) 2, 4 mg vitamin B6 (pyridoxine hydrochloride) 3 mg vitamin B12 (cyanocobalamin) 2 μg nicotinamide 27 mg pantothenic acid (calcium pantothenate) 9 mg folic acid 400 μg c calcium vitamin (s) carbonate) 160 mg magnesium (magnesium oxide) 75 mg iron (iron fumarate) 14 mg zinc (zinc oxide) 15 mg copper (copper sulfate) 2 mg manganese (manganese sulfate) 2.5 mg chromium (chromium chloride) 50 mcg selenium (sodium selenate) 50 mcg iodine (potassium iodide) 150 mcg inactive ingredients found in su stations sucrose gelatin starch butylhydroxytoluene sodium aluminosilicate triglycerides hypromellose corn starch maltodextrin sodium citrate citric acid water excipients: MCC calcium hydrogen phosphate dihydrate starch corn croscarmellose sodium sodium methylcellulose acid ascorbic magnesium stearate gelatin silicon dioxide colloidal anhydrous glycerol 85% acid stearic water purified shell: hypromellose 3 hypromellose 15 glycerol 85% titre dioxide . active substance: letrozole 2.5 mg excipients: magnesium aluminometasilicate – 10 mg croscarmellose sodium – 3 mg silicon dioxide colloid – 3 mg magnesium stearate – 0.5 mg sludge based on: monohydrate – 75.3 mg, povidone – 2.84 mg, crospovidone – 2.84 mg) – 81 mg film sheath: Opadry II yellow 85F32733 (polyvinyl alcohol – from 35 to 49%, talc – from 9.8 to 25%, macrogol 3350 – from 7.35 to 35.2%, titanium dioxide and iron oxide yellow – from 15.15 to 30 %) – 5 mg Dosage and Administration Inside, regardless of food intake. The recommended dose of Estrolet ® is 2.5 mg (1 tablet) once a day, daily, for a long time. As an extended adjuvant therapy, treatment should be continued for 5 years (no longer). If signs of disease progression appear, you should stop taking Estrolet ®. In elderly patients, dose adjustment of Estrolet ® is not required. Patients with impaired liver and / or kidney function. In case of hepatic or renal (creatinine Cl 10 ml / min) dose adjustment is not required. However, in severe liver failure (severity – C on the Child-Pugh scale), patients should be constantly monitored. Side effects Headache, dizziness, general weakness, nausea, vomiting, change in appetite (often decrease), constipation, peripheral edema, hot flashes, myalgia, ossalgia, changes in body weight, thinning hair, gynecological bleeding, spotting spotting skin rashes. Storage conditions In a dry, dark place, at a temperature not exceeding 25 ° C. Keep out of the reach of children. Shelf life 2 years. Active ingredient Letrozole Terms and conditions prescription lekarstvennaja tablet form Nativa / Pharmstandard, Russia
