Description
Latin name
FLUTAMID
Release form
Film-coated tablets.
Packaging
In a plastic bottle 84 tablets. In a cardboard box 1 plastic bottle.
Pharmacological action
Pharmacodynamics
Antiandrogenic agent of non-steroidal structure. By blocking the androgen receptors of target cells, it prevents the development of biological effects of endogenous androgens, which leads to impaired replication of tumor cells. Helps reduce the size and density of the prostate gland, prevents the development of a metastatic process.
Does not have estrogenic, antiestrogenic, gestagenic and antigestagenic activity.
Pharmacokinetics
After oral administration, it is rapidly and completely absorbed from the digestive tract.
Binding to plasma proteins is 94-96%. After repeated oral administration at a dose of 250 mg 3 times / day, the equilibrium concentration of flutamide and its active metabolite in blood plasma was reached after the 4th dose.
Metabolized to form the active metabolite of hydroxyflutamide and 5 other metabolites.
Excreted mainly in urine, 4.2% of the dose excreted in the feces within 72 hours. T1 / 2 hydroxyflutamide is 6 hours.
In elderly patients, T1 / 2 is 8 hours after a single injection and 9.6 hours at equilibrium concentration.
Indications
Palliative treatment of prostate cancer with metastases in the absence of previous therapy or with ineffective hormone therapy.
Contraindications
Hypersensitivity to flutamide or acetanilide.
Special instructions
In the treatment of prostate cancer, liver function must be monitored (laboratory tests should be carried out once a month for the first four months and then regularly). In the case of an increase in the level of liver enzymes by 2 ² 3 times compared with the upper limit of normal values ² ¹ ² ¹and / or the appearance of jaundice in the absence of liver metastases, the use of flutamide should be discontinued. If the first symptoms of liver dysfunction appear, such as skin itching, dark urine, nausea, vomiting, persistent loss of appetite, yellowing of the skin or whites of the eyes, pain in the right hypochondrium or flu-like symptoms of unclear origin, you should immediately consult a doctor.
When evaluating the results of the differential diagnosis of male hypogonadism,In secondary hypogonadism, the initial excretion of gonadotropins is reduced, less often – normal, a significant increase in their excretion after taking the drug is not observed.
Composition
1 tablet contains:
Active substances: flutamide 250 mg.
Dosage and administration of
Inside 250 mg 3 times / day. The frequency and duration of use depend on the treatment regimen.
Side effects of
From the endocrine system: gynecomastia and / or galactorrhea.
From the digestive system: nausea, vomiting, jaundice, diarrhea, increased activity of hepatic transaminases.
On the part of water-electrolyte metabolism: fluid retention.
Other: rarely – headache, thromboembolism, impaired renal function, sleep disturbances, subcutaneous hemorrhage, lupus-like syndrome.
Drug interaction
It is believed that drug interaction is possible with the simultaneous use of flutamide with paracetamol, opioid analgesics, NSAIDs.
Storage conditions
Store in a dry, dark place at 15-30 ° C.
Expiration
3 years.
active substance
Flutamide
Orion Corporation, Finland
