Flutamide tablets 250mg, No. 84

Palliative treatment of metastatic prostate cancer in the absence of previous therapy or ineffective hormone therapy.

The method of application and dosage regimen of a particular drug depends on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly observe the compliance of the used dosage form of a particular drug with the indications for use and the dosage regimen.

Inside, 250 mg 3 times / day. The frequency and duration of use depend on the treatment regimen.

1 tab.

Active ingredient: flutamide - 250 mg

Excipients : mannitol, sodium lauryl sulfate, povidone K30, microcrystalline cellulose, colloidal anhydrous silicon dioxide, sodium starch glycolate, magnesium stearate, purified water.

Hypersensitivity to flutamide or acetanilide.

Tablets are light yellow, round, biconvex, without dividing lines.

Composition:

1 tab.

Active ingredient: flutamide - 250 mg

Excipients : mannitol, sodium lauryl sulfate, povidone K30, microcrystalline cellulose, colloidal anhydrous silicon dioxide, sodium starch glycolate, magnesium stearate, purified water.

Clinical and pharmacological group: Antiandrogenic non-steroidal drug with antitumor activity

Pharmaco-therapeutic group: Antineoplastic agent, antiandrogen

pharmachologic effect

Antiandrogenic agent of non-steroidal structure. By blocking the androgen receptors of target cells, it prevents the development of the biological effects of endogenous androgens, which leads to impaired replication of tumor cells. It helps to reduce the size and density of the prostate gland, prevents the development of the metastatic process.

Does not possess estrogenic, antiestrogenic, gestagenic and antigestagenic activity.

Pharmacokinetics

After oral administration, it is rapidly and completely absorbed from the gastrointestinal tract.

Plasma protein binding 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 achieved after the 4th dose.

It is metabolized to form an active metabolite of hydroxyflutamide and 5 other metabolites.

It is excreted mainly in the urine, 4.2% of the dose is excreted in the feces within 72 hours. T1 / 2 of hydroxyflutamide is 6 hours.

In elderly patients, T1 / 2 is 8 hours after a single administration and 9.6 hours at an equilibrium concentration.

Indications

Palliative treatment of metastatic prostate cancer in the absence of previous therapy or ineffective hormone therapy.

Dosage regimen

The method of application and dosage regimen of a particular drug depends on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly observe the compliance of the used dosage form of a particular drug with the indications for use and the dosage regimen.

Inside, 250 mg 3 times / day. The frequency and duration of use depend on the treatment regimen.

Side effect

From the endocrine system: gynecomastia and / or galactorrhea.

From the digestive system: nausea, vomiting, jaundice, diarrhea, increased activity of hepatic transaminases.

From the side of water-electrolyte metabolism: fluid retention.

Others: rarely - headache, thromboembolism, impaired renal function, sleep disturbances, subcutaneous hemorrhages, lupus-like syndrome.

Contraindications for use

Hypersensitivity to flutamide or acetanilide.

special instructions

During the period of treatment, it is necessary to monitor the functions of the liver and kidneys.

The use of flutamide in humans leads to a decrease in the number of sperm.

Drug interactions

It is believed that drug interaction is possible with the simultaneous use of flutamide with paracetamol, opioid analgesics, NSAIDs.