Flutamide swim

Active material: Flutamid
When ATH: L02BB01
CCF: Non-steroidal anti-androgen drug with anti-tumor activity
When CSF: 15.13.03.02
Manufacturer: PLIVA HRVATSKA d.o.o. (Croatia)

PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

 

Pills light yellow, round, chamfered.

1 tab.
flutamid250 mg

Excipients: microcrystalline cellulose, corn starch, lactose monohydrate, sodium lauryl, colloidal silicon dioxide, magnesium stearate.

10 PC. – blisters (10) – packs cardboard.

 

DESCRIPTION OF ACTIVE SUBSTANCES

Pharmacological action

Nonsteroidal antiandrogen structure. By blocking the androgen receptors of target cells, It prevents the development of the biological effects of endogenous androgens, which leads to disruption of tumor cell replication. It helps to reduce the size and density of the prostate, It prevents the development of metastatic disease.

It does not have estrogenic, Antiestrogenic, antigestagens and progestin activity.

 

Pharmacokinetics

Once inside quickly and completely absorbed from the gastrointestinal tract.

Plasma protein binding is 94-96%. After repeated oral dose 250 mg 3 times / day flutamide equilibrium concentration and its active metabolite in plasma is achieved after the 4th dose.

Metaboliziruetsya with obrazovaniem aktivnogo metabolites and gidroksiflutamida 5 other metabolites.

Write mainly in the urine, 4.2% the dose is excreted in the feces within 72 no. T1/2 hydroxyflutamide is 6 no.

Elderly patients T1/2 is 8 h after a single administration, and 9.6 no – when the equilibrium concentration.

 

Testimony

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

 

Dosage regimen

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

 

Side effect

On the part of the endocrine system: gynecomastia and / or galactorrhea.

From the digestive system: nausea, vomiting, jaundice, diarrhea, increase in liver transaminases.

From the water-electrolyte metabolism: fluid retention.

Other: rarely – headache, thromboembolism, impairment of renal function, sleep disorders, subcutaneous hemorrhage, lupus-like syndrome.

 

Contraindications

Hypersensitivity to flutamide or acetanilide.

 

Cautions

In the period of treatment is necessary to monitor liver and kidney function.

Application flutamide humans reduces the number of spermatozoa.

 

Drug Interactions

It is believed, possible drug interactions that while the application of flutamide with paracetamol, opioid analgesics, NSAIDs.

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