Lutamide Flutamide Tablets

Lutamide®
Flutamide 250mg Tablets

 

COMPOSITION

Each uncoated tablet contains:

Flutamide USP 250mg.

Excipients Q.S.

 

INDICATIONS

LUTAMIDE is indicated in the treatment of advanced prostatic cancer (D2) as initial treatment in combination with a luteinizing hormone-releasing hormone (LHRH) agonist, as adjunctive therapy in patients already receiving LHRH agonist, in surgically castrated patients and in patients who have not responded or have become refractory to or who cannot tolerate other hormonal manipulation.

LUTAMIDE is also indicated in combination with LHRH agonists for the management of locally confined B2-C2 (T2b-T4) prostate carcinoma as initial therapy; bulky primary tumors confined to the prostate (stage B2 or T2b) or extending beyond the capsule (stage C or T3-T4), with or without pelvic node involvement.

 

DOSAGE AND ADMINISTRATION

The patient should not interrupt or alter the dosage regimen without consulting the clinician.

The recommended dosage is 250mg three times daily at 8-hour intervals.

In combination with an LHRH agonist, it is recommended that LUTAMIDE therapy should be started 3 days prior to initiation of the LHRH agonist, to reduce the flare reaction. During radiation therapy, administration of both LUTAMIDE and LHRH agonist should begin 8 weeks prior and continue through the course of radiation (usually about 8 weeks), i.e. a total of about 16 weeks.

 

CONTRAINDICATIONS

Hypersensitivity to flutamide or any component of this preparation.

 

WARNINGS AND PRECAUTIONS

Drug interactions

On concomitant therapy with anticoagulants, adjustment of the initiating dose or maintenance anticoagulant dose may be necessary because increases in prothrombin time have been noted. Close monitoring of prothrombin time is recommended. Avoid concomitant administration of potentially hepatotoxic drugs. Cases of increased theophylline plasma concentrations have been reported in patients receiving concomitant theophylline and flutamide. Theophylline is primarily metabolized by CYP 1A2 which is the primary enzyme responsible for the conversion of flutamide to its active agent 2-hydroxyflutamide.

 

Pregnancy

LUTAMIDE is indicated only for use in male patients. There is no data on pregnant women.

 

Lactation

LUTAMIDE is indicated only for use in male patients. There is no data on lactating women.

 

Paediatric use

Flutamide has not been studied in paediatric subjects.

 

UNDESIRABLE EFFECTS

Most frequent side-effects are gynaecomastia and breast tenderness, some times galactorrhoea. These disappear on stopping treatment.

Less frequent adverse reactions are diarrhoea, nausea, vomiting, insomnia, tiredness, transient abnormal liver function and hepatitis. Decreased libido, upset stomach, anorexia, ulcer-like pain, heartburn, constipation, oedema, ecchymosis, pruritus, lupus-like syndrome, headache, dizziness, weakness, malaise, blurred vision and reduced sperm counts have been reported rarely.

Rarely anaemia, leukopenia, anorexia, jaundice, hypertension, central nervous system adverse events and thrombocytopenia may be observed.

Additional adverse experiences: Very rarely, the following have been reported:
haemolytic anaemia, methaemoglobinaemia, photosensitivity reactions, cholestatic jaundice, hepatic encephalopathy and hepatic necrosis. The hepatic conditions were usually reversible after stopping treatment.

 

OVERDOSAGE

The single dose of flutamide associated with symptoms of overdose or considered life threatening has not been established. Since flutamide is highly protein bound, dialysis may not be of any use as treatment for overdose. Gastric lavage may be considered.

 

PACKAGING IN FORMATION

5 x 4 x 21 Tablets in Blister pack.

 

Manufactured by

WEST COAST PHARMACEUTICAL WORKS LTD.

FP No.: 17, 16/5, Meldi Estate, B/S Medi Mata Temple,

NR Gota Railway Crossing, Gota, Ahmedabad-382481, India

 

Manufactured for

Stallion LABORATORIES PVT. LTD.

C-1B, 305/2 & 3, G.I.D.C. Kerala (Bavla) Dist: Ahmedabad-382 220. Gujarat.