Source: Υπουργείο Υγείας (CY) Revision Year: 2015 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Treatment of advanced prostatic carcinoma in which suppression of testosterone effects is indicated:
As a component of the treatment used in the management of locally confined B2-C2 (T2b-T4) prostate carcinoma, Flutan tablets are also indicated to reduce tumour volume, to increase tumour control and to extend the disease-free interval.
Tablets are for oral administration. Administration is for male patients only.
250mg (one tablet), three times a day, at eight hour intervals.
When used as an initial treatment with an LHRH agonist, a greater reduction in the incidence and severity of the LHRH agonist flare reaction may be achieved if flutamide is introduced before rather than concomitantly with the agonist. It is, therefore, recommended that flutamide one tablet three times daily should be started simultaneously or 24 or more hours prior to initiation of the LHRH agonist and continued thereafter at the same dose.
In the management of locally confined prostatic carcinoma, the recommended dosage is one 250mg tablet three times daily at eight-hour intervals. If an LHRH agonist is part of the treatment regimen, flutamide should be started simultaneously or 24 hours prior to initiation of the LHRH agonist. Administration of flutamide should begin eight weeks prior to radiation therapy and continue through the course of radiation therapy.
In patients with impaired liver function, long-term treatment with flutamide should only be administered after very careful assessment of the individual benefits and risks.
Monitoring advice: Flutamide is highly protein bound and will not be removed by dialysis.
No special dosage recommendations.
Not recommended.
In animal studies with flutamide alone, signs of overdose included hypoactivity, piloerection, slow respiration, ataxia and/or lacrimation, anorexia, tranquilization, emesis and methemoglobinemia.
The single dose of flutamide ordinarily associated with symptoms of overdose or considered to be life-threatening has not been established. One patient survived after taking more than 5g as a single dose – no adverse effects were observed.
Since flutamide is highly protein bound, dialysis may not be of any use as treatment for overdose. Gastric lavage may be considered.
5 years.
Store below 25°C in the original package.
The tablets are packed in aluminium foil and polyvinylchloride blisters with a patient information leaflet, in a card carton. Packs containing 20 and 100 tablets are available. Not all pack sizes may be marketed.
None.
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