Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Generics [UK] Ltd t/a Mylan, Station Close, Potters Bar, Herts. EN6 lTL
Flutamide is indicated for the treatment of advanced prostatic carcinoma in which suppression of testosterone effects is indicated. Flutamide may be used in combination with an LHRH agonist, both on commencement of treatment or as an adjunctive therapy in patients already receiving an LHRH agonist. Flutamide may also be used in surgically castrated patients.
One tablet three times daily at 8 hour intervals. When Flutamide is used as initial treatment with an LHRH agonist, a reduction in severity of the flare reaction may be achieved if treatment with Flutamide is initiated before the LHRH agonist. Consequently, it is recommended that treatment with Flutamide should commence simultaneously or at least 24 or more hours before the LHRH agonist.
The administration of Flutamide should begin 8 weeks prior to radiotherapy and continue for its duration, or for 12 weeks pre-prostatectomy.
In patients with impaired liver function, long-term treatment with Flutamide should only be initiated after careful assessment of the individual benefits and risks.
Flutamide should be administered with caution in patients with impaired renal function.
For oral use.
The tablets are to be taken preferably after food.
In animal studies with flutamide alone, signs of overdose included hypoactivity, piloerection, slow respiration, ataxia and/or lacrimation, anorexia, tranquilisation, emesis and methaemoglobinaemia.
Clinical trials have been carried out with flutamide at doses of up to 1500 mg per day for periods of up to 36 weeks without reports of severe undesirable effects. The undesirable effects reported were gynaecomastia, breast sensitivity and some increases in SGOT.
The acute toxic dose of flutamide in man has not been established. One patient survived after ingesting more than 5 g as a single dose, with no apparent adverse effects. Since flutamide is an anilide compound, it has the theoretic potential of producing methaemoglobinaemia. Accordingly, a patient with acute intoxication may be cyanotic.
If vomiting does not occur spontaneously it should be induced, provided that the patient is alert. Gastric lavage may be considered. As in the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken. General supportive measures are appropriate, including frequent monitoring of vital signs and close observation of the patient. Since flutamide is highly protein bound, dialysis may not be of any use as treatment for overdose.
4 years.
Do not store above 25°C.
Flutamide tablets are packaged either in PVC/aluminium blister packs or in polypropylene pots with polyethylene caps (with optional polyethylene ullage filler), containing 20, 21, 30 50, 60, 84, 100, 105, 250 or 10*21 tablets.
Not all pack sizes may be marketed.
No special requirements.
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