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Flutamide oral


Flutamide oral formulations

Drugs List

  • flutamide 250mg tablets
  • Therapeutic Indications


    Carcinoma - prostate

    Treatment of advanced prostate cancer, alone or in combination with luteinizing hormone-releasing hormone (LHRH) analogue therapy.


    Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.

    Doses may vary significantly if this agent is used as monotherapy or different combinations.


    250mg three times daily.

    When used as an initial treatment with an LHRH agonist, it is recommended that flutamide be started at the recommended dose, at least 3 days prior to initiation of the LHRH, and continued at the same dose thereafter.


    250mg three times daily.

    When used as an initial treatment with an LHRH agonist, it is recommended that flutamide be started at the recommended dose, at least 3 days prior to initiation of the LHRH, and continued at the same dose thereafter.


    Children under 18 years
    Elevated serum transaminases - greater than twice the upper limit of normal
    Long QT syndrome
    Torsade de pointes

    Precautions and Warnings

    Family history of long QT syndrome
    Major risk factors for decreased bone mineral content
    Predisposition to fluid retention
    Cardiac disorder
    Electrolyte imbalance
    Glucose-galactose malabsorption syndrome
    Hepatic impairment
    History of torsade de pointes
    Lactose intolerance
    Renal impairment

    Adjustment of anticoagulant dose may be necessary during concurrent therapy
    Correct electrolyte disorders before treatment
    Advise ability to drive/operate machinery may be affected by side effects
    Treatment to be initiated and supervised by a specialist
    Contains lactose
    Consult local policy on the safe use of oral anti-cancer drugs
    Staff: Not to be handled by pregnant staff
    Monitor bone mineral density prior to and at least at 1 year post treatment
    Monitor hepatic function before, monthly for 4 months, then periodically
    Consider non-infectious pneumonitis in patients with respiratory symptoms
    Monitor ECG in patients at risk of QT prolongation
    Monitor serum electrolytes
    Periodic sperm count determinations may be considered during therapy
    Advise patients to discontinue therapy if signs of hepatotoxicity occur
    Advise patients to seek medical advice if signs of hepatotoxicity occur
    May cause loss of bone mineral density
    Potentially hepatotoxic
    Reduce dose or discontinue therapy if liver injury or jaundice occurs
    Advise patient to avoid alcohol during treatment
    Male: Ensure adequate contraception during treatment

    In patients who have not received medical or surgical castration, periodic sperm count determinations may be considered during long term treatment. In such patients, flutamide tends to elevate plasma testosterone and estradiol levels.

    Pregnancy and Lactation


    Flutamide is not indicated in women

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Flutamide is not indicated in women

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at

    Side Effects

    Abdominal pain
    Acute renal failure
    Blurred vision
    Breast tenderness
    Bullous eruption
    Cardiovascular disturbances
    Chest pain
    Cholestatic jaundice
    Decrease in bone mineral density
    Discolouration of urine
    Epidermal necrolysis
    Exacerbation of diabetes
    Gastro-intestinal symptoms
    Haemolytic anaemia
    Hepatic encephalopathy
    Hepatic necrosis
    Herpes zoster
    Hot flushes
    Increase in blood urea nitrogen
    Increased appetite
    Increased thirst
    Interstitial pneumonitis
    Liver function disturbances (reversible)
    Lupus erythematosus-like syndrome
    Macrocytic anaemia
    Malignant male breast neoplasm
    Muscle cramps
    Prolongation of QT interval
    Reduced libido
    Serum creatinine increased
    Spermatogenesis suppression
    Urinary frequency


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: June 2014

    Reference Sources

    Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press [Accessed on June 2, 2014].

    Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

    Summary of Product Characteristics: Flutamide tablets 250mg. Generics UK T/A Mylan. Revised May 2015.

    Napos. The drug database for acute porphyria.
    Available at
    Flutamide Last revised: July 23, 2010
    Last accessed: June 2, 2014

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    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.