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Flutamide Dosage

Medically reviewed on October 22, 2018.

Applies to the following strengths: 125 mg

Usual Adult Dose for Prostate Cancer

For use in locally confined stage B2-C and stage D2 metastatic carcinoma of the prostate: 250 mg orally every 8 hours.

Usual Adult Dose for Hirsutism

Data has been reported in which 250 mg of flutamide 2 to 3 times daily in combination with oral contraceptives has been used in the treatment of female patients with hirsutism.

However, FDA approved package labeling states that flutamide has no indication for women, and should not be used in this population, particularly for nonserious or non-life threatening conditions.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

-Mild and Moderate Hepatic Impairment: Data not available
-Severe Hepatic Impairment: Contraindicated

Dose Adjustments

Consider dosage reduction in patients with liver disease based on desired clinical response and patient tolerance.

Precautions

US BOXED WARNING:
HEPATIC INJURY: There have been postmarketing reports of hospitalization and rarely death due to liver failure in patients taking this drug. Approximately half of the reported cases occurred within the initial 3 months of treatment. Evidence of hepatic injury, which was reversible in some patients after therapy discontinuation, included elevated serum transaminase levels, jaundice, hepatic encephalopathy, and death related to acute hepatic failure. This drug is not recommended in patients whose ALT values exceed twice the upper limit of normal (ULN). Measure serum transaminase levels prior to treatment initiation, monthly for the first 4 months of treatment, then periodically thereafter. Obtain liver function tests (LFTs) at the first signs and symptoms suggestive of liver dysfunction. Immediately discontinue this drug if a patient has jaundice or their ALT rises above 2 times the ULN; perform close follow-up of LFTs until resolution.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Doses > 750 mg/day are not recommended. When treating B2-C prostatic carcinoma, flutamide and LHRH agonists should be started 8 weeks prior to initiating radiation therapy and continued during radiation therapy. When treating single stage D2 metastatic carcinoma, flutamide should be initiated with the LHRH agonist and continued until progression.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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