Medically reviewed by Drugs.com. Last updated on Oct 12, 2020.
Applies to the following strengths: 125 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Prostate Cancer
250 mg orally every 8 hours
-This drug may be taken with or without food.
-Stage B2-C Prostatic Carcinoma: Treatment with this drug and the goserelin acetate implant starting 8 weeks prior to initiating radiation therapy and continue during radiation therapy.
-Stage D2 Metastatic Carcinoma: This drug should be initiated with the LHRH-agonist and continued until progression.
Use: Locally confined Stage B2-C and Stage D2 metastatic carcinoma of the prostate
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Mild or moderate hepatic impairment: Data not available
Severe hepatic impairment: Contraindicated
US BOXED WARNINGS:
-Liver failure has been reported. Symptoms include elevated serum transaminase levels, jaundice, hepatic encephalopathy, and death related to acute hepatic failure. Hepatic injury was reversible after discontinuation of therapy in some patients. Approximately half of the reported cases occurred within the initial 3 months of therapy.
-Measure serum transaminase levels prior to initiating therapy, monthly for the first 4 months of therapy, and periodically thereafter.
-This drug is not recommended in patients whose ALT values exceed 2 times the upper limit of normal.
-Assess liver function tests at the first sign of liver dysfunction (e.g., nausea, vomiting, abdominal pain, fatigue, anorexia, "influenza-like" symptoms, hyperbilirubinuria, jaundice, right upper quadrant tenderness).
-If a patient develops jaundice or their ALT rises above 2 times the upper limit of normal, discontinue therapy and follow-up with liver function tests until resolution.
-Hypersensitivity to the active component or any of the ingredients
-Severe hepatic impairment (baseline hepatic enzymes should be evaluated prior to therapy)
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
This drug is highly protein bound and not dialyzable to a significant degree.
-Store at 20C to 25C (68F to 77F).
-Dispense in a tight, light-resistant container.
-Liver function tests
-Inform patients that this drug and the drug used for medical castration should be administered concomitantly, and that they should not interrupt their dosing or stop taking these medications without consulting the physician.
-This drug can damage the liver; therefore, it is important to avoid excessive consumption of alcohol.
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