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Other brands with the same active ingredient
These brands contain the same active ingredient (Flutamide). Strength and form may differ — confirm substitution with your doctor or pharmacist before switching.
Indications & Uses
Prostalex is indicated for:
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Recommended Adult Dosage Flutamide is generally prescribed as one 250 mg tablet taken three times a day, spaced eight hours apart, whether it is used alongside surgical removal of the testicles (orchiectomy) or together with an LHRH agonist injection. When paired with an LHRH agonist, the two treatments can either be started on the same day, or Flutamide can be started a day (24 hours) beforehand. For bulky, locally advanced prostate cancer (Stage B2 and Stage C), the same dosing schedule applies: one 250 mg tablet, three times daily at eight-hour intervals, with Flutamide again started either at the same time as the LHRH agonist or a day earlier. When Flutamide is used alongside external beam radiation therapy, it is typically started eight weeks before radiation begins and continued for the entire course of treatment.
Side Effects
Cardiovascular effects: about 1% of patients develop high blood pressure. Rarely, inflammation of a vein with clotting (thrombophlebitis), a blood clot in the lung (pulmonary embolism), or a heart attack (myocardial infarction) may occur. Central nervous system (CNS) effects: CNS reactions such as drowsiness, confusion, depression, anxiety, and nervousness occurred in about 1% of patients. Rarely, insomnia, tiredness, headache, dizziness, weakness, general discomfort (malaise), blurred vision, and reduced sex drive have been reported. Endocrine system effects: breast enlargement in men (gynecomastia) occurred in about 9% of patients. Rarely, breast tenderness, sometimes with milky discharge (galactorrhoea), has been reported. Gastrointestinal system effects: nausea and vomiting occurred in about 11% of patients, diarrhoea in 12%, loss of appetite in 4%, and other digestive disturbances in 6%. Increased appetite, indigestion, and constipation have also been reported. Hematopoietic (blood-forming) system effects: anaemia occurred in about 6% of patients, a low white blood cell count (leukopenia) in 3%, and a low platelet count (thrombocytopenia) in 1%. Liver and biliary system effects: clearly diagnosed hepatitis and jaundice occurred in fewer than 1% of patients. Skin effects: irritation at the injection site and rash occurred in about 3% of patients. Sensitivity to sunlight (photosensitivity reactions) has been reported in five patients.
Cautions & Contraindications
Warnings & Precautions
Periodic liver function tests and sperm count determinations must be performed in patients on long-term treatment with Proscan. After long-term administration in rats, Proscan produced testicular interstitial cell adenomas and dose-related increases in mammary gland adenomas or carcinomas. The relevance of these findings to humans is unknown. It should be noted that few cases of malignant breast neoplasms have been reported in male patients receiving Proscan; causality has not been established. Since Proscan tends to elevate plasma testosterone and estradiol levels, fluid retention may occur. Accordingly, Proscan should be used with caution in those patients with cardiac disease.Hepatic Injury: Treatment with Proscan should not be initiated in patients with serum transaminase levels exceeding 2 to 3 times the upper limit of normal. Since transaminase abnormalities, cholestatic jaundice, hepatic necrosis and hepatic encephalopathy have been reported with the use of Proscan, periodic liver function tests must be performed in all patients. Appropriate laboratory testing should be done monthly for the first 4 months, and periodically thereafter and at the first symptom/sign of liver dysfunction (e.g., pruritus, dark urine, persistent anorexia, jaundice, right upper quadrant tenderness or unexplained "flu-like" symptoms). If the patient has laboratory evidence of liver injury or jaundice, in the absence of biopsy-confirmed liver metastases, Proscan therapy should be discontinued if the patient develops jaundice or if serum transaminase levels rise to 2 to 3 times the upper limit of normal, even in clinically asymptomatic patients. The hepatic injury is usually reversible after discontinuation of therapy and in some patients, after dosage reduction. However, there have been reports of death following severe hepatic injury associated with the use of Proscan.
Contraindications
Flutamide tablets should not be used by anyone who is hypersensitive to flutamide or to any ingredient in the preparation. They are also not recommended for patients with severe liver impairment. Because flutamide's use in women has not been studied, it is not indicated for female patients, especially for conditions that are mild or not life-threatening.