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Cytomid (Generic Flutamide): Manufacturers Information Sheet |
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Cytomid 250 Tablets
Composition
Each uncoated tablet contains Flutamide 250 mg
Description
Flutamide, an acetanilide, is a nonsteroidal, orally active antiandrogen.
Indications
Cytomid is indicated as monotherapy (with or without orchidectomy) or in combination with a luteinizing hormone-releasing hormone (LHRH) agonist for the management of advanced prostatic cancer in previously untreated patients or in those who have not responded or who have become refractory to hormonal manipulation.
Dosage and Administration
The patient should not interrupt or alter the dosage regimen without consulting the physician.
In monotherapy or in combination with an LHRH agonist the recommended dosage is 250 mg thrice daily. The maximum daily dose is 1500 mg.
In combination with an LHRH agonist, either the two agents may be initiated simultaneously or Cytomid tablet therapy may be started 24 hours prior to initiation of the LHRH agonist.
Contraindications
Hypersensitivity to flutamide or any component of this preparation.
Warnings and Precautions
DRUG INTERACTIONS
Anticoagulants: On concomitant therapy with anticoagulants, adjustment of the initiating dose or maintenance anticoagulant dose may be necessary because increase in prothrombin time has been noted.
PREGNANCY
Cytomid is indicated only for use in male patients. There is no data on pregnant or lactating women.
HEPATIC INJURY
Periodic liver function tests should be considered since transaminase abnormalities, cholestatic jaundice, hepatic necrosis and hepatic encephalopathies have been reported.
Appropriate laboratory testing should be done at the first sign/symptom of liver dysfunction. If the patient has laboratory evidence of liver dysfunction, Cytomid therapy should be discontinued. Hepatic injury is 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 flutamide.
MUTAGENICITY
Flutamide did not demonstrate mutagenic potential in the Ames test. DNA repair test, in vivo sister chromatid exchange assay or the dominant lethal assay in rats.
Flutamide produced testicular interstitial cell adenomas in rats after longterm administration. The relevance of this finding to humans is unknown.
Side Effects
MONOTHERAPY
Most frequent side effects are gynaecomastia and breast tenderness, some times galactorrhoea. These disappear on stopping treatment.
Less frequent adverse reactions are diarrhoea, nausea, vomiting, insomnia and tiredness. Decreased libido, upset stomach, anorexia, ulcerlike pain, heartburn, constipation, oedema, ecchymosis, pruritus, lupuslike syndrome, headache, dizziness, weakness, malaise, blurred vision and reduced sperm counts have been reported rarely.
COMBINATION THERAPY
In combination with LHRH agonist, hot flushes, decreased libido, impotence, diarrhoea, nausea and vomiting have been reported.
The incidence of gynaecomastia observed with flutamide monotherapy is greatly reduced in combination therapy.
Rarely anaemia, leukopenia, anorexia, jaundice, hypertension, central nervous system adverse events and thrombocytopenia may be observed.
Additional adverse experiences: Very rarely, the following have been reported: haemolytic anaemia, methaemoglobinaemia, photosensitivity reactions, cholestatic jaundice, hepatic conditions were usually reversible after stopping treatment.
Presentation
Cytomid250 Strip of 10 tablets |
Inhouse Pharmacy Europe
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