Active ingredient: Each tablet contains 250 mg Flutamide.
Excipients/Inactive ingredients: Sodium lauryl sulphate, microcrystalline cellulose, maize starch, lactose monohydrate, colloidal, anhydrous silica, magnesium stearate.
Pharmacology: Flutamide (Fluta-cell) is a non-steroidal antiandrogen. It is a type of hormone therapy. Flutamide has shown potent anti-androgenic effects. The basis for its anti-androgenic action is inhibition of androgen uptake and/or inhibition of nuclear binding in the target organs. If Flutamide is administered in combination with surgical or medical castration, both testicular and adrenal androgen activity is surpassed.
Pharmacokinetics: Flutamide (Fluta-cell) is well absorbed after oral ingestion.
Appropriate tests performed with radiolabelled Flutamide showed that the active ingredient is rapidly and extensively converted into its metabolites which are detectible in plasma for up to 8 hours after administration. Within the first two days, approximately 46% of the administered dose is excreted via the urine and 2% via the faeces. The radiolabel is removed by metabolism, so that excretion appears to slow down due to retention of the label as titrated water. Accordingly, excretion and metabolism are practically complete within two days.
Flutamide is indicated for the treatment of patients with advanced prostate cancer in which suppression of testosterone effects is indicated: Initial treatment in combination with an LH-RH analogue or in conjunction with orchiectomy (total blocking of androgen), as well as in patients who are already being treated with an LH-RH analogue or in those who have undergone surgical removal of the testes.
For the treatment of patients who did not respond to other forms of endocrine treatment or for whom other endocrine treatment is not tolerated but a necessity.
Unless prescribed otherwise: 1 Flutamide tablet 250 mg 3 times daily (equivalent to 750 mg Flutamide daily).
The tablets should be swallowed whole with a small amount of fluid, preferable after meals.
During initial treatment with an LH-RH analogue, Flutamide tablets 250 mg can reduce the occurrence and intensity of a tumour flare phenomenon if it is introduced before the LH-RH analogue.
It is therefore advised to start with the ingestion of one (1) Flutamide tablet 250 mg 3 times daily at least 3 days before initial administration of the LH-RH analogue and to continue with this dose thereafter.
The attending physician determines the duration of therapy.
Symptoms and management of overdose: The Flutamide dose associated with clinical signs of overdose, or considered to be life-threatening, has not been established to date.
As Flutamide is an anilide compound, it is theoretically possible that it may cause methaemoglobinaemia.
Vomiting should be induced in alert patients if it does not occur spontaneously. General supportive measures such as frequent monitoring of vital signs and close patient observation are indicated.
As Flutamide is bound to proteins to a great extent, it cannot be removed from the blood by dialysis.
Flutamide (Fluta-cell) 250 mg may not be used in patients who are hypersensitive to Flutamide or to one of the other components of Flutamide tablets 250 mg.
In patients with impaired liver function, the risk-benefit ratio of long-term administration of Flutamide tablets 250 mg should be assessed carefully for each individual case. Treatment using Flutamide tablets 250 mg should be discontinued if laboratory findings indicate liver damage or jaundice which are not a result of biopsy-confirmed liver metastasis.
Flutamide tablets 250 mg should be used with caution in patients with impaired renal function.
Treatment with Flutamide tablets 250 mg must be discontinued immediately if hypersensitivity reactions to Flutamide occurs.
Flutamide may lead to elevated plasma testosterone and oestradiol levels and thus fluid retention. This medicinal product must therefore be used with caution in the presence of cardiovascular diseases.
Disturbances in liver function which may occur are usually reversible after treatment with Flutamide tablets 250 mg has been discontinued. However, as there have been isolated reports of disturbances in liver function which sometimes had a severe course and which were in temporal connection with the treatment, liver function must be checked before initiating treatment and monitored regularly during long-term treatment. This is particularly the case when the first symptoms/signs of liver dysfunction appear, e.g. pruritus, dark urine, persistent anorexia, jaundice, pain in the right upper abdomen or non-specific "flu-like symptoms". In the case of long term treatment in patients who have not undergone medical or surgical castration, a sperm count should be performed at regular intervals.
Suitable contraceptive methods should be used consistently during treatment.
Flutamide is only intended for use in male patients. Suitable contraceptive methods should be used consistently during treatment.
Monotherapy: The most common undesirable effects observed during clinical trials using Flutamide tablets 250 mg are gynaecomastia and/or chest pain, sometimes accompanied by galactorrhoea. Micronodular changes in the corpus mammae may occur. These undesirable effects are reversible when treatment is discontinued or when dose is reduced.
Initially, monotherapy using Flutamide tablets 250 mg may lead to a reversible increase in serum testosterone, as well as to flush and changes in hair growth.
Cardiovascular disorders occur rarely, but with significantly less probability than with diethylstilbestrol.
Diarrhoea, nausea, vomiting, increased appetite, insomnia, tiredness, transient abnormal liver function and hepatitis have been reported occassionally.
The following undesirable effects occur rarely: decreased libido, dyspepsia, anorexia, ulcer-like pain, heartburn, constipation, oedema, ecchymoses, herpes zoster, pruritus, lupoid syndrome, headache, hot flashes, dizziness, weakness, malaise, blurred vision, thirst, chest pain, anxiety, depression and lymphedoema, loss or head hair and muscle spasms.
Combined treatment: The most common undesirable effect observed during clinical trials using Flutamide tablets 250 mg and LH-RH agonist were hot flashes, decreased libido, impotence, diarrhoea, nausea and vomiting. With the exception of diarrhoea, these undesirable effects are known to occur with an LH-RH agonist alone, and with a comparable incidence.
Gynaecomastia which commonly occurs with Flutamide monotherapy was reduced greatly in combination treatment.
Clinical trials showed no significant difference in the incidence of gynaecomastia between placebo / LH-RH agonist and Flutamide / LH-RH agonist treatment.
Hepatitis occurred occasionally.
The following occurred rarely: anaemia, leucopenia, thrombopenia, non-specific gastrointestinal complaints, anorexia, rash, neuromuscular symptoms, jaundice, urogenital tract symptoms, hypertension, oedema and CNS side effects (somnolence, depression, confusion, anxiety and nervousness).
Pulmonary symptoms such as dyspnea occurred very rarely.
The following further undesirable effects caused by Flutamide were also reported: haemolytic anaemia, macrocytic anaemia, methaemoglobinaemia, thromboembolism, photosensitivity reactions including arythema, ulcerations, bullous eruptions and epidermal necrolysis.
Cholestatic jaundice as well as hepatic encephalopathy and liver cell necrosis, particularly in patients with liver metastasis, were also observed. These undesirable effects usually receded once treatment is discontinued. However, there were isolated reports of liver damage with a fatal outcome in connection with the use of Flutamide.
Concomitant administration of oral anticoagulants may prolong the prothrombin time. Close monitoring of this parameter is therefore recommended, with dose adjustment of the anticoagulant if necessary.
Note for diabetics: Contains carbohydrates, equivalent to a carbohydrate exchange (i.e. bread units) of 0.08 per daily dose (750 mg).
Store at temperature not exceeding 25°C. Store away from light. The medicinal product has a shelf life of 5 years.
Keep all medicines out of reach from children.
L02BB01 - flutamide ; Belongs to the class of anti-androgens. Used in treatment of neoplastic diseases.
Fluta-cell 250 tab 250 mg
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