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FLUTAMIDE is a brand name for Flutamide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Flutamide is indicated for the treatment of advanced prostatic carcinoma in which suppression of testosterone effects is indicated. Flutamide may be used in combination with an LHRH agonist, both on commencement of treatment or as an adjunctive therapy in patients already receiving an LHRH agonist. Flutamide may also…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults and older people:
One 250mg tablet 3 times daily at 8 hour intervals When Flutamide is used as initial treatment with an LHRH agonist, a reduction in severity of the flare reaction may be achieved if treatment with Flutamide is initiated before the LHRH agonist.
Consequently, it is recommended that treatment with Flutamide should commence simultaneously or at least 24 or more hours before the LHRH agonist. The administration of Flutamide should begin eight weeks prior to radio therapy and continue for its duration, or for 12 weeks pre-prostatectomy.
Method of administration For Oral use. The tablets are to be taken preferably after food.
Monotherapy The undesirable effects of flutamide most frequently reported are gynaecomastia and/or breast tenderness, sometimes accompanied by periods of galactorrhoea. These reactions often disappear with the suspension of treatment or reduction in dosage.
It has been proven that famotidine has a low cardiovascular risk potential, significantly less than that of diethylstilboestrol. Combined therapy The undesirable effects most frequently reported during combined treatment of famotidine with an LHRH agonist were hot flushes, reduced libido, erectile dysfunction, diarrhoea, nausea and vomiting.
With the exception of diarrhoea, these are known undesirable effects of LHRH agonist alone, with a similar frequency. The high rate of occurrence of gynecomastia observed with monotherapy with Famotidine decreased greatly in combined treatment.
In clinical trials, no significant difference was observed in the rate of occurrence of gynecomastia between the placebo group and the group treated with famotidine and LHRH agonist. g. 4) Hepatic dysfunction, Jaundice Very rare Cholestatic jaundice, hepatic encephalopathy, liver cell necrosis, hepatotoxicity with fatal outcome.
Skin and subcutaneous tissue disorders Rare Urticaria, Pruritus, ecchymosis ,alteration of the hair growth pattern and loss of hair (head) Rash Very rare Photosensitivity reactions Photosensitivity reactions, erythema, ulcer, bullous eruptions, epidermal necrolysis Musculoskeletal and connective tissue disorders Rare Muscle cramps Neuromuscular symptoms ,reduced bone mineral density, osteoporotic disorders, arthralgia, myalgia Renal and urinary disorder Rare Genitourinary tract symptoms, dysuria, changes in urinary frequency, change in urine colour to amber or yellow-green.
Reproductive system and breast disorders Very Common Gynecomastia and/or breast pain ,breast tenderness, galactorrhoea Decreased libido, impotence Uncommon Gynecomastia Rare Reversible increase of serum testosterone levels , Decreased libido Reduced sperm counts General disorders and administration site conditions Common Somnolence ,Tiredness Rare Oedema, asthenia , weakness, malaise, thirst, chest pain, hot flushes Oedema, Injection site irritation Investigations Common Transient abnormal liver function Changes in liver function Rare elevated blood urea nitrogen (BUN) values , Elevated serum creatinine values *There have been a few cases reported of malignant breast neoplasms in male patients treated with famotidine.
Hepatic injury:
Flutamide may be hepatotoxic and should be used with caution in patients with pre-existing hepatic dysfunction only after considering the benefits and potential risks. There have been reports of elevated serum transaminase levels, cholestatic jaundice, hepatic necrosis and hepatic encephalopathy associated with Flutamide treatment.
The hepatic effects were usually reversible following discontinuation of flutamide, although cases have been reported of death after severe liver damage linked to the use of flutamide. Hepatotoxicity, which may be fatal, may occur after several weeks or months of therapy.
Hepatic function should be monitored regularly before, during and after initiation of Flutamide therapy. Treatment with Flutamide should not be initiated in patients with serum transaminase levels exceeding 2-3 times the upper limit of normal.
Periodic liver function tests must be performed before initiation and during treatment, especially in patients receiving long term treatment with flutamide. , pruritus, dark urine, persistent anorexia, jaundice, right upper quadrant tenderness or unexplained "flu-like" symptoms).
Patients should be advised to discontinue Flutamide therapy and seek medical advice immediately if any symptoms or sign suggestive of hepatotoxicity occur. If the patient presents liver function test results indicative of liver damage, clinical jaundice in the absence of hepatic metastasis confirmed by biopsy, or serum transaminase levels of 2 to 3 times above the normal limits in patients that do not present pathological signs, treatment with flutamide must be suspended.
Impaired renal function In patients with impaired liver function, long –term treatment with Flutamide should only be initiated after careful assessment of the individual benefits and risks. Flutamide should be administered with caution in patients with impaired renal function.
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One of them consisted of the aggravation of a lump that had been detected previously, three or four months prior to commencing monotherapy with flutamide in a patient with benign prostatic hypertrophy. After the excision, a diagnosis was made of slightly differentiated ductal carcinoma.
The other case consisted of gynaecomastia and a lump, observed, respectively, two to six months after the start of monotherapy with flutamide to treat an advanced prostate carcinoma. Nine months after the treatment began, the lump was removed and a moderately differentiated invasive ductal tumour was diagnosed in T4N0M0, G3 state.
Micronodular alterations of the body of breast can uncommonly occur. An increase in serum testosterone is initially possible during monotherapy with flutamide; in addition, hot flushes and changes in hair character can occur. Following the marketing of flutamide, cases of acute renal failure, interstitial nephritis, and myocardial ischemia have been reported with frequency unknown.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Cardiovascular Periodic sperm count should be considered in patients receiving chronic treatment with Flutamide who have not received medical or surgical castration. Flutamide administration may lead to elevated plasma testosterone and oestradiol levels in such patients, resulting in fluid retention.
In severe cases this can lead to an increased risk of angina and heart failure. Therefore caution should be exercised in the use of Flutamide if cardiac disease is present. Flutamide can exacerbate oedema or ankle swelling in patients prone to these conditions.
The increase in levels of oestradiol may predispose to thromboembolic events. It has been reported in the literature that increased cardiovascular risk (myocardial infarction, cardiac insufficiency, sudden cardiac death) and the adverse effect on independent cardiovascular risk factors (serum lipoproteins, insulin sensitivity and obesity) may be linked to androgen deprivation with LHRH analogues in patients with prostate cancer.
It must be evaluated whether the benefits of the combined androgen blockade compensate the potential cardiovascular risk in patients with risk factors. Patients treated whose signs or symptoms suggest the development of a cardiovascular disease must be monitored.
Effect on QT/QTc interval The potential QT/QTc prolongation with flutamide has not been studied. Androgen deprivation therapy may prolong the QT interval. 5) physician should assess the benefit risk ratio including the potential for Torsade de pointes prior to initiating Flutamide Endocrinology and metabolism A decreased tolerance to glucose has been observed in males in treatment with combined androgen blockade.
This may manifest as diabetes or a loss of glycaemic control in patients with pre-existing diabetes. Monitoring of the blood glucose and/or glycosylated haemoglobin (HbA1c) levels must be considered in patients who are in treatment with flutamide in combination with LHRH agonists.
Musculoskeletal/changes in bone density Androgen depletion therapy is known to reduce bone mineral density and increase the risk of osteoporotic fractures. In recent studies this has been seen in patients treated with LHRH analogues plus flutamide.
The risk of bone fractures increases with the duration of combined androgen blockade. These complications may be potentiated when patients are already osteoporotic due to their advanced age at diagnosis of prostate cancer. Bone mineral density (BMD) should be measured regularly to identify patients at higher risk for fractures.
BMD should be measured at baseline, and then a year later as a minimum. Further measurements can be considered at yearly intervals in men with BMD approaching osteoporosis or those with decreased bone mineral density in whom life expectancy warrants it.
In patients with significant risk factors for decreased bone mineral content and/or bone mass such as chronic consumers of alcohol and/or tobacco, a presumed or marked family history of osteoporosis or chronic use of medicinal products that can reduce bone mass such as anticonvulsants or corticosteroids, the combined androgen blockade can represent an additional risk.
In these patients the risk and benefit must be weighed up carefully before starting the treatment. There have been cases of interstitial pneumonitis reported in patients undergoing treatment with flutamide. Patients should be monitored for the development of respiratory symptoms such as dyspnoea during the first few weeks of therapy.
Flutamide is indicated for use only in male patients. Contraceptive measures should be taken during treatment. The tablets contain lactose. Patients with rare hereditary problems of galactose-intolerance, total […]