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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: Treatment of advanced prostate cancer in which suppression of testosterone effects is indicated: as initial treatment in combination with an LHRH-agonist; as adjunctive therapy in patients already receiving LHRH-agonist therapy; in surgically castrated patients; in the treatment of patients who have not responded to…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology One tablet three times daily. When used as initial treatment with an LHRH- agonist, a greater reduction in the incidence and severity of the LHRH-agonist flare reaction may be achieved if Flutamide 250 mg Tablets is introduced before rather than concomitantly with the agonist.
It is, therefore, recommended that Flutamide 250 mg Tablets, one tablet three times daily should be started at least three days before an LHRH-agonist and continued thereafter at the same dose. 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 250 mg Tablets should be administered with caution in patients with impaired renal function. Method of Administration The tablets are to be taken preferably after meals.
5) Common Nausea, vomiting, diarrhoea,Gastrointestinal disorders Rare Constipation, ulcer-like pain, thirst, dyspepsia, colitis, upset stomach, heartburn Hepato-biliary disorders Rare Hepatitis, liver function test abnormalities. 4 Special warnings and precautions for use.
Rare Urticaria, pruritus, alteration of the hair growth pattern and loss of hair (head). Skin and subcutaneous tissue disorders Very rare Photosensitivity Musculoskeletal, Connective tissue and bone disorders Rare Muscle cramps Renal and Urinary disorders Very Rare Acute renal failure Very common Gynaecomastia, breast tenderness, galactorrhoea.
(These reactions disappear upon discontinuation of treatment or dosage reduction). Reproductive system and breast disorders Rare Reversible increase of serum testosterone levels. Reduced sperm counts, decreased libido. Common Somnolence, tirednessGeneral Disorders Rare Asthenia, headache, dizziness, chest pain, malaise, hot flushes, weakness.
Investigations Common Transient abnormal liver function Combination Therapy SOC Frequency Reactions Rare Anaemia, leukopenia, thrombocytopenia, oedema. Reproductive system and breast disorders Rare Gynaecomastia Psychiatric and Nervous system disorders Rare Drowsiness, depression, confusion, anxiety, nervousness.
Cardiac and Vascular disorders Very Rare Pulmonary symptoms, such as dyspnoea and hypertension. Respiratory, thoracic and mediastinal disorders Very Rare Interstitial lung disease Very Common Nausea, vomiting, diarrhoeaGastrointestinal disorders Rare Unspecified gastrointestinal disorders, abdominal pain.
Rare Hepatitis, jaundiceHepato-biliary disorders Very rare Cholestatic jaundice, hepatic encephalopathy, hepatic necrosis, cases of severe hepatic injury with some fatal outcomes. Rare RashSkin and Subcutaneous tissue disorders Very rare Photosensitivity, erythema, ulcerations, bullous eruptions, epidermal necrolysis Musculoskeletal, Connective tissue and Bone disorders Rare Neuromuscular symptoms, Reduced bone mineral density, osteoporotic disorders, arthralgia, myalgia.
Hepatic injury:
In cases where impaired hepatic function exists, chronic flutamide therapy should only be used after a careful evaluation of the benefit- risk ratio. Liver function tests should be performed before treatment is started. Treatment with flutamide should not be started if the patient`s serum transaminase values are more than two- to threefold normal values.
Since transaminase abnormalities, cholestatic jaundice, hepatic encephalopathy, and liver cell necrosis have been observed with the use of flutamide, periodic liver function tests should be considered. Hepatotoxicity, which may be fatal, may occur after several weeks or months of therapy.
The hepatic conditions were usually reversible after discontinuing therapy; however, there have been reports of death following severe hepatic injury associated with use of flutamide. g. pruritus, dark urine, persistent anorexia, jaundice, right upper quadrant tenderness or unexplained flu-like symptoms) occur.
Flutamide therapy should be discontinued if the patient has laboratory evidence of liver injury or clinical jaundice in the absence of biopsy-confirmed liver metastases, or if the serum transaminase values exceed two-to threefold normal values in patients without pathological findings.
Patients should be advised to discontinue flutamide therapy and seek medical advice immediately if any symptoms or signs suggestive of hepatotoxicity occur. In patients who have not received medical or surgical castration, periodic sperm-count determination may be considered during long-term treatment.
In such patients flutamide administration tends to elevate plasma testosterone and oestradiol levels, fluid retention may occur, thus the drug should be used with caution in cardiovascular disease. Flutamide may lead to elevated testosterone and estradiol plasma levels, resulting in fluid retention.
Flutamide is contraindicated in patients who are hypersensitive to flutamide or any other component of this preparation. If hypersensitivity reactions occur, Flutamide must be withdrawn immediately.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Rare Genitourinary tract symptoms, dysuria, changes in urinary frequency, change in urine colour to amber or yellow-green. Renal and Urinary disorders Very Rare Acute renal failure General disorders Rare Injection site irritation Common Changes in liver functionInvestigations Very rare Elevated blood urea nitrogen (BUN), elevated serum creatinine *Few reports of malignant male breast neoplasms in patients being dosed with flutamide tablets have been reported.
One involved aggravation of a pre-existing nodule which was first detected three to four months before initiation of flutamide monotherapy in a patient with bening prostatic hypertrophy. After excision, this was diagnosed as a poorly differential ductal carcinoma.
The other report involved gynaecomastia and a nodule noted two and six months, respectively, after initiation of flutamide monotherapy for the treatment of advanced prostatic carcinoma. Nine months after the initiation of therapy the nodule was excised and diagnosed as a moderately differentiated invasive ductal tumour staged T4N0M0, G3, no metastases had advanced.
The high incidence of gynaecomastia seen with flutamide monotherapy is generally reduced with combination therapy. 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.
In severe cases this can lead to an increased risk of angina and heart failure. Therefore, flutamide should be used with caution in the presence of cardiovascular disease. Flutamide can exacerbate oedema or ankle swelling in patients prone to these conditions.
An increase in estradiol levels may predispose to thromboembolic events. Androgen deprivation therapy may prolong the QT interval. 5) physicians should assess the benefit risk ratio including the potential for Torsade de pointes prior to initiating Flutamide.
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. 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.
Flutamide should be used with caution in patients with impaired renal function. Flutamide is indicated only for use in male patients. Contraceptive measures should be taken during 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. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.