POM: Prescription only medicine
This information is intended for use by health professionals
AdultsEssential hypertension: A dose of 2.5mg torasemide once daily is recommended. If necessary, the dose may be increased to 5mg once daily. Studies suggest that doses above 5mg daily will not lead to further reduction in blood pressure. The maximum effect is exhibited after approximately twelve weeks of continuous treatment.Oedema: The usual dose is 5mg once daily. If necessary, the dose can be increased stepwise up to 20mg once daily. In individual cases, as much as 40mg torasemide/day has been administered.
ElderlyNo special dosage adjustments are necessary.
ChildrenThere is no experience of torasemide in children.
Difficulty with micturitionParticular caution is required in patients with difficulty with micturition including prostatic hypertrophy because they have an increased risk of developing acute urinary retention and require careful close monitoring.
Blood and lymphatic system disordersFrequency not known: Thrombocytopenia, Leukopenia, Anaemia
Immune system disordersVery rare: Allergic skin reactions (eg Pruritus, Exanthema), Photosensitivity reactionFrequency not known: Serious skin reactions (eg Stevens-Johnson syndrome, Toxic epidermal necrolysis)
Metabolism and nutrition disordersCommon: Metabolic alkalosis, Fluid and electrolyte imbalance (eg Hypovolaemia, Hyponatraemia)
Nervous system disordersCommon: Headache, DizzinessFrequency not known: Cerebral ischaemia, Parenthesia, confusional state
Eye disordersFrequency not known: Visual impairment
Ear and labyrinth disordersFrequency not known: tinnitus, Deafness
Cardiac disordersFrequency not known: Acute myocardial infarction, Myocardial ischaemia, Angina pertoris, Syncope, Hypotension
Vascular disordersFrequency not known: Embolism
Gastrointestinal disordersCommon: Gastrointestinal disorder (e.g. Loss of appetite, Abdominal pain upper, Nausea, Vomiting, Diarrhoea, Constipation)Frequency not known: Dry mouth, Pancreatitis
Hepatobiliary disordersUncommon: Hepatic enzyme increased (e.g. Gamma-glutamyltransferase increased)
Skin and subcutaneous tissue disordersVery rare: Allergic skin reactions (e.g. Pruritus, Exanthema), Photosensitivity reaction Frequency not known: Serious skin reactions (e.g. Stevens-Johnson syndrome, Toxic epidermal necrolysis)
Musculoskeletal and connective tissue disordersCommon: Muscle spasms
Renal and urinary disordersUncommon: Urinary retention, Bladder dilatation Rare: Blood urea increased, Blood creatinine increased
General disorders and administration site conditionsCommon: Fatigue, Asthenia
InvestigationsUncommon: Blood uric acid increased, Blood glucose increased, Lipids increased (e.g. Blood triglycerides increased, Blood cholesterol increased)
Reporting of suspected adverse reactionsReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
Symptoms and signsNo typical picture of intoxication is known. If overdosage occurs, then there may be marked diuresis with the danger of loss of fluid and electrolytes which may lead to somnolence, confusion, hypotension, hyponatremia, hypokalemia, hypochloremic alkalosis, hemoconcentration dehydration and circulatory collapse. Gastrointestinal disturbances may occur.
TreatmentNo specific antidote is known. Symptoms and signs of overdosage require the reduction of the dose or withdrawal of torasemide, and simultaneous replacement of fluid and electrolytes.
Serum protein bindingMore than 99% of torasemide is bound to plasma proteins.
DistributionThe apparent distribution volume is 16 litres.
MetabolismTorasemide is metabolised to three metabolites, M1, M3 and M5 by stepwise oxidation, hydroxylation or ring hydroxylation. Further metabolites (M2 and M4) have been found in animal experiments, but not in humans.EliminationThe terminal half-life of torasemide and its metabolites is three to four hours in healthy subjects. Total clearance of torasemide is 40ml/min and renal clearance about 10ml/min. About 80% of the dose administered is excreted as torasemide and metabolites into the renal tubule - torasemide 24%, M1 12%, M3 3%, M5 41%.In patients with congestive heart failure and disorders of liver fnction, the elimination half-lives of torasemide and metabolite M5 are only slightly increased compared with those in healthy volunteers. The amounts of torasemide and metabolites excreted in the urine are similar to those in healthy subjects; therefore no accumulation is to be expected.In the presence of renal failure, elimination half-life of torasemide is unchanged.
Acute toxicityVery low toxicity.
Chronic toxicityThe changes observed in toxicity studies in dogs and rats at high doses are attributable to an excess pharmacodynamic action (diuresis). Changes observed were weight reduction, increases in creatinine and urea and renal alterations such as tubular dilatation and interstitial nephritis. All drug induced changes were shown to be reversible.
TeratogenicityReproduction toxicology studies in the rat have shown no teratogenic effect, but malformed foetuses have been observed after high doses in pregnant rabbits. No effects on fertility have been seen.Torasemide showed no mutagenic potential. Carcinogenicity studies in rats and mice showed no tumourigenic potential.
Mylan Products Ltd,
Building 4, Trident Place, Mosquito Way, Hatfield, Hertfordshire, AL10 9UL
+44 (0)1707 853 000
+44 (0)1707 853 000
+44 (0)1707 853 000 select option 2
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