Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Renal failure with anuria; hepatic coma and pre-coma; hypotension; pre-existing hypovolaemia; pregnancy and lactation; hypersensitivity to torasemide and sulphonylureas; cardiac arrhythmias, simultaneous therapy with aminoglycosides or cephalosporins, or renal dysfunction due to drugs which cause renal damage.
Hypokalaemia, hyponatraemia, hypovolaemia and disorders of micturition must be corrected before treatment.
On long-term treatment with torasemide, regular monitoring of the electrolyte balance, glucose, uric acid, creatinine and lipids in the blood, is recommended.
Careful monitoring of patients with a tendency to hyperuricaemia and gout is recommended. Carbohydrate metabolism in latent or manifest diabetes mellitus should be monitored.
As for other drugs which produce changes in blood pressure, patients taking torasemide should be warned not to drive or operate machinery if they experience dizziness or related symptoms.
Patients with rare hereditary problems of glucose intolerance, the Lapp lactase deficiency of glucose-galactose malabsorption should not take this medication.
Particular 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.
When used simultaneously with cardiac glycosides, a potassium and/or magnesium deficiency may increase sensitivity of the cardiac muscle to such drugs. The kaliuretic effect of mineralo-and glucocorticoids and laxatives may be increased.
As with other diuretics, the effect of antihypertensive drugs given concomitantly may be potentiated.
Torasemide, especially at high doses, may potentiate the toxicity of aminoglycoside antibiotics, cisplatin preparations, the nephrotoxic effects of cephalosporins, and the cardio-and neurotoxic effect of lithium. The action of curare-containing muscle relaxants and of theophylline can be potentiated. In patients receiving high doses of salicylates, salicylate toxicity may be increased. The action of anti-diabetic drugs may be reduced.
Sequential or combined treatment, or starting a new co-medication with an ACE inhibitor may result in transient hypotension. This may be minimised by lowering the starting dose of the ACE inhibitor and/or reducing or stopping temporarily the dose of torasemide. Torasemide may decrease arterial responsiveness to pressor agents e.g. adrenaline, noradrenaline.
Non-steroidal anti-inflammatory drugs (eg. Indometacin) and probenecid may reduce the diuretic and hypotensive effect of torasemide.
Concomitant use of torasemide and colestyramine has not been studied in humans, but in an animal study co-administration of cholestyramine decreased absorption of oral torasemide.
There are no data from experience in humans of the effect of torasemide on the embryo and foetus. Whilst studies in the rat have shown no teratogenic effect, malformed foetuses have been observed after high doses in pregnant rabbits. No studies have been conducted on excretion in breast milk. Consequently, torasemide is contra-indicated in pregnancy and lactation.
As for other drugs which produce changes in blood pressure, patients taking torasemide should be warned not to drive or operate machinery if they experience dizziness or related symptoms.
Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from available data).
The following undesirable effects were observed whereas the frequency of undesirable effect is not known:
Frequency not known: Thrombocytopenia, Leukopenia, Anaemia
Very rare: Allergic skin reactions (eg Pruritus, Exanthema), Photosensitivity reaction
Frequency not known: Serious skin reactions (eg Stevens-Johnson syndrome, Toxic epidermal necrolysis)
Common: Metabolic alkalosis, Fluid and electrolyte imbalance (eg Hypovolaemia, Hyponatraemia)
Common: Headache, Dizziness
Frequency not known: Cerebral ischaemia, Parenthesia, confusional state
Frequency not known: Visual impairment
Frequency not known: tinnitus, Deafness
Frequency not known: Acute myocardial infarction, Myocardial ischaemia, Angina pertoris, Syncope, Hypotension
Frequency not known: Embolism
Common: Gastrointestinal disorder (e.g. Loss of appetite, Abdominal pain upper, Nausea, Vomiting, Diarrhoea, Constipation)
Frequency not known: Dry mouth, Pancreatitis
Uncommon: Hepatic enzyme increased (e.g. Gamma-glutamyltransferase increased)
Very rare: Allergic skin reactions (e.g. Pruritus, Exanthema), Photosensitivity reaction
Frequency not known: Serious skin reactions (e.g. Stevens-Johnson syndrome, Toxic epidermal necrolysis)
Common: Muscle spasms
Uncommon: Urinary retention, Bladder dilatation
Rare: Blood urea increased, Blood creatinine increased
Common: Fatigue, Asthenia
Uncommon: Blood uric acid increased, Blood glucose increased, Lipids increased (e.g. Blood triglycerides increased, Blood cholesterol increased)
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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
Not applicable.
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