Target species
Dogs
Indications for use, for each target species
For treatment of clinical signs, including oedema and effusion, related to congestive heart failure.
Contraindications
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in cases of renal failure.
Do not use in cases of severe dehydration, hypovolaemia or hypotension. Do not use concomitantly with other loop diuretics.
Special warnings
None
Special precautions for use
Special precautions for safe use in the target species:
In dogs presenting in acute crisis with pulmonary oedema, pleural effusion and/or ascites requiring emergency treatment, the use of injectable drugs should be considered first before commencing oral diuretic therapy.
Renal function, hydration status and serum electrolytes status should be monitored:
-at treatment initiation
-from 24 hours to 48 hours after treatment initiation
-from 24 hours to 48 hours after dose change
-in case of adverse events.
While the animal is on treatment, these parameters should be monitored at very regular intervals according to the benefit-risk assessment performed by the responsible veterinarian (see sections Contraindications and Adverse events).
Torasemide should be used with caution in cases of diabetes mellitus, and in dogs with previously prescribed high doses of an alternative loop diuretic. In dogs with pre-existing electrolyte and/or water imbalance, this should be corrected prior to treatment with torasemide.
Torasemide treatment should not be initiated in dogs already clinically stable on an alternative diuretic for treatment of the signs of congestive heart failure, except where this has been justified taking into account the risk of de-stabilising the clinical condition and of adverse reactions as indicated in Adverse events.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to torasemide or other sulphonamides should administer the veterinary medicinal product with caution.
This product may cause increased urination and/or gastrointestinal disturbances if ingested.
Keep tablets in the blister packs until required, and keep the blisters in the outer carton.
In case of accidental ingestion, particularly in the case of children, seek medical advice immediately and show the package leaflet or the label to the physician.
Special precautions for the protection of the environment
Not applicable
Adverse events
Dogs:
Very common (>1 animal / 10 animals treated): | Elevated renal parameters, Renal insufficiency Haemoconcentration, Polyuria, Polydipsia |
Very rare (<1 animal/ 10,000 animals treated, including isolated reports): | Hypokalaemia*1, Hypochloraemia*1, Hypomagnesaemic condition *1 Dehydration Emesis, Constipation, Reduced faecal output, Diarrhoea*2 Pinnal erythema |
*1: In cases of prolonged treatment
*2: Transient, mild, and does not necessitate the withdrawal of the treatment
Reporting adverse events is important. It allows continuous safety monitoring of veterinary medicinal products. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system.
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy or lactation.
Pregnancy and lactation:
The use is not recommended during pregnancy and lactation.
Fertility:
Do not use in breeding animals.
Interaction with other medicinal products and other forms of interaction
Co-administration of loop diuretics and non-steroidal anti-inflammatory drugs (NSAIDs) can result in a decreased natriuretic response.
Concomitant use with veterinary medicinal products affecting electrolyte balance (corticosteroids, amphotericin B, cardiac glycosides, other diuretics) requires careful monitoring.
Concurrent use of veterinary medicinal products that increase the risk of renal injury or renal insufficiency should be avoided. Concomitant use with aminoglycosides or cephalosporins may increase the risk of nephrotoxicity and ototoxicity.
Torasemide may increase the risk of sulfonamide allergy.
Torasemide can reduce the renal excretion of salicylates, leading to an increased risk of toxicity. Care should be exercised when administering torasemide with other highly plasma protein-bound drugs.
Since protein binding facilitates the renal secretion of torasemide, a decrease in binding due to displacement by another drug may be a cause of diuretic resistance.
Concomitant administration of torasemide with other veterinary medicinal products metabolised by cytochrome P450 isoforms such as 3A4 (e.g.: enalapril, buprenorphine, doxycycline, cyclosporine) and 2E1 (isoflurane, sevoflurane, theophylline) may decrease their clearance from the systemic circulation.
The effect of antihypertensive medicinal products, especially angiotensin-converting enzyme (ACE) inhibitors, may be potentiated when co-administered with torasemide.
When used in combination with cardiac treatments (e.g. ACE-inhibitors, digoxin), the dose regimen may need to be modified depending upon the animal’s response to therapy.
Administration routes and dosage
Oral use.
The veterinary medicinal product can be administered with or without food.
The recommended dose of torasemide is 0.1 to 0.6 mg/kg bodyweight, once daily. The majority of dogs are stabilised at a dose of torasemide less than or equal to 0.3 mg/kg bodyweight, once daily. The dosage should be titrated to maintain patient comfort with attention to renal function and electrolyte status. If the level of diuresis requires alteration, the dose may be increased or decreased within the recommended dose range by increments of 0.1 mg/kg bodyweight. Once signs of congestive heart failure have been controlled and the patient is stable, if long term diuretic therapy with this product is required it should be continued at the lowest effective dose.
Frequent re-examinations of the dog will enhance the establishment of an appropriate diuretic dose.
The daily schedule of administration can be timed to control the period of micturition according to need.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
Doses greater than 0.8 mg/kg/day have not been evaluated in the target animal safety or controlled clinical studies. However, it is anticipated that overdose increases the risk of dehydration, electrolyte imbalance, renal insufficiency, anorexia, weight loss and cardiovascular collapse.
Treatment should be symptomatic.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
Withdrawal period
Not applicable.