Target species
Cats and dogs.
Indications for use
For the treatment of oedema associated with cardiac insufficiency, renal dysfunction and trauma in cats and dogs.
In animals with pulmonary oedema of cardiac origin, combined therapy with other medicinal products may be indicated.
Contraindications
Do not use in animals with acute glomerular nephritis, renal failure with anuria, electrolyte deficiency disease or in animals that have received an overdosage of digitalis.
Do not use concurrently with aminoglycoside antibiotics.
Do not use in animals weighing less than 4 kg.
Special precautions for use in animals
Do not exceed the recommended dosage.
Therapeutic efficacy may be impaired by increased intake of drinking water. Where the animal's condition permits, water intake should be restricted during treatment with Frusedale 40 mg oral tablets.
Monitoring of plasma potassium levels is advisable during periods of prolonged treatment of combined therapy with cardiac glycosides. Potassium supplements may be necessary.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Wear gloves, or wash your hands immediately after handling the tablets.
Adverse reactions
During the post-authorisation period and following use of the product in dogs displaying signs of cardiac disease, lethargy, malaise and a fast or irregular
heartbeat have been recorded rarely.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Use during pregnancy and lactation
Frusedale 40 mg oral tablets are not contraindicated in pregnant or lactating animals.
Interactions
Concurrent administration with corticosteroids may increase the risk of hypokalaemia.
Concurrent administration with aminoglycoside antibiotics may result in ototoxicity.
Concurrent administration with cephalosporin antibiotics may result in nephrotoxicity.
Concurrent administration with digoxin enhances the cardiac glycoside.
Concurrent administration with sulphonamide antibacterials may result in sulphonamide allergy.
Amounts to be administered and administration route
For oral administration only. Cats and dogs:
Dosage up to 5 mg/kg body weight, or one Frusedale 40 mg oral tablet per 8 kg body weight, 1-2 times daily with an interval of 6-8 hours between administrations.
For maintenance, the dosage should be reduced to 1-2 mg/kg per day.
For animals weighing between 4 and 8 kg, one half of one tablet should be administered. The tablets may be divided by breaking along the score line.
Not to be used in animals under 4 kg body weight.
Overdose
Transitory deafness may occur in animals administered the product at doses higher than those recommended. Cardiovascular side effects may occur in weak and old animals following overdosage. Excessive doses can lead to hypovolaemia and decompensate renal function. Management of signs of overdosage is symptomatic.