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Date: Saturday, December 4, 2021 7:20

Description: Dechra
Release 6.36
Frusedale® 40 mg Oral Tablets
 
Species: Cats, Dogs
Therapeutic indication: Pharmaceuticals: Diuretics
Active ingredient: Frusemide (Furosemide)
Product:Frusedale® 40 mg Oral Tablets
Product index: Frusedale 40 mg Oral Tablets
Qualitative and quantitative composition
Each tablet contains: Active ingredient:
Furosemide (Frusemide) 40 mg
Pharmaceutical form
Tablets. White, circular, biconvex, flat-faced tablets with bevelled edges and a breakline.
Clinical particulars
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
Administration at the recommended dosage level is not normally associated with undesirable effects.
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.
Pharmacological particulars
Pharmacotherapeutic group: Furosemide.
ATCvet code: QC03CA01
Pharmacodynamic properties
Frusedale 40 mg oral tablets contain Furosemide. Furosemide is a potent loop diuretic with a rapid action.
Pharmacokinetic properties
Furosemide inhibits electrolyte resorption in the proximal and distal renal tubules and in the ascending Loop of Henle. Excretion of sodium, potassium and chloride ions is enhanced, and also water excretion is enhanced. Furosemide has no effect on carbonic anhydrase. Diuretic activity begins one hour after oral administration and continues for four hours. The potency ensures diuretic action even when renal function is poor. Loop diuretics may cause severe potassium loss.
Pharmaceutical particulars
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 4 years.
Special precautions for storage
Do not store above 25°C.
Protect from light.
Immediate packaging
Polypropylene containers containing 1000 white, circular, biconvex, flat-faced tablets with bevelled edges, a breakline and which are embossed F40 on one face, CP or DP on the reverse.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Dechra Limited, Snaygill Industrial Estate, Keighley Road, Skipton, North Yorkshire, BD23 2RW, United Kingdom.
Marketing Authorisation Number
Vm 10434/4033
Significant changes
Date of the first authorisation or date of renewal
14 August 1998
Date of revision of the text
September 2016
Any other information
For animal treatment only. To be supplied only on veterinary prescription. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN
GTIN description:Frusedale 40 mg Oral Tablets:
GTIN:05055031410583