Frusemide (Furosamide) Tablets for Dogs & Cats

V DATA SHEETFUROSEMIDE TABLETS B.P. (Vet.) 20mgFUROSEMIDE TABLETS B.P. (Vet.) 40mgTablets containing the stated amount of Furosemide. The tablets are white, circular with bevelled edges and a break-line. The 20mg tablets are flat facedand are embossed ‘F20’. The 40mg tablets are bi-convex and embossed ‘F40’. Both strengths are embossed ‘CP’ on the reverse.Uses:Furosemide tablets B.P. (Vet.) 20mg and 40mg are for use in cats and dogs only. It is a potent ‘loop’ diuretic. So called because it acts primarily by inhibiting electrolyte absorption in the loop of Henlé. It has a rapid onset of action, normally within 1 hour of administration, but a relatively short duration of activity of approximately 4 hours. These characteristics mean that dosing can be timed within the day, to allow consequent passage of water at socially convenient times.Furosemide Tablets B.P. (Vet.) are used in the treatment of oedema. Conditions suitable for treatment include ascites, hydrothorax, pulmonary oedema and oedema of the mammary gland or of the legs, as well as oedema resulting from cardiac insufficiency, hepatic or renal dysfunction, parasitism or of a traumaticorigin. Combined therapy with other medicinal products may be indicated.Dosage:For oral administration only. 5mg per Kilogram bodyweight, one to two times daily.Diuresis occurs within one hour and is normally complete within six hours. Dosing at an interval of at least six hours (and up to ten hours) allows for twice daily dosing, usually without the need for excess urine to be passed during the night. Not to be used in cats or dogs weighing less than 4 kg in bodyweightContra-indications, warnings, etc:Do not use in acute glomerula nephritis, in electrolyte deficiencydiseases, inpatients with anuria, or patients that have received excessive doses of cardiac glycosides.Do not use concurrently with aminoglycoside antibiotics or corticosteroids. Allergic reactions have been associated with use with sulphonamides.For patients weighing less than 8Kg, dosage with the 20mg tablet (which may be halved) is recommended. Whinleys Estate Clarborough Retford Notts DN22 9NATel: 01777 708440 Fax: 01777 860020Rev. 08/06V DATA SHEETFUROSEMIDE TABLETS B.P. (Vet.) 20mgFUROSEMIDE TABLETS B.P. (Vet.) 40mgPatients may increase their water intake to compensate for the diuresis. Consideration should be given to restricting water intake if the animal’s condition permits.Doses higher than that which is recommended may cause transitory deafness.Monitoring of plasma potassium levels is advisable during periods of prolonged treatment of combined therapy with cardiac glycosides. Potassium supplements may be necessary. Furosemide tablets B.P. (Vet.) may be used in pregnant or lactating animals.Wear gloves during, or wash your hands immediately after, handling the tablets.Pharmaceutical precautions:Do not store above 25°C. Protect from light. Keep out of reach of children. Legal category:POM-VPackage quantities:20mg tablets in 500’s.40mg tablets in 1,000’s.Further information:Nil.Marketing authorisation numbers:Furosemide Tablets B.P. (Vet.) 20mg Vm 04409/4001Furosemide Tablets B.P. (Vet.) 40mg Vm 04409/4000

SUMMARY OF PRODUCT CHARACTERISTICS

1. Name of THE Veterinary Medicinal Product

   Frusemide 40 mg Tablets

2. Qualitative and Quantitative Composition

   Active substance Qualitative composition Quantitative composition Furosemide (Frusemide) 40 mg per tablet

   Excipients For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Tablets. White, circular, biconvex, flat-faced tablets with bevelled edges, with F40 on one side and CP or DP on the reverse, and a breakline.

4. Clinical Particulars

4.1 Target species

Cats and dogs.

4.2 Indications for use, specifying the target species

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.

4.3 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 warnings for each target species

There are no special warnings required for either target species.

Special precautions for use

i. 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 Frusemide 40 mg tablets.

Monitoring of plasma potassium levels is advisable during periods of prolonged treatment of combined therapy with cardiac glycosides. Potassium supplements may be necessary.

ii. 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.

4.6 Adverse reactions (frequency and seriousness)

Administration at the recommended dosage level is not normally associated with undesirable effects.

4.7 Use during pregnancy, lactation or lay

Frusemide 40 mg tablets are not contraindicated in pregnant or lactating animals.

4.8 Interaction with other medicinal products and other forms of interaction

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.

4.9 Amounts to be administered and administration route

For oral administration only. Cats and dogs: Dosage up to 5 mg/kg bodyweight, or one tablet, per 8 kg bodyweight, one to two times daily with an interval of 6 - 8 hours between administrations. 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. For maintenance, the dosage should be reduced to 1 - 2 mg/kg per day. Not to be used in animals under 4 kg bodyweight.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

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.

4.11 Withdrawal periods

Not applicable.

5. Pharmacological Particulars

Pharmacotherapeutic group: Furosemide

ATC Vet Code: QC03CA01

5.1 Pharmacodynamic properties

The tablets contain Furosemide. Furosemide is a potent loop diuretic with a rapid action.

5.2 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.

6. Pharmaceutical Particulars

6.1 List of excipients

Maize starch Pregelatinised starch Magnesium stearate Lactose monohydrate Water, purified

6.2 Incompatibilities

None known.

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 4 years. 6.4 Special precautions for storage

Do not store above 25°C. Protect from light.

6.5 Nature and composition of immediate packaging

White polypropylene containers with low density polyethylene, push fit, tamper evident caps, containing 250 or 1000 tablets. Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate

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

Dechra Limited Snaygill Industrial Estate Keighley Road Skipton North Yorkshire BD23 2RW United Kingdom

8. MARKETING AUTHORISATION NUMBER

Vm 10434/4059

DATE OF FIRST AUTHORISATION

21 May 2003

DATE OF REVISION OF THE TEXT

September 2016

29 September 2016