SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Furosemide Tablets B.P. (Vet) 40mg

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredients
Furosemide (The recommended INN and European Pharmacopoeia title of Frusemide B.P. is Furosemide 40mg)
Other ingredients
For full list of excipients see section 6.1

3. PHARMACEUTICAL FORM

Tablet – Oral Tablets containing the stated amount of Furosemide. Flat faced, white circular with bevelled edges and a scored half break line, embossed F40 and CP on the reverse.

4. PHARMACOLOGICAL PROPERTIES

ATC vet Code: QC03CA01

4.1 Pharmacodynamic properties

Furosemide is a diuretic with a rapid action. It exerts inhibiting effects on electrolyte reabsorption in the proximal and distal renal tubes and in the ascending loop of Henle. It may be effective in patients who do not respond to thiazide diuretics, including those with impaired renal function.

4.2 Pharmacokinetic particulars

Furosemide is incompletely but fairly rapidly absorbed from the gastrointestinal tract. It has a biphasic half life in the plasma with a terminal elimination phase that hs been estimated to range up to 1.5 hours. Furosemide is mainly excreted in the urine. Furosemide crosses the placental barrier and is excreted in milk.

5. Clinical Particulars

Dog and Cat.

5.2 Indications for Use

For the treatment of oedema, the product may be used in ascites, hydrothorax, pulmonary oedema of the mammary glands or legs, as well as oedema resulting from cardiac insufficiency, hepatic or renal dysfunction, parasitism or of a traumatic origin.

5.3 Contra-indications

Do not use in acute glomerular nephritis, in electrolyte diseases, in patients with anuria, or patients that have received excessive doses of cardiac glycosides. Because of the danger of potentiating their toxic effects do not use with aminoglycoside or cephalosporin antibiotics. Allergic reactions have been associated with use of sulphonamides.

The patient may increase its water intake to compensate for the diuresis. Consideration should be given to restricting water intake if the patient’s condition makes such a course appropriate.

5.5 Special Precautions for Use

5.5.1 i. Special Precautions for Use in Animals

Prolonged dosage may on occasions justify potassium supplementation and thus monitoring for hypokalaemia should be considered, especially if the product is used in conjunction with cardiac glycosides.

ii. Special Precautions to be Taken by the Person Administering the Medicinal Product to Animals

Wear gloves or wash hands immediately after handling tablets. In case of accidental ingestion seek medical attention and show product label and/or pack insert to the doctor.

The safety of use in pregnancy is not well established and a careful assessment of the likely benefits and potential risks should be made. A deleterious effect on lactation is to be expected, particularly if drinking water is restricted. Furosemide passes into milk, but to a great extent.

5.7 Interaction with Other Medicaments and Other Forms of Interaction

Potential interactions with other drugs include ototoxicity with aminoglycosides and nephrotoxicity with cephalosporins. Use in combination with sulphonamide treatment may lead to sulphonamide allergy. There is a possibility of interaction with cardiac glycosides.

5mg/KgBW, one or two times per day. For patients weighing less than 8Kg dosage with the 20mg tablet (which may be halved) is recommended. Avoid overdosage in weak and old patients.

Dehydration and electrolyte depletion may occur. Monitor and correct as necessary. Dosage higher than that which is recommended, may cause transitory deafness. Cardiovascular side effects may be observed in weak and old patients following overdose.

5.10 Withdrawal Periods

None for these species.

6. PHARMACEUTICAL PARTICULARS

Lactose

maize starch

pregelatinised maize starch

magnesium stearate.

6.2 Major Incompatibilities

None.

6.3 Shelf Life

5 Years.

6.4 Special Precautions for Storage

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

6.5 Nature and Contents of Immediate Packaging

Polypropylene/polyethylene containers containing 1000 tablets of 40mg each placed in an individual carton.

6.6 Special Precautions for the Disposal of Unused Medicinal Product or Waste Materials, if any

Any unused product or waste material should be disposed of in accordance with guidance from local waste regulations authority.

7. FINAL INFORMATION

Name and Permanent Address of the Holder of the Authorisation to Market the Product

a) Marketing Authorisation: Vm 04409/4000

b) Marketing Authorisation: MILLPLEDGE LIMITED, Whinleys Estate,

Clarborough, Retford, Notts, DN22 9NA

c) Date Renewal Issued: 30 March 2006