Furosemide Tablets Bp (Vet) 20 Mg
SUMMARY OF PRODUCT CHARACTERISTICS
1. Name: Furosemide Tablets B.P. (Vet) 20mg
2. Composition:
active (s): Furosemide
The recommended INN and European Pharmacopoeia title of Frusemide B.P. is Furosemide
20mg
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 F20 and CP on the reverse
Clinical particulars:
4.1. Target species: dog and cat.
4.2 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.
4.3 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 no use with aminoglycoside or cephalosporin antibiotics. Allergic reactions have been associated with use with sulphonamides.
4.4 Special warnings: 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.
Special precautions:
4.5.1 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.
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.
4.6 Adverse reactions: None reported
4.7 Pregnancy and lactation: 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 not to a great extent.
4.8 Interactions: 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.
4.9 Amounts to be administered and administration route: 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.
4.10 Overdose: 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.
4.11 Withdrawal periods: None for these species.
5. Pharmacological properties:
ATC vet Code: QC03CA01
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 Henlè. It may be effective in patients who do not respond to thiazide diuretics, including those with impaired renal function.
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 has been estimated to range up to about 1.5 hours. Furosemide is mainly excreted in the urine. Furosemide crosses the placental barrier and is excreted in milk.
6. Pharmaceutical particulars:
6.1 List of excipients: Lactose
Maize starch
Pregelatinised maize starch
Magnesium stearate
6.2 Major incompatibilities: none
6.3 Shelf life: 5 years
6.4 Storage precautions: Do not store above 25°C. Protect from light.
Nature and contents of
Immediate packaging : Polypropylene/polyethylene containers containing 500 tablets of 20mg each placed in an individual carton.
Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products, if appropriate:
Any unused product or waste material should be disposed of in accordance with national requirements
7. M/A holder
MILLPLEDGE LIMITED
Whinleys Estate, Clarborough, Retford, Notts DN22 9NA
8. M/A number: Vm 04409/4001
9. Date of first authorisation or date of renewal of authorisation: 30 March 2006.