Vetmedin for Dogs

Vetmedin Flavour Tablets

Presentation

Vetmedin Flavour Tablets, containing 1.25 mg or 5.0 mg pimobendan per tablet.

Uses

For the treatment of canine congestive heart failure originating from dilated cardiomyopathy or valvular insufficiency (mitral and/or tricuspid regurgitation). When used in cases of valvular insufficiency in conjunction with frusemide the product has been shown to improve the quality of life and extend life expectancy in treated dogs. When used in a limited number of cases of dilated cardiomyopathy in conjunction with frusemide, enalapril and digoxin, the product has been shown to improve the quality of life and to extend life expectancy in treated dogs.

Dosage and administration

See dosing table below.

Vetmedin 1.25 mg and 5.0 mg Tablets Dosage Guide
Bodyweight	Daily Dosage	Morning	Evening
(kg)	(mg)	1.25 mg	5.0 mg	1.25 mg	5.0 mg
< 5	1.25	½	-	½	-
5-10	2.5	1	-	1	-
11-20	5	-	½	-	½
21-40	10	-	1	-	1
41-60	20	-	2	-	2
> 60	30	-	3	-	3

Vetmedin Flavour Tablets should be administered orally at a dose of 0.2 mg to 0.6 mg pimobendan/kg body weight per day. The preferable daily dose is 0.5 mg pimobendan/kg bodyweight. The daily dose should be divided into two equal administrations, one half of the dose given in the morning and the other half approximately 12 hours later. Each dose should be given approximately one hour before feeding. The tablet is flavoured and may be given as a treat. The large size of 5.0 mg can be readily divided into two halves, using the scored line on the tablet to give a dose that contains 2.5 mg. Do not exceed the recommended dosage.

Determine the bodyweight accurately before prescribing to ensure administration of the correct dosage.

Vetmedin Flavour Tablets may be combined with a diuretic treatment such as furosemide.

Contra-indications, warnings, etc

Vetmedin Tablets should not be used in cases of hypertrophic cardiomyopathies or clinical conditions where an augmentation of cardiac output is not possible for functional or anatomical reasons (e.g. aortic stenosis). The product should only be used in dogs with cardiac insufficiency.

A moderate positive chronotropic effect and vomiting may occur in rare cases. However, these effects are dose-dependent and may be avoided by reducing the dose in these cases. In rare cases transient diarrhoea, anorexia or lethargy have been observed.

In studies with rats and rabbits pimobendan had no effect on fertility and embryotoxic effects only occurred at maternotoxic doses. In rat experiments it has been shown that pimobendan is excreted into milk. Therefore, the product should only be administered to pregnant and lactating bitches if the expected therapeutic benefits overweigh the potential risk.

The pimobendan-induced increase in contractility of the heart is attenuated in the presence of the calcium antagonist verapamil and the β-antagonist propranolol. In pharmacological studies no interaction between the cardiac glycoside ouabain and pimobendan was detected. Do not exceed the recommended dosage.

In the case of overdose, symptomatic treatment should be initiated.

Any unused product or waste material derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

For animal treatment only.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. Wash hands after use. Advice to doctors: accidental ingestion, especially by a child, may lead to the occurrence of tachycardia, orthostatic hypotension, flushing of the face and headaches.

Pharmaceutical precautions

Do not store above 25°C.

Store in the original package tightly closed in order to protect from moisture.

Keep out of reach and sight of children.

Legal category

POM-V

Packaging Quantities

50 tablets or 100 tablets of 1.25 mg tablets packed in white child-resistant polypropylene bottles.

50 tablets of 5.0 mg tablets packed in white child-resistant polypropylene bottles.

Not all pack sizes may be marketed

Further information

Pharmacodynamic properties

Pimobendan, a benzimidazole-pyridazinone derivative, is a non-sympathomimetic, non-glycoside inotropic substance with potent vasodilatative properties.

Pimobendan exerts its stimulatory myocardial effect by a dual mechanism of action: increase in calcium sensitivity of cardiac myofilaments and inhibition of phosphodiesterase (type III). It also exhibits a vasodilating action through an inhibitory action on phosphodiesterase III activity. The combined evidence from cell culture, laboratory animal and small studies in the target species suggests that the combination of the specific PD properties of pimobendan may reduce the progression of myocardial damage in dogs with MVD and DCM when used together with other standard therapy.

Pharmacokinetic particulars

Absorption: Following oral administration of pimobendan, the absolute biovailability of the active principle is 60 - 63 %. Since this bioavailability is considerably reduced when pimobendan is administered with food or shortly thereafter, it is recommended to treat animals approximately 1 hour before feeding.

Distribution: The volume of distribution is 2.6 l/kg, indicating that pimobendan is distributed readily into the tissues. The mean plasma protein binding is 93 %.

Metabolism: The compound is oxidatively demethylated to its major active metabolite (UD-CG 212). Further metabolic pathways are phase II conjugates of UD-CG 212, in essence glucuronides and sulfates.

Elimination: The plasma elimination half-life of pimobendan is 0.4 + 0.1 hours, consistent with the high clearance of 90 + 19 ml/min/kg and a short mean residence time of 0.5 + 0.1 hours.

The main active metabolite is eliminated with a plasma elimination half-life of 2.0 + 0.3 hours. Almost the entire dose is eliminated via faeces.

Marketing authorisation number

Vm 00015/4077 Vetmedin 1.25 mg Flavour Tablets.

Vm 00015/4076 Vetmedin 5.0 mg Flavour Tablets.

GTIN (Global Trade Item No)

Vetmedin 1.25mg Flavour Tablets x 50 -

5012917025200

Vetmedin 1.25mg Flavour Tablets x 100 -

5012917025248

Vetmedin 5 mg Flavour Tablets x 50 -

5012917025217

Vetmedin 5 mg hard capsules

Presentation

Hard gelatin capsules white to orange in colour, containing 5 mg pimobendan per capsule.

Excipients: Titanium Dioxide (E171) 1.2320 mg/capsule and Sunset Yellow (E110) 0.3080 mg/capsule.

Uses

For the treatment of canine congestive heart failure originating from dilated cardiomyopathy or valvular insufficiency (mitral and/or tricuspid regurgitation). When used in cases of valvular insufficiency in conjunction with frusemide the product has been shown to improve the quality of life and extend life expectancy in treated dogs. When used in a limited number of cases of dilated cardiomyopathy in conjunction with frusemide, enalapril and digoxin, the product has been shown to improve the quality of life and to extend life expectancy in treated dogs.

Dosage and administration

See dosing table below.

Vetmedin 5 mg Capsules Dosage Guide
Bodyweight (kg)	Daily Dosage (mg)	Morning	Evening
21-40	10	1	1
41-60	20	2	2
>60	30	3	3

Vetmedin capsules should be administered orally (approximately one hour before feeding) at a dose of 0.2 mg to 0.6 mg pimobendan/kg body weight per day. The daily dose should be divided into two equal administrations, one half of the dose given in the morning and the other half approximately 12 hours later.

Determine the bodyweight accurately before prescribing to ensure administration of the correct dosage.

In cases of mild congestive heart failure, a daily dosage at the lower end of the dose range may be adequate. If, however, a clear response is not observable within one week, the dosage should be raised.

Vetmedin capsules may be combined with a diuretic treatment such as frusemide.

Contra-indications, warnings, etc

Vetmedin capsules should not be used in cases of hypertrophic cardiomyopathies or clinical conditions where an augmentation of cardiac output is not possible for functional or anatomical reasons (e.g. aortic stenosis). The product should only be used in dogs with cardiac insufficiency.

Do not exceed the recommend dosage.

A moderate positive chronotropic effect and vomiting may occur in rare cases. However, these effects are dose-dependent and may be avoided by reducing the dose in these cases. In rare cases transient diarrhoea, anorexia or lethargy have been observed.

In studies with rats and rabbits, pimobendan had no effect on fertility and embryotoxic effects occurred only at maternotoxic doses. In experiments with rats it has been shown that pimobendan is excreted into milk. No information is available on the safety of Vetmedin in pregnant and lactating bitches.

The pimobendan-induced increase in contractility of the heart is attenuated in the presence of the calcium antagonist verapamil and the β-antagonist propranolol. In pharmacological studies no interaction between the cardiac glycoside ouabain and pimobendan was detected.

In the case of overdose, symptomatic treatment should be initiated.

User precautions

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

For animal treatment only.

Pharmaceutical precautions

Do not store above 25°C.

Store in a dry place.

Store in tightly closed original container.

Keep out of the reach and sight of children.

Legal category

POM-V

Packaging Quantities

100 capsules of 5 mg capsules packed in white child-resistant polypropylene bottles.

Further information

Pharmacodynamic properties

Pimobendan, a benzimidazole-pyridazinone derivative, is a non-sympathomimetic, non-glycoside inotropic substance with potent vasodilatative properties. Pimobendan exerts its stimulatory myocardial effect by a dual mechanism of action: increase in calcium sensitivity of cardiac myofilaments and inhibition of phosphodiesterase (type III). It also exhibits a vasodilating action through an inhibitory action on phosphodiesterase III activity. The combined evidence from cell culture, laboratory animal and small studies in the target species suggests that the combination of the specific PD properties of pimobendan may reduce the progression of myocardial damage in dogs with MVD and DCM when used together with other standard therapy.

Pharmacokinetic particulars

Absorption Following oral administration of Vetmedin capsules the absolute bioavailability of the active principle is 60 – 63%. Since this bioavailability is considerably reduced when pimobendan is administered with food or shortly thereafter, it is recommended to treat animals approximately 1 hour before feeding.

Distribution The volume of distribution is 2.61/kg, indicating that pimobendan is distributed readily into the tissues. The mean plasma protein binding is 93%

Metabolism The compound is oxidatively demethylated to its major active metabolite (UD-CG12). Further metabolic pathways are phase II conjugates of UD-CG 212, in essence glucuronides and sulphates.

Elimination The plasma elimination half-life of pimobendan is 0.4±0.1 hours which is consistent with a high clearance of 90±19 ml/min/kg and a short mean residence time of 0.5 ± 0.1hours.

The main active metabolite is eliminated with a plasma elimination half-life of 2.0 ± 0.3 hours. Almost the entire dose is eliminated via faeces.

Marketing authorisation number

Vm 00015/4050 Vetmedin 5 mg Capsules.

GTIN (Global Trade Item No)

Vetmedin 5 mg hard capsules

5012917025118