Target species
Dogs.
Indications for use for each target species
For the treatment of canine congestive heart failure originating from valvular insufficiency (mitral and/or tricuspid regurgitation) or dilated cardiomyopathy.
Contraindications
Do not use in cases of hypertrophic cardiomyopathies or diseases in which an improvement in cardiac output cannot be achieved for functional or anatomical reasons (e.g. aortic stenosis).
Since pimobendan is metabolised mainly via the liver, do not use in dogs with severe impairment of liver function. See also section "use during pregnancy, lactation or lay".
Special warnings
None.
Special precautions for use
Special precautions for safe use in the target species:
Blood glucose should be tested regularly during treatment in dogs with existing diabetes mellitus.
Monitoring of cardiac function and morphology is recommended in animals treated with pimobendan.
See also section "adverse events".
The tablets are flavoured. In order to avoid any accidental ingestion, store tablets out of reach of animals.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Wash hands after use.
To the physician: accidental ingestion, especially by a child, may lead to the occurrence of tachycardia, orthostatic hypotension, flushing of the face and headaches.
This veterinary medicinal product may cause cardiovascular effects in the event of accidental ingestion.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
Dogs:
Rare (1 to 10 animals / 10 000 animals treated): | Increased heart rate1,2, Increase in mitral valve regurgitation3 Vomiting2, Diarrhoea4 Anorexia4, Lethargy4 |
Very rare (<1 animal / 10 000 animals treated, including isolated reports): | Mucosa petechiae5, Haemorrhages (subcutaneous)5 |
1 Due to a slight positively chronotropic effect.
2 These effects are dose-dependent and can be avoided by reducing the dose.
3 Observed during chronic pimobendan treatment in dogs with mitral valve disease.
4 Transient.
5 A relationship with pimobendan has not been clearly established, signs disappear when the treatment is withdrawn.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Pregnancy and lactation:
Laboratory studies in rats and rabbits have not produced any evidence of teratogenic or foetotoxic effects. However, these studies have shown evidence of maternotoxic and embryotoxic effects at high doses, and have also shown that pimobendan is excreted into milk. The safety of the veterinary medicinal product has not been assessed in pregnant or nursing bitches. Use only according to the benefit-risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction
In pharmacological studies no interaction between the cardiac glycoside ouabain and pimobendan was detected. The pimobendan-induced increase in contractility of the heart is attenuated in the presence of the calcium antagonist verapamil and diltiazem and the β-antagonist propranolol.
Administration routes and dosage
Oral use.
To ensure a correct dosage, body weight should be determined as accurately as possible.
The tablets should be administered orally at a dose range of 0.2 mg to 0.6 mg pimobendan/kg body weight per day. The preferable daily dose is 0.5 mg pimobendan/kg body weight. The dose should be divided into two administrations (0.25 mg/kg body weight each), one half of the dose in the morning and the other half approximately 12 hours later. Each dose should be given approximately one hour before feeding.
Do not exceed the recommended dosage.
The veterinary medicinal product may be combined with a diuretic treatment such as furosemide.
To break a double scored tablet into quarters, place the tablet on an even surface with the scored side up and apply pressure on the middle with your thumb.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
An overdose may cause vomiting, a positive chronotropic effect, apathy, ataxia, heart murmurs or hypotension. In this situation, the dosage should be reduced and appropriate symptomatic treatment should be initiated.
In prolonged exposure (6 months) of healthy beagle dogs at 3 and 5 times the recommended dose, mitral valve thickening and left ventricular hypertrophy were observed in some dogs. These changes are of pharmacodynamic origin.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
Withdrawal periods
Not applicable