Microsoft word - vetmedin 2.5 mg.doc

DIN 02248158

PrVetmedin®

2.5 mg capsules for dogs
2.5 mg pimobendan per capsule
Net Contents: 100 capsules
Veterinary Use Only

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

Pharmacology
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.
Following oral administration of Vetmedin® capsules, the absolute bioavailability of the active principle is
60–63%. Mean plasma protein binding is 93%. The plasma elimination half-life of pimobendan is
approximately 30 minutes and the main active metabolite elimination half-life is approximately 2 hours.
Almost the entire dose is eliminated via feces.
The tolerance of pimobendan has been evaluated in pre-clinical studies in healthy Beagle dogs with
nondiseased hearts. Daily intravenous administration of pimobendan at dosages of 0.5 mg/kg to 8.0 mg/kg
over a period of 2 to 4 weeks was associated with exaggerated myocardial contractility and jet lesions to
the myocardium. These intravenous dosages are equivalent to one-time oral dosages of 0.8 mg/kg to 12.8
mg/kg. Lesions were not seen at intravenous dosages of 0.25 mg/kg (equivalent to 0.4 mg/kg orally)
administered over a 2 to 4 week period.

Indications: Dogs
For the treatment of congestive heart failure originating from dilated cardiomyopathy or valvular
insufficiency. It is recommended that the diagnosis of congestive heart failure be confirmed by radiographs
or diuretic responsiveness.
Treatment should be initiated only in symptomatic cases which will benefit from increased myocardial
contractility (positive inotropy).

Dosage and administration
Vetmedin® capsules 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 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.
Vetmedin® capsules may be combined with a diuretic treatment such as furosemide.

Caution
Atrial fibrillation occurs commonly in cases of congestive heart failure and indicates a more guarded
prognosis. According to good veterinary practice, dogs with congestive heart failure should be monitored
for presence of arrhythmias during cardiac therapy. Appropriate anti-arrhythmic should be initiated if
indicated.

Contra-indications
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).
Use during pregnancy and lactation
In studies with rats and rabbits, pimobendan had no effect on fertility and embryotoxic effects only
occurred in maternotoxic doses. In rat experiments it has been shown that pimobendan is excreted into
milk.
Therefore, Vetmedin® capsules should only be administered to pregnant and lactating bitches if the
expected therapeutic benefits overweigh the potential risk.

Drug Interactions
There is always a risk of drug interactions when using multiple medications in a compromised or geriatric
patient. Use with caution with other positive inotropes. As pimobendan is highly protein bound, monitor
carefully if using other drugs with high protein binding. Concurrent use of beta blockers or calcium-
channel blockers may decrease pimobendan-induced effects on myocardial contractility.

Side Effects
Pimobendan administered as an overdose orally may result in profuse vomiting. Patients should be treated
symptomatically.
The following suspected adverse effects have been reported following clinical use.
Cardiovascular: Tachycardia (may be dose dependent and avoided by reducing the dose).
Gastrointestinal: Vomiting, diarrhea, inappetence.
Nervous system/Behavioural: Uneasiness, incoordination, convulsions.
Renal: Polyuria, polydypsia.

Warning: KEEP OUT OF REACH OF CHILDREN.
If poisoning occurs, contact a doctor or Poisons Information Center.
Storage: Store below 25°C. Keep the container tightly closed.
Presentations
Vetmedin® 1.25 mg capsule contains 1.25 mg pimobendan.
Vetmedin® 2.5 mg capsule contains 2.5 mg pimobendan.
Vetmedin® 5.0 mg capsule contains 5.0 mg pimobendan.
Boehringer Ingelheim (Canada) Ltd.
Burlington, Ontario L7L 5H4
Black
60004058/CA/1

Source: ftp://ftpvet:[email protected]/vetcatalog/759.pdf