Vetmedin 2.5 mg Capsules (Canada)

Company: Boehringer Ingelheim Animal Health

Pimobendan capsules

For Dogs

1.25 mg DIN 02248211; 2.5 mg DIN 02248158; 5.0 mg DIN 02248159

Description

The active ingredient in Vetmedin^® is pimobendan.

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.

Pimobendan, a benzimidazole-pyridazinone derivative, is a nonsympathomimetic, non-glycoside inotropic drug with vasodilatory properties.

Therapeutic Class

Positive inotropic vasodilator

Indications: Dogs

1. 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).

2. To delay the time of onset of congestive heart failure or sudden death in Doberman Pinscher dogs with clinically asymptomatic dilated cardiomyopathy.

Clinically asymptomatic dilated cardiomyopathy is characterized by an increase in left ventricular end-systolic and end-diastolic diameter and should be diagnosed by means of a comprehensive cardiac examination (including echocardiographic examination and possibly Holter monitoring).

Vetmedin 2.5 mg Capsules 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 in dogs with pulmonary edema and/or ascites associated with congestive heart failure.

Contraindications

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).

Vetmedin 2.5 mg Capsules Caution

Cardiac arrhythmias may indicate 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. The safety in pregnant and lactating dogs has not been established. 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.

Warning: KEEP OUT OF REACH OF CHILDREN.

If poisoning occurs, contact a doctor or Poisons Information Center.

Adverse Reaction

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.

Clinical 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.

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.

Safety And Efficacy Study Information

The tolerance of pimobendan has been evaluated in pre-clinical studies in healthy Beagle dogs with non-diseased 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.

In a randomized, blinded placebo controlled study, 76 client-owned Doberman Pinschers were recruited at 10 centers in the UK, USA and Canada. The dogs had preclinical dilated cardiomyopathy (asymptomatic with an increase in left ventricular end-systolic and end-diastolic diameter following echocardiographic diagnosis). Dogs were allocated in a 1:1 ratio to receive pimobendan or a visually identical placebo. The primary endpoint was the time to onset of overt (clinical) dilated cardiomyopathy (DCM) defined as congestive heart failure or sudden death. The time to the onset of CHF or sudden death was statistically significantly improved in the pimobendan treated dogs compared with the placebo treated dogs (hazard ratio [HR] 0.319; 95% CI: 0.167 to 0.617; log rank test p=0.0088), corresponding to a 68.1% reduction in the risk of CHF or sudden death and an increase in the median time to onset of CHF or sudden death to 718 days for the pimobendan from 441 days for placebo. Additionally, in the first 20 to 56 days of up to a 5 year study dogs treated with pimobendan in the preclinical stage of dilated cardiomyopathy the median change (range) in LVIDS was -4 mm (-11.7 to 3mm) and LVIDD was -3.1 mm (-11.7 to 4mm). In the placebo treated dogs the median change in LVIDS was 0 mm (-7.8 to 5.5mm) and LVIDD was 0.8 mm (-6.6 to 6mm).

Storage Information

Store below 25 °C.

Keep the container tightly closed.

How Supplied

Vetmedin^® 1.25 mg capsules

Vetmedin^® 2.5 mg capsules.

Vetmedin^® 5.0 mg capsules.

Boehringer Ingelheim Animal Health Canada Inc., Burlington ON L7L 5H4

Revised: 2020-09

Vetmedin^® is a registered trademark of Boehringer Ingelheim Vetmedica GmbH, used under license.

600096807/CA/3

Presentation: 100 capsules.

CPN: 1182199.0