Vetmedin: Product Information (Page 2 of 2)

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

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.

Principal Display Panel – 1.25 mg bottle label, 100 capsules

DIN 02248211

Vetmedin®

1.25 mg Pimobendan capsules

Veterinary Use Only

For dogs

Net: 100 capsules

Picture of 1.25 mg container label for Vetmedin Capsules
(click image for full-size original)

Principal Display Panel – 1.25 mg display carton, 100 capsules

DIN 02248211

Vetmedin®

1.25 mg Pimobendan capsules

Veterinary Use Only

For dogs

Net Contents: 100 capsules

Picture of the 1.25 mg display carton for Vetmedin Capsules
(click image for full-size original)

Principal Display Panel – 2.5 mg bottle label, 100 capsules

Picture of 2.5 mg container label for Vetmedin Capsules
(click image for full-size original)

Principal Display Panel – 2.5 mg display carton, 100 capsules

Picture of 2.5 mg display carton for Vetmedin Capsules
(click image for full-size original)

Principal Display Panel – 5 mg bottle label

DIN 02248159

Vetmedin®

5.0 mg Pimobendan capsules

Veterinary Use Only

For dogs

Net: 100 capsules

Picture of 5 mg bottle label for Vetmedin Capsules
(click image for full-size original)

Principal Display Panel – 5 mg display carton, 100 capsules

DIN 02248159

Vetmedin®

5.0 mg Pimobendan capsules

Veterinary Use Only

For dogs

Net: 100 capsules

Picture of 5 mg display carton for Vetmedin Capsules
(click image for full-size original)
VETMEDIN
pimobendan capsule
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:0010-4512
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PIMOBENDAN (PIMOBENDAN) PIMOBENDAN 1.25 mg
Product Characteristics
Color YELLOW (light yellow opaque/white opaque) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0010-4512-01 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 100 CAPSULE in 1 BOTTLE, PLASTIC This package is contained within the CARTON (0010-4512-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 02/23/2021
VETMEDIN
pimobendan capsule
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:0010-4518
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PIMOBENDAN (PIMOBENDAN) PIMOBENDAN 2.5 mg
Product Characteristics
Color ORANGE (brown-orange opaque/white opaque) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0010-4518-01 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 100 CAPSULE in 1 BOTTLE, PLASTIC This package is contained within the CARTON (0010-4518-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 02/23/2021
VETMEDIN
pimobendan capsule
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:0010-4513
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PIMOBENDAN (PIMOBENDAN) PIMOBENDAN 5 mg
Product Characteristics
Color ORANGE (medium orange opaque/white opaque) Score no score
Shape CAPSULE Size 20mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0010-4513-01 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 100 CAPSULE in 1 BOTTLE, PLASTIC This package is contained within the CARTON (0010-4513-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 02/23/2021
Labeler — Boehringer Ingelheim Animal Health USA Inc. (007134091)

Revised: 02/2021 Boehringer Ingelheim Animal Health USA Inc.

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