REST ASSURED -
VETMEDIN can be prescribed with confidence

Safety and administration

Veterinarians around the world have demonstrated VETMEDIN to be safe and effective for over 15 years. VETMEDIN was first licensed in 1999 in Europe for use in dogs with CHF.¹

Rigorous licensing and toxicity studies demonstrated the excellent safety profile of VETMEDIN.² In addition, the extensive VetSCOPE³ and QUEST^4,5 clinical trials assure veterinarians of VETMEDIN safety for use in dogs with congestive heart failure (CHF).

VETMEDIN also offers convenient, easy administration to help ensure client compliance and best results in patients. Packaged in 50-count bottles, VETMEDIN Chewable Tablets are scored and highly palatable. This convenience and ease of administration helps ensure client and patient compliance for best possible results.

Caution:
Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Contraindications:
VETMEDIN should not be given in cases of hypertrophic cardiomyopathy, aortic stenosis, or any other clinical condition where an augmentation of cardiac output is inappropriate for functional or anatomical reasons.

Warnings:
Only for use in dogs with clinical evidence of heart failure. At 3 and 5 times the recommended dosage, administered over a 6-month period of time, pimobendan caused an exaggerated hemodynamic response in the normal dog heart, which was associated with cardiac pathology (See Animal Safety).

Human Warnings:
Not for use in humans. Keep this and all medications out of reach of children. Consult a physician in case of accidental ingestion by humans.

Precautions:
The safety of VETMEDIN has not been established in dogs with asymptomatic heart disease or in heart failure caused by etiologies other than AVVI or DCM. The safe use of VETMEDIN has not been evaluated in dogs younger than 6 months of age, dogs with congenital heart defects, dogs with diabetes mellitus or other serious metabolic diseases, dogs used for breeding, or pregnant or lactating bitches.

Adverse Reactions:
Clinical findings/adverse reactions were recorded in a 56-day field study of dogs with congestive heart failure (CHF) due to AVVI (256 dogs) or DCM (99 dogs). Dogs were treated with either VETMEDIN (175 dogs) or the active control enalapril maleate (180 dogs). Dogs in both treatment groups received additional background cardiac therapy (See Effectiveness for details and the difference in digoxin administration between treatment groups).

The VETMEDIN group had the following prevalence (percent of dogs with at least one occurrence) of common adverse reactions/new clinical findings (not present in a dog prior to beginning study treatments):

• Poor appetite (38%)
• Lethargy (33%)
• Diarrhea (30%)
• Dyspnea (29%)
• Azotemia (14%)
• Weakness and ataxia (13%)
• Pleural effusion (10%)
• Syncope (9%)
• Cough (7%)
• Sudden death (6%)
• Ascites (6%)
• Heart murmur (3%)

Prevalence was similar in the active control group. The prevalence of renal failure was higher in the active control group (4%) compared to the VETMEDIN group (1%).

Adverse reactions/new clinical findings were seen in both treatment groups and were potentially related to CHF, the therapy of CHF, or both. The following adverse reactions/new clinical findings are listed according to body system and are not in order of prevalence: CHF death, sudden death, chordae tendineae rupture, left atrial tear, arrhythmias overall, tachycardia, syncope, weak pulses, irregular pulses, increased pulmonary edema, dyspnea, increased respiratory rate, coughing, gagging, pleural effusion, ascites, hepatic congestion, decreased appetite, vomiting, diarrhea, melena, weight loss, lethargy, depression, weakness, collapse, shaking, trembling, ataxia, seizures, restlessness, agitation, pruritus, increased water consumption, increased urination, urinary accidents, azotemia, dehydration, abnormal serum electrolyte, protein, and glucose values, mild increases in serum hepatic enzyme levels, and mildly decreased platelet counts.

Important safety information from foreign study

In foreign, post-approval drug experience reporting, the following additional suspected adverse reactions were reported in dogs treated with a capsule formulation of VETMEDIN:

• Hemorrhage
• Petechia
• Anemia
• Hyperactivity
• Excited behavior
• Erythema
• Rash
• Drooling
• Constipation
• Diabetes mellitus

In the QUEST trial, VETMEDIN appeared to be well tolerated with a low number of adverse events. Observed adverse events in both the VETMEDIN (n=18) and ACE inhibitor (n=17) groups were very similar. Gastrointestinal disorders were most common (n=6 and 4, respectively), followed by abnormal behavior, such as lethargy, confusion, or uneasiness (n=3 and 4, respectively). Three dogs treated with VETMEDIN were reported to have had a seizure.

Animal safety

In a laboratory study, VETMEDIN Chewable Tablets were administered to 6 healthy Beagles per treatment group at 0 (control), 1, 3, and 5 times the recommended dosage for 6 months. See Table 3 for cardiac pathology results. The cardiac pathology/histopathology noted in the 3X and 5X dose groups is typical of positive inotropic and vasodilator drug toxicity in normal dog hearts, and is associated with exaggerated hemodynamic responses to these drugs. None of the dogs developed signs of heart failure and there was no mortality.