VETMEDIN^®-CA1 (pimobendan) Chewable Tablets

VETMEDIN^®-CA1 (pimobendan) Chewable Tablets are indicated for the delay of onset of congestive heart failure in dogs with Stage B2 preclinical myxomatous mitral valve disease (2019 American College of Veterinary Internal Medicine Consensus Statement¹).

It is a violation of Federal law to use VETMEDIN^®-CA1 other than as directed in the labeling. Conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-556. Adverse reactions not related to disease progression in dogs receiving VETMEDIN-CA1 included diarrhea, vomiting, pain, lameness, arthritis, urinary tract infection, and seizure.

The unique mode of action of VETMEDIN^®-CA1 (pimobendan) Chewable Tablets acts as both a positive inotrope and potent, balanced vasodilator, simultaneously dilating veins and arteries. In this form, the chew enters the GI tract and is rapidly dissolved and absorbed.

• Proprietary formulation ensures optimal bioavailability that in turn ensures optimal therapeutic effect

• Recommended by the American College of Veterinary Internal Medicine (Specialty of Cardiology) panel as part of first-line therapy in dogs diagnosed with Stage B2 myxomatous mitral valve disease (MMVD) to ensure optimal patient outcomes¹    

• Beef-flavored chewable tablet ensures high levels of acceptability that in turn promotes compliance^2,3

• Meets FDA standards of product safety, stability, and strength

VETMEDIN^®-CA1 (pimobendan) Chewable Tablets should be administered orally at a total daily dose of 0.23 mg/lb (0.5 mg/kg) body weight.

• The total daily dose should be divided into 2 portions that are not necessarily equal, and the portions should be administered approximately 12 hours apart (ie, morning and evening)

• Any suitable combination of whole or half tablets may be used

• The tablets are scored and the calculated dosage should be provided to the nearest half-tablet increment

Dosage Chart

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Please note: These examples given in the dosage chart do not necessarily depict the only way to provide the correct dose. Other combinations of whole and half tablets may also be appropriate.

Conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-556.

It is a violation of Federal law to use VETMEDIN-CA1 other than as directed in the labeling.

Contraindications: Do not administer VETMEDIN^®-CA1 (pimobendan) Chewable Tablets 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.

Do not administer VETMEDIN-CA1 to dogs with Stage A or B1 preclinical myxomatous mitral valve disease (MMDV) (2019 ACVIM Consensus Statement¹) due to the risk of cardiac pathology associated with exaggerated hemodynamic responses to VETMEDIN-CA1.

Warnings:

User Safety 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.

Animal Safety Warnings: Keep VETMEDIN-CA1 in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.

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 Target Animal Safety).

Precautions: For use only in dogs with preclinical MMVD that have a moderate or loud mitral murmur due to mitral regurgitation and cardiomegaly (Stage B2 MMVD, 2019 ACVIM Consensus Statement¹). A diagnosis of MMVD should be made by means of a comprehensive physical and cardiac examination, which should include radiography and echocardiography.

Stage B2 cardiomegaly is diagnosed based on meeting all three of the following criteria:

• Radiographic vertebral heart score (VHS) >10.5, and

• Echocardiographic left atrium/aorta ratio (LA/Ao ratio) ≥1.6, and

• Echocardiographic left ventricular internal diastolic diameter normalized to body weight (LVIDDN) ≥1.7.

Echocardiographic examination is recommended in all cases to diagnose MMVD and confirm cardiomegaly. If therapy is initiated prior to the development of cardiomegaly, treated dogs are at risk for cardiac pathology associated with exaggerated hemodynamic responses to VETMEDIN-CA1.

If only radiographic examination is possible, cardiomegaly may be diagnosed in cases where the VHS ≥11.5 and the vertebral left atrial size (VLAS) ≥3.0.^1,4 If radiographic cardiomegaly does not meet both of these criteria, an echocardiogram should be performed prior to the initiation of therapy with VETMEDIN-CA1.

VETMEDIN-CA1 has not been evaluated in dogs receiving concomitant heart medications.

The safety of VETMEDIN-CA1 has not been established in dogs with asymptomatic heart disease caused by etiologies other than MMVD. The safe use of VETMEDIN-CA1 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: The most common side effects seen in dogs with Stage B2 MMVD while taking VETMEDIN-CA1 Chewable Tablets are cough, vomiting, diarrhea, lethargy, and localized pain (such as in the neck or legs). Adverse reactions not related to disease progression in dogs receiving VETMEDIN-CA1 included diarrhea, vomiting, pain, lameness, arthritis, urinary tract infection, and seizure. 

For more information, please see full prescribing information.