VETMEDIN-CA1- pimobendan tablet, chewable

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PIMOBENDAN (UNII: 34AP3BBP9T) (PIMOBENDAN - UNII:34AP3BBP9T)

Available from:

Boehringer Ingelheim Animal Health USA Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

VETMEDIN-CA1 (pimobendan) is indicated for the delay of onset of congestive heart failure in dogs with Stage B2 preclinical myxomatous mitral valve disease (2019 ACVIM Consensus Statement1 ). Stage B2 preclinical myxomatous mitral valve disease (MMVD) refers to dogs with asymptomatic MMVD that have a moderate or loud mitral murmur due to mitral regurgitation and cardiomegaly. Do not administer VETMEDIN-CA1 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 MMVD (2019 ACVIM Consensus Statement) due to the risk of cardiac pathology associated with exaggerated hemodynamic responses to VETMEDIN-CA1.

Product summary:

VETMEDIN®-CA1 (pimobendan) Chewable Tablets: Available as 1.25 and 5 mg oblong half-scored chewable tablets - 50 tablets per bottle. NDC 0010-4610-01 - 1.25 mg - 50 tablets NDC 0010-4612-01 - 5 mg - 50 tablets

Authorization status:

Conditional New Animal Drug Application

Summary of Product characteristics

VETMEDIN-CA1- PIMOBENDAN TABLET, CHEWABLE
BOEHRINGER INGELHEIM ANIMAL HEALTH USA INC.
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VETMEDIN®-CA1 (PIMOBENDAN)
CHEWABLE TABLETS
Cardiac drug for oral use in dogs only
CAUTION:
Federal law restricts this drug to use by or on the order of a
licensed veterinarian. Use
only as directed.
IT IS A VIOLATION OF FEDERAL LAW TO USE THIS PRODUCT OTHER THAN AS
DIRECTED IN
THE LABELING.
CONDITIONALLY APPROVED BY FDA PENDING A FULL DEMONSTRATION OF
EFFECTIVENESS
UNDER APPLICATION NUMBER 141-556.
DESCRIPTION:
VETMEDIN-CA1 (pimobendan) is supplied as oblong half-scored chewable
tablets
containing 1.25 or 5 mg pimobendan per tablet. Pimobendan, a
benzimidazole-
pyridazinone derivative, is a non-sympathomimetic, non-glycoside
inotropic drug with
vasodilatative properties. Pimobendan exerts a stimulatory myocardial
effect by a dual
mechanism of action consisting of an increase in calcium sensitivity
of cardiac
myofilaments and inhibition of phosphodiesterase (Type III).
Pimobendan exhibits
vasodilating activity by inhibiting phosphodiesterase III activity.
The chemical name of
pimobendan is
4,5-dihydro-6-[2-(4-methoxyphenyl)-1H-benzimidazole-5-yl]-5-methyl-
3(2H)-pyridazinone. The structural formula of pimobendan is:
INDICATIONS:
VETMEDIN-CA1 (pimobendan) is indicated for the delay of onset of
congestive heart
failure in dogs with Stage B2 preclinical myxomatous mitral valve
disease (2019 ACVIM
Consensus Statement ).
Stage B2 preclinical myxomatous mitral valve disease (MMVD) refers to
dogs with
asymptomatic MMVD that have a moderate or loud mitral murmur due to
mitral
regurgitation and cardiomegaly.
1
DOSAGE AND ADMINISTRATION:
ALWAYS PROVIDE THE CLIENT INFORMATION SHEET TO THE DOG OWNER WITH EACH
PRESCRIPTION. VETMEDIN-CA1 should be administered orally at a total
daily dose of 0.23
mg/lb (0.5 mg/kg) body weight, using a suitable combination of whole
or half tablets. The
total daily dose should be divided into 2 portions that are not
necessarily equal, and the
portions should be administered approximately 12 hours ap