VETMEDIN- pimobendan tablet, chewable

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Boehringer Ingelheim Animal Health USA Inc.

INN:

PIMOBENDAN

composition:

PIMOBENDAN 1.25 mg

administration_route:

ORAL

prescription_type:

PRESCRIPTION

therapeutic_indication:

VETMEDIN (pimobendan) is indicated for the management of the signs of mild, moderate, or severe congestive heart failure in dogs due to clinical myxomatous mitral valve disease (MMVD) or dilated cardiomyopathy (DCM). VETMEDIN is indicated for use with concurrent therapy for congestive heart failure (e.g.,furosemide, etc.) as appropriate on a case-by-case basis. 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. 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 in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose. Only for use in dogs with clinical evidence of heart failure. At 3 and 5 times the recommended dosage, administered over a 6-month

leaflet_short:

VETMEDIN® (pimobendan) Chewable Tablets: Available as 1.25, 2.5, 5 and 10 mg oblong half-scored chewable tablets - 50 tablets per bottle. NDC 0010-4480-01 - 1.25 mg - 50 tablets NDC 0010-4482-01 - 5 mg - 50 tablets NDC 0010-4481-01 - 2.5 mg - 50 tablets NDC 0010-4479-01 - 10 mg - 50 tablets

authorization_status:

New Animal Drug Application

SPC

VETMEDIN- PIMOBENDAN TABLET, CHEWABLE
BOEHRINGER INGELHEIM ANIMAL HEALTH USA INC.
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VETMEDIN® (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.
DESCRIPTION:
VETMEDIN (pimobendan) is supplied as oblong half-scored chewable
tablets containing
1.25, 2.5, 5 or 10 mg pimobendan per tablet. Pimobendan, a
benzimidazole-pyridazinone
derivative, is a nonsympathomimetic, 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 (pimobendan) is indicated for the management of the signs of
mild,
moderate, or severe congestive heart failure in dogs due to clinical
myxomatous mitral
valve disease (MMVD) or dilated cardiomyopathy (DCM). VETMEDIN is
indicated for use
with concurrent therapy for congestive heart failure (e.g.,furosemide,
etc.) as
appropriate on a case-by-case basis.
DOSAGE AND ADMINISTRATION:
VETMEDIN 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 apart (i.e., morning and
evening). The tablets
are scored and the calculated dosage should be provided to the nearest
half tablet
increment.
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 f