Regulatory product record
VETMEDIN
Product identity, ingredients and source provenance from the regulatory catalogue. Linked clinical evidence has a separate review status.
Owner information handout
Plain-language medication information to review with the owner. Open the handout to print it or download a PDF.
Product identity
- Brand name
- VETMEDIN
- DIN
- 02248211
- DPD drug code
- 72547
- Regulatory category
- APPROVED_VET_DRUG
- Market status
- MARKETED
- Route(s)
- ORAL
- Pharmaceutical form(s)
- CAPSULE
- Ingredients
- PIMOBENDAN (1.25 MG)
- Species (DPD record)
- DOGS
- Company
- BOEHRINGER INGELHEIM ANIMAL HEALTH CANADA INC. (DIN owner)
Source and provenance
- Source dataset
- health_canada_dpd_marketed
- Source snapshot date
- Not available in this source
- Source record key
- 72547
- Archive fingerprint (SHA-256)
- 85cc3ce208af3aa57018c3d14d83f90220c436baef7455384b6d48d9774e1c88
Linked clinical reference
Clinical entries are linked through the active molecule. Check their species, formulation, source and review status separately from this product record.
Clinical evidence
Pending clinical review (PROPOSED)Rule-based (RULE_BASED)— applies to the facts and dose entries in this species selection; individual source records retain their own status.
Indications3
CHF from DCM or myxomatous mitral valve disease (MMVD)
DogOn-label (ON_LABEL)1 source record · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 977–979; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 638–640 — Indications table · Not applicable · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Original excerpt: CHF from DCM or myxomatous mitral valve disease (MMVD) — Authorized (FDA)
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 977–979; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 638–640 — Indications table · Not applicable · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Heart failure from DCM (not HCM)
CatExtra-label (EXTRA_LABEL)1 source record · View provenance
- Cat · Plumb's Veterinary Drug Handbook, 7th ed., p. 977–979; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 638–640 — Indications table · Not applicable · Extra-label (EXTRA_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Original excerpt: Heart failure from DCM (not HCM) — Extra-label, limited data
- Cat · Plumb's Veterinary Drug Handbook, 7th ed., p. 977–979; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 638–640 — Indications table · Not applicable · Extra-label (EXTRA_LABEL) · Pending clinical review (PROPOSED) · Rule-based
VETMEDIN Solution (pimobendan oral solution) is indicated for the delay of onset of congestive heart failure in dogs with Stage B2 preclinical myxomatous mitral valve disease. 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. VETMEDIN Solution (pimobendan oral solution) is indicated for the management of the signs of mild, moderate, or severe congestive heart failure (CHF) in dogs due to clinical MMVD or dilated cardiomyopathy (DCM). VETMEDIN Solution is indicated for use with concurrent therapy for congestive heart failure (e.g., furosemide, etc.) as appropriate on a case-by-case basis.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34067-9 (INDICATIONS & USAGE SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Dose regimens4
This calculator performs arithmetic only on the sourced dosing field shown for each result — it does not verify the field's accuracy, does not select which field to use for a patient, and does not replace a veterinarian's order. Not for clinical use. Confirm every result against the primary source before dispensing.
Select a species above to calculate a dose.
Adverse effects205
Poor appetite, lethargy, diarrhea — Common in field trials (30–38%)
DogNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 977–979; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 638–640 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Arrhythmias (atrial fibrillation, VPCs) — Uncommon, causation vs. underlying disease unclear
DogNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 977–979; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 638–640 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Worsening mitral valve lesions (in one comparative study vs benazepril) — Reported — recommend regular monitoring
DogNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 977–979; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 638–640 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Clinical Pharmacology The safety and effectiveness of VETMEDIN Solution was established by demonstrating bioequivalence with VETMEDIN Chewable Tablets. (See). Pre-Approval Experience in Stage B2 Preclinical MMVD: Clinical findings/adverse reactions were recorded in two multi-site field studies of dogs diagnosed with Stage B2 preclinical MMVD. Study 1 : In the first study, 363 dogs with Stage B2 preclinical MMVD received at least one dose of VETMEDIN (n=182) or the vehicle control chewable tablets (n=181). Dogs were followed until the development of left-sided CHF, cardiac-related death or euthanasia, or until the end of the study (up to 3 years). Adverse reactions were seen in both treatment groups with many findings associated with MMVD and comorbidities consistent with the age of the enrolled dogs. Cough was the most frequently reported adverse reaction in this study. This clinical finding is commonly reported in cases of MMVD, and the incidence was similar between treatment groups. Gastrointestinal upset (vomiting and diarrhea) was the most frequently reported non-cardiac adverse reaction associated with VETMEDIN. Mortality rate, regardless of reason, prior to CHF was similar between the VETMEDIN and the control groups. a Table 1: Cardiac Related Adverse Reactions(Study 1) Table 2: Non-cardiac Adverse Reactions (Study 1) a These adverse reactions are commonly associated with cardiac disease, although some cases may have non-cardiac causes. b Most cases of collapse, syncope, and seizure were reported by the owner. These clinical signs can be difficult to differentiate. Study 2: In the second study, 161 dogs with Stage B2 preclinical MMVD were treated with at least one dose of VETMEDIN. All enrolled dogs were treated with VETMEDIN. The dogs were followed for up to 1 year (365 days), or until the development of left-sided CHF, malignant arrhythmias, syncope, advanced coughing, increased resting respiration rate (RRR), or death. Adverse reactions identified in this study were similar to the first study with many findings associated with MMVD and age-related comorbidities. Cough was the most frequently reported cardiac related adverse reaction and gastrointestinal upset (vomiting and diarrhea) was the most frequently reported non-cardiac adverse reaction associated with VETMEDIN. Chordae tendineae rupture occurred in 3 dogs receiving VETMEDIN in Study 2, resulting in the euthanasia of one dog. In Study 1, chordae tendineae rupture was observed in 3 control dogs and in 0 VETMEDIN-treated dogs. In Study 2, 14 VETMEDIN-treated dogs died or were euthanized by Day 365; 8 for cardiac related reasons and 6 for reasons unrelated to MMVD or treatment with VETMEDIN. a Table 3: Cardiac Related Adverse Reactions(Study 2) Table 4: Non-cardiac Adverse Reactions (Study 2) a These adverse reactions are commonly associated with cardiac disease, although some cases may have non-cardiac causes. b Most cases of collapse, syncope, and seizure were reported by the owner. These clinical signs can be difficult to differentiate. Pre-Approval Experience in Clinical MMVD or DCM: Effectiveness In a separate study, clinical findings/adverse reactions were recorded in a 56-day field study of dogs with CHF due to MMVD (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 (Seefor details and the difference in digoxin administration between treatment groups). The VETMEDIN group had the following incidence (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). Incidence was similar in the active control group. The incidence of renal failure was higher in the active control group (4%) compared to the VETMEDIN group (1%). Table 5: Adverse Reactions (Clinical MMVD or DCM) 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. See Table 6 for mortality due to CHF (including euthanasia, natural death, and sudden death… [truncated]
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34084-4 (ADVERSE REACTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
To report suspected adverse reactions, to obtain a Safety Data Sheet (SDS), or for technical assistance, contact Boehringer Ingelheim Animal Health USA Inc. at 1-888-637-4251. For additional information about adverse drug experience reporting for animal drugs, contact the FDA at 1-888-FDA-VETS or at www.fda.gov/reportanimalae.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34084-4 (ADVERSE REACTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
These are counts of spontaneously reported events, not proven adverse effects, causal relationships, or incidence rates.
Bars compare report counts within each species; they do not show incidence.
More reportsFewer reportsDog
- Vomiting899 reports
- Diarrhoea832 reports
- Lethargy (see also Central nervous system depression in 'Neurological')445 reports
- Cough407 reports
- Death393 reports
- Anorexia357 reports
- Death by euthanasia352 reports
- Seizure NOS229 reports
- Lethargy (see also Central nervous system depression in Neurological)220 reports
- Lack of efficacy - NOS211 reports
- Elevated blood urea nitrogen (BUN)208 reports
- Decreased appetite205 reports
Cat
- Vomiting31 reports
- Anorexia20 reports
- Death by euthanasia20 reports
- Death16 reports
- Accidental exposure14 reports
- Dyspnoea11 reports
- Weight loss11 reports
- Pleural effusion10 reports
- Tachycardia10 reports
- Lethargy (see also Central nervous system depression in 'Neurological')9 reports
- Depression7 reports
- Diarrhoea6 reports
Monitoring1
ECG (rate/rhythm), blood pressure, echocardiogram, clinical signs
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 977–979; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 638–640 — Monitoring Parameters · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Contraindications2
Hypertrophic cardiomyopathy, aortic stenosis, or any condition where increased cardiac output is functionally/anatomically inappropriate
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 977–979; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 638–640 — Contraindications & Warnings table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Do not administer VETMEDIN Solution 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 Solution to dogs with Stage A or B1 preclinical MMVD due to the risk of cardiac pathology associated with exaggerated hemodynamic responses to VETMEDIN Solution.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34070-3 (CONTRAINDICATIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Precautions6
Uncontrolled arrhythmias; not evaluated <6 months age, congenital heart defects, diabetes, breeding/pregnant/lactating
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 977–979; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 638–640 — Contraindications & Warnings table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Give ~1 hour before feeding — food affects absorption and label directs empty-stomach dosing.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 977–979; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 638–640 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Never use in cats with HCM — positive inotropy is contraindicated in obstructive/hypertrophic disease; only appropriate for feline DCM.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 977–979; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 638–640 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Considered essential first-line therapy (often alongside an ACE inhibitor) for canine DCM and MMVD-associated CHF — improves both survival and quality of life per QUEST study data.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 977–979; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 638–640 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
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. Wash hands after use. This product may cause eye irritation. Avoid contact with eyes. In case of contact, flush affected eye(s) immediately and thoroughly with water. If wearing contact lenses, flush the eyes first with water and then remove the lens(es) and continue to flush thoroughly with water. If eye irritation continues, seek medical advice and provide this product information to the physician. Exposure to product may induce a local or systemic allergic reaction in sensitized individuals. Animal Safety Warnings: Target Animal Safety Only for use in dogs with Stage B2 preclinical MMVD or clinical evidence of CHF. 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). Keep VETMEDIN Solution in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34071-1 (WARNINGS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Interactions2
Verapamil, propranolol (and by extension diltiazem, atenolol) — May attenuate pimobendan's positive inotropic effect
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 977–979; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 638–640 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Labeled as safe with — Furosemide, digoxin, enalapril, atenolol, nitroglycerin, hydralazine, diltiazem, antiparasitics, antibiotics, famotidine, theophylline, levothyroxine
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 977–979; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 638–640 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Pharmacokinetics7
Bioavailability — Food-dependent — reduced by food (aqueous solution data); pH-dependent absorption
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 977–979; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 638–640 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Protein binding — >90%
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 977–979; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 638–640 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Half-life — ~0.5h parent / ~2h active metabolite (dog)
DogCatNot applicable (NOT_APPLICABLE)2 source records · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 977–979; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 638–640 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
- Cat · Plumb's Veterinary Drug Handbook, 7th ed., p. 977–979; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 638–640 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Metabolism — Oxidative demethylation → active metabolite
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 977–979; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 638–640 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Elimination — Mainly fecal
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 977–979; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 638–640 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Pregnancy / lactation considerations1
Not evaluated in breeding/pregnant/lactating dogs (label). High-dose (300 mg/kg) rat studies showed increased resorptions; rabbits at 100 mg/kg showed no fetal effects.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 977–979; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 638–640 — Pregnancy & Lactation · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Literature references14
References are linked to this drug. Species applicability is not recorded here, so the species filter does not narrow this list. Imported dates do not retain their original precision; confirm dates in the original citation.
- Canine radiography and echocardiography sensor fusion for deep learning-based detection and classification of myxomatous mitral valve disease.
Study summary not available in the imported record. Open the original citation to review the study.
- From prototype to veterinary patient: a pharmacokinetic clinical trial of 3D-printed pimobendan tablets in beagle dogs.
Study summary not available in the imported record. Open the original citation to review the study.
- Case Report: Bexagliflozin as an adjunct decongestive strategy in a cat with congestive heart failure and advanced chronic kidney disease.
Study summary not available in the imported record. Open the original citation to review the study.
- Use of pimobendan in cats: a practical evidence-based review.
Study summary not available in the imported record. Open the original citation to review the study.
- Oral administration of pimobendan in healthy horses results in low plasma concentrations.
Study summary not available in the imported record. Open the original citation to review the study.
Sources: DailyMed, U.S. National Library of Medicine; PubMed, National Library of Medicine; openFDA, U.S. Food and Drug Administration; Plumb DC. Plumb's Veterinary Drug Handbook. 7th ed. PharmaVet Inc; 2011.