Pimobendan

Vetmedin® 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. For the management of the signs of mild, moderate, or severe congestive heart failure in dogs due to clinical MMVD or dilated cardiomyopathy (DCM); for use with concurrent therapy for congestive heart failure (e.g., furosemide, etc.) as appropriate on a case-by-case basis.

Vetmedin®

For the delay of onset of congestive heart failure (CHF) in dogs with Stage B2 preclinical myxomatous mitral valve disease (MMVD). Stage B2 preclinical MMVD refers to dogs with asymptomatic MMVD that have a moderate or loud mitral murmur due to mitral regurgitation and cardiomegaly. For the management of the signs of mild, moderate, or severe CHF in dogs due to clinical MMVD or dilated cardiomyopathy (DCM). For use with concurrent therapy for CHF (e.g., furosemide, etc.) as appropriate on a case-by-case basis.

Vetmedin® Solution

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); for use with concurrent therapy for congestive heart failure (e.g., furosemide, etc.) as appropriate on a case-by-case basis.

Pimobendan Chewable Tablets

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.

Vetmedin® Solution(pimobendan oral solution)

VETMEDIN (pimobendan) 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 (pimobendan) 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 is indicated for use with concurrent therapy for congestive heart failure (e.g., furosemide, etc.) as appropriate on a case-by-case basis.

Vetmedin® (pimobendan) Chewable Tablets

Pimobendan Chewable Tablets are indicated for the management of the signs of mild, moderate, or severe congestive heart failure (CHF) in dogs due to clinical myxomatous mitral valve disease (MMVD) or dilated cardiomyopathy (DCM). Pimobendan Chewable Tablets are indicated for use with concurrent therapy for congestive heart failure (e.g., furosemide, etc.) as appropriate on a case-by-case basis.

Pimobendan Chewable Tablets

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.

Vetmedin®-CA1 (pimobendan)Chewable Tablets

CaniBendan™ is indicated for the management of the signs of mild, moderate, or severe congestive heart failure (CHF) in dogs due to clinical myxomatous mitral valve disease (MMVD) or dilated cardiomyopathy (DCM). CaniBendan™ is indicated for use with concurrent therapy for congestive heart failure (e.g., furosemide, etc.) as appropriate on a case-by-case basis.

VET OneCaniBendan™(pimobendan chewable tablets)

Pimobendan is oxidatively demethylated to a pharmacologically active metabolite which is then conjugated with sulfate or glucuronic acid and excreted mainly via feces. The mean extent of protein binding of pimobendan and the active metabolite in dog plasma is >90%. Following a single oral administration of 0.25 mg/kg pimobendan tablets the maximal mean (± 1 SD) plasma concentrations (Cmax) of pimobendan and the active metabolite were 3.09 (0.76) ng/mL and 3.66 (1.21) ng/mL, respectively. Individual dog Cmax values for pimobendan and the active metabolite were observed 1 to 4 hours post-dose (mean: 2 and 3 hours, respectively). The total body clearance of pimobendan was approximately 90 mL/min/kg, and the terminal elimination half-lives of pimobendan and the active metabolite were approximately 0.5 hours and 2 hours, respectively. Plasma levels of pimobendan and active metabolite were below quantifiable levels by 4 and 8 hours after oral administration, respectively. The steady-state volume of distribution of pimobendan is 2.6 L/kg indicating that the drug is readily distributed into tissues. Food decreased the bioavailability of an aqueous solution of pimobendan, but the effect of food on the absorption of pimobendan from pimobendan tablets is unknown. In normal dogs instrumented with left ventricular (LV) pressure transducers, pimobendan increased LV dP/dtmax (a measure of contractility of the heart) in a dose dependent manner between 0.1 and 0.5 mg/kg orally. The effect was still present 8 hours after dosing. There was a delay between peak blood levels of pimobendan and active metabolite and the maximum physiologic response (peak LV dP/dtmax). Blood levels of pimobendan and active metabolite began to drop before maximum contractility was seen. Repeated oral administration of pimobendan did not result in evidence of tachyphylaxis (decreased positive inotropic effect) or drug accumulation (increased positive inotropic effect). Laboratory studies indicate that the positive inotropic effect of pimobendan may be attenuated by the concurrent use of a β-adrenergic blocker or a calcium channel blocker.

Pimobendan Chewable Tablets

Pimobendan is oxidatively demethylated to a pharmacologically active metabolite which is then conjugated with sulfate or glucuronic acid and excreted mainly via feces. The mean extent of protein binding of pimobendan and the active metabolite in dog plasma is >90%. Following a single oral administration of 0.25 mg/kg VETMEDIN-CA1, the maximal mean (± 1 SD) plasma concentrations (Cmax) of pimobendan and the active metabolite were 3.09 (0.76) ng/mL and 3.66 (1.21) ng/mL, respectively. Individual dog Cmax values for pimobendan and the active metabolite were observed 1 to 4 hours post-dose (mean: 2 and 3 hours, respectively). The total body clearance of pimobendan was approximately 90 mL/min/kg, and the terminal elimination half-lives of pimobendan and the active metabolite were approximately 0.5 hours and 2 hours, respectively. Plasma levels of pimobendan and active metabolite were below quantifiable levels by 4 and 8 hours after oral administration, respectively. The steady-state volume of distribution of pimobendan is 2.6 L/kg indicating that the drug is readily distributed into tissues. Food decreased the bioavailability of an aqueous solution of pimobendan, but the effect of food on the absorption of pimobendan from VETMEDIN-CA1 is unknown. In normal dogs instrumented with left ventricular (LV) pressure transducers, pimobendan increased LV dP/dtmax (a measure of contractility of the heart) in a dose dependent manner between 0.1 and 0.5 mg/kg orally. The effect was still present 8 hours after dosing. There was a delay between peak blood levels of pimobendan and active metabolite and the maximum physiologic response (peak LV dP/dtmax). Blood levels of pimobendan and active metabolite began to drop before maximum contractility was seen. Repeated oral administration of pimobendan did not result in evidence of tachyphylaxis (decreased positive inotropic effect) or drug accumulation (increased positive inotropic effect). Laboratory studies indicate that the positive inotropic effect of pimobendan may be attenuated by the concurrent use of a β-adrenergic blocker or a calcium channel blocker.

Vetmedin®-CA1 (pimobendan)Chewable Tablets

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.

Vetmedin®-CA1 (pimobendan)Chewable Tablets

Do not administer 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.

Pimobendan Chewable Tablets

Do not administer CaniBendan™ 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.

VET OneCaniBendan™(pimobendan chewable tablets)

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

Vetmedin® Solution(pimobendan oral solution)

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

Vetmedin® (pimobendan) Chewable Tablets

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: Only for use in dogs with 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: Target Animal Safety). Keep Pimobendan Chewable Tablets in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.

Pimobendan Chewable Tablets

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).

Vetmedin®-CA1 (pimobendan)Chewable Tablets

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. Table 1: Cardiac Related Adverse Reactionsa (Study 1) Adverse Reaction VETMEDIN Group (n=182) Vehicle Control (n=181) Cough 39 (21.4%) 42 (23.2%) Lethargy 16 (8.8%) 13 (7.2%) Inappetence 14 (7.7%) 13 (7.2%) Tachypnea/panting 13 (7.1%) 12 (6.6%) Arrhythmia 7 (3.9%) 3 (1.7%) Collapseb 4 (2.2%) 2 (1.1%) Dyspnea 4 (2.2%) 3 (1.7%) Syncopeb 0 (0.0%) 5 (2.8%) Table 2: Non-cardiac Adverse Reactions (Study 1) Adverse Reaction VETMEDIN Group (n=182) Vehicle Control (n=181) Musculoskeletal pain 24 (13.2%) 12 (6.6%) Diarrhea 21 (11.5%) 16 (8.8%) Vomiting 18 (9.9%) 24 (13.3%) Seizureb 7 (3.8%) 2 (1.1%) Pruritus 7 (3.9%) 3 (1.7%) Lameness 7 (3.9%) 3 (1.7%) Urinary tract infection 7 (3.9%) 2 (1.1%) Restlessness 4 (2.2%) 0 (0%) 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. Table 3: Cardiac Related Adverse Reactionsa (Study 2) Adverse Reaction VETMEDIN (n=161) Cough 48 (29.8%) Inappetence 30 (18.6%) Lethargy 25 (15.5%) Tachypnea/panting 17 (10.6%) Arrhythmia 13 (8.1%) Dyspnea 6 (3.7%) Syncopeb 5 (3.1%) Collapseb 2 (1.2%) Table 4: Non-cardiac Adverse Reactions (Study 2) Adverse Reaction VETMEDIN (n=161) Vomiting 59 (36.6%) Diarrhea 53 (32.9%) Musculoskeletal pain 12 (7.5%) Lameness 10 (6.2%) Dermal mass 9 (5.6%) Polydipsia 9 (5.6%) Pruritus 7 (4.3%) Polyuria 6 (3.7%) Urinary tract infection 6 (3.7%) Restlessness 4 (2.5%) Seizureb 3 (1.9%) 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: 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 (See Effectiveness for 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 Reaction VETMEDIN (n=175) Poor appetite 67 (38%) Lethargy 58 (33%) Diarrhea 53 (30%) Dyspnea 51 (29%) Azotemia 25 (14%) Weakness/ataxia 23 (13%) Pleural effusion 18 (10%) Syncope 16 (9%) Cough 12 (7%) Sudden death 11 (6%) Ascites 11 (6%) Heart Murmur 5 (3%) 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) and for the development of new arrhythmias (not present in a dog prior to beginning study treatments) by treatment group and type of heart disease (MMVD or DCM) in the 56-day field study. Table 6: CHF Death and New Arrhythmias in the 56-Day Field Study VETMEDIN Group Active Control Group Dogs that died due to CHF 14.3% n = 175 14.4% n = 180 9 of 126 dogs with MMVD 16 of 130 dogs with MMVD 16 of 49 dogs with DCM 10 of 50 dogs with DCM Dogs that developed new arrhythmias a 39.4% n = 175 45.0% n = 180 45 of 126 dogs with MMVD 59 of 130 dogs with MMVD 24 of 49 dogs with DCM 22 of 50 dogs with DCM a New arrhythmias included supraventricular premature beats and tachycardia, atrial fibrillation, atrioventricular block, sinus bradycardia, ventricular premature beats and tachycardia, and bundle branch block. Following the 56-day masked field study, 137 dogs in the VETMEDIN group were allowed to continue on VETMEDIN in an open-label extended-use study without restrictions on concurrent therapy. The adverse reactions/new clinical findings in the extended-use study were consistent with those reported in the 56-day study, with the following exception: One dog in the extended-use study developed acute cholestatic liver failure after 140 days on VETMEDIN and furosemide. Post-Approval Experience (2023): The following adverse events are based on post-approval adverse drug experience reporting for VETMEDIN. Not all adverse events are reported to FDA/CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data. The following adverse events reported in dogs, are listed in decreasing order of reporting frequency: Diarrhea, lethargy, anorexia, emesis, cough, tachycardia, ataxia, dyspnea, convulsion, elevated liver enzymes (ALT, ALP), increased BUN and/or creatinine, tremors, hyperactivity, pruritus, syncope, allergic reactions (including allergic edema/facial edema, erythema, and hives), hypotension, hypertension, coagulation abnormalities (including thrombocytopenia, hemorrhage and petechia), and hyperglycemia (with or without diabetes mellitus). Death has been reported in some cases. Contact Information: 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.

Vetmedin® (pimobendan) Chewable Tablets

Pre-Approval Experience in Clinical MMVD or DCM: 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 pimobendan (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 pimobendan 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 pimobendan group (1 %). Table 1: Adverse Reactions (Clinical MMVD or DCM) Adverse Reaction Pimobendan (n=175) Poor appetite 67 (38%) Lethargy 58 (33%) Diarrhea 53 (30%) Dyspnea 51 (29%) Azotemia 25 (14%) Weakness/ataxia 23(13%) Pleural effusion 18 (10%) Syncope 16 (9%) Cough 12 (7%) Sudden death 11 (6%) Ascites 11 (6%) Heart Murmur 5 (3%) 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 2 for mortality due to CHF (including euthanasia, natural death, and sudden death) and for the development of new arrhythmias (not present in a dog prior to beginning study treatments) by treatment group and type of heart disease (MMVD or DCM) in the 56-day field study. Table 2: CHF Death and New Arrhythmias in the 56-Day Field Study Dogs that died due to CHF Pimobendan Group Active Control Group 14.3% n = 175 14.4% n = 180 9 of 126 dogs with MMVD 16 of 130 dogs with MMVD 16 of 49 dogs with DCM 10 of 50 dogs with DCM Dogs that developed new arrhythmiasa 39.4% n = 175 45.0% n = 180 45 of 126 dogs with MMVD 59 of 130 dogs with MMVD 24 of 49 dogs with DCM 22 of 50 dogs with DCM a New arrhythmias included supraventricular premature beats and tachycardia, atrial fibrillation, atrioventricular block, sinus bradycardia, ventricular premature beats and tachycardia, and bundle branch block. Following the 56-day masked field study, 137 dogs in the pimobendan group were allowed to continue on pimobendan in an open-label extended-use study without restrictions on concurrent therapy. The adverse reactions/new clinical findings in the extended-use study were consistent with those reported in the 56-day study, with the following exception: One dog in the extended-use study developed acute cholestatic liver failure after 140 days on pimobendan and furosemide.

Pimobendan Chewable Tablets

In a controlled multi-center field study, 363 dogs with preclinical MMVD (Stage B2 MMVD, 2019 ACVIM Consensus Statement) received at least one dose of VETMEDIN-CA1 (n=182) or the placebo control chewable tablets (n=181) for up to 1563 days. During this long-term study, dogs were followed until the development of congestive heart failure (CHF). Adverse reactions were seen in both treatment groups with many findings associated with the progression of MMVD and comorbidities consistent with the age of the enrolled dogs. The median time to the primary endpoint (development of left-sided CHF or cardiac death/euthanasia) was 38% longer in the VETMEDIN-CA1 group. Despite the longer duration on study, the incidence of reported adverse reactions was similar between treatment groups. Cough was the most frequently reported adverse reaction. This clinical finding is commonly reported in cases of MMVD and the incidence was similar between treatment groups. Lethargy, inappetence, tachypnea, collapse, arrhythmia, and syncope may also be associated with the progression of MMVD and were reported in dogs receiving VETMEDIN-CA1. Adverse reactions not related to disease progression in dogs receiving VETMEDIN-CA1 included diarrhea, vomiting, pain, lameness, arthritis, urinary tract infection, and seizure. Mortality rate, regardless of reason, prior to CHF was similar between the VETMEDIN-CA1 and the control groups. Contact Information: 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 reporting adverse drug experiences for animal drugs, contact FDA at 1-888-FDA-VETS or at www.fda.gov/reportanimalae.

Vetmedin®-CA1 (pimobendan)Chewable Tablets

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.

Vetmedin® Solution(pimobendan oral solution)

Administer 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.

Oral

Vetmedin®

Administer 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).

Oral

Pimobendan Chewable Tablets

Administer 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 equal portions administered approximately 12 hours apart (i.e., morning and evening).

Oral

Vetmedin® Solution

VETMEDIN Solution 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 equal portions administered approximately 12 hours apart (i.e., morning and evening). The syringe is calibrated to deliver the appropriate morning or evening dose when drawn to the dog’s nearest weight in pounds. VETMEDIN Solution should be administered directly into the mouth. Do not mix into food. VETMEDIN Solution includes an amber glass bottle sealed with a white cap (A), an orange cap with integrated plastic plug (B), and an orange dosing syringe (C). Do not shake the bottle before or during use to avoid foaming. VETMEDIN Solution should be administered using the orange dosing syringe provided in the package. At the time of first use, the white cap should be removed and discarded. Once the orange cap has been screwed onto the bottle and the integrated plastic plug is in place, the dosing syringe fits onto plug. The dosing syringe has 1 pound incremental marks. Each dose should be rounded to the nearest 1 pound increment (e.g., a dose for a dog 5.5 lb or greater should be rounded up to 6 lb). An in-use video demonstration can be found using the URL https://go.boehringer.com/q7lKE or the QR code below. Close the bottle tightly using the orange cap. After administration, clean the outside of the syringe by wiping with a clean, dry cloth or tissue after each use. If the syringe clogs, rinse without removing the plunger by using water and wiping the outside of the syringe dry with a clean cloth or tissue.

ORAL

Vetmedin® Solution(pimobendan oral solution)

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 apart (i.e., morning and evening). The tablets are scored, and the calculated dosage should be provided to the nearest half tablet increment.

ORAL

Vetmedin®-CA1 (pimobendan)Chewable Tablets

Pimobendan Chewable Tablets 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.

ORAL

Pimobendan Chewable Tablets