 |
GENERIC NAME:
Pimobendan Chewable Tablet
MAIN COMPONENT:
Pimobendan
DESCRIPTION:
The product is a light brown tablet with score lines in the middle on both sides and a beef flavor.
PHARMACOLOGICAL EFFECTS:
Pharmacodynamics Pimobendan is a non-glycoside cardiotonic drug. It is a benzimidazole pyridazinone derivative, and a non-sympathomimetic non-glycoside positive inotropic drug that exerts positive inotropic effects by increasing the calcium sensitivity of the cardiac muscle fiber and inhibiting phosphodiesterase (Type III) activity, and meanwhile exhibits vasodilating activity by inhibiting phosphodiesterase. Pimobendan, in combination with diuretics such as furosemide, is effective in improving the quality of life and extending life expectancy in dogs with dilated cardiomyopathy or heart valve insufficiency. When used alone to treat preclinical dilated cardiomyopathy (asymptomatic, accompanied by increased left ventricular end-systolic and end-diastolic diameters as diagnosed by echocardiography) in large breed dogs, pimobendan is able to delay the age at onset of heart failure or sudden death in the dogs and prolong their survival.
Pimobendan can decrease the volume of the heart in the treatment of preclinical myxomatous mitral valve disease (asymptomatic with a systolic mitral murmur and evidence of increased heart size) in dogs. Pimobendan prolongs the onset of clinical signs of heart failure or cardiac death in dogs by approximately 15 months, while decreasing the volume of the heart and prolonging overall survival by approximately 170 days.
Pharmacokinetics Pimobendan is oxidatively demethylated in vivo into a biologically active metabolite, which is then conjugated with sulfate or glucuronide and excreted mainly via feces. The mean extent of protein binding of pimobendan and its active metabolite in dog plasma is >90%.
A bioequivalence study has been conducted for the product versus the reference listed drug (RLD) Pimobendan Chewable Tablet (Vetmedin®) as a reference formulation. The results showed that the product was bioequivalent to the RLD.
INDICATIONS:
The product is used for the treatment of congestive cardiac failure (CCF) in dogs due to heart valve insufficiency (mitral and/or tricuspid regurgitation) or dilated cardiomyopathy, as well as preclinical dilated cardiomyopathy (asymptomatic with an increase in left ventricular end-systolic and end-diastolic diameter as diagnosed by echocardiography) in large dogs. It is used to treat preclinical myxomatous mitral valve disease (asymptomatic with a systolic mitral murmur and evidence of increased heart size) in dogs, so as to prolong the onset of clinical signs of CCF.
DOSAGE AND ADMINISTRATION:
Calculated based on pimobendan. Oral dose for dogs: 0.25 mg/kg body weight twice daily.
ADVERSE REACTIONS:
1. A slight positively chronotropic effect (rise in heart rate) and vomiting may occur in a very small number of affected dogs. However, these effects are dose-dependent and may resolve spontaneously after dose reduction. Transient diarrhea, anorexia or lethargy may occur in a very small number of affected dogs.
2. Although a relationship with pimobendan has not been clearly established, in a very small number of affected dogs, signs of effects on primary haemostasis (mucosal hemorrhage or subcutaneous haemorrhage) may be observed during treatment. These signs may resolve spontaneously after the treatment is withdrawn.
3. In very rare cases, an increase in mitral regurgitation may occur during pimobendan treatment in dogs with mitral valve disease.
PRECAUTIONS:
1. Do not use the product in hypertrophic cardiomyopathies or in diseases in which an improvement in cardiac output cannot be achieved for functional or anatomical reasons (e.g., aortic stenosis). Since the product is metabolized mainly via the liver, it is contraindicated in dogs with serious hepatic insufficiency.
2. The product has not been tested in cases of asymptomatic dilated cardiomyopathy (DCM) in Dobermans with atrial fibrillation or sustained ventricular tachycardia.
3. The product has not been tested in cases of asymptomatic myxomatous mitral valve disease in dogs with significant supraventricular or ventricular tachyarrhythmia.
4. Laboratory studies in rats and rabbits have not produced any evidence of teratogenic or foetotoxic effects of the drug. However, these studies have shown evidence of maternotoxic and embryotoxic effects at high doses, and have also shown that the drug is excreted into milk. The safety of the product has not been assessed in pregnant or nursing bitches. Use only according to the benefit/risk assessment by the responsible veterinarian.
5. Blood glucose should be tested regularly during treatment in dogs with existing diabetes mellitus.
6. For use in the "preclinical stage" of dilated cardiomyopathy (asymptomatic with an increase in left ventricular end-systolic and end-diastolic diameter), a diagnosis should be made by means of a comprehensive cardiac examination (including echocardiography and ambulatory ECG monitoring).
7. For use in preclinical myxomatous mitral valve disease (stage B2, according to ACVIM consensus: asymptomatic with a mitral murmur ≥3/6 and cardiomegaly due to myxomatous mitral valve disease), a diagnosis should be made by means of a comprehensive cardiac examination (including echocardiography and radiography).
8. Monitoring of cardiac function and morphology is recommended in animals treated with pimobendan.
9. Pharmacological studies show no interaction between pimobendan and the cardiac glycoside ouabain. The pimobendan-induced increase in cardiac contractility is attenuated in the presence of calcium antagonists (e.g., verapamil and diltiazem) and ß-antagonists (e.g., propranolol).
10. Do not overdose. An overdose may cause a positive chronotropic effect or vomiting. In this situation, the dosage should be reduced and appropriate symptomatic treatment should be initiated.
11. In prolonged exposure (6 months) of healthy Beagle dogs at 3 and 5 times the recommended dose, mitral valve thickening and left ventricular hypertrophy were observed in some dogs. These changes are of pharmacodynamic origin.
12. Keep out of reach of children.
13. Wash hands after use.
14. In case of accidental ingestion, seek medical advice immediately and show the product label or package insert to the physician. Accidental ingestion, especially by a child, may lead to the occurrence of tachycardia, orthostatic hypotension, flushing of the face and headaches.
15. Any unused veterinary medicinal product or waste material derived from such veterinary medicinal product should be disposed of in accordance with local requirements. Consult local veterinarians on how to dispose of these waste medicinal products that are no longer in use, and these measures should be in line with environmental protection requirements.
Meet multiple application scenarios: It can meet the application scenarios of various heart diseases.
Big manufacturers are trustworthy: they have their own GMP production lines and guaranteed quality.
Independent sealed packaging: finely crafted, with stable efficacy, and trustworthy.
| WITHDRAWAL PERIOD | Not required for its establishment |
| STRENGTH | 5 mg |
| PACKAGING | 8 tablets/plate × 4 plates/box. |
| SHELF LIFE | 2 years |
GENERIC NAME:
Pimobendan Chewable Tablet
MAIN COMPONENT:
Pimobendan
DESCRIPTION:
The product is a light brown tablet with score lines in the middle on both sides and a beef flavor.
PHARMACOLOGICAL EFFECTS:
Pharmacodynamics Pimobendan is a non-glycoside cardiotonic drug. It is a benzimidazole pyridazinone derivative, and a non-sympathomimetic non-glycoside positive inotropic drug that exerts positive inotropic effects by increasing the calcium sensitivity of the cardiac muscle fiber and inhibiting phosphodiesterase (Type III) activity, and meanwhile exhibits vasodilating activity by inhibiting phosphodiesterase. Pimobendan, in combination with diuretics such as furosemide, is effective in improving the quality of life and extending life expectancy in dogs with dilated cardiomyopathy or heart valve insufficiency. When used alone to treat preclinical dilated cardiomyopathy (asymptomatic, accompanied by increased left ventricular end-systolic and end-diastolic diameters as diagnosed by echocardiography) in large breed dogs, pimobendan is able to delay the age at onset of heart failure or sudden death in the dogs and prolong their survival.
Pimobendan can decrease the volume of the heart in the treatment of preclinical myxomatous mitral valve disease (asymptomatic with a systolic mitral murmur and evidence of increased heart size) in dogs. Pimobendan prolongs the onset of clinical signs of heart failure or cardiac death in dogs by approximately 15 months, while decreasing the volume of the heart and prolonging overall survival by approximately 170 days.
Pharmacokinetics Pimobendan is oxidatively demethylated in vivo into a biologically active metabolite, which is then conjugated with sulfate or glucuronide and excreted mainly via feces. The mean extent of protein binding of pimobendan and its active metabolite in dog plasma is >90%.
A bioequivalence study has been conducted for the product versus the reference listed drug (RLD) Pimobendan Chewable Tablet (Vetmedin®) as a reference formulation. The results showed that the product was bioequivalent to the RLD.
INDICATIONS:
The product is used for the treatment of congestive cardiac failure (CCF) in dogs due to heart valve insufficiency (mitral and/or tricuspid regurgitation) or dilated cardiomyopathy, as well as preclinical dilated cardiomyopathy (asymptomatic with an increase in left ventricular end-systolic and end-diastolic diameter as diagnosed by echocardiography) in large dogs. It is used to treat preclinical myxomatous mitral valve disease (asymptomatic with a systolic mitral murmur and evidence of increased heart size) in dogs, so as to prolong the onset of clinical signs of CCF.
DOSAGE AND ADMINISTRATION:
Calculated based on pimobendan. Oral dose for dogs: 0.25 mg/kg body weight twice daily.
ADVERSE REACTIONS:
1. A slight positively chronotropic effect (rise in heart rate) and vomiting may occur in a very small number of affected dogs. However, these effects are dose-dependent and may resolve spontaneously after dose reduction. Transient diarrhea, anorexia or lethargy may occur in a very small number of affected dogs.
2. Although a relationship with pimobendan has not been clearly established, in a very small number of affected dogs, signs of effects on primary haemostasis (mucosal hemorrhage or subcutaneous haemorrhage) may be observed during treatment. These signs may resolve spontaneously after the treatment is withdrawn.
3. In very rare cases, an increase in mitral regurgitation may occur during pimobendan treatment in dogs with mitral valve disease.
PRECAUTIONS:
1. Do not use the product in hypertrophic cardiomyopathies or in diseases in which an improvement in cardiac output cannot be achieved for functional or anatomical reasons (e.g., aortic stenosis). Since the product is metabolized mainly via the liver, it is contraindicated in dogs with serious hepatic insufficiency.
2. The product has not been tested in cases of asymptomatic dilated cardiomyopathy (DCM) in Dobermans with atrial fibrillation or sustained ventricular tachycardia.
3. The product has not been tested in cases of asymptomatic myxomatous mitral valve disease in dogs with significant supraventricular or ventricular tachyarrhythmia.
4. Laboratory studies in rats and rabbits have not produced any evidence of teratogenic or foetotoxic effects of the drug. However, these studies have shown evidence of maternotoxic and embryotoxic effects at high doses, and have also shown that the drug is excreted into milk. The safety of the product has not been assessed in pregnant or nursing bitches. Use only according to the benefit/risk assessment by the responsible veterinarian.
5. Blood glucose should be tested regularly during treatment in dogs with existing diabetes mellitus.
6. For use in the "preclinical stage" of dilated cardiomyopathy (asymptomatic with an increase in left ventricular end-systolic and end-diastolic diameter), a diagnosis should be made by means of a comprehensive cardiac examination (including echocardiography and ambulatory ECG monitoring).
7. For use in preclinical myxomatous mitral valve disease (stage B2, according to ACVIM consensus: asymptomatic with a mitral murmur ≥3/6 and cardiomegaly due to myxomatous mitral valve disease), a diagnosis should be made by means of a comprehensive cardiac examination (including echocardiography and radiography).
8. Monitoring of cardiac function and morphology is recommended in animals treated with pimobendan.
9. Pharmacological studies show no interaction between pimobendan and the cardiac glycoside ouabain. The pimobendan-induced increase in cardiac contractility is attenuated in the presence of calcium antagonists (e.g., verapamil and diltiazem) and ß-antagonists (e.g., propranolol).
10. Do not overdose. An overdose may cause a positive chronotropic effect or vomiting. In this situation, the dosage should be reduced and appropriate symptomatic treatment should be initiated.
11. In prolonged exposure (6 months) of healthy Beagle dogs at 3 and 5 times the recommended dose, mitral valve thickening and left ventricular hypertrophy were observed in some dogs. These changes are of pharmacodynamic origin.
12. Keep out of reach of children.
13. Wash hands after use.
14. In case of accidental ingestion, seek medical advice immediately and show the product label or package insert to the physician. Accidental ingestion, especially by a child, may lead to the occurrence of tachycardia, orthostatic hypotension, flushing of the face and headaches.
15. Any unused veterinary medicinal product or waste material derived from such veterinary medicinal product should be disposed of in accordance with local requirements. Consult local veterinarians on how to dispose of these waste medicinal products that are no longer in use, and these measures should be in line with environmental protection requirements.
Meet multiple application scenarios: It can meet the application scenarios of various heart diseases.
Big manufacturers are trustworthy: they have their own GMP production lines and guaranteed quality.
Independent sealed packaging: finely crafted, with stable efficacy, and trustworthy.
| WITHDRAWAL PERIOD | Not required for its establishment |
| STRENGTH | 5 mg |
| PACKAGING | 8 tablets/plate × 4 plates/box. |
| SHELF LIFE | 2 years |
