Indications for use
For the treatment of congestive heart failure due to atrioventricular valve insufficiency or dilated cardiomyopathy in dogs. FORTEKOR PLUS is a fixed dose combination and should only be used in patients whose clinical signs are successfully controlled by administration of the same doses of the individual components (pimobendan and benazepril hydrochloride) given concurrently.
Do not use in cases of hypertrophic cardiomyopathies or clinical conditions where an augmentation of cardiac output is not possible for functional or anatomical reasons (e.g. aortic or pulmonary stenosis).
Do not use in cases of hypotension, hypovolaemia, hyponatraemia or acute renal failure.
Do not use during pregnancy and lactation (see section below).
Do not use in case of hypersensitivity to the active substances or to any of the excipients.
Special warnings for each target species
Special precautions for use
Special precautions for use in animals
In cases of chronic kidney disease, it is recommended to check the dog’s hydration status before starting therapy, and to monitor its plasma creatinine and blood erythrocyte counts during therapy.
As pimobendan is metabolised in the liver, the product should not be administered to dogs with severe hepatic insufficiency.
The efficacy and safety of the product has not been established in dogs below 2.5 kg bodyweight or under 4 months of age.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Wash hands after use.
People with known hypersensitivity to pimobendan or benazepril hydrochloride should avoid contact with the veterinary medicinal product.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Pregnant women should take special care to avoid accidental oral exposure because angiotensin converting enzyme (ACE) inhibitors have been found to affect the unborn child during pregnancy in humans.
A moderate positive chronotropic effect and vomiting may occur in rare cases. However, these effects are dose-dependent and can be avoided by reducing the dose in those cases.
Transient diarrhoea, anorexia or lethargy have been observed in rare cases.
Transient vomiting, incoordination or signs of fatigue have been reported in dogs very rarely, during post
authorization experience. In dogs with chronic kidney disease, benazepril may increase plasma creatinine concentrations at the start of therapy very rarely. A moderate increase in plasma creatinine concentrations following administration of ACE inhibitors is compatible with the reduction in glomerular hypertension induced by these agents, and is therefore not necessarily a reason to stop therapy in the absence of other signs.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Use during pregnancy, lactation or lay
Do not use during pregnancy or lactation.
The safety of the veterinary medicinal product has not been established in breeding, pregnant or lactating dogs.
Laboratory studies in rats and rabbits with pimobendan have shown foetotoxic effects at maternotoxic doses. Laboratory studies in rats and rabbits with pimobendan have not shown any effect on fertility. Laboratory studies in rats have shown that pimobendan is excreted into milk.
Laboratory studies in rats with benazepril have shown foetotoxic effects (foetal urinary tract malformation) at maternally non-toxic doses. It is not known if benazepril is secreted into the milk of lactating bitches.
In dogs with congestive heart failure, benazepril hydrochloride and pimobendan have been given in combination with digoxin and diuretics without demonstrable adverse interactions.
In pharmacological studies no interaction between the cardiac glycoside ouabain and pimobendan was detected. The pimobendan-induced increase in contractility of the heart is attenuated in the presence of the calcium antagonist verapamil and the ß-antagonist propranolol.
In man, the combination of angiotensin converting enzyme (ACE) inhibitors and non-steroidal anti- inflammatory drugs (NSAIDs) can lead to reduced anti-hypertensive efficacy or impaired renal function. Therefore, the concurrent use of FORTEKOR PLUS with NSAIDs or any other medications with a hypotensive effect should be considered carefully before using such combinations.
The combination of FORTEKOR PLUS and other anti-hypertensive agents (e.g. calcium channel blockers, β-blockers or diuretics), anaesthetics or sedatives may lead to additive hypotensive effects. Renal function and signs of hypotension (lethargy, weakness, etc) should be monitored closely and treated as necessary.
Interactions with potassium-sparing diuretics such as spironolactone, triamterene or amiloride cannot be ruled out. It is therefore recommended to monitor plasma potassium levels when using FORTEKOR PLUS in combination with a potassium sparing diuretic because of the risk of hyperkalemia.
Amounts to be administered and administration route
For oral use.
Dose and treatment schedule:
FORTEKOR PLUS is a fixed combination product which should only be used in dogs which require both active substances to be administered concomitantly at this fixed dose.
The recommended dose range for FORTEKOR PLUS is 0.25–0.5 mg pimobendan per kg bodyweight and 0.5–1 mg benazepril hydrochloride per kg bodyweight divided into two daily doses. FORTEKOR PLUS tablets should be administered orally, twice daily 12 hours apart (morning and evening) and approximately 1 hour before feeding.
The tablets are breakable along the score line.
The table below may be used for guidance.
Strength and number of tablets to be administered
Bodyweight (kg) of dog
Fortekor Plus 1.25mg/2.5mg tablets
Fortekor Plus 5mg/10mg tablets
2.5 - 5
5 - 10
10 - 20
In case of overdose the dog should be treated symptomatically. Transient reversible hypotension may occur in accidental overdose. Therapy should consist of intravenous infusion(s) of warm isotonic saline as required.