Target species
Dogs
Indications for use
For the treatment of congestive heart failure due to atrioventricular valve insufficiency or dilated cardiomyopathy in dogs. This veterinary medicinal product 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.
Contra-indications
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
None
Special precautions for use
Special precautions for use in the target species
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 veterinary medicinal product should not be administered to dogs with severe hepatic insufficiency.
The efficacy and safety of the veterinary medicinal 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.
Adverse reactions
Rare (1 to 10 animals / 10,000 animals treated): | Increased heart rate1 Diarrhoea2, Vomiting1,2 Anorexia2, Lethargy2 |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Elevated creatinine3 Incoordination2 Fatigue2 |
2Transient.
3At the start of therapy in dogs with chronic kidney disease. 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.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy and in lactating dogs.
Pregnancy and lactation:
Do not use in pregnancy or lactation.
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.
Fertility:
Do not use in breeding animals.
Interaction with other medicinal products and other forms of interaction
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 the veterinary medicinal product with NSAIDs or any other medications with a hypotensive effect should be considered carefully before using such combinations.
The combination of the veterinary medicinal product 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 the veterinary medicinal product 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:
This veterinary medicinal product 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 this veterinary medicinal product 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. This veterinary medicinal product 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.
Fortekor Plus | Strength and number of tablets to be administered |
Bodyweight (kg) of dog | Fortekor Plus 1.25mg/2.5mg tablets | Fortekor Plus 5mg/10mg tablets |
| Morning | Evening | Morning | Evening |
2.5 - 5 | 0.5 | 0.5 | | |
5 - 10 | 1 | 1 | | |
10 - 20 | | | 0.5 | 0.5 |
20 -40 | | | 1 | 1 |
Over 40kg | | | 2 | 2 |
Overdose
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.
Withdrawal periods
Not applicable.