Cardisure for Dogs Tablets

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Cardisure contains the drug pimobendan, widely acknowledged as the drug of choice in the treatment of congestive heart failure in dogs. Pimobendan is known as a positive inotrope, which means it increases the force of contraction of the heart muscle. It does this without increasing the consumption of oxygen and energy. (Pimobendan increases the sensitivity and binding efficiency of heart muscle to calcium ions, which are involved in the process of contraction of cardiac muscle.) The increased force of contraction means that the heart works more efficiently as a pump, circulating blood to the internal organs to provide oxygen and nutrition. An additional beneficial effect of pimobendan is that it causes blood vessels around the body to open up slightly (peripheral vasodilation). This reduces the resistance to flow of blood through them, reducing the workload on the heart. Hence the failing heart receives a double benefit from the medication. Improved quality of life with better exercise tolerance result, along with greater life expectancy.

Cardisure is supplied as a range of tablet sizes. The most economical are 10mg tablets, which are cleverly scored so that they are easily broken into four quarters. Hence doses of 2.5mg, 5mg, 7.5mg and 10mg are easily given using this one tablet size. Smaller tablets, also easily divided, are available in 1.25mg, 2.5mg and 5mg sizes. Hence accurate and economical dosing of dogs of all different sizes is possible. Cardisure should be given twice daily without food. The tablets are meat flavoured to make it easier to give as a treats. Cardisure tablets come in blister packs with a long shelf life of 30 months from date of manufacture.

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Qualitative and quantitative composition

Active substance: Pimobendan.

Each 1.25 mg tablet contains 1.25 mg pimobendan.

Each 2.5 mg tablet contains 2.5 mg pimobendan.

Each 5 mg tablet contains 5 mg pimobendan.

Each 10 mg tablet contains 10 mg pimobendan.

Excipients: For a full list of excipients, see Excipients.

Pharmaceutical form

Light brown round tablets, scored on one side and plain on the other side.

The 1.25 mg tablets can be divided into 2 equal parts.

The 2.5 mg, 5 mg and 10 mg tablets can be divided into 4 equal parts.

Clinical particulars

Target species

Dogs.

Indications for use

For the treatment of canine congestive heart failure originating from valvular insufficiency (mitral and/or tricuspid regurgitation) or dilated cardiomyopathy.

Contraindications

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 stenosis).

See also Use during pregnancy and lactation.

Special warnings for each target species

The product should be administered on an empty stomach at least one hour before meals, as absorption is reduced when given with feed.

Special precautions for use in animals

The product is flavoured. To avoid accidental ingestion the tablets should be stored out of reach of dogs. An in vitro study in rat tissue demonstrated that pimobendan increased glucose-induced insulin release from pancreatic beta-cells in a dose dependent manner. If the product is administered to diabetic dogs, blood glucose levels should be carefully monitored. As pimobendan is metabolised in the liver, particular care should be taken when administering the product to dogs with severe hepatic insufficiency.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

Wash hands after use.

Advice to doctors: Accidental ingestion, especially by a child, may lead to the occurrence of tachycardia, orthostatic hypotension, flushing of the face and headaches.

Adverse reactions

A moderate positive chronotropic effect and vomiting may occur in rare cases. However, these effects are dose-dependent and may be avoided by reducing the dose in these cases. In rare cases transient diarrhoea, anorexia or lethargy have been observed. Although a relationship with pimobendan has not been clearly established, in very rare cases, signs of effects on primary haemostasis (petechiae on mucous membranes, subcutaneous haemorrhages) may be observed during treatment. These signs disappear when the treatment is withdrawn. In rare cases, an increase in mitral valve regurgitation has been observed during chronic pimobendan treatment in dogs with mitral valve disease. Monitoring of cardiac function and morphology is recommended in animals treated with pimobendan.

Use during pregnancy and lactation

Laboratory studies in rats and rabbits have not produced any evidence of teratogenic or foetotoxic effects. However, these studies have shown evidence of maternotoxic and embryotoxic effects at high doses, and have also shown that pimobendan 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.

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 beta-antagonist propranolol.

Amounts to be administered and administration route

The preferable daily dose is 0.5 mg pimobendan/kg body weight.

Do not exceed the recommended dosage.

Determine the body weight accurately before treatment to ensure correct dosage. The tablets should be administered orally at a dose range of 0.2 mg to 0.6 mg pimobendan/kg body weight per day. The dose should be divided into two administrations (0.25 mg/kg body weight each), one half of the dose in the morning and the other half approximately 12 hours later. The maintenance dose should be individually adjusted by the responsible veterinarian according to the severity of the disease.

The product may be combined with a diuretic treatment, e.g. furosemide.

1.25 mg tablets: To break a tablet into two halves, place the tablet on an even surface with the scored side up, hold one half of the tablet and press down on the other half.

2.5 mg, 5 mg and 10 mg tablets: To break a double scored tablet into quarters, place the tablet on an even surface with the scored side up and apply pressure on the middle with your thumb.

Each dose should be given approximately one hour before feeding.

Table to show dosing guide:

No. of tablets per administration (morning and evening)

Body weight (kg)

Daily dosage (mg)

1.25 mg

2.5 mg

5 mg

10 mg

< 5

1.25

½

-

-

-

5-10

2.5

1

-

-

-

11-20

5

-

1

-

-

21-40

10

-

-

1

-

41-60

20

-

-

-

1

> 60

30

-

-

-

Overdose

In the case of overdose, a positive chronotropic effect and vomiting may occur. In this situation, the dosage should be reduced and appropriate symptomatic treatment should be initiated.

Withdrawal period

Not applicable.

Pharmacological particulars

Pharmacotherapeutic group: Cardiac stimulant (phosphodiesterase inhibitor).

ATC Vet code: QC01CE90

Pharmacodynamic properties

Pimobendan, a benzimidazole-pyridazinone derivative, is a non-sympathomimetic, non-glycoside inotropic substance with potent vasodilatative properties.

Pimobendan exerts its stimulatory myocardial effect by a dual mode of action: it increases calcium sensitivity of cardiac myofilaments and inhibits phosphodiesterase (type III). It also exhibits a vasodilatory action through inhibition of phosphodiesterase III activity.

When used in cases of valvular insufficiency in conjunction with furosemide, the product has been shown to improve the quality of life and extend life expectancy in treated dogs. When used in a limited number of cases of dilated cardiomyopathy in conjunction with furosemide, enalapril and digoxin the product has been shown to improve the quality of life and to extend life expectancy in treated dogs.

Pharmacokinetic properties

Absorption: Following oral administration of this veterinary medicinal product the absolute bioavailability of the active principle is 60-63%. Since this bio-availability is considerably reduced when pimobendan is administered with food or shortly thereafter, it is recommended to treat animals approximately 1 hour before feeding.

Distribution: The volume of distribution is 2.6 l/kg, indicating that pimobendan is distributed readily into the tissues. The mean plasma protein binding is 93%.

Metabolism: The compound is oxidatively demethylated to its major active metabolite (UD-CG 212). Further metabolic pathways are phase II conjugates of UD-CG-212, in essence glucuronides and sulphates.

Elimination: The plasma elimination half-life of pimobendan is 1.1 ± 0.7 hours.

The main active metabolite is eliminated with a plasma elimination half-life of 1.5 ± 0.2 hours. Almost the entire dose is eliminated via faeces.

Pharmaceutical particulars

Excipients

Cellulose (microcrystalline (E460)), croscarmellose sodium, magnesium stearate, natural meat flavour.

Incompatibilities

None known.

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 30 months.

Shelf life of divided tablets after first opening the blister: 3 days.

Special precautions for storage

Return any divided tablet to the opened blister and use within 3 days. Do not store above 30°C. Keep out of the reach and sight of children.

Immediate packaging

Aluminium – PVC/PE/PVDC blister: 10 tablets per blister. 2, 5, 10 or 25 blisters per carton.

Aluminium – Aluminium blister:

1.25 mg and 2.5 mg tablets: 10 tablets per blister. 2, 5, 10 or 25 blisters per carton.

5 mg and 10 mg tablets: 5 tablets per blister. 4, 10, 20 or 50 blisters per carton.

Not all pack sizes may be marketed.

Disposal

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Marketing authorisation holder (if different from distributor)

Eurovet Animal Health BV, Handelsweg 25, 5531 AE Bladel, The Netherlands.

Marketing authorisation number

Cardisure 1.25 mg tablets: Vm 16849/4026.

Cardisure 2.5 mg tablets: Vm 16849/4027

Cardisure 5 mg tablets: Vm 16849/4028

Cardisure 10 mg tablets: Vm 16849/4029

Date of the first authorisation or date of renewal

09.08.2011

Date of revision of the text

August 2011

Any other information

For animal treatment only. To be supplied only on veterinary prescription.

Legal category

POM-V

GTIN (Global Trade Item No)

Cardisure Flavoured 1.25 mg Tablets for Dogs 100 tablets:

08714225153114

Cardisure Flavoured 2.5 mg Tablets for Dogs 100 tablets:

08714225153121

Cardisure Flavoured 5 mg Tablets for Dogs 100 tablets:

08714225153138

Cardisure Flavoured 10 mg Tablets for Dogs 100 tablets:

08714225153145

Need help or advice? Contact us:

  • Freephone: 0800 084 2608
  • Mon - Fri: 8:30am - 7:00pm
  • Sat: 10:00am - 3:00pm
  • Email: support@viovet.co.uk

All prices include VAT where applicable.

Information regarding the safe use of all licensed medication supplied in the UK can be found on the Veterinary Medicine Directorate website. Follow this link and then search for the brand name of the product to find the official Summary of Product Characteristics for that product. Unlicensed medication, such as herbal supplements, will not be found here and there is no such formal recognition of any scientifically proven therapeutic effects from any unlicensed medication.

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