Advertisement

Vetmedin

Main information

  • Trade name:
  • Vetmedin 1.25 mg Hard Capsules
  • Available from:
  • Boehringer Ingelheim Ltd
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug
Advertisement

Documents

Localization

  • Available in:
  • Vetmedin 1.25 mg Hard Capsules
    United Kingdom
  • Language:
  • English

Other information

Advertisement

Status

  • Source:
  • VMD - Veterinary Medicines Directorate
  • Authorization status:
  • Expired
  • Authorization number:
  • 00015/4066
  • Last update:
  • 21-12-2016

Summary of Product characteristics

Advertisement

Revised: 30 September 2009

AN: 00187/2009

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Vetmedin® 1.25 mg hard capsules.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each capsule contains:

Active Substance

Pimobendan 1.25 mg/capsule

Excipients

Titanium Dioxide (E171) 0.976 mg/capsule

Ferric Oxide Yellow (E172) 0.0439 mg/capsule

For a full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Capsule, hard

yellow/white in colour

4. CLINICAL PARTICULARS

4.1 Target species

Dog.

4.2 Indications for use, specifying the target species

For the treatment of canine congestive heart failure originating from

valvular insufficiency (mitral and/or tricuspid regurgitation) or dilated

cardiomyopathy.

When used in cases of valvular insufficiency in conjunction with

frusemide, 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 frusemide, enalapril and digoxin the product has been

shown to improve the quality of life and to extend life expectancy in treated

dogs.

4.3 Contraindications

Vetmedin capsules should not be used 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).

Revised: 30 September 2009

AN: 00187/2009

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

i Special precautions for use in animals

This product should be used only in dogs with cardiac insufficiency.

Do not exceed the recommend dosage.

ii 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.

4.6 Adverse reactions (frequency and seriousness)

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.

4.7 Use during pregnancy, lactation or lay

In studies with rats and rabbits pimobendan had no effect on fertility and

embryotoxic effects only occurred at maternotoxic doses. In experiments

with rats it has been shown that pimobendan is excreted into milk. No

information is available on the safety of Vetmedin in pregnant and lactating

bitches. Therefore, Vetmedin capsules should only be administered to

pregnant and lactating bitches if the expected therapeutic benefits

outweigh the potential risks.

4.8 Interaction with other medicinal products and other forms of

interaction

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 pharmacological studies no interaction between the cardiac glycoside

ouabain and pimobendan was detected.

Revised: 30 September 2009

AN: 00187/2009

4.9 Amounts to be administered and administration route

See dosing guide below.

Vetmedin capsules should be administered orally (approximately one

hour before feeding) at a dose of 0.2 mg to 0.6 mg pimobendan/kg

bodyweight per day. The daily dose should be divided into two equal

administrations, one half of the dose in the morning and the other half

approximately 12 hours later.

Determine the bodyweight accurately before prescribing to ensure

administration of the correct dosage.

In cases of mild congestive heart failure, a daily dosage at the lower end

of the dose range may be adequate. If, however, a clear response is not

observable within one week, the dosage should be raised.

Dosing Guide

Note: For larger dogs Vetmedin 2.5mg or 5.0mg capsules are more

suitable.

Daily Pimobendan Dosage: 0.2 – 0.6 mg/kg

No. of capsules per administration

Body

Weight

(kg) Daily

Dosage

(mg) Morning

1.25mg 25.mg

5mg Evening

1.25mg 2.5mg

5mg

<10 2.5 1 1

10-20 5 1 1

21-40 10 1 1

41-60 20 2 2

>60 30 3 3

Vetmedin capsules may be combined with a diuretic treatment such as

furosemide.

4.10 Overdose (symptoms, emergency procedures, antidotes), if

necessary

In the case of overdose symptomatic treatment should be initiated.

4.11 Withdrawal period(s)

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Summary presentation of the active ingredients:

Pimobendan, a benzimidazole-pyridazinone derivative, is a non-

sympathomimetic, non-glycoside inotropic substance with potent

vasodilatative properties

Revised: 30 September 2009

AN: 00187/2009

5.1 Pharmacodynamic 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

5.2 Pharmacokinetic particulars

Absorption

Following oral administration of Vetmedin capsules the absolute

bioavailability of the active principle is 60 – 63%. Since this

bioavailability 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 2.61/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-CG12). Further metabolic pathways are phase II conjugates of UD-

CG 212, in essence glucuronides and sulphates.

5.2 Pharmacokinetic particulars (Cont/d)

Elimination

The plasma elimination half-life of pimobendan is 0.4±0.1 hours which is

consistent with a high clearance of 90±19 ml/min/kg and a short mean

residence time of 0.5 ± 0.1hours.

The main active metabolite is eliminated with a plasma elimination half-life

of 2.0 ± 0.3 hours. Almost the entire dose is eliminated via faeces.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Each capsule contains:

Citric Acid, anhydrous

Colloidal Silica

Microcrystalline Cellulose

Povidone

Magnesium Stearate

Capsule Shell

Titanium Dioxide (E171)

Ferric Oxide Yellow (E172)

Gelatin

Revised: 30 September 2009

AN: 00187/2009

6.2 Incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale : 3

years.

6.4. Special precautions for storage

Do not store above 25°C.

Store in a dry place.

Store in tightly closed original container

6.5 Nature and composition of immediate packaging

Vetmedin 1.25 mg capsules are presented in white high density

polyethylene bottles with white polypropylene child-resistant screw-caps

OR white polypropylene bottle with white polypropylene child resistant

screw-caps. Each bottle contains 100 capsules and is packed in a

cardboard carton. The capsules may also be presented in

aluminium/polyethylene strips which are then packed into a cardboard

carton containing 100 capsules.

Not all presentations may be marketed.

6.6 Special precautions for the disposal of unused veterinary

medicinal product or waste materials derived from the use of

such products

Any unused veterinary medicinal product or waste materials derived from

such veterinary medicinal products should be disposed of in accordance with local

requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Ltd.,

Ellesfield Avenue,

Bracknell,

Berkshire,

RG12 8YS,

United Kingdom.

8. MARKETING AUTHORISATION NUMBER(S)

Vm

00015/4066

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

18 July 2001/18 July 2006

Revised: 30 September 2009

AN: 00187/2009

10. DATE OF REVISION OF THE TEXT

September 2009

2-12-2016

PIMOBENDAN Powder [Attix Pharmaceuticals Inc]

PIMOBENDAN Powder [Attix Pharmaceuticals Inc]

Updated Date: Dec 2, 2016 EST

US - DailyMed

29-11-2016

PIMOBENDAN Powder [Attix Pharmaceuticals]

PIMOBENDAN Powder [Attix Pharmaceuticals]

Updated Date: Nov 29, 2016 EST

US - DailyMed

16-11-2016

PIMOBENDAN Powder [Darmerica, LLC]

PIMOBENDAN Powder [Darmerica, LLC]

Updated Date: Nov 16, 2016 EST

US - DailyMed

19-10-2016

PIMOBENDAN Powder [Wisdom Pharmaceutical Co., Ltd]

PIMOBENDAN Powder [Wisdom Pharmaceutical Co., Ltd]

Updated Date: Oct 19, 2016 EST

US - DailyMed

29-8-2016

X (Pimobendan) Powder [AX Pharmaceutical Corp]

X (Pimobendan) Powder [AX Pharmaceutical Corp]

Updated Date: Aug 29, 2016 EST

US - DailyMed

24-8-2016

PIMOBENDAN Powder [Medisca Inc.]

PIMOBENDAN Powder [Medisca Inc.]

Updated Date: Aug 24, 2016 EST

US - DailyMed

9-6-2016

VETMEDIN (Pimobendan) Tablet, Chewable [Boehringer Ingelheim Vetmedica, Inc.]

VETMEDIN (Pimobendan) Tablet, Chewable [Boehringer Ingelheim Vetmedica, Inc.]

Updated Date: Jun 9, 2016 EST

US - DailyMed

15-3-2016

PIMOBENDAN EP5 Powder [LETCO MEDICAL, LLC]

PIMOBENDAN EP5 Powder [LETCO MEDICAL, LLC]

Updated Date: Mar 15, 2016 EST

US - DailyMed

18-2-2016

PIMOBENDAN Powder [Boehringer Ingelheim Espana, SA]

PIMOBENDAN Powder [Boehringer Ingelheim Espana, SA]

Updated Date: Feb 18, 2016 EST

US - DailyMed

Other products from the same company

Advertisement