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Date: Sunday, August 14, 2022 21:59

Description: MSD-AH
Release 2.67
Vivitonin® 50 mg tablets
Vivitonin® 100 mg tablets
 
Species: Dogs
Therapeutic indication: Pharmaceuticals: Cardiovascular and respiratory preparations
Active ingredient: Propentofylline
Product:Vivitonin® 50 mg tablets and Vivitonin® 100 mg tablets
Product index: Vivitonin® 50 mg and 100 mg tablets
Qualitative and quantitative composition
Vivitonin 50 mg tablets:
Active substance:
Propentofylline 50.00 mg/tablet
Film coating ingredients:
Yellow ferric oxide (E172) (colouring) 0.125 mg/tablet
Titanium Dioxide (E171) (colouring) 0.359 mg/tablet
Vivitonin 100mg tablets:
Active substance:
Propentofylline 100.00 mg/tablet
Film coating ingredients:
Yellow ferric oxide (E172) (colouring) 0.258 mg/tablet
Titanium Dioxide (E171) (colouring) 0.856 mg/tablet
For the full list of excipients, see section “Pharmaceutical particulars”.
Pharmaceutical form
Vivitonin 50 mg tablets: Orange-yellow film coated tablets.
Vivitonin 100 mg tablets: Ochre, biconvex, oblong filmcoated tablets.
Clinical particulars
Target Species
Dogs.
Indications for use
For improvement in dullness, lethargy and overall demeanour in dogs. Vivitonin is particularly useful in older dogs, where it may increase willingness to exercise and exercise tolerance.
Contraindications
Not to be administered to pregnant bitches or breeding animals.
Do not use in animals with known hypersensitivity to the active substance or any of the excipients.
Special warnings for each target species
None.
Special precautions for use
Specific diseases (e.g. kidney disease) should be treated accordingly.
In the case of renal failure, the dose should be reduced.
Consideration should be given to rationalising the medication of dogs already receiving treatment for congestive heart failure or bronchial disease.
Operator warnings
Care should be taken to avoid accidental ingestion.
Wash hands after use.
Adverse Reactions
Vomiting has been observed on rare occasions, particularly at the
commencement of therapy.
In rare cases allergic reactions (e.g. urticaria) may occur and these necessitate
discontinuation of the treatment.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals displaying adverse reaction(s) during
the course of one treatment)
- common (more than 1 but less than 10 animals in 100 animals)
- uncommon (more than 1 but less than 10 animals in 1,000 animals)
- rare (more than 1 but less than 10 animals in 10,000 animals)
- very rare (less than 1 animal in 10,000 animals, including isolated reports).
Use during pregnancy or lactation
Do not use in pregnant bitches as the product has not been evaluated in these animals.
Interactions
None known.
Amounts to be administered and administration route
Vivitonin 50 mg tablets:
Half a tablet per 5 kg body weight twice a day (equivalent to 6-10 mg propentofylline per kg bodyweight per day).
Dogs of less than 5 kg may receive a quarter of a tablet twice a day. Dogs of more than 20 kg can be given Vivitonin 100mg tablets.
The tablets can be administered directly onto the back of the dog's tongue or can be mixed in a small ball of food and should be administered at least 30 minutes before feeding.
Divide the tablets in halves and quarters with a knife or with a tablet splitter.
Vivitonin 100 mg tablets:
Half a tablet per 10kg body weight twice a day
The tablets should not be quartered. More accurate dosing may be achieved using a combination of 100 mg and 50 mg tablets. Dogs of less than 20 kg can be given 50 mg tablets.
The tablets can be administered directly onto the back of the dog's tongue or can be mixed in a small ball of food and should be administered at least 30 minutes before feeding.
Divide the tablets in halves with a knife or with a tablet splitter.
Overdose
Symptoms of cardiac and cerebral overstimulation have been observed. In such
cases, animals should be treated symptomatically.
Withdrawal periods
Not applicable.
Pharmacological particulars
ATC Vet Code QC04AD90
Pharmacotherapeutic group
Pharmacodynamic properties
Propentofylline has been shown to increase blood flow, particularly of the heart and skeletal muscle. It also increases the blood flow of the brain and therefore its oxygen supply, without increasing the brain's glucose demand. It has a modest positive chronotropic effect and a marked positive inotropic effect. In addition, it has been shown to have an anti-arrhythmic effect in dogs with myocardial ischemia and a bronchodilator action equivalent to that of aminofylline.
Propentofylline inhibits platelet aggregation and improves the flow properties of erythrocytes.
It has a direct effect on the heart and reduces peripheral vascular resistance thereby lowering cardiac load.
Pharmacokinetic particulars
After oral administration, propentofylline is rapidly and completely absorbed and quickly distributed into the tissues. Maximum plasma levels are reached by 15 minutes following oral dosing in dogs.
The half-life is approximately 30 minutes and the bioavailability of the parent compound is approximately 30%.
There are a number of effective metabolites and biotransformation takes place mainly in the liver.
80-90% of propentofylline is excreted in the form of metabolites via the kidneys. The rest is eliminated with the faeces.
There is no bioaccumulation.
Pharmaceutical particulars
Excipients
Lactose monohydrate
Maize Starch
Crospovidone
Talc
Magnesium Stearate
Colloidal Anhydrous silica
Film Coating:
Methylhydroxpropylcellulose 5mPa’s
Talc
Titanium dioxide (E171)
Yellow ferric oxide (E172)
Macrogol 8000
Major incompatibilities
None known.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Special precautions for storage
Do not store above 25oC. Store in a dry place.
Keep blister packs in outer carton.
Immediate packaging
2 Polyvinylchloride/aluminium blister packs of 30 tablets per carton.
Disposal
Any unused product or waste material should be disposed of in accordance with national requirements.
Marketing Authorisation Holder (if different from distributor)
Marketing Authorisation Number
UK: Vm 01708/4417, 46
Significant changes
Date of the first authorisation or date of renewal
Vivitonin 50 mg tablets: 17 September 1991 Vivitonin 100 mg tablets: 30 September 1994
Date of revision of the text
April 2021.
Any other information
For animal treatment only. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN
GTIN description:Vivitonin 50mg 2x30tab:
GTIN:08713184044174
GTIN description:Vivitonin 100mg 6x10tab:
GTIN:08713184044426