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Date: Sunday, May 29, 2022 11:58

Release 2.92
Vitofyllin film-coated tablets for dogs
 
Species: Dogs
Therapeutic indication: Pharmaceuticals: Cardiovascular and respiratory preparations
Active ingredient: Propentofylline
Product:Vitofyllin film-coated tablets for dogs
Product index: Vitofyllin film-coated tablets for dogs
Incorporating:Vitofyllin 50mg and 100mg Tablets
Qualitative and quantitative composition
Vitofyllin 50 mg film-coated tablets for dogs
Active substance:
Propentofylline 50.00 mg/tablet
Excipients:
Ferric Oxide, yellow, (E 172) 0.075 mg/tablet
Titanium Dioxide, (E171) 0.215 mg/tablet
For the full list of excipients, see pharmaceutical particulars
Vitofyllin 100 mg film-coated tablets for dogs
Active substance:
Propentofylline 100.00 mg/tablet
Excipients:
Ferric Oxide, yellow, (E 172) 0.150 mg/tablet
Titanium Dioxide, (E171) 0.430 mg/tablet
For the full list of excipients, see pharmaceutical particulars
Pharmaceutical form
Film-coated tablets.
Yellow, round convex tablets with cross-snap-tab on one side and imprinting "50" or "100" on the other side.
The tablet can be divided into 2 or 4 equal parts.
Clinical particulars
Target species
Dogs.
Indications for use, specifying the target species
For the improvement of peripheral and cerebral vascular blood circulation. For improvement in dullness, lethargy and overall demeanour in dogs.
Contraindications
Do not use vitofyllin 50mg tablets in dogs weighing less than 2.5 kg or vitofyllin 100mg tablets in dogs weighing less than 5kg.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Special warnings
None.
Special precautions for use
Special precautions for use in animals
Specific diseases (e.g. kidney disease) should be treated accordingly.
Consideration should be given to rationalising the medication of dogs already receiving treatment for congestive heart failure or bronchial disease.
In the case of renal failure, the dose should be reduced.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Care should be taken to avoid accidental ingestion.
In the event of accidental ingestion of the tablets, seek medical advice immediately and show the package leaflet to the physician.
Wash hands after use.
Adverse reactions (frequency and seriousness)
On rare occasions,(more than 1 but less than 10 animals in 10,000 animals treated), allergic skin reactions, vomiting and cardiac disturbances have been reported. In these cases, the treatment should be stopped.
Use during pregnancy, lactation or lay
The safety of the product has not been established during pregnancy and lactation. Do not use in pregnant or lactating bitches or breeding animals.
Interaction with other medicinal products and other forms of interaction
None known.
Amounts to be administered and administration route
The basic dosage is 6-10 mg propentofylline/kg bodyweight, divided into two 3-5mg/kg doses.
To ensure administration of the correct dose, the body weight of the animal should be determined before treatment.
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.
Vitofyllin 50 mg film-coated tablets for dogs:
Bodyweight (kg)
Tablets
Daily total tablets
Daily total dose (mg/kg)
am
pm
2.5 - 4 kg
¼
¼
½
6.3 - 10.0
5 - 7 kg
½
½
1
7.1 - 10.0
8-9 kg
¾
¾
8.3 - 9.4
10 - 15 kg
1
1
2
6.7 - 10.0
16 - 25 kg
3
6.0 - 9.4
26 - 33 kg
2
2
4
6.1 - 7.7
Dogs of more than 20 kg can be given Vitofyllin 100 mg film-coated tablets for dogs.
Vitofyllin 100 mg film-coated tablets for dogs:
Bodyweight (kg)
Tablets
Daily total tablets
Daily total dose (mg/kg)
am
pm
20 - 33 kg
1
1
2
6.0 - 10.0
34 - 49 kg
3
6.1 - 8.8
50 - 66 kg
2
2
4
6.1 - 8.0
67 - 83 kg
5
6.0 - 7.5
More accurate dosing may be achieved by using either quarters of the 100mg tablets or a combination of 100 mg and 50 mg tablets. Dogs of less than 20 kg can be given Vitofyllin 50 mg film-coated tablets for dogs.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Excitation tachycardia, hypotension, reddening of mucous membranes and vomiting.
The withdrawal of the treatment leads to a spontaneous remission of these signs.
Withdrawal period(s)
Not applicable.
Pharmacological particulars
Pharmacotherapeutic group: peripheral vasodilator; purine derivatives; propentofylline
ATCvet code: QC04AD90
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 ionotropic 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.
Propentofylline may increase willingness to exercise and exercise tolerance, particularly in older dogs.
Pharmacokinetic particulars
After oral administration propentofylline is fast and completely absorbed and quickly distributed in the tissues. Given orally to dogs, maximum plasma levels are reached already after 15 minutes.
The half-time is about 30 minutes and the bioavailability for the mother substance amounts to about 30%. There are a number of effective metabolites and the biotransformation takes place mainly in the liver. Propentofylline is excreted in form of its metabolites in 80-90% via the kidneys. The rest is eliminated with the faeces. There is no accumulation.
Pharmaceutical particulars
List of excipients
Lactose monohydrate, Maize Starch, Crospovidone, Talc, Silica, Colloidal Anhydrous, Magnesium Stearate
Film Coating:
Titanium Dioxide, E171, Ferric Oxide, yellow, E 172, Hypromellose, Macrogol 6000, Talc
Incompatibilities
Not applicable.
Shelf-life
Shelf-life of the veterinary medicinal product as packaged for sale: 5 years. Shelf-life of divided tablet portions: 72 hours
Special precautions for storage
Store in the original blister package. Keep the blister packs in the outer carton. Store in a dry place. Divided tablets should be stored in the blister pack.
Nature and composition of immediate packaging
Polyvinylchloride– PolyVinylidene dichloride /Aluminium blister with 14 tablets, in a cardboard box containing 4 blisters (56 tablets).
Polyvinylchloride– PolyVinylidene dichloride /Aluminium blister with 14 tablets, in a cardboard box containing 10 blisters (140 tablets).
Not all pack sizes may be marketed.
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.
Marketing Authorisation Holder (if different from distributor)
Marketing Authorisation Number
50 mg: UK (GB) Vm 10347/4032, UK (Northern Ireland) Vm 10347/4032
100 mg: UK (GB) Vm 10347/4033, UK (Northern Ireland) Vm 10347/4033
Significant changes
Date of the first authorisation or date of renewal
May 2012
Date of revision of the text
April 2017
Any other information
Legal category
Legal category: POM-V
GTIN
GTIN description:Vitofyllin 50mg (56pk)
GTIN:5055037401639
GTIN description:Vitofyllin 100mg (56pk)
GTIN:5055037401653