Pexion
Active substance
ATC code
Species
Dogs
Indications
For the reduction of the frequency of generalised seizures due to idiopathic epilepsy in dogs for use after careful evaluation of alternative treatment options.
For the reduction of anxiety and fear associated with noise phobia in dogs.
Dose to be administered and administration route
Idiopathic epilepsy
Oral administration at a dose range of 10 mg to 30 mg imepitoin per kg bodyweight twice daily, approximately 12 hours apart. Each tablet can be halved for appropriate dosing according to the individual bodyweight of the dog. Any remaining half-tablet should be used for the next dose.
The required dose will vary between dogs and will depend on the severity of the disorder. The recommended initial dose of imepitoin is 10 mg per kg bodyweight twice daily.
Initiate therapy using the bodyweight in kg and the dosing table. If seizures are not adequately reduced following a minimum of 1 week of treatment at the current dose the supervising veterinary surgeon should re-assess the dog. Assuming that the veterinary medicinal product is well tolerated by the dog, the dose can be increased by 50 to 100% increments up to a maximum dosage of 30 mg per kg administered twice daily.
Bioavailability is greater when administered to fasted dogs. The timing of tablet administration in relation to feeding should be kept consistent.
Number of tablets (to be given twice daily) for initiation of epilepsy treatment:
|
Dose: 10 mg/kg twice daily |
Number of tablets per administration |
|
|
Bodyweight (kg) |
100 mg tablet |
400 mg tablet |
|
5 |
½ |
|
|
5.1–10 |
1 |
|
|
10.1–15 |
1 ½ |
|
|
15.1–20 |
½ |
|
|
20.1–40 |
1 |
|
|
40.1–60 |
1 ½ |
|
|
Over 60 |
2 |
|
Noise phobia
Oral administration at a dose of 30 mg imepitoin per kg bodyweight twice daily, approximately 12 hours apart.
Each tablet can be halved for appropriate dosing according to the individual bodyweight of the dog.
Initiate therapy 2 days prior to the day of the expected noise event and continue through the noise event using the bodyweight in kg and the dosing table below.
Bioavailability is greater when administered to fasted dogs. The timing of tablet administration in relation to feeding should be kept consistent.
Number of tablets (to be given twice daily) for noise phobia treatment:
|
Dose: 30 mg/kg twice daily |
Number of tablets per administration |
|
|
Bodyweight (kg) |
100 mg tablet |
400 mg tablet |
|
2.5 – 3.9 |
1 |
|
|
4 – 5.9 |
1 ½ |
|
|
6 – 7.9 |
2 |
|
|
8 – 10.9 |
3 |
|
|
11 – 15.9 |
1 |
|
|
16 – 22.9 |
1 ½ |
|
|
23 – 29.9 |
2 |
|
|
30 – 36.9 |
2 ½ |
|
|
37 – 43.9 |
3 |
|
|
44 – 49.9 |
3 ½ |
|
|
50 – 55.9 |
4 |
|
|
56 – 71.9 |
4 ½ |
|
|
72 – 80 |
5 |
|
Adverse reactions
The following mild and generally transient adverse reactions have been observed in pre-clinical and clinical studies for the epilepsy claim in order of decreasing frequency: ataxia, emesis, polyphagia at the beginning of treatment, somnolence (very common); hyperactivity, apathy, polydipsia, diarrhoea, disorientation, anorexia, hypersalivation, polyuria (common); prolapsed nictitating membrane and decreased sight (isolated reports).
In epileptic dogs, aggression has been uncommonly reported, and increased sensitivity to sound and anxiety have been rarely reported in the field. These signs are potentially treatment related. They may also be present during the preictal or postictal period or as behaviour changes which occur as part of the disease itself.
A mild elevation in plasma creatinine, urea and cholesterol levels has been observed in dogs treated with imepitoin; however these generally did not exceed the normal reference ranges and were not associated with any clinically significant observations or events.
Noise phobiaThe following adverse reactions have been observed during preclinical and clinical studies conducted to support the noise phobia claim: ataxia, increased appetite, lethargy (very common); emesis, aggression (see section 4.5) (common); hyperactivity, somnolence, hypersalivation (uncommon). Most events are transient, resolving during or shortly after the end of the treatment course.
Transient ataxia was reported very commonly during a clinical trial for noise phobia and occurred early in the treatment course. In more than half of the dogs that experienced ataxia during this clinical trial the signs resolved spontaneously within 24 hours in spite of continued treatment and in half of the remaining dogs within 48 hours.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
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|---|---|
| Art. Nr. | 04491/5040 |
| EAN | 5012917030068 |
