Pexion 400 mg for dogs – 100 Tabs
1. Pexion 100mg, Pexion 400 mg for dogs – 100 Tabs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains:
Imepitoin 100 mg
Imepitoin 400 mg
The tablet can be divided into equal halves.
4. CLINICAL PARTICULARS
4.1 Target species Dogs
4.2 Indications for use, specifying the target species 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.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients. Do not use in dogs with severely impaired hepatic function, severe renal or severe cardiovascular disorders.
4.4 Special warnings for each target species
The pharmacological response to imepitoin may vary and efficacy may not be complete. On treatment, some dogs will be free of seizures, in other dogs a reduction of the number of seizures will be observed, whilst others will be non-responders. For this reason, careful consideration should be given before deciding to switch a stabilized dog onto imepitoin from a different treatment. In nonresponders, an increase in seizure frequency may be observed. Should seizures not be adequately controlled, further diagnostic measures and other antiepileptic treatment should be considered. When transition between different antiepileptic therapies is medically required, this should be done gradually and with appropriate clinical supervision. 3 The efficacy of the veterinary medicinal product in dogs with status epilepticus and cluster seizures has not been investigated. Therefore, imepitoin should not be used as primary treatment in dogs with cluster seizures and status epilepticus. No loss of anticonvulsant efficacy (tolerance development) during continuous treatment of 4 weeks was observed in experimental studies lasting 4 weeks. No definitive conclusions can be drawn on the effectiveness of imepitoin as an add-on therapy to phenobarbital, potassium bromide and/or levetiracetam from the limited studies available (see section 4.8).
Efficacy for reduction of anxiety and fear associated with noise phobia has not been tested in dogs younger than 12 months. Up to 2 days of pre-treatment may be necessary to achieve optimal anxiolytic efficacy in dogs with noise phobia. See section 4.9 (amounts to be administered and administration route).
4.5 Special precautions for use
Special precautions for use in animals The safety of the veterinary medicinal product has not been tested in dogs weighing less than 2 kg or in dogs with safety concerns such as renal, liver, cardiac, gastrointestinal or other disease. Anxiolytic drugs acting at the benzodiazepine receptor site, such as imepitoin, may lead to disinhibition of fear-based behaviours. The product may therefore result in an increase or decrease in aggression levels. In dogs with a history of aggression problems, a careful benefit-risk evaluation should be made prior to treatment. This evaluation may include consideration of inciting factors or situations associated with previous aggressive episodes. Prior to initiating treatment in these cases, behaviour therapy or referral to a behaviour specialist should be considered. In these dogs, additional measures to mitigate the risk of aggression problems should be implemented as appropriate before treatment is initiated. Mild behavioural or muscular signs may be observed in dogs upon abrupt termination of treatment with imepitoin. The claim for the treatment of noise phobia is based on a pivotal field study which investigated a 3 day course of treatment for a noise event associated with fireworks. Longer treatment durations for noise phobia should be at the benefit-risk assessment of the veterinarian. Consideration should be given to use of a behavioural modification programme. Special precautions to be taken by the person administering the veterinary medicinal product to animals Ingestion of this product may cause dizziness, lethargy and nausea. In case of accidental ingestion especially by a child, seek medical advice immediately and show the package leaflet or the label to the physician. To prevent accidental ingestion of tablets, the cap of the bottle should be replaced immediately after withdrawing the required number of tablets for one administration.
4.6 Adverse reactions (frequency and seriousness)
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). 4 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 phobia The 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).
4.7 Use during pregnancy, lactation or lay The use of the veterinary medicinal product is not recommended in male breeding dogs or in female dogs during pregnancy and lactation (see section 4.10).
4.8 Interaction with other medicinal products and other forms of interaction The product has been used in combination with phenobarbital, potassium bromide and/or in a small number of cases with levetiracetam and no harmful clinical interactions were observed (see section 4.4).
4.9 Amounts to be administered and administration route
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:
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:
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
In case of repeated overdose of up to 5 times the highest recommended dose of 30 mg imepitoin per kg bodyweight, central nervous system (CNS) effects, gastrointestinal-related effects and reversible prolongation of the QT interval have been noted. At such doses, the symptoms are not usually life-threatening and generally resolve within 24 hours if symptomatic treatment is given.
These CNS effects may include loss of righting reflex, decreased activity, eyelid closure, lacrimation, dry eye and nystagmus.
At 5 times the recommended dose, decreased bodyweight may be observed.
In male dogs administered 10 times the upper recommended therapeutic dose, diffuse atrophy of
seminiferous tubules in the testes and associated decreased sperm counts were seen.
See also section 4.7.
4.11 Withdrawal period(s)