PEXION 400MG 100 TABLETS | ANTIEPILEPTIC FOR DOGS

PEXION 400MG Oral Antiepileptic Tablet for Dogs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One tablet contains:

Active substance:

• Imepitoína 100 mg
• Imepitoína 400 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

White, scored, oblong tablets with the logo “I 01” (100 mg) or “I 02” (400 mg) debossed on one side.

The tablet can be divided into equal halves.

4. CLINICAL DATA

4.1 Target species

Dogs

4.2 Indications for use, specifying the target species

To reduce the frequency of generalized seizures due to idiopathic epilepsy in dogs using it after careful evaluation of alternative treatment options.

To reduce anxiety and fear associated with noise phobia in dogs.

4.3 Contraindications

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 liver function, with severe kidney disorders or with severe cardiovascular disorders.

4.4 Special warnings for each target species

Idiopathic epilepsy

The pharmacological response to imepitoin may vary and the efficacy may not be complete. Some dogs will not have seizures with treatment, others will see a reduction in the number of seizures, while other dogs will not respond to treatment. For this reason, before deciding to switch a dog stabilized with another treatment to imepitoin, it should be carefully considered. In those who do not respond, an increase in seizure frequency may be observed. When seizures are not adequately controlled, other diagnostic measures and other antiepileptic treatments should be considered. When a transition between different antiepileptic therapies is medically required, it should be done gradually and with appropriate clinical supervision.

The efficacy of the veterinary medicinal product has not been investigated in dogs with status epilepticus and cluster seizures. Therefore, imepitoin should not be used as primary treatment in dogs with cluster seizures and status epilepticus.

In 4-week experimental studies, no loss of anticonvulsant efficacy (development of tolerance) was observed during continuous 4-week treatment.

No definitive conclusions can be drawn on the efficacy of imepitoin as an add-on treatment to phenobarbital, potassium bromide and / or levetiracetam from the limited studies available (see section 4.8).

Noise phobia

Efficacy in reducing anxiety and fear associated with noise phobia in dogs younger than 12 months has not been evaluated.

For optimal anxiolytic efficacy in dogs with noise phobia, a pretreatment of up to 2 days may be necessary. See section 4.9 (Posology and route of administration).

Idiopathic epilepsy

Oral administration in doses between 10 mg and 30 mg of imepitoin per kg of body weight twice a day, separated by an interval of approximately 12 hours. The tablets can be divided for precise administration based on the weight of the dog. Any split tablet should be used in the next administration.

The dosage required will vary between dogs and will depend on the severity of the disease.

The recommended starting dose of imepitoin is 10 mg per kg of body weight twice a day.

Treatment should be started using the weight in kg and the dosage table. If the seizures are not adequately reduced after a minimum of 1 week of treatment at the current dose, the veterinarian should retest the dog. Assuming that the veterinary drug is well tolerated by the dog, the dose can be increased from 50 to 100%, up to a maximum dose of 30 mg per kg administered twice daily.

Bioavailability is higher when administered to fasting dogs. The schedule of administration of the tablets in relation to meals should remain constant.

The number of tablets (to be administered twice a day) for the initiation of epilepsy treatment is as follows:

Dose: 10 mg / kg twice a day

Noise phobia

Oral administration in doses of 30 mg of imepitoin per kg of body weight twice a day, separated by an interval of approximately 12 hours.

The tablets can be divided for precise administration based on the weight of the dog.

Treatment should start 2 days before the expected day of the noise episode and continue during the noise episode using the weight in kg and the dosage table.

Bioavailability is higher when administered to fasting dogs. The schedule of administration of the tablets in relation to meals should remain constant.

The number of tablets (to be administered twice a day) for the treatment of noise phobia is as follows:

Dose: 30 mg / kg twice daily

PEXION 400MG

Pexion