Epityl vet.
Active substance
ATC code
Species
Dogs
Indications
Prevention of seizures due to generalized epilepsy in dogs.
Dose to be administered and administration route
For oral administration. The required dosage will differ to some extent between individuals and with the nature and severity of the disorder.
Tablets must be given at the same time each day and should be co-ordinated with feeding times in a consistent manner to optimise treatment success.
Dogs should be dosed orally, starting with a dose of 2-5mg per kg bodyweight per day. The dose should be divided and administered twice daily.
Steady-state serum concentrations are not reached until 1-2 weeks after treatment is initiated. The full effect of the medication does not appear for two weeks and doses should not be increased during this time.
If seizures are not being controlled, the dosage may be increased by 20% at a time, with associated monitoring of serum phenobarbital levels. The phenobarbital serum concentration may be checked after steady-state has been achieved, and if it is less than 15 µg/ml the dose may be adjusted accordingly. If seizures recur the dose may be raised up to a maximum serum concentration of 45 µg/ml. High plasma concentrations may be associated with hepatotoxicity. Blood samples could be taken at the same time to allow plasma phenobarbital concentration to be determined preferably during trough levels, shortly before the next dose of phenobarbital is due. Plasma concentrations should be interpreted in conjunction with the observed response to therapy and a full clinical assessment including monitoring for evidence of toxic effects in each animal.
Clinical data suggests that considerable variation in plasma concentrations of phenobarbital may be observed in some animals. This variation may result in an animal with a trough plasma concentration of phenobarbital below the typical minimum therapeutic level (15 µg/ml) and a peak plasma concentration approaching the maximum level (45 µg/ml). If the seizure control is inadequate in such animals, care should be taken when increasing the dose as toxic levels may be reached or exceeded. Peak and trough plasma concentrations of phenobarbital may need to be measured in such animals. (Peak plasma concentrations are reached within approximately 3 hours after administration).
If the seizures are not being satisfactorily controlled and if the maximum plasma concentration of phenobarbital is about 40 µg/ml, then the diagnosis should be reconsidered and/or a second antiepileptic product (such as bromides) should be added to the treatment protocol.
Tablets can be divided into equal halves or quarters to ensure accurate dosing. To break a cross scored tablet into quarters, place the tablet on an even surface with the scored side up and apply pressure on the middle with your thumb.
To break a tablet into two halves, place the tablet on an even surface with the scored side up, hold one half of the tablet and press down on the other half.
Adverse reactions
Dogs:
|
Very rare (<1 animal / 10,000 animals treated, including isolated reports): |
Ataxia (incoordination) and sedation1 Paradoxical hyperexcitability (unusually excitable)2 Polyuria (increased urination), polydipsia (increased thirst) and polyphagia (increased appetite)3 Hepatotoxicity4 Pancytopenia and/or neutropenia5 Low free thyroxine (FT4) or low thyroxine (T4)6 |
1: During start of therapy these effects can occur but are usually transitory and disappear in most, but not all, patients with continued medication. Sedation and ataxia often become significant concerns as serum levels reach the higher ends of the therapeutic range.
2: Some animals can demonstrate a paradoxical hyperexcitability, particularly after first starting therapy. As this hyperexcitability is not linked to overdosage, no reduction of dosage is needed.
3: These effects can occur at average or higher therapeutic active serum concentrations; these effects can be diminished by limiting intake of food.
4: High plasma concentrations may be associated with hepatotoxicity.
5: Phenobarbital can have deleterious effects on stem cells from bone marrow. Consequences are immunotoxic pancytopenia and/or neutropenia. These reactions disappear after the treatment’s withdrawal.
6: Treating dogs with phenobarbital may lower their TT4 or FT4 serum levels, however this may not be an indication of hypothyroidism. Treatment with thyroid hormone replacement should only be started if there are clinical signs of the disease.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See also the package leaflet for respective contact details.
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| Art. Nr. | 08749/5045 |
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