Libromide (> 11 kg)
Active substance
ATC code
Species
Dogs
Indications
An anti-epileptic agent for use as an adjunct to phenobarbital in the control of refractory cases of epilepsy in dogs.
Dose to be administered and administration route
For oral use. Administer with food.
Administer to dogs with refractory epilepsy, where seizure control is unsatisfactory despite appropriate phenobarbital therapy, when serum phenobarbital concentrations are at a steady-state within the therapeutic range.
The dose should be titrated to the individual dog as the required dosage will depend on the nature and severity of the underlying disease.
Administer with food at an initial dose of 15 mg/kg bodyweight twice daily (equivalent to a total daily dose of 30 mg/kg). Twice daily administration is advised in order to reduce the risk of gastrointestinal disturbances.
Due to the 24 day half-life of bromide, it can take several weeks or months to achieve steady-state serum concentrations. For at least the first three months following commencement of therapy, measure serum bromide concentrations every 4 weeks. The expected therapeutic serum bromide concentration (when used in conjunction with phenobarbital) is 800 to 2000 µg/ml. Adjustments to the dose should be made with regard to the frequency of seizures, the half-life of bromide and the serum bromide concentration. Long term monitoring of serum bromide (and associated phenobarbital) concentrations should be performed as clinically justified by the individual case.
Close monitoring for side effects is advisable at higher serum bromide concentrations.
Use in dogs with a body weight of less than 11 kg should be subject to a risk/benefit assessment, see section 4.5.
Adverse reactions
Dogs receiving potassium bromide in combination with phenobarbital will commonly exhibit elevated serum pancreatic lipase immunoreactivity concentrations (cPLI) which may or may not be associated with clinical signs of pancreatitis.
In cases of pancreatitis or dermatitis, symptomatic treatment may be required. Uncommon adverse reactions also include behavioural changes such as irritability or restlessness.
Adverse clinical signs which may appear in dogs on higher doses of therapy usually disappear following a reduction in dose. If the dog is too sedated, assess the serum concentrations of both bromide and phenobarbital to determine whether the dose of either should be reduced.
If the dose is reduced, measure the serum bromide concentration to ensure it remains within the therapeutic range.
Commonly reported adverse reactions include polyuria/polydipsia, polyphagia, vomiting, somnolence, ataxia (hind end weakness and loss of coordination), nausea and erythematous dermatitis (bromide rash). In rare cases transient diarrhoea may occur. Haemorrhagic diarrhoea, pancreatitis, anorexia, hepatopathy, dyspnoea and vocalisation may appear very rarely.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)
- common (more than 1 but less than 10 animals in 100 animals)
- uncommon (more than 1 but less than 10 animals in 1,000 animals)
- rare (more than 1 but less than 10 animals in 10,000 animals)
- very rare (less than 1 animal in 10,000 animals, including isolated reports).
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Art. Nr. | 10434/4073 |
EAN | 5701170449235 |