Vetbromide
Active substance
ATC code
Species
Dogs
Indications
An antiepileptic agent for use in the control of idiopathic epileptic seizures, either as a single agent or as an adjunct to phenobarbital in the control of refractory cases of idiopathic epilepsy.
Dose to be administered and administration route
Oral use.
Administer twice daily with food in order to reduce the risk of gastrointestinal irritation.
In dogs with severe and frequent seizures or when a dog is being switched rapidly from phenobarbital to potassium bromide, a loading dose of 60 mg/kg bodyweight twice daily, for 5 days (equivalent to a total daily dose of 120 mg/kg) can be administered in order to quickly reach therapeutic serum concentrations.
The maintenance dose should be titrated to the individual dog as the required dosage and therapeutic serum bromide concentration may vary between animals and depends on the nature and severity of the underlying disease.
Monotherapy:
The recommended starting dose is 30 mg/kg bodyweight twice daily (equivalent to a total daily dose of 60 mg/kg).
Adjunctive treatment, in combination with phenobarbital:
The recommended starting dose is 15 mg/kg bodyweight twice daily (equivalent to a total daily dose of 30 mg/kg). Use in dogs with a bodyweight of less than 10 kg should be subject to a risk/benefit assessment, see section 4.5.
At the beginning of treatment, bromide serum concentrations should be checked regularly, e.g. 1 week and 1 month after the loading period and three months after treatment initiation at maintenance dosage. Therapeutic serum levels vary between 1000 mg/L to 3000 mg/L when potassium bromide is used as monotherapy and between 800 mg/L and 2000 mg/L, when used as adjunctive treatment. Close monitoring for side effects is advisable, particularly when serum bromide concentrations have reached the upper limit of the therapeutic range for monotherapy.
It is recommended to administer at least half of the initial starting dose to dogs with mild or moderate renal insufficiency, with more frequent monitoring of serum bromide levels (see section 4.5).
If the clinical response is not satisfactory or if adverse reactions occur, the dose may be adjusted based on the dog’s serum bromide levels. Serum concentrations should be measured after each dose adjustment once steady state serum levels have been reached (typically 3 months after a change), unless earlier evaluation is necessary. Long term monitoring of serum bromide concentrations should be performed as clinically justified by the individual case.
Adverse reactions
The most commonly reported adverse reactions are:
- polyphagia, with or without weight gain (very common),
- neurologic signs: ataxia, sedation, hind limb weakness (very common),
- polydipsia (very common), with or without polyuria,
- gastrointestinal disorders: loose stools or diarrhoea, vomiting (very common),
- behavioural changes: depression/ apathy, hyperexcitability, aggression (common),
- abnormal snoring (common),
- cough (common),
- loss of appetite (common),
- urinary incontinence and/or nocturnal urination (common) - skin disorders (uncommon).
These adverse reactions may disappear after the first stage of treatment but may also persist in dogs on higher doses of therapy. In these cases, symptoms usually disappear following a reduction in dose. If the dog appears too sedated, assess the serum concentrations of bromide and, if applicable, phenobarbital to determine whether the dose of either should be reduced.
If potassium bromide dose is reduced, serum bromide concentrations should be monitored in order to ensure that they fall within the therapeutic range.
In some cases, an increase in serum cPLi after treatment with KBr was observed. Although pancreatitis has been suggested to occur in association with the administration of bromide and/or phenobarbital, there is no conclusive evidence of a direct causal relationship between bromide administration and the development of pancreatitis in dogs.
Treating dogs with potassium bromide can cause a decrease in T4 plasma concentration, although this is not necessarily clinically relevant.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- 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).
Dispensing
POM-V
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