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Contra-indications, warnings, etc
Do not use in known cases of hypersensitivity to the active substance, or to any of the excipients.
Do not use in dogs with severe renal insufficiency.
Adverse reactions (frequency and seriousness)
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).
Special precautions for use
Special precautions for use in animals
Do not abruptly discontinue therapy as this may precipitate seizures.
This product should be used with caution in dogs with mild or moderate renal insufficiency, since excretion of bromide is reduced. To prevent bromide accumulation and a relative overdose of bromide, administer a reduced dose and monitor the serum bromide concentration closely.
A reduction in chloride intake (low sodium diet) can increase the likelihood of adverse reactions or bromide intoxication.
Close monitoring for adverse reactions is advisable at higher serum bromide concentrations.
Administration on an empty stomach may induce vomiting.
Dogs weighing less than 10 kg cannot be accurately dosed with the recommended starting dose for adjunctive treatment of 15 mg/kg twice daily, as the minimum dose achievable by division of the Vetbromide 600 mg tablet is 150 mg.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
This product may cause eye-irritation. Avoid hand-to-eye contact. If the product comes into contact with the eyes, rinse immediately and thoroughly with clean water.
This product may be harmful upon ingestion, and cause adverse effects such as nausea and vomiting. Avoid oral ingestion including hand-to-mouth contact. To avoid accidental ingestion, particularly by a child, unused tablet parts should be returned to the open blister space and inserted back into the carton. Store in a closed cabinet. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. Wash hands thoroughly, immediately after breaking or handling tablets.
To the physician:
An intravenous administration of isotonic sodium chloride (0.9%) will rapidly eliminate bromide ions in humans.
Use during pregnancy, lactation or lay
Studies in laboratory animals have not revealed any adverse effects of potassium bromide on reproduction at non-maternotoxic doses. The safety of the veterinary medicinal product has not been established during pregnancy and lactation in dogs.
Use only according to the benefit/risk assessment by the responsible veterinarian.
Potassium bromide crosses the placental barrier. Since bromide may be excreted into milk, monitor suckling puppies for somnolence/sedative effects; if necessary, consider early weaning, or an artificial suckling method.
Interaction with other medicinal products and other forms of interaction
Due to the competition between chloride ions and bromide ions for reabsorption by the kidneys, any major change in chloride intake can modify serum bromide concentrations which are directly correlated to treatment efficacy and the occurrence of adverse reactions. A reduction in chloride intake (low sodium diet) can cause a rise in serum bromide levels and increase the likelihood of bromide intoxication. An increase in chloride intake (high salt diet) can cause a fall in serum bromide levels which could lead to seizures. Where possible, the diet of treated dogs should therefore not be altered. Seek veterinary advice before making any change to the dog's diet.
On biochemistry profiles serum chloride concentrations are often falsely elevated because the assays cannot distinguish between chloride and bromide ions.
Loop diuretics such as furosemide can increase bromide excretion and lower the efficacy of the treatment (risk of recurrence of seizures) if the dose is not adjusted.
Administration of fluids or drug formulations containing chloride can lower serum bromide concentrations.
Bromide is synergistic with other GABA-ergic drugs such as phenobarbital.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Clinical signs of bromide toxicity (e.g. ataxia, somnolence) can occur in dogs with renal insufficiency or when a very high dose of bromide is administered. If overdose is suspected, the dosage should be reduced immediately, with close monitoring of serum bromide concentrations in order to establish an appropriate therapeutic concentration. Dose and serum bromide levels at which intolerance is observed vary between dogs. In cases of overdose requiring medical attention, administer 0.9% sodium chloride solution intravenously to reduce serum bromide concentrations.