Target species
Dogs.
Indications for use for each target species
An anti-epileptic agent for use as an adjunct to phenobarbital in the control of refractory cases of epilepsy in dogs.
Contraindications
Do not use in cases of known hypersensitivity to bromide, or to any of the excipients.
Do not use in dogs with severe renal insufficiency.
Special warnings
It is advisable not to change the dog’s diet during therapy due to the effect of chloride intake on serum bromide concentrations, see Interactions.
Special precautions for use
Special precautions for safe use in the target species:
Do not abruptly discontinue therapy as this may precipitate seizures.
In renal insufficiency, excretion of bromide is reduced. To prevent bromide accumulation, and a relative overdose of potassium bromide (see Overdose) administer a reduced dose of the veterinary medicinal product and monitor the serum bromide concentration closely.
A reduction in chloride intake could cause bromide intoxication (see Interactions).
Administration on an empty stomach may induce vomiting.
Dogs weighing less than 11 kg cannot be accurately dosed with the recommended initial dose rate of 15 mg/kg twice daily as the minimum dose achievable by division of the veterinary medicinal product is 162.5 mg, see Amounts to be administered and administration route.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Do not handle this product if you are pregnant, think you are pregnant or if you are breast feeding.
People with known hypersensitivity to bromide should avoid contact with the veterinary medicinal product.
Wash hands thoroughly immediately after breaking or handling any tablets.
Discontinue handling the veterinary medicinal product if you develop any signs of skin irritation, including itchiness, rash, peeling or flaking of skin or redness. In case of irritation of the skin or eyes, or in case of accidental self-administration, seek medical advice immediately and show the package leaflet or the label to the physician.
To the physician:
Bromide intoxication can be treated by administration of sodium chloride or a suitable chloruretic agent.
Special precautions for the protection of the environment:
Not applicable.
Other precautions:
Potentially severe side effects can be associated with the use of potassium bromide in cats.
Adverse reactions
Dogs:
Common (1 to 10 animals / 100 animals treated): | High pancreatic-specific lipasea Dermatitis (bromide rash)b Polyuria Polyphagia, polydipsia Vomiting, nausea Somnolence, ataxiac |
Uncommon (1 to 10 animals / 1,000 animals treated): | Behavioural disorders (e.g. restlessness, irritability) |
Rare (1 to 10 animals / 10,000 animals treated): | Diarrhoead |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Pancreatitisb, haemorrhagic diarrhoeaAnorexia Sedatione Hepatopathy Dyspnoea Vocalisation |
a In dogs receiving potassium bromide in combination with phenobarbital. This may or may not be associated
with clinical signs of pancreatitis.
b Symptomatic therapy may be required.
c Hind end weakness and loss of coordination.
d Transient.
e 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.
Adverse clinical signs which may appear in dogs on higher doses of therapy usually disappear following a reduction in dose. If the dose is reduced, measure the serum bromide concentration to ensure it remains within the therapeutic range.
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 the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Pregnancy and lactation:
The safety of the veterinary medicinal product has not been established during pregnancy or lactation in dogs. Although there was no evidence of reproductive toxicity in laboratory animals, bromide can cross the placenta and cases of neonatal bromide toxicity have been reported in humans. In the absence of specific data, continued use during pregnancy should be subject to a benefit/risk assessment by the responsible veterinarian.
Since bromide may be excreted into milk, monitor nursing puppies for somnolescence/sedative effects; if necessary, consider early weaning, or an artificial suckling method.
Interaction with other medicinal products and other forms of interaction
Bromide and chloride compete for re-absorption by the kidneys. Increasing dietary chloride (salt) intake will decrease renal re-absorption of bromide, causing decreased serum bromide concentrations, which could lead to seizures. Conversely, changing to a diet low in chloride will increase serum bromide concentrations, which could cause bromide intoxication (see section "overdose").
Loop diuretics (e.g. furosemide) can increase bromide excretion, lowering serum bromide concentrations.
Administration of fluids or drug formulations containing chloride can lower serum bromide concentrations.
Bromide is synergistic with other GABA-ergic drugs such as phenobarbital.
Administration routes and dosage
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.
The tablets can be divided into halves.
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 "special precautions for use".
To ensure a correct dosage, body weight should be determined as accurately as possible.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
Clinical signs of bromide toxicity, such as ataxia, somnolescence, nausea and pancreatitis may occur in dogs when a high dose is administered.
If overdose is suspected, immediately reduce the dosage. Closely monitor the serum bromide concentration in order to establish an appropriate therapeutic concentration.
In cases of overdose, if necessary and appropriate, administer 0.9% sodium chloride solution intravenously to reduce serum bromide concentrations
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
Withdrawal periods
Not applicable.