Description
Each tablet contains:
Potassium bromide. Plain white circular biconvex tablet with a single scored line on one face.
Indications for use, specifying the target species
This product is indicated for use as an anti-epileptic therapy adjunct to phenobarbital in refractory cases of epilepsy in dogs.
Special warnings for each target species
The concentration of bromide in serum, the clinical response and the therapeutic effect of administration of the product vary between individuals. A high chloride intake can increase the elimination of bromide. Therefore, whilst it is not necessary for dogs receiving this product to be on a low salt diet, an increase in the dogs salt intake may require an adjustment in bromide dose. The salt content of a dogs diet during the treatment period should not be altered drastically, and should be maintained at a stable level. It is advisable not to change the dog’s diet during therapy.
Special Precautions
Do not abruptly discontinue therapy as this may precipitate seizures.
This product should be used with caution in dogs with renal insufficiency. A reduction in chloride intake could cause bromide intoxication.
Special precautions for the person administering the veterinary medicinal
product to animals.
This product can cause skin and eye-irritation. Avoid contact with the eyes.
Wash hands thoroughly immediately after breaking or handling any tablets and before touching eyes. If the product comes in to contact with the eyes, rinse the eyes immediately with plenty of water and seek medical attention if irritation persists. Do not handle this product if you are pregnant, think you are pregnant or if you are breast feeding.
Do not use this product if you have a known sensitivity to bromide.
Discontinue handling this product if you develop any signs of skin irritation, including itchiness, rash, peeling or flaking of skin or redness. Seek medical attention if irritation persists, showing the doctor this information. If this product is ingested, seek medical attention as soon as possible, showing the doctor this information. Advice to doctor: Bromide intoxication can be treated by administration of sodium chloride or a suitable chloruretic agent.
Adverse reactions (frequency and seriousness)
The most common side effects of bromide therapy are somnolence, ataxia (hind
end weakness and loss of coordination), polyuria, polydipsia, nausea which may be
accompanied by vomiting, pancreatitis and erythematous dermatitis (bromide rash).
A less common side effect of bromide therapy is behavioural changes such as irritability or restlessness.
Side effects may appear in dogs on higher doses of therapy, and symptoms usually disappear after the dose is decreased. If the dog appears too sedated, since the product is intended to be used as an adjunct therapy to phenobarbital, it may be preferable to decrease the phenobarbital dose rather than the bromide. If potassium bromide dose is reduced, bromide serum concentrations should be monitored in order to ensure they fall within therapeutic range if seizures begin again. Not for use in pregnant animals or nursing bitches.
Interaction with other medicinal products and other forms of interaction Bromide and chloride compete for re-absorption by the kidneys. A substantial increase in dietary chloride (salt) will cause decreased re-absorption of bromide by the kidneys. This means that if the amount of salt in the diet increases, bromide levels will decrease, which could lead to seizures. Conversely, switching to a diet low in chloride will cause bromide levels to increase, which could cause bromide intoxication. Loop diuretics (e.g. furosemide) can increase bromide excretion and can lower the level of bromide in the blood. Administration of fluids or drug formulations containing chloride would also be expected to lower serum bromide concentrations.
Dosage
Amount(s) to be administered and administration route
LIBROMIDE 325 mg Tablets for Dogs are intended for use in epileptic dogs that have already commenced therapy with phenobarbital for a minimum of approximately 1-2 weeks prior to commencement of therapy with potassium bromide.
The daily dose of Libromide 325 mg Tablets for Dogs is intended to be divided and administered as two portions a day with food (i.e. oral administration). The amounts to be administered are shown below, and depend on the results of therapeutic serum bromide concentration monitoring.
Monitor serum bromide levels regularly:
• Therapeutic serum bromide concentration when used in conjunction with phenobarbital: 800 to 1500 =g Br- /ml
This serum concentration is usually achieved when Libromide is used at 30 mg KBr/kg/day in conjunction with phenobarbital.
For dogs with a bodyweight of 10kg or less the dose regimen may need to be adjusted by the prescribing veterinarian, with due consideration to the pharmacokinetics of the active substance, therapeutic serum bromide levels, clinical effect and a benefit: risk assessment. It is advisable that during commencement of therapy with this product that serum bromide levels are checked regularly e.g. at 4, 8 and 12 weeks post dose administration with Libromide. Close monitoring for side effects is advisable at the
higher therapeutic concentrations.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Bromide toxicity is uncommon. It can occur in dogs with renal insufficiency or those that are on a very high dose of bromide. However, an overdose of this product can produce brominism, characterised by ataxia, somnolence, nausea and pancreatitis
If overdose is suspected, the dosage of the product should be reduced immediately, with close monitoring of bromide serum concentrations in order to establish an appropriate therapeutic level. In cases of overdose, if necessary and appropriate, 0.9% sodium chloride may be used intravenously to reduce serum bromide concentrations.
Pharmacodynamic properties
Potassium bromide is a halide anticonvulsant. Bromide replaces chloride in all body fluids. It competes with chloride transport across nerve cell membranes and inhibits sodium transport and so causes membrane hyperpolarisation. This hyperpolarisation raises the seizure threshold and prevents the spread of epileptic discharges. Bromide has effects on active transport across ganglial cell membranes and affects passive movements of ions by competition with chloride for anion channels in post-synaptic membranes that are activated by inhibitory
neurotransmitters. This potentiates the effect of GABA which results in a synergistic activity of bromide with other drugs that have GABA-ergic activity, such as phenobarbital.
Pharmacokinetic properties
The pharmacokinetics of potassium bromide has been studied in dogs. The half-life is approximately 24 days. Due to this extremely long half-life, it can take several weeks / months to achieve steady state serum concentrations. Potassium bromide is well absorbed orally with peak absorption in about 1.5 hours. Once ingested, the potassium bromide salt dissociates, and the bromide ion is rapidly absorbed by the gastrointestinal tract. After absorption, the bromide ion rapidly distributes, as does chloride, throughout the extra-cellular space and into cells. Chloride is distributed passively across most cell membranes according to the trans-membrane potential, and it is likely that bromide distributes in the same manner. As the bromide level is increased in the body, the concentration of chloride is decreased in direct proportion to the increase in bromide.
Bromide is not metabolised by the body, it enters and leaves the body only as the monovalent anion. Bromide is eliminated from the body by the kidneys. Bromide is not cleared by the liver, so may be used in dogs with hepatic compromise.
List of excipients
Lactose monohydrate
Microcrystalline cellulose
Magnesium stearate
Stearic acid
Sodium saccharin
Incompatibilities
None known.
Nature and composition of immediate packaging
Pack sizes: 100 and 500 tablets.
White, polypropylene container with polypropylene, tamper-evident, push-fit closure.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
