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Libromide 325mg Tablets for Dogs

  • Pot of 100 £34.65
  • Pot of 500 £173.42
  • Priced per Tablet £0.34

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Description

Libromide comes in tablets containing 325mg of potassium bromide (KBr). It is used to treat epilepsy in dogs and is usually combined with phenobarbitone (phenobarbital or "Epiphen"). Treated dogs are much less likely to have fits (seizures), but if any do occur, they are likely to be milder and last for a shorter time. Dogs have to take Libromide every day for a few weeks before the full effects are achieved. The amount of salt in the dog's diet affects how much potassium bromide is in the blood stream, so blood tests are often needed to establish the correct dose for a particular dog.

Side effects are seen in some dogs which are particularly sensitive to potassium bromide, or in cases of overdose. The main side effects are sleepiness and weak or incoordinate hind legs, increased thirst and nausea. These soon pass if treatment is temporarily withdrawn, or continued at a lower dose. Sometimes it is more appropriate to reduce the dose of the phenobarbitone instead, which has similar side effects.

Qualitative and quantitative composition

Each tablet contains: Active substance:

Potassium bromide 325 mg

For a full list of excipients, see Excipients.

Pharmaceutical form

Tablet. Plain white circular biconvex tablet with a single scored line on one face. The tablets can be divided into equal halves.

Clinical particulars

Target species

Dogs.

Indications for use

An anti-epileptic agent for use as an adjunct to phenobarbital in the control of refractory cases of epilepsy in dogs.

Contraindications

None.

Special warnings for each target species

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 in animals

Do not abruptly discontinue therapy as this may precipitate seizures.

Signs of intoxication (see Overdose) may occur when administering this product to animals with renal insufficiency; in this case the dose should be reduced.

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 Libromide 325 mg tablet is 162.5 mg, see Amounts to be administered and administration route.

Special precautions for 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.

Do not use this product if you have a known sensitivity to bromide.

Wash hands thoroughly immediately after breaking or handling any tablets.

Discontinue handling this 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.

Adverse reactions

Commonly reported adverse reactions include polyuria/polydipsia, polyphagia, vomiting, somnolence, ataxia (hind end weakness and loss of coordination), nausea and erythematous dermatitis (bromide rash).

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.

Use during pregnancy and lactation

Safety 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 or lactation should be subject to a benefit/risk assessment by the responsible veterinarian.

Interactions

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 Overdose section).

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.

Amounts 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 body weight 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 benefit/risk assessment, see Special precautions for use in animals.

Overdose

Clinical signs of bromide toxicity, such as ataxia, somnolence, 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.

Pharmacological particulars

Pharmacotherapeutic group: Psycholeptics: Other hypnotics and sedatives: Bromides.

ATC Vet code: QN05CM11

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 glial 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 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 concentration 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. Excretion of bromide is mainly via the kidneys, where it competes with chloride for tubular reabsorption.

Pharmaceutical particulars

Excipients

Lactose monohydrate, microcrystalline cellulose, magnesium stearate, stearic acid, sodium saccharin.

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years. Use any halved tablet within 12 hours.

Special precautions for storage

This product does not require any special temperature storage conditions. Keep the tablet container tightly closed in order to protect from moisture. Keep out of the reach and sight of children. Do not use after the expiry date stated on the label after EXP.

Immediate packaging

Pack sizes: 100 and 500 tablets. Not all pack sizes may be marketed. White, polypropylene container with polypropylene, tamper-evident, push-fit closure.

Disposal

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Marketing authorisation holder (if different from distributor)

Dechra Limited, Dechra House, Jamage Industrial Estate, Talke Pits, Stoke-on-Trent, Staffordshire, ST7 1XW.

Marketing authorisation number

Vm 10434/4073.

Date of the first authorisation or date of renewal

04.02.2010

Date of revision of the text

November 2011

Any other information

For animal treatment only. To be supplied only on veterinary prescription.

Manufacturer for the batch release: Surepharm Services Limited, Bretby Business Park, Ashby Road, Bretby, Burton-on-Trent, Staffordshire, DE15 0YZ.

Legal category

POM-V

GTIN (Global Trade Item No)

Libromide 325 mg Tablets for Dogs 100 tablets:

5701170321524

Libromide 325 mg Tablets for Dogs 500 tablets:

5701170321531

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