Libromide datasheet

Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication. For a non-technical article, please click the link in the blue bar above.
 
 

Introduction

Company name: Dechra Veterinary Products Limited
Address: (A business unit of Dechra Pharmaceuticals PLC)
Sansaw Business Park
Hadnall, Shrewsbury
Shropshire SY4 4AS
Telephone: 01939 211200
Fax: 01939 211201
Email: info@dechra-uk.com
Website: www.dechra.com

Qualitative and quantitative composition

Each tablet contains: Potassium bromide 325 mg.

Pharmaceutical form

Tablet.
Plain white circular biconvex tablet with a single scored line on one face.

Clinical particulars

Target species
Dogs.
Indications for use
This product is indicated for use as an anti-epileptic therapy adjunct to phenobarbital in refractory cases of epilepsy in dogs.
Contraindications
None.
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 (see Amounts for administration and administration route).
A high chloride intake can increase the elimination of bromide (see Interactions). Therefore, whilst it is not necessary for dogs receiving this product to be on a low salt diet, an increase in the dog's salt intake may require an adjustment in bromide dose. The salt content of a dog's 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 for use in animals
Do not abruptly discontinue therapy as this may precipitate seizures.
This product should be used with caution in dogs with renal insufficiency (see Adverse reactions and Overdose).
A reduction in chloride intake could cause bromide intoxication (see Interactions and Overdose).
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 into 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.
Other precautions
For animal treatment only.
Adverse reactions
The most common side effects of bromide therapy are somnolence, ataxia (hind end weakness and loss of coordination), polyuria, polydipsia, and nausea which may be accompanied by vomiting, pancreatitis and erythematous dermatitis (bromide rash).
A less common side effect of bromide therapy is behavioural change, 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.
Use during pregnancy and lactation
Not for use in pregnant animals or nursing bitches.
Interactions
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 (see Special precautions for use in animals and Overdose).
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.
Amounts 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 µg 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 body weight of 10 kg 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
Bromide toxicity is uncommon. It can occur in dogs with renal insufficiency or those that are on a very high dose of bromide (see Special precautions for use in animals and Amounts to be administered and administration route). However, an overdose of this product can produce brominism, characterised by ataxia, somnolence, nausea and pancreatitis (i.e. symptoms similar to those listed under Adverse reactions).
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.
Withdrawal period
Not applicable.

Pharmacological particulars

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

Pharmaceutical particulars

Excipients
Lactose monohydrate
Microcrystalline cellulose
Magnesium stearate
Stearic acid
Sodium saccharin
Incompatibilities
None known.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Special precautions for storage
Keep out of the reach and sight of children.
Immediate packaging
Pack sizes: 100 and 500 tablets.
White, polypropylene container with polypropylene, tamper-evident, push-fit closure.
Not all pack sizes may be marketed.
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)

Genitrix Limited, Genitrix House, Daux House, Billingshurst, West Sussex, RH14 9SJ.

Marketing authorisation number

Vm 19886/4002.

Date of the first authorisation or date of renewal

04.02.2010

Date of revision of the text

04.02.2010

Any other information

Nil.

Legal category

POM-V