| Epiphen Tablets for Dogs | 
Epiphen is the most commonly used medication to control fits in dogs resulting from idiopathic epilepsy in the UK. A dose is given twice daily, usually for the rest of the animal's life. Epiphen can be used alone or in conjunction with other medicines. Regular blood tests are recommended to ensure that blood levels of phenobarbitone are appropriate for treatment, and to check for any possible signs of liver trouble. Epiphen side effects are seen on occasions (the main one being liver damage), but these are normally mild as long as blood tests are performed periodically by your vet to monitor treatment progress. Epiphen is a controlled drug and so certain restrictions apply to its sale. However if you get a written prescription for Epiphen from your vet, Viovet can supply it to you. Place your order online or over the telephone, then send us the original prescription by post. We will send you the Epiphen as soon as we have received the order and prescription.
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| Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication. Introduction 
Company name: Vétoquinol UK Ltd
Address: Vétoquinol House
Great Slade
Buckingham Industrial Park
Buckingham
MK18 1PA
Telephone: 01280 814500
Fax: 01280 825460
Email: office@vetoquinol.co.uk
Website: www.vetoquinol.co.uk
Presentation
Tablets for oral administration.
Phenobarbital tablets are available in two strengths:
White, circular biconvex tablets plain on both sides containing 30 mg phenobarbital.
White, embossed, circular, biconvex tablets containing 60 mg phenobarbital.
Uses
Phenobarbital is an antiepileptic, for use in the control of epilepsy in dogs.
Dosage and administration
The required dosage will differ to some extent between individuals and with the nature and severity of the disorder.
Dogs should be dosed orally, starting with a dose of 2–5 mg per kg bodyweight per day. The dose should be divided and administered twice daily.
Steady state serum concentrations are not reached until 1–2 weeks after treatment is initiated. The full effect of the medication does not appear for two weeks and doses should not be increased during this time.
If seizures are not being controlled, the dosage may be increased by 20% at a time, with associated monitoring of serum phenobarbital levels. The phenobarbital serum concentration may be checked after steady state has been achieved, and if it is less than 15 microgram/ml the dose may be adjusted accordingly. If seizures recur the dose may be raised up to a maximum concentration of 45 microgram/ml. High plasma concentrations may be associated with hepatotoxicity. Blood samples could be taken at the same time to allow plasma phenobarbital concentrations to be determined preferably during trough levels, shortly before the next dose of phenobarbital is due.
Tablets are not intended to be subdivided. For accuracy of dosing, dogs less than 12kg should commence therapy with Epiphen Solution.
Tablets are not intended to be subdivided.
Contra-indications, warnings, etc
Contra-indications
Not for use in pregnant animals. Do not administer to animals with impaired hepatic function.
Special precautions for use in animals
Withdrawal of phenobarbital or transition to or from another type of antiepileptic therapy should be made gradually to avoid precipitating an increase in the frequency of seizures.
Phenobarbital may reduce the activity of some drugs by increasing the rate of metabolism through induction of drug-metabolising enzymes in liver microsomes.
Use of phenobarbital tablets in conjunction with primidone is not recommended as primidone is predominantly metabolised to phenobarbital.
Smaller quantities dispensed from this bulk pack should be supplied in a container with a child resistant closure.
User Warnings
In case of accidental ingestion seek medical attention immediately advising medical services of barbiturate poisoning. Wash hands thoroughly after use.
Adverse Reactions
Occasionally polyphagia, polyuria and polydipsia have been reported, but these effects are usually transitory and disappear with continued medication.
Toxicity may develop at doses over 20 mg/kg/day or when serum phenobarbital levels rise above 45 microgram/ml.
In the light of isolated reports describing hepatotoxicity associated with combination anticonvulsant therapy, it is recommended that:
1.Hepatic function is evaluated prior to initiation of therapy (e.g. measurement of serum bile acids).
2.Therapeutic phenobarbital serum concentrations are monitored to enable the lowest effective dose to be used. Typically concentrations of 15–45 microgram/ml are effective in controlling epilepsy.
3.Hepatic function is re-evaluated on a regular (6 to 12 month) basis.
4.Seizure activity is re-evaluated on a regular basis.
Use during pregnancy or lactation
In humans, mothers receiving antiepileptic medication have a 6 to 10% incidence of significant abnormality in their offspring. Neonatal sedation and drug dependence may occur if given close to term. Phenobarbital crosses the placental barrier and small amounts are excreted in breast milk. For these reasons, phenobarbital is contraindicated in pregnancy and nursing bitches.
Interaction with other medicinal products and other forms of interaction
Phenobarbital will potentially reduce therapeutic levels of a wide range of drugs due to its inducing effect on hepatic enzymes.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Overdosage may result in coma, severe respiratory and cardiovascular depression, hypotension and shock leading to renal failure and death. Following the recent ingestion of an overdose, the stomach may be emptied by lavage. The prime objectives of management are then intensive symptomatic and supportive therapy with particular attention being paid to the maintenance of cardiovascular, respiratory and renal functions and to the maintenance of the electrolyte balance.
Withdrawal period
Not applicable
Pharmaceutical precautions
Do not store above 25°C. Protect from light. Store in a dry place and replace the closure promptly.
Any unused product must be destroyed in accordance with the Misuse of Drugs Regulations (2001). Any waste material should be disposed of in accordance with local requirements.
Legal category
POM-V CD(Sch 3)
Packaging Quantities
Polypropylene tubes with low density polyethylene caps containing 1000 tablets.
Further information
The antiepileptic effects of phenobarbital are probably the result of at least two mechanisms: - Decreased monosynaptic transmission, which presumably results in reduced neuronal excitability and an increase in the motor cortex's threshold for electrical stimulation.
After oral administration of phenobarbital to dogs, the drug is rapidly absorbed and maximal plasma concentrations are reached within 4 - 8 hours. Bioavailability is between 86% - 96%. About 45% of the plasma concentration is protein bound. Metabolism is by aromatic hydroxylation of the phenyl group in the para position, and about one third of the drug is excreted unchanged in the urine. Elimination half-lives vary considerably between individuals and range from about 40 - 90 hours.
Marketing authorisation numbers
Epiphen 60 mg tablets:Vm 08007/4066
Epiphen 30 mg tablets:Vm 08007/4067
Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication. Introduction
Company name: Vétoquinol UK Ltd
Address: Vétoquinol House
Great Slade
Buckingham Industrial Park
Buckingham
MK18 1PA
Telephone: 01280 814500
Fax: 01280 825460
Email: office@vetoquinol.co.uk
Website: www.vetoquinol.co.uk
Presentation
Tablets for oral administration.
Phenobarbital tablets are available in two strengths:
White, circular biconvex tablets plain on both sides containing 30 mg phenobarbital.
White, embossed, circular, biconvex tablets containing 60 mg phenobarbital.
Uses
Phenobarbital is an antiepileptic, for use in the control of epilepsy in dogs.
Dosage and administration
The required dosage will differ to some extent between individuals and with the nature and severity of the disorder.
Dogs should be dosed orally, starting with a dose of 2–5 mg per kg bodyweight per day. The dose should be divided and administered twice daily.
Steady state serum concentrations are not reached until 1–2 weeks after treatment is initiated. The full effect of the medication does not appear for two weeks and doses should not be increased during this time.
If seizures are not being controlled, the dosage may be increased by 20% at a time, with associated monitoring of serum phenobarbital levels. The phenobarbital serum concentration may be checked after steady state has been achieved, and if it is less than 15 microgram/ml the dose may be adjusted accordingly. If seizures recur the dose may be raised up to a maximum concentration of 45 microgram/ml. High plasma concentrations may be associated with hepatotoxicity. Blood samples could be taken at the same time to allow plasma phenobarbital concentrations to be determined preferably during trough levels, shortly before the next dose of phenobarbital is due.
Tablets are not intended to be subdivided. For accuracy of dosing, dogs less than 12kg should commence therapy with Epiphen Solution.
Tablets are not intended to be subdivided.
Contra-indications, warnings, etc
Contra-indications
Not for use in pregnant animals. Do not administer to animals with impaired hepatic function.
Special precautions for use in animals
Withdrawal of phenobarbital or transition to or from another type of antiepileptic therapy should be made gradually to avoid precipitating an increase in the frequency of seizures.
Phenobarbital may reduce the activity of some drugs by increasing the rate of metabolism through induction of drug-metabolising enzymes in liver microsomes.
Use of phenobarbital tablets in conjunction with primidone is not recommended as primidone is predominantly metabolised to phenobarbital.
Smaller quantities dispensed from this bulk pack should be supplied in a container with a child resistant closure.
User Warnings
In case of accidental ingestion seek medical attention immediately advising medical services of barbiturate poisoning. Wash hands thoroughly after use.
Adverse Reactions
Occasionally polyphagia, polyuria and polydipsia have been reported, but these effects are usually transitory and disappear with continued medication.
Toxicity may develop at doses over 20 mg/kg/day or when serum phenobarbital levels rise above 45 microgram/ml.
In the light of isolated reports describing hepatotoxicity associated with combination anticonvulsant therapy, it is recommended that:
1.Hepatic function is evaluated prior to initiation of therapy (e.g. measurement of serum bile acids).
2.Therapeutic phenobarbital serum concentrations are monitored to enable the lowest effective dose to be used. Typically concentrations of 15–45 microgram/ml are effective in controlling epilepsy.
3.Hepatic function is re-evaluated on a regular (6 to 12 month) basis.
4.Seizure activity is re-evaluated on a regular basis.
Use during pregnancy or lactation
In humans, mothers receiving antiepileptic medication have a 6 to 10% incidence of significant abnormality in their offspring. Neonatal sedation and drug dependence may occur if given close to term. Phenobarbital crosses the placental barrier and small amounts are excreted in breast milk. For these reasons, phenobarbital is contraindicated in pregnancy and nursing bitches.
Interaction with other medicinal products and other forms of interaction
Phenobarbital will potentially reduce therapeutic levels of a wide range of drugs due to its inducing effect on hepatic enzymes.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Overdosage may result in coma, severe respiratory and cardiovascular depression, hypotension and shock leading to renal failure and death. Following the recent ingestion of an overdose, the stomach may be emptied by lavage. The prime objectives of management are then intensive symptomatic and supportive therapy with particular attention being paid to the maintenance of cardiovascular, respiratory and renal functions and to the maintenance of the electrolyte balance.
Withdrawal period
Not applicable
Pharmaceutical precautions
Do not store above 25°C. Protect from light. Store in a dry place and replace the closure promptly.
Any unused product must be destroyed in accordance with the Misuse of Drugs Regulations (2001). Any waste material should be disposed of in accordance with local requirements.
Legal category
POM-V CD(Sch 3)
Packaging Quantities
Polypropylene tubes with low density polyethylene caps containing 1000 tablets.
Further information
The antiepileptic effects of phenobarbital are probably the result of at least two mechanisms: - Decreased monosynaptic transmission, which presumably results in reduced neuronal excitability and an increase in the motor cortex's threshold for electrical stimulation.
After oral administration of phenobarbital to dogs, the drug is rapidly absorbed and maximal plasma concentrations are reached within 4 - 8 hours. Bioavailability is between 86% - 96%. About 45% of the plasma concentration is protein bound. Metabolism is by aromatic hydroxylation of the phenyl group in the para position, and about one third of the drug is excreted unchanged in the urine. Elimination half-lives vary considerably between individuals and range from about 40 - 90 hours.
Marketing authorisation numbers
Epiphen 60 mg tablets:Vm 08007/4066
Epiphen 30 mg tablets:Vm 08007/4067
To see more information on this product, please click on the title of the particular section below that you are intrested in.
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Solution containing 4% Phenobarbitone PhEur (INN = phenobarbital).
Phenobarbitone is an antiepileptic agent for use in the control of epilepsy in the dog. Weight of dog
| 30ml bottle
|
|
2kg
|
4-7 drops per day
|
|
5kg
|
8-16 drops per day
|
| The required dosage will differ to some extent between individuals and with the nature and severity of the disorder. Dogs should be dosed orally, starting with a dose of 2.5 - 5.0 mg/kg (0.06 - 0.125ml per kg) bodyweight per day. The dose should be divided and administered twice daily. The volume given may be measured for the 30ml dropper pack by counting out drops. Each drop contains approximately 1.5mg and 1ml contains 40mg of phenobarbitone.
Alternatively, the correct volume may be measured directly using an oral syringe. Weight of dog
| Dose
|
2-4kg
|
0.15 - 0.25ml per day
|
5-9kg
|
0.30 - 0.60ml per day
|
10-14kg
|
0.65 - 1.25ml per day
|
15-19kg
|
0.95 - 1.90ml per day
|
20-29kg
|
1.30 - 2.50ml per day
|
30-39kg
|
1.90 - 3.75ml per day
|
Over 40kg
|
2.50 - 5.00ml per day
|
Steady state serum concentrations are not reached until 1 - 2 weeks after treatment is initiated. The full effect of the medication does not appear for two weeks and doses should not be increased during this time.
If seizures are not being controlled, the dosage may be increased by 20% at a time, with associated monitoring of serum phenobarbitone levels. The phenobarbitone serum concentration may be checked after steady state has been achieved, and if it is less than 15 microgram/ml the dose may be adjusted accordingly. If seizures recur the dose may be raised up to a maximum serum concentration of 45 microgram/ml. High plasma concentrations may be associated with hepatotoxicity. Blood samples should be taken at the same time to allow plasma phenobarbitone concentration to be determined preferably during trough levels, shortly before the next dose of phenobarbitone is due.
Not for use in pregnant animals or nursing bitches.
Do not administer to animals with impaired hepatic function.
Occasionally polyphagia, polyuria and polydipsia have been reported, but these effects are usually transitory and disappear with continued medication.
Toxicity may develop at doses over 20mg/kg/day or when serum phenobarbitone levels rise above 45 microgram/ml.
In the light of isolated reports describing hepatotoxicity associated with combination anticonvulsant therapy, it is recommended that:-
1.Hepatic function is evaluated prior to initiation of therapy (e.g. measurement of serum bile acids).
2.Therapeutic phenobarbitone serum concentrations are monitored to enable the lowest effective dose to be used. Typically concentrations of 15 - 45microgram/ml are effective in controlling epilepsy.
3.Hepatic function is re-evaluated on a regular (6 to 12 month) basis.
4.Seizure activity is re-evaluated on a regular basis.
Withdrawal of phenobarbitone or transition to, or from, another type of antiepileptic therapy should be made gradually to avoid precipitating an increase in the frequency of seizures.
Use of phenobarbitone in conjunction with primidone is not recommended as primidone is predominantly metabolised to phenobarbitone.
Phenobarbitone may reduce the activity of some drugs by increasing the rate of metabolism through induction of drug-metabolising enzymes in liver microsomes.
Overdosage may result in coma, severe respiratory and cardiovascular depression, hypotension and shock leading to renal failure and death. Following the recent ingestion of an overdose, the stomach may be emptied by lavage. The prime objectives of management are then intensive symptomatic and supportive therapy with particular attention being paid to the maintenance of cardiovascular, respiratory and renal functions and to the maintenance of the electrolyte balance.
Withdrawal periods
Not applicable
Operator warnings
In case of accidental ingestion, seek medical attention immediately advising medical services of barbiturate poisoning, or show this container.
Flammable, keep away from sources of ignition. Do not smoke.
Wash hands after use.
Do not store above 25°C.
Protect from light.
Keep container tightly closed
Dispose of in accordance with local authority regulations.
30ml amber glass bottle with integral LDPE dropper and Child Resistant Closure.
The antiepileptic effects of phenobarbitone are probably the result of at least two mechanisms: - Decreased monosynaptic transmission, which presumably results in reduced neuronal excitability and an increase in the motor cortex's threshold for electrical stimulation.
After oral administration of phenobarbitone to dogs, the drug is rapidly absorbed and maximal plasma concentrations are reached within 4 - 8 hours. Bioavailability is between 86% - 96%. About 45% of the plasma concentration is protein bound. Metabolism is by aromatic hydroxylation of the phenyl group in the para position, and about one third of the drug is excreted unchanged in the urine. Elimination half-lives vary considerably between individuals and range from about 40 - 90 hours.  |
