POM-V
Prescription Required
Companion Animal
Epiphen Solution 4% w/v, Oral Drops for Dogs
Active ingredient: Phenobarbital
Form
Drops
Species
Dogs
Manufacturer
Vetoquinol UK Limited
VMD MA No.
08007/5018
What it's used for
Phenobarbital is an antiepileptic agent for use in the control of epilepsy in the dog.
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Clinical information
Epiphen Solution 4% w/v, Oral Drops for Dogs — SPC Details
Source: VMD Summary of Product Characteristics (SPC). Last updated 26 Mar 2026.
Phenobarbital is an antiepileptic agent for use in the control of epilepsy in the dog.
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 using the 2ml syringe provided. 1ml contains 40mg of
phenobarbital.
DOSAGE GUIDE
Weight of dogVolume of Epiphen
Solution
Dosage range
mg/kg
1 - 1.5 kg0.1ml2.7 – 4.02 – 3 kg0.2ml2.7 – 4.04 – 5 kg0.4ml3.2 – 4.06 - 9 kg0.7ml3.1 – 4.710 – 15 kg1.2ml3.2 – 4.816 – 20 kg1.6ml3.2 – 4.0
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 µg/ml the dose may be adjusted accordingly. If
seizures recur the dose may be raised up to a maximum serum concentration of
40 µg/ml (see special precautions for use). High plasma concentrations may be
associated with hepatotoxicity. Blood samples should be taken at the same time
to allow plasma phenobarbital concentration to be determined preferably during
trough levels, shortly before the next dose of phenobarbital is due.
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 using the 2ml syringe provided. 1ml contains 40mg of
phenobarbital.
DOSAGE GUIDE
Weight of dogVolume of Epiphen
Solution
Dosage range
mg/kg
1 - 1.5 kg0.1ml2.7 – 4.02 – 3 kg0.2ml2.7 – 4.04 – 5 kg0.4ml3.2 – 4.06 - 9 kg0.7ml3.1 – 4.710 – 15 kg1.2ml3.2 – 4.816 – 20 kg1.6ml3.2 – 4.0
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 µg/ml the dose may be adjusted accordingly. If
seizures recur the dose may be raised up to a maximum serum concentration of
40 µg/ml (see special precautions for use). High plasma concentrations may be
associated with hepatotoxicity. Blood samples should be taken at the same time
to allow plasma phenobarbital concentration to be determined preferably during
trough levels, shortly before the next dose of phenobarbital is due.
Not for use in pregnant animals or nursing bitches.
Do not administer to animals with impaired hepatic function.
Do not use in cases of hypersensitivity to the active substance(s), to any other
barbiturates or to any of the excipients
Do not use in animals with serious renal and/or cardiovascular/respiratory
disorders.
Do not administer to animals with impaired hepatic function.
Do not use in cases of hypersensitivity to the active substance(s), to any other
barbiturates or to any of the excipients
Do not use in animals with serious renal and/or cardiovascular/respiratory
disorders.
Ataxia, somnolence, listlessness and dizziness may occur rarely at the start of
treatment. In some cases, these effects may persist for the entire duration of
treatment.
A paradoxical hyperexcitability may occur rarely, particularly after first starting
therapy. As this hyperexcitability is not linked to overdosage, no reduction of
dosage is needed.
Sedation and ataxia may very rarely become significant concerns as serum levels
reach the higher end of the therapeutic range.
Polyphagia, polyuria and polydipsia have been reported rarely, but these effects
are usually transitory and disappear with continued medication.
Hepatotoxicity may develop very rarely at doses over 20mg/kg/day or when serum
Phenobarbital levels are high (see special precautions for use)
Revised: July 2025
MA split from NI MA following AN: 01034/2025 Page 4 of 8
Phenobarbital can have deleterious effects on stem cells from bone marrow,
immunotoxic pancytopenia and/or neutropenia and anaemia may occur very
rarely.
Superficial necrolytic dermatitis may occur after administration of phenobarbital
very rarely.
Hypoalbuminaemia was rarely reported. Phenobarbital may increase the activity of
serum alkaline phosphatase and transaminases. These may demonstrate non-
pathological changes, but could also represent hepatotoxicity, so liver function
tests are recommended (see section 4.5).
In very rare cases, change of behaviour such as aggression was reported.
If adverse effects are severe, it is recommended to decrease the daily dose.
The frequency of adverse reactions is defined using the following
convention:
- very common (more than 1 in 10 animals treated displaying adverse
reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals
treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated
reports)
treatment. In some cases, these effects may persist for the entire duration of
treatment.
A paradoxical hyperexcitability may occur rarely, particularly after first starting
therapy. As this hyperexcitability is not linked to overdosage, no reduction of
dosage is needed.
Sedation and ataxia may very rarely become significant concerns as serum levels
reach the higher end of the therapeutic range.
Polyphagia, polyuria and polydipsia have been reported rarely, but these effects
are usually transitory and disappear with continued medication.
Hepatotoxicity may develop very rarely at doses over 20mg/kg/day or when serum
Phenobarbital levels are high (see special precautions for use)
Revised: July 2025
MA split from NI MA following AN: 01034/2025 Page 4 of 8
Phenobarbital can have deleterious effects on stem cells from bone marrow,
immunotoxic pancytopenia and/or neutropenia and anaemia may occur very
rarely.
Superficial necrolytic dermatitis may occur after administration of phenobarbital
very rarely.
Hypoalbuminaemia was rarely reported. Phenobarbital may increase the activity of
serum alkaline phosphatase and transaminases. These may demonstrate non-
pathological changes, but could also represent hepatotoxicity, so liver function
tests are recommended (see section 4.5).
In very rare cases, change of behaviour such as aggression was reported.
If adverse effects are severe, it is recommended to decrease the daily dose.
The frequency of adverse reactions is defined using the following
convention:
- very common (more than 1 in 10 animals treated displaying adverse
reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals
treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated
reports)
The decision to start antiepileptic drug therapy with phenobarbital should be
evaluated for each individual case and depends on number, frequency, duration and
severity of seizures in dogs.
To achieve successful therapy, administration of drops should occur at the same
time(s) each day and should be co-ordinated with feeding times in a consistent
manner.
Revised: July 2025
MA split from NI MA following AN: 01034/2025 Page 2 of 8
Withdrawal or transition from other types of antiepileptic therapy should be made
gradually to avoid precipitating an increase in the frequency of seizures.
Some dogs are free of epileptic seizures during the treatment, but some dogs show
only a seizure reduction, and some dogs are considered to be non-responders.
(i) Special precautions for use in animals
Caution is recommended in animals with:
- impaired hepatic and renal function
- hypovolemia, anaemia and
- cardiac or respiratory dysfunction
The chance of hepatotoxic side effects can be diminished or delayed using the
minimum effective dose. Monitoring of hepatic parameters is recommended in case
of a prolonged therapy.
It is recommended to assess the clinical pathology of the patient 2-3 weeks after start
of treatment and afterwards every 4-6 months, e. g. measurement of hepatic
enzymes and serum bile acids. It is important to know that the effects of hypoxia etc.
do cause increased levels of hepatic enzymes after a seizure.
Phenobarbital may increase the activity of serum alkaline phosphatase and
transaminases. These may demonstrate non-pathological changes but could also
represent hepatotoxicity. Therefore, in the case of suspected hepatotoxicity, liver
function tests are recommended.
Treating dogs with phenobarbital may lower TT4 or FT4 serum levels, however this
may not be an indication of hypothyroidism. Treatment with thyroid hormone
replacement should only be started if there are clinical signs of the disease.
In stabilised epileptic patients, it is not recommended to switch between
phenobarbital formulations. However, if this cannot be avoided then additional
caution should be taken. This includes more frequent plasma concentration sampling
to ensure that therapeutic levels are maintained. Monitoring for increased side effects
and for hepatic dysfunction should be conducted more regularly until stabilisation is
confirmed.
A wide therapeutic range of phenobarbital concentration in the serum of 15 mg/l to
40 mg/l is often stated. Optimal seizure control is achieved in most dogs with a serum
phenobarbital concentration of between 25
more than 35 mg/l should be avoided due to increased risk of hepatotoxicity. Below
these ranges, in dogs with good seizure control, no change of dose may be
necessary, as the concentration may be sufficient for that individual. As a general
guide, serum phenobarbital concentration should be the lowest to achieve a
decrease in seizure frequency of greater than 50%, or absence of seizures where
possible, without intolerable side effects.
Revised: July 2025
MA split from NI MA following AN: 01034/2025 Page 3 of 8
(ii) Special precautions to be taken by the person administering the
veterinary medicinal product to animals
Flammable, keep away from sources of ignition. Do not smoke.
People with known hypersensitivity to phenobarbital or other
barbiturates should avoid contact with this veterinary medicinal
product.
It is advisable to wear disposable gloves when handling the product, to
reduce skin contact.
Phenobarbital is a teratogen and developmental neurotoxicant and
transfers to breast milk.
The product should not be administered by pregnant women, women
intending to become pregnant or whose pregnancy status is unknown,
as well as lactating women.
Ingestion of Phenobarbital can cause neurotoxicity which may prove
fatal. Take utmost care that children do not come into any contact with
the product. Children are particularly at risk of intoxication. To prevent
accidental ingestion of phenobarbital, the vial should be closed
immediately after withdrawing the required number of drops for one
administration. The vial should be stored in a safe place out of the
sight and reach of children.
In case of accidental ingestion, seek medical advice immediately and
show the package leaflet or the label to the physician. If possible, the
physician should be informed about the time and amount of ingestion,
as this information may help to ensure that appropriate treatment is
given.
Wash hands after use.
evaluated for each individual case and depends on number, frequency, duration and
severity of seizures in dogs.
To achieve successful therapy, administration of drops should occur at the same
time(s) each day and should be co-ordinated with feeding times in a consistent
manner.
Revised: July 2025
MA split from NI MA following AN: 01034/2025 Page 2 of 8
Withdrawal or transition from other types of antiepileptic therapy should be made
gradually to avoid precipitating an increase in the frequency of seizures.
Some dogs are free of epileptic seizures during the treatment, but some dogs show
only a seizure reduction, and some dogs are considered to be non-responders.
(i) Special precautions for use in animals
Caution is recommended in animals with:
- impaired hepatic and renal function
- hypovolemia, anaemia and
- cardiac or respiratory dysfunction
The chance of hepatotoxic side effects can be diminished or delayed using the
minimum effective dose. Monitoring of hepatic parameters is recommended in case
of a prolonged therapy.
It is recommended to assess the clinical pathology of the patient 2-3 weeks after start
of treatment and afterwards every 4-6 months, e. g. measurement of hepatic
enzymes and serum bile acids. It is important to know that the effects of hypoxia etc.
do cause increased levels of hepatic enzymes after a seizure.
Phenobarbital may increase the activity of serum alkaline phosphatase and
transaminases. These may demonstrate non-pathological changes but could also
represent hepatotoxicity. Therefore, in the case of suspected hepatotoxicity, liver
function tests are recommended.
Treating dogs with phenobarbital may lower TT4 or FT4 serum levels, however this
may not be an indication of hypothyroidism. Treatment with thyroid hormone
replacement should only be started if there are clinical signs of the disease.
In stabilised epileptic patients, it is not recommended to switch between
phenobarbital formulations. However, if this cannot be avoided then additional
caution should be taken. This includes more frequent plasma concentration sampling
to ensure that therapeutic levels are maintained. Monitoring for increased side effects
and for hepatic dysfunction should be conducted more regularly until stabilisation is
confirmed.
A wide therapeutic range of phenobarbital concentration in the serum of 15 mg/l to
40 mg/l is often stated. Optimal seizure control is achieved in most dogs with a serum
phenobarbital concentration of between 25
more than 35 mg/l should be avoided due to increased risk of hepatotoxicity. Below
these ranges, in dogs with good seizure control, no change of dose may be
necessary, as the concentration may be sufficient for that individual. As a general
guide, serum phenobarbital concentration should be the lowest to achieve a
decrease in seizure frequency of greater than 50%, or absence of seizures where
possible, without intolerable side effects.
Revised: July 2025
MA split from NI MA following AN: 01034/2025 Page 3 of 8
(ii) Special precautions to be taken by the person administering the
veterinary medicinal product to animals
Flammable, keep away from sources of ignition. Do not smoke.
People with known hypersensitivity to phenobarbital or other
barbiturates should avoid contact with this veterinary medicinal
product.
It is advisable to wear disposable gloves when handling the product, to
reduce skin contact.
Phenobarbital is a teratogen and developmental neurotoxicant and
transfers to breast milk.
The product should not be administered by pregnant women, women
intending to become pregnant or whose pregnancy status is unknown,
as well as lactating women.
Ingestion of Phenobarbital can cause neurotoxicity which may prove
fatal. Take utmost care that children do not come into any contact with
the product. Children are particularly at risk of intoxication. To prevent
accidental ingestion of phenobarbital, the vial should be closed
immediately after withdrawing the required number of drops for one
administration. The vial should be stored in a safe place out of the
sight and reach of children.
In case of accidental ingestion, seek medical advice immediately and
show the package leaflet or the label to the physician. If possible, the
physician should be informed about the time and amount of ingestion,
as this information may help to ensure that appropriate treatment is
given.
Wash hands after use.
Phenobarbital may reduce the activity of some drugs by increasing the rate of
metabolism through induction of drug-metabolising enzymes in liver microsomes.
A therapeutic dose of phenobarbital for antiepileptic therapy can significantly
induce plasma protein (such as glycoprotein, AGP), which bind drugs.
Therefore, special attention must be paid to the pharmacokinetics and doses of
drugs simultaneously administered.
The plasmatic concentration of cyclosporine, thyroid hormones and theophylline
is decreased in the case of concurrent administration of phenobarbital. The
effectiveness of these substances is diminished, too.
Concurrent use with potassium bromide increases the risk of pancreatitis.
Concurrent use with other drugs having a central depressive effect can result in
an increase of the effect of central depressive drugs.
Phenobarbital may enhance the metabolism of, and therefore decrease the effect
of, antiepileptics, chloramphenicol, corticosteroids, doxycycline, beta blockers
and metronidazole.
The reliability of oral contraceptives is lower.
Phenobarbital may decrease the blood concentration of griseofulvin by reducing
its absorption and/or inducing hepatic microsomal enzymes.
The following drugs can decrease the convulsive threshold: quinolones, high
doses of antibiotic, theophylline, aminophylline, cyclosporine and
propofol for example). Medications which may alter the seizure threshold should
only be used if really necessary and when no safer alternative exists.
Use of phenobarbital in conjunction with primidone is not recommended as
primidone is predominantly metabolised to phenobarbital.
Revised: July 2025
MA split from NI MA following AN: 01034/2025 Page 6 of 8
metabolism through induction of drug-metabolising enzymes in liver microsomes.
A therapeutic dose of phenobarbital for antiepileptic therapy can significantly
induce plasma protein (such as glycoprotein, AGP), which bind drugs.
Therefore, special attention must be paid to the pharmacokinetics and doses of
drugs simultaneously administered.
The plasmatic concentration of cyclosporine, thyroid hormones and theophylline
is decreased in the case of concurrent administration of phenobarbital. The
effectiveness of these substances is diminished, too.
Concurrent use with potassium bromide increases the risk of pancreatitis.
Concurrent use with other drugs having a central depressive effect can result in
an increase of the effect of central depressive drugs.
Phenobarbital may enhance the metabolism of, and therefore decrease the effect
of, antiepileptics, chloramphenicol, corticosteroids, doxycycline, beta blockers
and metronidazole.
The reliability of oral contraceptives is lower.
Phenobarbital may decrease the blood concentration of griseofulvin by reducing
its absorption and/or inducing hepatic microsomal enzymes.
The following drugs can decrease the convulsive threshold: quinolones, high
doses of antibiotic, theophylline, aminophylline, cyclosporine and
propofol for example). Medications which may alter the seizure threshold should
only be used if really necessary and when no safer alternative exists.
Use of phenobarbital in conjunction with primidone is not recommended as
primidone is predominantly metabolised to phenobarbital.
Revised: July 2025
MA split from NI MA following AN: 01034/2025 Page 6 of 8
0.125ml per kg) bodyweight per day. The dose should be divided and
administered twice daily using the 2ml syringe provided. 1ml contains 40mg of
phenobarbital.
DOSAGE GUIDE
Weight of dogVolume of Epiphen
Solution
Dosage range
mg/kg
1 - 1.5 kg0.1ml2.7 – 4.02 – 3 kg0.2ml2.7 – 4.04 – 5 kg0.4ml3.2 – 4.06 - 9 kg0.7ml3.1 – 4.710 – 15 kg1.2ml3.2 – 4.816 – 20 kg1.6ml3.2 – 4.0
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 µg/ml the dose may be adjusted accordingly. If
seizures recur the dose may be raised up to a maximum serum concentration of
40 µg/ml (see special precautions for use). High plasma concentrations may be
associated with hepatotoxicity. Blood samples should be taken at the same time
to allow plasma phenobarbital concentration to be determined preferably during
trough levels, shortly before the next dose of phenobarbital is due.
4.10 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.
4.11 Withdrawal period(s)
N/A
Revised: July 2025
MA split from NI MA following AN: 01034/2025 Page 7 of 8
5.
administered twice daily using the 2ml syringe provided. 1ml contains 40mg of
phenobarbital.
DOSAGE GUIDE
Weight of dogVolume of Epiphen
Solution
Dosage range
mg/kg
1 - 1.5 kg0.1ml2.7 – 4.02 – 3 kg0.2ml2.7 – 4.04 – 5 kg0.4ml3.2 – 4.06 - 9 kg0.7ml3.1 – 4.710 – 15 kg1.2ml3.2 – 4.816 – 20 kg1.6ml3.2 – 4.0
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 µg/ml the dose may be adjusted accordingly. If
seizures recur the dose may be raised up to a maximum serum concentration of
40 µg/ml (see special precautions for use). High plasma concentrations may be
associated with hepatotoxicity. Blood samples should be taken at the same time
to allow plasma phenobarbital concentration to be determined preferably during
trough levels, shortly before the next dose of phenobarbital is due.
4.10 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.
4.11 Withdrawal period(s)
N/A
Revised: July 2025
MA split from NI MA following AN: 01034/2025 Page 7 of 8
5.
This information is sourced from the official Summary of Product Characteristics (SPC) published by the Veterinary Medicines Directorate (VMD). It is provided for informational purposes only and does not replace professional veterinary advice. Always consult your vet before administering any medication.
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Related Conditions
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