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Epiphen tablets 60mg

Item Number: EPIPHEN60

Epiphen tablets 60mg

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Description


Data Sheets

Epiphen 30 mg and 60 mg Tablets Species:Dogs

Therapeutic indication:Pharmaceuticals: Neurological preparations: Others

Active ingredient:Phenobarbital

Product:Epiphen 30 mg and 60 mg Tablets

Product index:Epiphen Tablets

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.

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:

1Hepatic function is evaluated prior to initiation of therapy (e.g. measurement of serum bile acids).

2Therapeutic 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.

3Hepatic function is re-evaluated on a regular (6 to 12 month) basis.

4Seizure 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

Legal category:POM-V

Legal category description:CD(Sch 3)

Packaging quantities

Polypropylene tubes with low density polyethylene caps or high density polyethylene jar securitainer and polypropylene lid containing a dessiccant (silica gel). Pack size 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 Number

Epiphen 60 mg tablets, UK: Vm 08007/4066

Epiphen 30 mg tablets, UK: Vm 08007/4067

Delivery

Shipping charges mainland UK zone1

ValueWeightDelivery Charge
Over £49.00Any WeightFREE
Under £49.00No weight limit£4.50
Under £49.00Under 250g£2.99

Most orders are despatched the same day and standard delivery is 3 to 5 working days from despatch. FAST Expedited options are available.

NB: Orders placed with faster delivery must be placed before 13:00 to ensure same day dispatch (excluding weekends and bank holidays). Please also check on the product page that the items ordered show 'In Stock' otherwise your order will be delayed until the stock becomes available, which in most cases will only be 24hrs.

Estimated "Usually shipped in" information is shown against most products

Overseas orders

Postage outside of the UK is from £4.50

Prescription Items

Prescription items will be sent on receipt of a valid signed and dated prescription.

Pick up

We offer a pickup service for orders placed over the phone.

Please ring us on 01833 641112 for more information.

Refrigerated Items

Refrigerated items will be sent by carrier or Royal Mail with coolpacks unless you pay for a premium for a refrigerated delivery. We will contact you prior to despatch for your instructions.

Returns

We want you to be completely satisfied with any purchase. If not any item* can be returned to us within 14 days of receipt for exchange or refund Please give us a ring for a returns number on 01833 641112 or alternatively email [email protected] to obtain a returns number.

*Due to legal requirements medicines may not be returned except to correct an error in despatch or in response to an "official recall". If an item is believed to be faulty it should be returned for inspection and it may be necessary to forward it to the manufacturers for testing before replacements or refunds can be authorised. This does not infringe legal rights. Please contact our customer services for a "Returns Number" which must appear on the outside of the package or it will not be accepted. We advise customers to use an insured method of shipping and to retain proof of despatch. We may refuse returns on products specially obtained or manufactured to order. Items must be returned unsoiled and unused and sent adequately packed and carriage paid.

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