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EPITOIN

Composition
Each capsule contains:
Phenytoin sodium 100 mg

Properties and Mode of Action

EPITOIN is an antiepileptic agent used to control tonic-clonic (grand mal) and partial (focal) seizures. It is believed to
stabilise rather than to elevate the seizure threshold and to limit the spread of seizure activity, possibly by promoting
sodium efflux from neurons.
EPITOIN is also considered an anti-arrhythmic agent.
EPITOIN is slowly but almost completely absorbed from the gastro-intestinal tract. It is largely insoluble at the acid pH of
the stomach, most being absorbed from the upper intestine and the absorption is affected by the presence of food.
EPITOIN is extensively metabolised in the liver to inactive metabolites, chiefly 5(4-hydroxy phenyl)-5-phenylhydantion. It
undergoes enterohepatic recycling and is excreted in urine, mainly as its hydroxylated metabolite, in either free or
conjugated form. EPITOIN has a plasma half-life of about 22 hours.

Indications
Control of grand mal and psychomotor seizures.
Prevention and treatment of seizures during and following neurosurgery.
Control of paroxysmal pain in trigeminal neuralgia.
Treatment of blisters and erosion in epidermolysis bullosa.

Dosage and Administration

Anticonvulsant:
Adult Dose:
One capsule (100 mg) three times daily, the dosage being adjusted at 7 - 10 day intervals as needed and tolerated.
Geriatric Dose:
Initially 3 mg/kg body weight daily in divided doses; the doses being adjusted according to the patient's response.
Paediatric Dose:
Initially 5 mg/kg body weight daily divided into two or three doses (not to exceed 300 mg/day).
Antineuralgic:
200 - 600 mg daily in divided doses; the dosage being adjusted as needed and tolerated.
In Epidermolysis Bullosa:
2 - 3 mg/kg body weight daily divided into two doses; the dosage being incresed at 2 - 3 week intervals as needed and
tolerated.

Precautions
Patients intolerant of one hydantoin may also be intolerant of EPITOIN.
EPITOIN crosses the placenta and is excreted in breast milk.
Risk-benefit must be considered for use of EPITOIN during pregnancy and lactation.

Drug Interactions
Concurrent use of EPITOIN with: adrenocorticoids, anticonvulsants, succinimide or carbamazepine, oral contraceptives
containing estrogen, corticotropin, cyclosporin, dacarbazine, digitalis glycoside, doxycycline, estrogens, levodopa,
mexiletine, quinidine may cause decrease in their therapeutic effects and dose adjustment of these medications may be
necessary.
Concurrent use of EPITOIN with alcohol or C.N.S. depressants may enhance C.N.S. depression and may decrease serum
concentrations and effectiveness of EPITOIN. Concurrent use of EPITOIN and aluminium - magnesium - containing and
calcium carbonate - containing antacids may decrease its bioavailability. Doses of EPITOIN and antacids should be
separated by about 2 - 3 hours.
Concurrent use of EPITOIN and anticoagulants (coumarins or indandione dervivative), chloramphenicol, cimetidine,
disulfiram, isoniazid, phenylbutazone or sulphonamides may cause increased serum concentrations of EPITOIN and

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dosage adjustment may be necessary.

EPITOIN may increase serum glucose concentrations with the possibility of hyperglycemia and so when used with oral
antidiabetic agents or insulin, dosage adjustment of either or both medications may be necessary.
EPITOIN depletes the body folate stores but supplementation with folic acid may result in lowered serum EPITOIN
concentrations and possible loss of seizure control, therefore an increase in EPITOIN dose may be necessary in patients
who receive folate supplementation.
Concurrent use of EPITOIN and valproic acid may increase the risk of liver toxicity and doses of EPITOIN must be
adjusted.
Concurrent use of EPITOIN and xanthines (aminophylline, theophylline, caffeine, oxtriphylline) may inhibit its absorption
and decrease EPITOIN serum concentrations.
Concurrent use of EPITOIN and acetaminophen may decrease the therapeutic effect of acetaminophen and its
hepatotoxicity may be increased especially with chronic EPITOIN administration.

Contra_indications
Hypersensitivity to phenytoin.

Side effects
EPITOIN may cause:
Lupus erythematosus, Stevens-Johnson Syndrome or phenytoin hypersensitivity syndrome which may be manifested by
(rash, local or generalized lymphadenopathy, hepatitis or nephritis), tenderness and hyperplasia of the gums particularly in
younger patients, lack of appetite, nausea, vomiting, constipation, headache, dizziness, insomnia, hirsutism,
agranulocytosis, thrombocytopenia, folic acid deficiency.
C.N.S. toxicity (nystagmus, confusion, mood or mental changes, increased frequency of seizures, slurring of speech,
trembling of hands, nervousness and irritability) usually with long-term use, but may be dose-related.

Presentation
Box of 5 or 10 blisters of 10 capsules each.

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