EPIROL Tablet Ref.[115236] Active ingredients: Valproic acid

Epirol should preferable be taken with or after food. The tablets should be swallowed, preferably with water, but not with aerated water.

Adult dose

Dosage should start at 600 mg per day in divided doses. The dosage may then be increased by 200 mg per day at three day intervals until control has been established.

Optimum control is usually obtained with doses of 1000 to 1600 mg per day. If adequate control has not been achieved after two weeks, the dose may be further increased, by stages, to a maximum of 2600 mg per day, or one other anti-epileptic agent may be added at a low dosage. In patients already receiving other therapy, the same pattern should be followed. Dosage of both Epirol and other agents should be adjusted, during the stabilisation period to give optimum control at the lowest possible combined dosage level, and it may be found possible to maintain optimum control with Epirol alone.

Children

Over 20 kg: Initial dosage should be 400 mg per day irrespective of mass, in divided doses with spaced increases until control is achieved. This is usually within the range of 20 to 30 mg per kg body mass per day.

Under 20 kg: 20 mg per kg of body mass per day. In severe cases up to 50 mg/kg/day. A dose of 50 mg/kg should be exceeded only in patients in whom plasma valproate levels are measured; plasma levels of 200 μg/ml should be exceeded only with caution and with monitoring of clinical chemistry and haematological function.

Once known enzyme-inducers (e.g. phenytoin, phenobarbitone, carbamazepine) have been withdrawn, or if side effects, such as tremor, are experienced, it may be possible to reduce the dose of Epirol, while still maintaining seizure control. A method of measuring plasma levels is available, should this be considered helpful; however, seizure control must ultimately determine the optimum dosage.

Known symptoms of overdosage and particulars of its treatment

For symptoms of overdosage - see side-effects.

Treatment consists of induced vomiting, gastrict lavage, assisted ventilation, forced diureses and other supportive measures. Naloxone has been used successfully in one patient.

It has been suggested that gastric lavage may be of limited value in view of the rapid absorption of valproic acid. Thus particular attention should be paid to maintaining an adequate urinary output.

Store in a dry place below 25°C and protect from light. Keep out of reach of children.

As the tablets are hygroscopic they must not be removed from their foil wrapper until ready for administration.

Amber glass bottles containing 100 and 500 tablets plus a dessicant or packs of 100 and 500 tablets of 200 mg packed in foil strips.