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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Epanutin 100 mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100 mg Phenytoin Sodium
Each capsule also contains lactose monohydrate
For full list of excipients, see Section 6.1
3 PHARMACEUTICAL FORM
Capsule, hard.
_Product imported from _the UK:
Half white and half orange capsules marked with “EPANUTIN 100” containing a white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Control of tonic-clonic seizures (grand mal epilepsy), partial seizures (focal including temporal lobe) or a combination
of these, and the prevention and treatment of seizures occurring during or following neurosurgery and/or severe head
injury. Epanutin has also been employed in the treatment of trigeminal neuralgia but it should only be used as second
line therapy if carbamazepine is ineffective or patients are intolerant to carbamazepine.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration only.
_Dosage:_
Dosage should be individualized as there may be wide interpatient variability in phenytoin serum levels with equivalent
dosage. Epanutin should be introduced in small dosages with gradual increments until control is achieved or until toxic
effects appear. In some cases serum level determinations may be necessary for optimal dosage adjustments – the
clinically effective level is usually 10–20mg/l (40–80 micromoles/l) although some cases of tonic-clonic seizures may
be controlled with lower serum levels of phenytoin. With recommended dosage a period of seven to ten days may be
required to achieve steady state serum levels with Epanutin and changes in dosage should not be carried out at intervals
shorter than seven to ten days. Maintenance of treatment should be the lowest
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