Ralvic Chrono
Sodium valproate/valproic acid
Prolonged release tablets ,300 and 500 mg
Composition:
Each prolonged release tablet contains:
200mg Sodium Valproate and 87mg Valproic acid together equivalent to 300mg Sodium Valproate.
Or
333mg Sodium Valproate and 145mg Valproic acid together equivalent to 500mg Sodium Valproate.
Mechanism of action:
Sodium valproate is an anticonvulsant.
The most likely mode of action for valproate is potentiation of the inhibitory action of gamma amino-butyric acid (gaba) through an action on the further synthesis or further metabolism of gaba.
Pharmacokinetics:
the half-life of sodium valproate is usually within the range 8 - 20 hours. It is usually shorter in children.
In patients with severe renal insufficiency it may be necessary to alter dosage in accordance with free plasma valproic acid levels.
The effective therapeutic range for plasma valproic acid levels is 40 - 100mg/litre. The percentage of free (unbound) drug is usually between 6% and 15% of the total plasma levels. An increased incidence of adverse effects may occur with plasma levels above the effective therapeutic range.
Indications:
Epilepsy: primary generalized epilepsy (petit mall absences, various forms of myoclonic and tonic clonic grand mall seizures) partial (focal) epilepsy either alone or as adjuvant therapy
Mania: for the treatment of mania where other therapy has proved inadequate or is inappropriate.
Use in pregnancy (category D ) :
During pregnancy, maternal tonic-clonic seizures and status epilepticus with hypoxia carry a particular risk of death for mother and for the unborn child. The risk of a mother with epilepsy giving birth to a baby with an abnormality is about three times that of the normal population.
Dose and use:
Initial dose is 25 mg/kg/day, increasing as rapidly as possible to achieve therapeutic response or desired plasma level.
The maximum recommended dosage is 60 mg/kg/day.
Start at 10 to 15 mg/kg/day, increasing at 1 week intervals by 5 to 10 mg/kg/day to achieve optimal clinical response; if response is not satisfactory, check valproate plasma level; see full prescribing information for conversion to monotherapy.
The maximum recommended dosage is 60 mg/kg/day.
The recommended starting dose is 500 mg/day for 1 week, thereafter increasing to 1,000 mg/day.
Packaging:
Ralvic Chrono 300mg 30 prolonged release tablets.
Ralvic Chrono 500mg 30 prolonged release tablets.