Valpros Pedia Dosage/Direction for Use

General Dosing Considerations: Daily doses vary according to age, body weight and seizure control. Dose must be carefully and slowly adjusted according to individual requirements and response. Sodium valproate may take several days to show an initial effect; in some cases, it may take from 2 to 6 weeks to exhibit its maximum effect. Measurement of plasma levels may be helpful where there is poor control or side effects are suspected.
Antiepileptic drugs (AEDs) should not be abruptly discontinued in patients in whom the drug is administered to prevent major seizures because of the strong possibility of precipitating status epileptics with attendant hypoxia and threat to life.
Any changes in dose and administration or the addition or discontinuance of concomitant drugs should be accompanied by close monitoring of clinical status and valproate plasma concentrations.
Patients should be informed to take sodium valproate everyday as prescribed. If a dose is missed, it should be taken as soon as possible, unless it is almost time for the next dose. If a dose is skipped, the patient should not double the dose.
Patients who experience gastrointestinal irritation may benefit from administration of sodium valproate with food or by slowly building up the dose from an initial low level.
Sodium valproate syrup should be given in divided doses taken preferably with or after meals. It should not be diluted.
Epilepsy: As Monotherapy, usual requirements are: Children >20 kg: Initially, 400 mg per day (irrespective of weight) with spaced increases until control is achieved (usually within the range of 20 to 30 mg/kg body weight per day). If adequate control of seizure is not achieved within this range, the dose may be increased to 35 mg/kg body weight per day.
Children <20 kg: 20 mg/kg body weight per day. Dose may be increased in severe cases, but only in patients in whom plasma valproate levels can be monitored. In patients receiving doses of > 40 mg/kg body weight per day, clinical chemistry and hematological parameters should be monitored.
Adult Dose: Initially, 600 mg per day increasing by 200 mg per day at 3-day intervals until control is achieved. This is generally within the range of 1,000 to 2,000 mg per day, (i.e., 20 to 30 mg/kg bodyweight per day). Where adequate control is not achieved within this range, the dose may be further increased to a maximum of 2,500 mg per day (in divided doses).
Combined Therapy: When sodium valproate is to be given to patients already on other anticonvulsants, these should be tapered slowly; initiation of sodium valproate should then be gradual, with a target dose being reached after about two weeks. In certain cases, it may be necessary to increase the dose by 5 to 10 mg/kg body weight per day when used in combination with anticonvulsants which induce liver enzyme activity (e.g., phenytoin, phenobarbital and carbamazapine). Once the enzyme inducers have been withdrawn, it may be possible to maintain seizure control on a reduced dose of sodium valproate.
When barbiturates are being given concomitantly and if sedation is observed, the dose of barbiturate should be reduced.
Bipolar Disorder in Adults ≥18 Years Old: Initially, 600 mg per day in 2 to 3 divided doses. From day 2, the dose should be increased as rapidly as possible to achieve the lowest therapeutic dose which produces the desired clinical effect. Daily dose is generally within the range of 1,000 to 2,000 mg per day, (i.e., 20 to 30 mg/kg body weight per day). If adequate control is not achieved within this range, the dose may be increased to a maximum of 2,500 mg per day.
Dosing in Special Populations: Elderly: Due to a decrease in unbound clearance of valproate and possibly a greater sensitivity to somnolence in the elderly, the starting dose should be reduced. Dose should be increased more slowly and with regular monitoring for fluid intake, dehydration, somnolence, urinary tract infection and other adverse events.
Elderly patients who experience excessive somnolence and those with decreased food or fluid intake should consider dose reductions or discontinuation of therapy. Therapeutic dose should be based on both the patents tolerability and clinical response.
Renal Insufficiency: It may be necessary to decrease the dose. Dose should be adjusted according to clinical monitoring since monitoring of plasma concentrations may be misleading.