Valpros/Valpros i-IV Dosage/Direction for Use

Valpros: General Dosing Recommendation: The controlled release tablets should be swallowed whole and not crushed or chewed since this may cause inappropriate release and absorption of the drug.
Daily dosage requirements vary according to age and body weight. Dosage must be carefully and slowly adjusted according to individual requirements and response.
Sodium valproate + valproic acid controlled release tablets may be given once or twice daily.
Epilepsy: Therapeutic Dose Range: 1,000 mg to 2,000 mg/day (i.e., 20 to 30 mg/kg/body weight/ day); Where adequate control is not achieved within this range, the dose may be further increased to 2,500 mg/day.
Or, as prescribed by a physician.
Combined Therapy with Anticonvulsants: When sodium valproate + valproic acid is to be given to patients already on other anticonvulants, these should be tapered slowly; initiation of sodium valproate + valproic acid should then be gradual, with a target dose being reached after about two weeks.
In certain cases, it may be necessary to raise the dose by 5 to 10 mg/kg/day when used in combination with anticonvulsants which induce liver enzyme activity (e.g., Phenytoin, phenobarbital and carbamazepine). Once the enzyme inducers have been withdrawn, it may be possible to maintain seizure control on a reduced dose of sodium valproate + valproic acid.
When barbiturates are being given concomitantly and if sedation is observed, the dosage of barbiturate should be reduced.
Bipolar Disorder: Recommended Initial Dose: 20 mg/kg/day; The dose may be adjusted according to individual clinical response. The maximum dose should not exceed 3,000 mg daily.
Recommended Maintenance Dose: 1,000 mg to 2,000 mg/day; Doses should be adjusted according to individual clinical response.
Prophylactic treatment should be established individually with the lowest effective dose.
Or, as prescribed by a physician.
Special Population: Elderly: Although the pharmacokinetics of sodium valproate + valproic acid are modified in the elderly, they have limited clinical significance and dosage should be determined by seizure control.
In the elderly, the volume of distribution is increased and because of decreased binding to serum albumin, the proportion of free drug is increased. This will affect the interpretation of
plasma valproic acid levels.
Patients with Renal Insufficiency: Dose reduction may be necessary. Dosage should be adjusted according to clinical monitoring since monitoring of plasma concentrations may be misleading.
Valpros i-IV: Sodium valproate 400 mg injection is intended for intravenous (IV) use only. It is administered by slow IV injection (3 to 5 minutes) or slow IV infusion.
The use of sodium valproate injection for periods of more than 14 days has not been studied. Patients should be switched to oral valproate products as soon as it is clinically feasible.
Sodium valproate should be diluted with at least 500 mL of a compatible diluent (0.9% sodium chloride, 5% glucose and Lactated Ringer's solution). It should be administered intravenously at an infusion rate of 1 to 2 mg/kg body weight per hour.
Any unused portion of the vial contents should be discarded.
Sodium valproate injection should not be injected intramuscularly as it may produce tissue necrosis.
Sodium valproate injection should not be administered at the same time as other IV additives via the same IV line. The IV solution is suitable for infusion by PVC, polyethylene or glass containers.
Dosing requirements vary according to age and body weight and should be adjusted individually to achieve adequate seizure control.
Recommended Daily Intravenous (IV) Dose: Monotherapy: Adults: Patients already satisfactorily treated with sodium valproate may be continued at their current dosage using continuous infusion. For example, a patient stabilized on 25 mg/kg body weight administered daily should be continued with an infusion rate of 1 mg/kg body weight per hour.
Other patients may be given a slow intravenous injection over 3 to 5 minutes, usually 400 to 800 mg depending on body weight (up to 10 mg/kg), followed by continuous infusion of 1 to 2 mg/kg body weight per hour to a maximum of 2,500 mg per day, according to the patient's clinical response.
Adjunctive Therapy: When starting sodium valproate in patients already on other anticonvulsants, these should be tapered slowly. Initiation of sodium valproate therapy should be gradual, with the target dose being reached after about two weeks. In some 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 carbamazepine). Once known enzyme inducers have been withdrawn, it may be possible to maintain symptom control on a reduced dose of sodium valproate.
Special Population: Pediatric:20 to 30 mg/kg body weight per day; Where adequate control is not achieved within this range, the dose may be increased up to 40 mg/kg body weight per day but only in patients in whom plasma valproate levels can be monitored. Clinical chemistry and hematological parameters should be monitored if more than 40 mg/kg body weight per day.
Elderly: Due to a decrease in unbound valproate clearance and possibly a greater sensitivity to somnolence in the elderly, the starting dose should be reduced in these patients. Subsequent dose should be increased more slowly. Likewise, regular monitoring of fluid and nutritional intake, dehydration, somnolence, and other adverse events is recommended. Dosage reduction or discontinuance of valproate should be considered in the elderly with decreased food or fluid intake and in those with excessive somnolence. The ultimate therapeutic dose in these patients should be determined on the basis of tolerability and clinical response.
Patients with impaired renal function: Lower doses may be required since free drug levels may be high owing to lowered serum albumin and poor urinary excretion of free drug metabolites. As monitoring of plasma concentrations may be misleading, dosage should be adjusted according to clinical monitoring.
Or, as prescribed by a physician.