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VELTILA-500 tablets are for oral administration.
VELTILA should preferably be taken with or after food. The tablets should be swallowed whole and not crushed or chewed.
VELTILA is a controlled release formulation, which reduces peak concentration and ensures a more even plasma concentration throughout the day. VELTILA may be given once or twice daily.
Daily dosage requirements vary according to age and body weight.
In patients where adequate control has been achieved, sodium valproate formulations are interchangeable with other conventional or controlled release formulations on an equivalent daily dosage basis.
For epilepsy: Initial daily dosage is usually 10 to 15 mg/kg. The dosage should be increased by successive dose level at 2-3 day intervals to reach the optimum dosage in about one week.
Adults: This is generally within the range of 1000 to 2000 mg/day (i.e. 20 - 30 mg/kg body mass). If adequate control has not been achieved after two weeks, the dose may be further increased to 2500 mg/day, or one other anti-epileptic agent may be added at a low dosage.
Children: This is usually within the range of 20 to 30 mg/kg of body mass per day. Where adequate control is not achieved within this range, the dose may be increased to 35 mg/kg body mass per day.
VELTILA for the treatment and prevention of mania associated with bipolar disorders: The recommended initial dose is 1000 mg/day. The dose should be increased as rapidly as possible to achieve the lowest therapeutic dose, the dose may be increased to not more than 3000 mg daily which produces the desired clinical effect.
Doses should be adjusted according to individual clinical response.
Prophylactic treatment should be established individually with the lowest effective dose.
Use in the elderly: Although the pharmacokinetics of VELTILA is modified in the elderly, this is of limited clinical significance and dosage should be determined by seizure control. The volume of distribution is increased in the elderly, and because of decreased binding to serum albumin, the proportion of free drug is increased. This will affect the clinical interpretation of plasma valproic acid levels.
In patients with renal insufficiency: It may be necessary to decrease dosage. Dosage should be adjusted according to clinical monitoring since monitoring of plasma concentrations may be misleading (see "Pharmacology: Pharmacokinetics under Actions").
Combined therapy: When starting VELTILA in patients already on other anticonvulsants, substitution with VELTILA should then be gradual, with target dose being reached after about 2 weeks. And other anticonvulsants should be tapered slowly then stopped. 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, phenobarbitone and carbamazepine. Once known enzyme inducers have been withdrawn, or if side-effects, such as tremor, are experienced, it may be possible to maintain seizure control on a reduced dose of VELTILA. When barbiturates are being administered concomitantly and particularly if sedation is observed (particularly in children) the dosage of barbiturate should be reduced.
General considerations: The concentration of valproate in plasma that appears to be associated with therapeutic effects is approximately 30-100 mcg/ml. Optimum dosage is mainly determined by seizure control and routine measurement of plasma levels is unnecessary. However, a method for measurement of plasma levels is available and may be helpful where there is poor control or side-effects are suspected (see "Pharmacology: Pharmacokinetics under Actions").
