SODIVAL SYP

It is indicated for the treatment of all forms of epilepsy.

Primary anti-epileptic drugs

Sodium Valproate, the active ingredient of this preparation is endowed with anti-epileptic activity against a variety of seizures. The mechanism by which Sodium Valproate exerts its anti-epileptic effects has not been established. However, it has been suggested that its activity is related to increase brain levels of gamma-aminobutyric acid (GABA).

Adults Dosage should start at 600mg in 2 divided doses daily increasing by 200mg at three-day intervals to a maximum 2500mg per day in divided doses until control is achieved. Usual maintenance dose: 1-2g per day (20-30mg/kg/day). Children under 12 years body-weight over 20 kg Initial dosage should be 400mg daily in divided doses (irrespective of weight) with spaced increases until control is achieved; this is usually within the range 20-30mg/kg per day. Where adequate control is not achieved within this range the dose may be increased to maximum 35mg/kg per day. Children body-weight upto 20 kg Initially 20mg/kg daily in divided doses; in severe cases this may be increased upto 40mg by monitoring patient plasma valproic acid level. But above 40mg/kg/day clinical chemistry and haematological parameters should be monitored. Use in the elderly Although the pharmacokinetics of it are modified in the elderly,they have 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.

Sodium Vaiproate appears to act as a non specific inhibitor of drug metabolism. Drugs to which it interacts most significantly are Phenobarbital, Phenytoin, Warfarin, Aspirin etc.

Sodium valproate is contraindicated in patients with severe hepatic dysfunction,porphyria and known hypersensitivity to the active substance or to any of the excipients.

Common: nausea,gastric irritation,diarrhea; weight gain; hyperammonaemia, thrombocytopenia; transient hair loss (regrowth may be curly); Less frequent: increased alertness,aggression,hyperactivity,behavioural disturbances,ataxia,tremor,and vasculitis; Rare: hepatic dysfunction,lethargy,drowsiness,confusion,stupor,hallucinations,menstrual disturbances,anaemia,leucopenia,pancytopenia,hearing loss,and rash; Very Rare: pancreatitis,peripheral oedema,increase in bleeding time,extrapyramidal symptoms, dementia,encephalopathy,coma,gynaecomastia,Fanconi's syndrome,hirsutism,acne, enuresis,hyponatraemia,toxic epidermal necrolysis,and Stevens-Johnson syndrome; suicidal ideation; reduced bone mineral density.

Increased risk of congenital malformations and developmental delay if used in the first trimester. Sodium Valproate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Excretion in breast milk is low & breast-feeding by a mother taking Sodium Valproate probably causes no risk to the child.

Cases of accidental and suicidal overdosage have been reported. Fatalities are rare. Symptoms At plasma concentrations of up to 5 or 6 times the maximum therapeutic levels, there are unlikely to be any symptoms other than nausea, vomiting and dizziness. Symptoms of overdosage may include serious CNS depression and impairment of respiration. In cases of overdose, long half-lives up to 30 hours have been reported. Signs of an acute massive overdose usually include coma, with muscular hypotonia, hyporeflexia and miosis, impaired respiratory functions and metabolic acidosis, hypotension and circulatory collapse/shock. Symptoms may however be variable and seizures have been reported in the presence of very high plasma levels. Cases of intracranial hypertension related to cerebral oedema have been reported. Deaths have occurred following massive overdose. Hospital management of overdose including assisted ventilation and other supportive measures are recommended. The presence of sodium content in the valproate formulations may lead to hypernatraemia when taken in overdose.

Do not store above 30°C. Keep away from light and out of the reach of children.

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Sodium Valproate tablet: Each enteric-coated tablet contains Sodium Valproate BP 200 mg. Sodium Valproate syrup: Each 5 ml syrup contains Sodium Valproate BP 200 mg. Sodium Valproate controlled release 200 tablet: Each enteric-coated controlled release tablet contains Sodium Valproate 200 mg as Sodium Valproate BP 133.2 mg & Valproic acid BP 58 mg. Sodium Valproate controlled release 300 tablet: Each enteric-coated controlled release tablet contains Sodium Valproate 300 mg as Sodium Valproate BP 199.8 mg & Valproic acid BP 87 mg. Sodium Valproate controlled release 500 tablet: Each enteric-coated controlled release tablet contains Sodium Valproate 500 mg as Sodium Valproate BP 333 mg & Valproic acid BP 145 mg. Sodium Valproate injection: Each 5 ml injectable solution contains Sodium Valproate BP eqv. to Valproic Acid 500 mg.