Indications

Valporin (Sodium Valproate) is indicated for treating all types of epilepsy, including:

• Partial seizures
• Absence seizures (petit mal)
• Generalized tonic-clonic seizures (grand mal)
• Myoclonic seizures
• Atonic seizures
• Mixed seizures that include absence attacks
• Prophylaxis of febrile convulsion
• Prophylaxis of post-traumatic epilepsy

It's also indicated for the treatment of bipolar disorder and the prophylaxis of migraine.

Pharmacology

Sodium Valproate's anti-epileptic mechanism is not fully understood. However, it's believed to be related to its ability to increase levels of gamma-aminobutyric acid (GABA) in the brain.

Dosage & Administration

• Oral:
  • Adults (Epilepsy): Initial dose is 600 mg daily in two divided doses, preferably after food. The dose can be increased by 200 mg/day every 3 days up to a maximum of 2.5 g daily until seizures are controlled. The usual maintenance dose is 1-2 g daily (20-30 mg/kg daily).
  • Children (over 20 kg): Initial dose is 400 mg daily in divided doses, increased until control is achieved (usually 20-30 mg/kg daily), with a maximum of 35 mg/kg daily.
  • Children (up to 20 kg): Initial dose is 20 mg/kg daily in divided doses.
  • Febrile Convulsion: 20-30 mg/kg/day in three divided doses.
  • Bipolar Disorder: Initial dose is 600 mg daily (20-30 mg/kg/day) in two to three divided doses. Maintenance is 1000-2000 mg daily.
  • Migraine Prophylaxis: 400-600 mg daily, but some patients may need 1000-1500 mg daily.
• Injection:
  • Adults: 400-800 mg (up to 10 mg/kg) via slow IV injection over 3-5 minutes, followed by a continuous or repeated infusion up to 2500 mg/day.
  • Children: Initial dose is 20-30 mg/kg/day, with a maximum of 40 mg/kg/day. It can be given via slow IV injection or infusion.

Interaction

Valporin is a non-specific inhibitor of drug metabolism. It interacts with drugs like Phenobarbital, Phenytoin, Warfarin, and Aspirin.

Contraindications

Sodium Valproate is contraindicated in patients with a known hypersensitivity to the drug and in those with liver dysfunction. Its use is also restricted during pregnancy and in women of childbearing potential.

Side Effects

The most common side effects are anorexia, nausea, and vomiting, which are less frequent with enteric-coated tablets. Central nervous system effects like sedation, ataxia, and tremor occur infrequently and usually respond to a dose reduction. Liver enzyme elevation is common (up to 40% of patients), but rarely, a fatal fulminant hepatitis can develop. This risk is higher in children under 2, especially those on multiple antiepileptic drugs. Acute pancreatitis and hyperammonemia are also associated with its use.

Pregnancy & Lactation

Sodium Valproate crosses the placenta and has been linked to neural tube defects such as anencephaly and spina bifida in newborns when exposure occurs in the first trimester. Pregnant women on this drug should be offered serum a-fetoprotein estimation. The drug is excreted in breast milk, but breastfeeding is likely not a risk to the child.

Precautions & Warnings

• Liver Function: Liver function should be monitored before and during the first 6 months of therapy, especially in high-risk patients.
• Bleeding: Ensure there is no unusual bleeding potential before starting treatment or before major surgery.
• Renal Impairment: Use with care in patients with renal impairment, pregnancy, and systemic lupus erythematosus.
• False Ketone Test: The drug's ketone metabolite may lead to a false interpretation of urine ketone tests.
• Withdrawal: Avoid sudden withdrawal of the medication.
• Pregnancy: It should not be used in pregnant women or women of childbearing potential.

Therapeutic Class

Valporin is a primary anti-epileptic drug.

Storage Conditions

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