VALPROIC acid = SODIUM VALPROATE oral

Prescription under medical supervision

Valproic acid should not be used during pregnancy and in women of childbearing age. The risk of foetal malformations is higher than with other antiepileptics.


Therapeutic action

– Antiepileptic

Indications

– Epilepsy (generalised and partial seizures)
– Prevention of recurrence of bipolar disorder 

Forms and strengths

– 200 mg and 500 mg enteric coated tablets

Dosage

– Epilepsy (generalised and partial seizures)
• Child under 20 kg: 10 mg/kg 2 times daily
• Child over 20 kg: start with 200 mg (irrespective of weight) 2 times daily, then increase gradually until the individual optimal dose is reached, usually 10 to 15 mg/kg 2 times daily
• Adult: start with 300 mg 2 times daily, then increase by 200 mg every 3 days until the individual optimal dose is reached, usually 500 to 1000 mg 2 times daily

– Prevention of recurrence of bipolar disorder 
Adult: start with 200 mg 2 times daily. Increase if necessary until the individual optimal dose is reached, usually around 500 mg 2 times daily (max. 1000 mg 2 times daily).

Duration

– Lifetime treatment

Contra-indications, adverse effects, precautions

– Do not administer:
• to women of childbearing age. If the treatment is absolutely necessary and if there is no alternative, an effective contraception is required (intrauterine device);
• to patients with pancreatitis, hepatic disease or history of hepatic disease.
– May cause:
• increase in the frequency of seizures at the beginning of therapy, drowsiness, weight gain, amenorrhoea, gastrointestinal disturbances, extrapyramidal symptoms, behavioural disturbances, confusion, thrombocytopenia;
• rarely: pancreatitis, hepatic disorders, severe allergic reactions (Lyell’s and Stevens-Johnson syndromes), prolongation of bleeding time. In these cases, stop treatment.
– Monitor, if possible, liver transaminases and prothrombin time during first 3-6 months of therapy (risk of hepatitis).
– Reduce dosage in patients with renal impairment.
– Do not combine with mefloquine (increased risk of seizures).
– Monitor combination with: tricyclic antidepressants, other antiepileptics.
– If other antiepileptics have been prescribed, increase the dose of valproic acid gradually over 2 weeks and reduce the dose of other antiepileptics.
– Pregnancy: do not start treatment during pregnancy (risk of neural tube defects; urogenital, limb and face malformations; psychomotor developmental disorders). If treatment was started before pregnancy: replace valporic acid with a safer antiepileptic.
– Breast-feeding: no contra-indication

Remarks

– Take with meals.
– Also comes in 100 mg crushable tablets and 200 mg/5 ml oral solution.
– Storage: below 25 °C -  -