Epilepsy (generalised and partial seizures) Prevention of recurrence of bipolar disorder
Forms and strengths
200 mg and 500 mg enteric coated tablets 200 mg/5 ml oral solution
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 optimal dose for the individual patient 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 optimal dose for the individual patient 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 optimal dose for the individual patient 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, extra pyramidal 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 doseof 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 valproic acid with a safer antiepileptic.