BNF for Children 2011-2012

228 4.8.1 Control of the epilepsies BNFC 2011–20124 Central nervous systemContra-indications family history of severe hepaticdysfunction; acute porphyria (section 9.8.2)Hepatic impairment avoid if possible—hepatotoxicityand hepatic failure may occasionally occur(usually in first 6 months); avoid in active liver disease;see also under CautionsRenal impairment reduce dose; adjust dosageaccording to free serum valproic acid concentrationPregnancy see Pregnancy, p. 216; neonatal bleeding(related to hypofibrinaemia) and neonatal hepatotoxicityalso reportedBreast-feeding amount too small to be harmful; seealso Breast-feeding, p. 217Side-effects nausea, gastric irritation, diarrhoea;weight gain; hyperammonaemia, thrombocytopenia;transient hair loss (regrowth may be curly); less frequentlyincreased alertness, aggression, hyperactivity,behavioural disturbances, ataxia, tremor, and vasculitis;rarely hepatic dysfunction (see under Cautions;withdraw treatment immediately if persistent vomitingand abdominal pain, anorexia, jaundice, oedema,malaise, drowsiness, or loss of seizure control),lethargy, drowsiness, confusion, stupor, hallucinations,blood disorders (including anaemia, leucopenia,and pancytopenia), hearing loss, and rash; very rarelypancreatitis (see under Cautions), peripheral oedema,increase in bleeding time, extrapyramidal symptoms,encephalopathy, coma, gynaecomastia, Fanconi’ssyndrome, hirsutism, enuresis, hyponatraemia, acne,toxic epidermal necrolysis, and Stevens-Johnsonsyndrome; suicidal ideation; reduced bone mineraldensity (see Cautions); also reported menstrual disturbancesIndication and doseAll forms of epilepsy. By mouth or by rectumNeonate initially 20 mg/kg once daily; usualmaintenance dose 10 mg/kg twice dailyChild 1 month–12 years initially 10–15 mg/kgdaily in 1–2 divided doses; usual maintenance dose25–30 mg/kg daily in 2 divided doses (up to60 mg/kg daily in 2 divided doses in infantilespasms; monitor clinical chemistry and haematologicalparameters if dose exceeds 40 mg/kg daily)Child 12–18 years initially 600 mg daily in 1–2divided doses increased gradually (in steps of 150–300 mg) every 3 days; usual maintenance dose 1–2 g daily in 2 divided doses; max. 2.5 g daily in 2divided doses. By intravenous administrationNote If switching from oral therapy to intravenous therapygive current oral daily dose by intravenous injectionor intermittent intravenous infusion in 2–4 divided doses,or by continuous intravenous infusionNeonate by intravenous injection 10 mg/kg twicedailyChild 1 month–12 years initially 10 mg/kg byintravenous injection, then 20–40 mg/kg daily bycontinuous intravenous infusion, or by intermittentintravenous infusion or intravenous injection in 2–4 divided dosesChild 12–18 years initially 10 mg/kg by intravenousinjection, then up to max. 2.5 g daily bycontinuous intravenous infusion, or by intermittentintravenous infusion or intravenous injection in 2–4 divided dosesAdministration for rectal administration, sodiumvalproate oral solution may be given rectally andretained for 15 minutes (may require dilution withwater to prevent rapid expulsion).For intravenous injection, may be diluted in Glucose5% or Sodium Chloride 0.9% and given over 3–5minutes.For intravenous infusion, dilute injection solution withGlucose 5% or Sodium Chloride 0.9%OralSodium Valproate (Non-proprietary) ATablets (crushable), scored, sodium valproate100 mg, net price 100 = £5.60. Label: 8, 21, counselling,pancreatitis, blood, or hepatic disorder symptoms(see above), driving (see notes above)Tablets, e/c, sodium valproate 200 mg, net price 100-tab pack = £4.83; 500 mg, 100-tab pack = £10.09.Label: 5, 8, 25, counselling, pancreatitis, blood, orhepatic disorder symptoms (see above), driving (seenotes above)Brands include Orlept cOral solution, sodium valproate 200 mg/5 mL, netprice 300 mL = £5.42. Label: 8, 21, counselling, pancreatitis,blood, or hepatic disorder symptoms (seeabove), driving (see notes above)Brands include Orlept c (sugar-free)Epilim c (Sanofi-Aventis) ATablets (crushable), scored, sodium valproate100 mg, net price 100 = £5.60. Label: 8, 21, counselling,pancreatitis, blood, or hepatic disorder symptoms(see above), driving (see notes above)Tablets, e/c, lilac, sodium valproate 200 mg, net price100 = £7.70; 500 mg, 100 = £19.25. Label: 5, 8, 25,counselling, pancreatitis, blood, or hepatic disordersymptoms (see above), driving (see notes above)Liquid, red, sugar-free, sodium valproate 200 mg/5 mL, net price 300-mL pack = £9.33. Label: 8, 21,counselling, pancreatitis, blood, or hepatic disordersymptoms (see above), driving (see notes above)Syrup, red, sodium valproate 200 mg/5 mL, net price300-mL pack = £7.78. Label: 8, 21, counselling, pancreatitis,blood, or hepatic disorder symptoms (seeabove), driving (see notes above)Note May be diluted, preferably in Syrup BP; use within 14daysModified releaseEpilim Chrono c (Sanofi-Aventis) ATablets, m/r, lilac, sodium valproate 200 mg (as sodiumvalproate and valproic acid), net price 100-tabpack = £11.65; 300 mg, 100-tab pack = £17.47;500 mg, 100-tab pack = £29.10. Label: 8, 21, 25,counselling, pancreatitis, blood, or hepatic disordersymptoms (see above), driving (see notes above)DoseChild body-weight over 20 kg as above, total daily dosegiven in 1–2 divided dosesEpilim Chronosphere c (Sanofi-Aventis) AGranules, m/r, sodium valproate 50 mg (as sodiumvalproate and valproic acid), net price 30-sachet pack= £30.00; 100 mg, 30-sachet pack = £30.00; 250 mg,30-sachet pack = £30.00; 500 mg, 30-sachet pack =£30.00; 750 mg, 30-sachet pack = £30.00; 1 g, 30-