BNF for Children 2011-2012

BNFC 2011–2012 4.8.1 Control of the epilepsies 225Child 3 months–18 years, 10–20 mg/litre (40–80 micromol/litre)Licensed use licensed for use in children (age rangenot specified by manufacturer)Indication and doseAll forms of epilepsy except absence seizures. By intravenous injection (over 20–30 minutes)and by mouthNeonate initial loading dose by slow intravenousinjection (section 4.8.2) 18 mg/kg then by mouth2.5–5 mg/kg twice daily adjusted according toresponse and plasma-phenytoin concentration(usual max. 7.5 mg/kg twice daily). By mouthChild 1 month–12 years initially 1.5–2.5 mg/kgtwice daily, then adjusted according to responseand plasma-phenytoin concentration to 2.5–5 mg/kg twice daily (usual max. 7.5 mg/kg twice daily or300 mg daily)Child 12–18 years initially 75–150 mg twice dailythen adjusted according to response and plasmaphenytoinconcentration to 150–200 mg twicedaily (usual max. 300 mg twice daily)Status epilepticus, acute symptomatic seizuresassociated with head trauma or neurosurgerysection 4.8.2Administration for administration by mouth, interruptenteral feeds for at least 1–2 hours before and aftergiving phenytoin; give with water to enhanceabsorptionFor administration by intravenous injection andintravenous infusion, see p. 235Phenytoin (Non-proprietary) ATablets, coated, phenytoin sodium 100 mg, net price28-tab pack = £30.00. Label: 8, counselling, administration,blood or skin disorder symptoms (seeabove), driving (see notes above)Note On the basis of single dose tests there are no clinicallyrelevant differences in bioavailability between availablephenytoin sodium tablets and capsules but there may be apharmacokinetic basis for maintaining the same brand ofphenytoin in some patientsEpanutin c (Pfizer) ACapsules, phenytoin sodium 25 mg (white/purple),net price 28-cap pack = 66p; 50 mg (white/pink), 28-cap pack = 67p; 100 mg (white/orange), 84-cap pack= £2.83; 300 mg (white/green), 28-cap pack = £2.83.Label: 8, counselling, administration, blood or skindisorder symptoms (see above), driving (see notesabove)Chewable tablets (Infatabs c ), yellow, scored,phenytoin 50 mg, net price 112 = £7.38. Label: 8, 24,counselling, blood or skin disorder symptoms (seeabove), driving (see notes above)Note Contain phenytoin 50 mg (as against phenytoin sodium)therefore care is needed on changing to capsules ortablets containing phenytoin sodiumSuspension, red, phenytoin 30 mg/5 mL, net price500 mL = £4.27. Label: 8, counselling, administration,blood or skin disorder symptoms (see above), driving(see notes above)Note Suspension of phenytoin 90 mg in 15 mL may beconsidered to be approximately equivalent in therapeuticeffect to capsules or tablets containing phenytoin sodium100 mg, but nevertheless care is needed in making changesParenteral preparationsSection 4.8.2RufinamideRufinamide is licensed for the adjunctive treatment ofseizures in Lennox-Gastaut syndrome.The Scottish Medicines Consortium (p. 3) has advised(October 2008) that rufinamide (Inovelon c ) is acceptedfor restricted use within NHS Scotland as adjunctivetherapy in the treatment of seizures associated withLennox-Gastaut syndrome in patients 4 years andabove. It is restricted for use when alternative traditionalantiepileptic drugs are unsatisfactory.RUFINAMIDECautions closely monitor and consider withdrawal ifrash, fever, or other signs of hypersensitivitysyndrome (see Side-effects) develop; avoid abruptwithdrawal; interactions: see p. 215 and Appendix 1(rufinamide)Hepatic impairment caution and careful dose titrationin mild to moderate impairment; avoid in severeimpairmentPregnancy see Pregnancy, p. 216Breast-feeding manufacturer advises avoid—noinformation available; see also Breast-feeding, p. 217Side-effects nausea, vomiting, constipation, diarrhoea,dyspepsia, abdominal pain; rhinitis, epistaxis;weight loss, anorexia, dizziness, headache, drowsiness,insomnia, anxiety, fatigue, increase in seizurefrequency, impaired coordination, hyperactivity, tremor,gait disturbances; influenza-like symptoms; oligomenorrhoea;back pain; nystagmus, diplopia,blurred vision; rash, and acne; hypersensitivitysyndrome (possibly including rash, fever, lymphadenopathy,hepatic dysfunction, haematuria, and multiorgandysfunction) also reportedHypersensitivity syndrome Serious hypersensitivitysyndrome (see above) has developed especially in childrenand upon initiation of therapy; consider withdrawal if rash orsigns or symptoms of hypersensitivity syndrome developCounselling Warn children and their carers to seekimmediate medical attention if signs or symptoms ofhypersensitivity syndrome developIndication and doseAdjunctive treatment of seizures in Lennox-Gastaut syndrome. By mouthChild 4–18 years body-weight less than 30 kg,initially 100 mg twice daily increased according toresponse in steps of 100 mg twice daily up to every2 days; max. 500 mg twice daily (max. 300 mgtwice daily if adjunctive therapy with valproate)Child 4–18 years body-weight over 30 kg, initially200 mg twice daily increased according toresponse in steps of 200 mg twice daily up to every2 days; body-weight 30–50 kg max. 900 mg twicedaily; body-weight 50–70 kg max. 1.2 g twice daily;body-weight over 70 kg max. 1.6 g twice dailyAdministration Tablets may be crushed and given in half aglass of waterInovelon c (Eisai) TATablets, pink, f/c, scored, rufinamide 100 mg, netprice 10-tab pack = £5.15; 200 mg, 60-tab pack =4 Central nervous system