BNF for Children 2011-2012

BNFC 2011–2012 4.8.1 Control of the epilepsies 227Side-effects nausea, diarrhoea, vomiting, constipation,dyspepsia, abdominal pain, dry mouth, tastedisturbance, gastritis, appetite changes, dyspnoea,impaired attention, cognitive impairment, movementdisorders, seizures, tremor, malaise, impaired coordination,speech disorder, drowsiness, dizziness, sleepdisturbance, anxiety, confusion, paraesthesia, aggression,mood changes, depression, agitation, irritability,nephrolithiasis, urinary disorders, anaemia, arthralgia,muscle spasm, myalgia, muscular weakness, visualdisturbances, nystagmus, tinnitus, epistaxis, alopecia,rash, pruritus; less commonly pancreatitis, flatulence,abdominal distension, gingival bleeding, salivation,halitosis, thirst, glossodynia, bradycardia, palpitation,hypotension, postural hypotension, flushing, alteredsense of smell, peripheral neuropathy, suicidal ideation,psychosis, panic attack, influenza-like symptoms,sexual dysfunction, urinary calculus, haematuria,blood disorders (including leucopenia, neutropenia,and thrombocytopenia), hypokalaemia, metabolicacidosis, dry eye, photophobia, blepharospasm,increased lacrimation, mydriasis, hearing loss,reduced sweating, skin discoloration; rarelyRaynaud’s syndrome, periorbital oedema, unilateralblindness, Stevens-Johnson syndrome, abnormal skinodour, calcinosis; very rarely angle-closure glaucoma;also reported hepatitis, hepatic failure, encephalopathy,hyperammonaemia, maculopathy, toxic epidermalnecrolysisLicensed use not licensed for use in children formigraine prophylaxisIndication and doseMonotherapy of generalised tonic-clonic seizuresor focal seizures with or without secondarygeneralisation. By mouthChild 6–18 years initially 0.5–1 mg/kg (max.25 mg) at night for 1 week then increased in stepsof 250–500 micrograms/kg (max. 25 mg) twicedaily at intervals of 1–2 weeks; initial target dose50 mg twice daily; max. 7.5 mg/kg (max. 250 mg)twice dailyAdjunctive treatment of generalised tonicclonicseizures or focal seizures with or withoutsecondary generalisation, adjunctive treatmentof seizures in Lennox-Gastaut syndrome. By mouthChild 2–18 years initially 1–3 mg/kg (max.25 mg) at night for 1 week then increased in stepsof 0.5–1.5 mg/kg (max. 25 mg) twice daily atintervals of 1–2 weeks; usual dose 2.5–4.5 mg/kgtwice daily; max. 7.5 mg/kg (max. 200 mg) twicedailyMigraine prophylaxis. By mouthChild 16–18 years initially 25 mg daily at night for1 week then increased in steps of 25 mg daily atintervals of 1 week; usual dose 50–100 mg daily in2 divided doses; max. 200 mg dailyNote If child cannot tolerate titration regimens recommendedabove then smaller steps or longer interval betweensteps may be usedTopiramate (Non-proprietary) TATablets, topiramate 25 mg, net price 60-tab pack =£6.17; 50 mg, 60-tab pack = £10.74; 100 mg, 60-tabpack = £12.52; 200 mg, 60-tab pack = £17.21. Label: 3,8, counselling, driving (see notes above)Capsules, topiramate 15 mg, net price 60-cap pack =£16.61; 25 mg, 60-cap pack = £24.91; 50 mg, 60-cappack = £40.93. Label: 3, 8, counselling, driving (seenotes above)Topamax c (Janssen) TATablets, f/c, topiramate 25 mg, net price 60-tab pack= £19.29; 50 mg (light yellow), 60-tab pack = £31.69;100 mg (yellow), 60-tab pack = £56.76; 200 mg (salmon),60-tab pack = £110.23. Label: 3, 8, counselling,driving (see notes above)Sprinkle capsules, topiramate 15 mg, net price 60-cap pack = £14.79; 25 mg, 60-cap pack = £22.18;50 mg, 60-cap pack = £36.45. Label: 3, 8, counselling,administration, driving (see notes above)Counselling Swallow whole or sprinkle contents of capsuleon soft food and swallow immediately without chewingValproateValproate (as either sodium valproate or valproic acid)is effective in controlling tonic-clonic seizures, particularlyin primary generalised epilepsy. It is a drug ofchoice in primary generalised epilepsy, generalisedabsences and myoclonic seizures, and can be tried inatypical absence, atonic, and tonic seizures. Valproateshould generally be avoided in children under 2 yearsespecially with other antiepileptics, but it may berequired in infants with continuing epileptic tendency.Sodium valproate has widespread metabolic effects, andmonitoring is essential (see Cautions below).Valproic acid (as semisodium valproate) is licensed inadults for acute mania associated with bipolar disorder.SODIUM VALPROATECautions see notes above; monitor liver functionbefore therapy and during first 6 months especially inchildren most at risk (see also below); measure fullblood count and ensure no undue potential forbleeding before starting and before surgery; systemiclupus erythematosus; false-positive urine tests forketones; avoid sudden withdrawal; consider vitamin Dsupplementation in patients that are immobilised forlong periods or who have inadequate sun exposure ordietary intake of calcium; interactions: see p. 215and Appendix 1 (valproate)Liver toxicity Liver dysfunction (including fatal hepatic failure)has occurred in association with valproate (especially inchildren under 3 years and in those with metabolic ordegenerative disorders, organic brain disease or severe seizuredisorders associated with mental retardation) usually infirst 6 months and usually involving multiple antiepileptictherapy. Raised liver enzymes during valproate treatment areusually transient but children should be reassessed clinicallyand liver function (including prothrombin time) monitoreduntil return to normal—discontinue if abnormally prolongedprothrombin time (particularly in association with otherrelevant abnormalities)Blood or hepatic disorders Children and their carers shouldbe told how to recognise signs of blood or liver disorders andadvised to seek immediate medical attention if symptomsdevelopPancreatitis Children and their carers should be told how torecognise signs and symptoms of pancreatitis and advised toseek immediate medical attention if symptoms such asabdominal pain, nausea, or vomiting develop; discontinue ifpancreatitis is diagnosed4 Central nervous system