BNF for Children 2011-2012

BNFC 2011–2012 4.8.1 Control of the epilepsies 221LACOSAMIDECautions risk of PR-interval prolongation (includingconduction problems, severe cardiac disease, andconcomitant use of drugs that prolong PR interval),elderly; interactions: Appendix 1 (lacosamide)Contra-indications second- or third-degree AV blockHepatic impairment caution in severe impairment—no information availableRenal impairment titrate dose with caution; max.250 mg daily if estimated glomerular filtration rate isless than 30 mL/minute/1.73 m 2Pregnancy see Pregnancy, p. 216Breast-feeding manufacturer advises avoid—presentin milk in animal studies; see also Breast-feeding,p. 217Side-effects nausea, vomiting, constipation, flatulence,dizziness, headache, impaired coordination,cognitive disorder, drowsiness, tremor, depression,fatigue, abnormal gait, blurred vision, nystagmus,pruritus; also reported dyspepsia, dry mouth, firstdegreeAV block, bradycardia, PR-interval prolongation,confusion, hypoesthesia, dysarthria, irritability,muscle spasm, tinnitus, rash; suicidal ideationIndication and doseAdjunctive treatment of focal seizures with orwithout secondary generalisation. By intravenous infusion over 15–60 minutes(for up to 5 days) or by mouthChild 16–18 years initially 50 mg twice daily,increased in steps of 50 mg twice daily every week;max. 200 mg twice dailyAdministration for intravenous infusion, give undilutedor dilute with Glucose 5% or Sodium Chloride0.9%Vimpat c (UCB Pharma) TATablets, f/c, lacosamide 50 mg (pink), net price 14-tabpack = £10.81; 100 mg (yellow), 14-tab pack = £21.62,56-tab pack = £86.50; 150 mg (salmon), 14-tab pack =£32.44, 56-tab pack £129.74; 200 mg (blue), 56-tabpack = £144.16. Label: 8, counselling, driving (seenotes above)Syrup, lacosamide 15 mg/mL, net price 200 mL =£38.61. Label: 8, counselling, driving (see notes above)Excipients include aspartame (section 9.4.1)Intravenous infusion, lacosamide 10 mg/mL netprice 200-mg vial = £29.70Electrolytes Na + 2.6 mmol/200-mg vialLamotrigineLamotrigine is an antiepileptic for focal seizures, primaryand secondary generalised tonic-clonic seizures,and for typical absence seizures. Efficacy may not bemaintained in all children treated for typical absenceseizures. It may be tried for atypical absence, atonic, andtonic seizures. Lamotrigine may cause serious skinreactions; dose recommendations should be adheredto closely.Lamotrigine is used either as sole treatment or as anadjunct to treatment with other antiepileptic drugs. Valproateincreases plasma-lamotrigine concentration,whereas the enzyme-inducing antiepileptics reduce it;care is therefore required in choosing the appropriateinitial dose and subsequent titration. When the potentialfor interaction is not known, treatment should beinitiated with lower doses, such as those used withvalproate.LAMOTRIGINECautions closely monitor and consider withdrawal ifrash, fever, or signs of hypersensitivity syndromedevelop; avoid abrupt withdrawal (taper off over 2weeks or longer) unless serious skin reaction occurs;myoclonic seizures (may be exacerbated); interactions:see p. 215 and Appendix 1 (lamotrigine)Blood disorders Children and their carers should be alert forsymptoms and signs suggestive of bone-marrow failure, suchas anaemia, bruising, or infection. Aplastic anaemia, bonemarrowdepression, and pancytopenia have been associatedrarely with lamotrigineHepatic impairment halve dose in moderate impairment;quarter dose in severe impairmentRenal impairment caution in renal failure; metabolitemay accumulate; consider reducing maintenancedose in significant impairmentPregnancy see Pregnancy, p. 216Breast-feeding present in milk, but limited data suggestno harmful effect on infant; see also Breastfeeding,p. 217Side-effects nausea, vomiting, diarrhoea, dry mouth,aggression, agitation, headache, drowsiness, dizziness,tremor, insomnia, ataxia, back pain, arthralgia,nystagmus, diplopia, blurred vision, rash (see SkinReactions, below); rarely conjunctivitis; very rarelyhepatic failure, movement disorders, unsteadiness,increase in seizure frequency, confusion, hallucination,blood disorders (including anaemia, leucopenia,thrombocytopenia, pancytopenia—see Blood Disorders,above), hypersensitivity syndrome (possiblyincluding rash, fever, facial oedema, lymphadenopathy,hepatic dysfunction, blood disorders, disseminatedintravascular coagulation, and multi-organdysfunction), lupus erythematosus-like reactions; alsoreported suicidal ideation, aseptic meningitisSkin reactions Serious skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis havedeveloped especially in children; most rashes occur in thefirst 8 weeks. Rash is sometimes associated with hypersensitivitysyndrome (see Side-effects, above) and is morecommon in patients with history of allergy or rash from otherantiepileptic drugs. Consider withdrawal if rash or signs ofhypersensitivity syndrome develop. Factors associated withincreased risk of serious skin reactions include concomitantuse of valproate, initial lamotrigine dosing higher thanrecommended, and more rapid dose escalation thanrecommended.Counselling Warn children and their carers to see theirdoctor immediately if rash or signs or symptoms of hypersensitivitysyndrome developIndication and doseMonotherapy and adjunctive treatment of focalseizures and primary and secondary generalisedtonic-clonic seizures; seizures associatedwith Lennox-Gastaut syndrome. By mouthAdjunctive therapy of seizures with valproateChild 2–12 years initially 150 micrograms/kgonce daily for 14 days (those weighing under 13 kgmay receive 2 mg on alternate days for first 14days) then 300 micrograms/kg once daily forfurther 14 days, thereafter increased by max. of300 micrograms/kg every 7–14 days; usual maintenance1–5 mg/kg daily in 1–2 divided doses(max. single dose 100 mg)4 Central nervous system