BNF for Children (BNFC) 2018-2019

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▶Trough plasma concentration for optimum response:
neonate– 3 months, 6 – 15 mg/litre ( 25 – 60 micromol/litre);
child 3 months– 18 years, 10 – 20 mg/litre
(^40 –^80 micromol/litre).
▶Manufacturer recommends blood counts (but evidence of
practical value uncertain).
▶With intravenous useMonitor ECG and blood pressure.


lDIRECTIONS FOR ADMINISTRATIONManufacturer advises
each injection or infusion should be preceded and followed
by an injection of Sodium Chloride 0. 9 % through the same
needle or catheter to avoid local venous irritation.
▶With intravenous usegForintravenous injection, give into
a large vein at a rate not exceeding 1 mg/kg/minute (max.
50 mg/minute).kManufacturer advises forintravenous
infusion, dilute to a concentration not exceeding 10 mg/mL
with Sodium Chloride 0. 9 % and give into a large vein
through an in-linefilter ( 0. 22 – 0. 50 micron).gGive at a
rate not exceeding 1 mg/kg/minute (max. 50 mg/minute).
kComplete administration within 1 hour of preparation.


lPRESCRIBING AND DISPENSING INFORMATION
Switching between formulationsDifferent formulations of oral
preparations may vary in bioavailability. Patients being
treated for epilepsy should be maintained on a specific
manufacturer’s product.


lPATIENT AND CARER ADVICE
Blood or skin disordersPatients or their carers should be told
how to recognise signs of blood or skin disorders, and
advised to seek immediate medical attention if symptoms
such as fever, rash, mouth ulcers, bruising, or bleeding
develop. Leucopenia that is severe, progressive, or
associated with clinical symptoms requires withdrawal (if
necessary under cover of a suitable alternative).
Medicines for Children leaflet: Phenytoin for preventing
seizureswww.medicinesforchildren.org.uk/phenytoin-for-
preventing-seizures


lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug. Forms available from special-order
manufacturers include: oral suspension, oral solution
Tablet
CAUTIONARY AND ADVISORY LABELS 8
▶Phenytoin (Non-proprietary)
Phenytoin sodium 100 mgPhenytoin sodium 100 mg tablets|
28 tabletP£ 30. 00 DT = £ 13. 89
Solution for injection
EXCIPIENTS:May contain Alcohol, propylene glycol
ELECTROLYTES:May contain Sodium
▶Phenytoin (Non-proprietary)
Phenytoin sodium 50 mg per 1 mlPhenytoin sodium 250 mg/ 5 ml
solution for injection ampoules| 5 ampouleP£ 24. 40 (Hospital
only)
▶Epanutin(Pfizer Ltd)
Phenytoin sodium 50 mg per 1 mlEpanutin Ready-Mixed
Parenteral 250 mg/ 5 ml solution for injection ampoules|
10 ampouleP£ 48. 79 (Hospital only)
Oral suspension
CAUTIONARY AND ADVISORY LABELS 8
▶Epanutin(Pfizer Ltd)
Phenytoin 6 mg per 1 mlEpanutin 30 mg/ 5 ml oral suspension|
500 mlP£ 4. 27 DT = £ 4. 27
Chewable tablet
CAUTIONARY AND ADVISORY LABELS8, 24
▶Epanutin(Pfizer Ltd)
Phenytoin 50 mgEpanutin Infatabs 50 mg chewable tablets|
200 tabletP£ 13. 18
Capsule
CAUTIONARY AND ADVISORY LABELS 8
▶Phenytoin (Non-proprietary)
Phenytoin sodium 25 mgPhenytoin sodium 25 mg capsules|
28 capsuleP£ 7. 24 DT = £ 7. 24
Phenytoin sodium 50 mgPhenytoin sodium 50 mg capsules|
28 capsuleP£ 7. 07 DT = £ 7. 07
Phenytoin sodium 100 mgPhenytoin sodium 100 mg capsules|
84 capsuleP£ 67. 50 DT = £ 9. 14


Phenytoin sodium 300 mgPhenytoin sodium 300 mg capsules|
28 capsuleP£ 9. 11 DT = £ 9. 11

Rufinamide


lINDICATIONS AND DOSE
Adjunctive treatment of seizures in Lennox-Gastaut
syndrome
▶BY MOUTH
▶Child 4–17 years (body-weight up to 30 kg):Initially
100 mg twice daily, then increased in steps of 100 mg
twice daily (max. per dose 500 mg twice daily), adjusted
according to response, dose to be increased at intervals
of not less than 2 days
▶Child 4–17 years (body-weight 30–49 kg):Initially 200 mg
twice daily, then increased in steps of 200 mg twice
daily (max. per dose 900 mg twice daily), adjusted
according to response, dose to be increased at intervals
of not less than 2 days
▶Child 4–17 years (body-weight 50–69 kg):Initially 200 mg
twice daily, then increased in steps of 200 mg twice
daily (max. per dose 1. 2 g twice daily), adjusted
according to response, dose to be increased at intervals
of not less than 2 days
▶Child 4–17 years (body-weight 70 kg and above):Initially
200 mg twice daily, then increased in steps of 200 mg
twice daily (max. per dose 1. 6 g twice daily), adjusted
according to response, dose to be increased at intervals
of not less than 2 days
Adjunctive treatment of seizures in Lennox-Gastaut
syndrome with valproate
▶BY MOUTH
▶Child 4–17 years (body-weight up to 30 kg):Initially
100 mg twice daily, then increased in steps of 100 mg
twice daily (max. per dose 300 mg twice daily), adjusted
according to response, dose to be increased at intervals
of not less than 2 days

lINTERACTIONS→Appendix 1 : antiepileptics
lSIDE-EFFECTS
▶Common or very commonAnxiety.appetite decreased.
back pain.constipation.diarrhoea.dizziness.drowsiness
.eating disorder.epistaxis.fatigue.gait abnormal.
gastrointestinal discomfort.headache.increased risk of
infection.insomnia.movement disorders.nausea.
nystagmus.oligomenorrhoea.seizures.skin reactions.
tremor.vertigo.vision disorders.vomiting.weight
decreased
▶UncommonHypersensitivity
lALLERGY AND CROSS-SENSITIVITYAntiepileptic
hypersensitivity syndrome associated with rufinamide. See
under Epilepsy p. 191 for more information.
lPREGNANCY
MonitoringThe dose should be monitored carefully during
pregnancy and after birth, and adjustments made on a
clinical basis.
lBREAST FEEDINGManufacturer advises avoid—no
information available.
lHEPATIC IMPAIRMENTAvoid in severe impairment.
Dose adjustmentsCaution and careful dose titration in
mild to moderate impairment.
lDIRECTIONS FOR ADMINISTRATIONTablets may be crushed
and given in half a glass of water.
lPRESCRIBING AND DISPENSING INFORMATION
Switching between formulationsCare should be taken when
switching between oral formulations. The need for
continued supply of a particular manufacturer’s product
should be based on clinical judgement and consultation
with the patient or their carer, taking into account factors
such as seizure frequency and treatment history.

BNFC 2018 – 2019 Epilepsy and other seizure disorders 207


Nervous system

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