BNF for Children (BNFC) 2018-2019

Patients may need to be maintained on a specific

manufacturer’s branded or generic rufinamide product.

lPATIENT AND CARER ADVICECounselling on antiepileptic

hypersensitivity syndrome is advised.

Medicines for Children leaflet: Rufinamide for preventing

seizureswww.medicinesforchildren.org.uk/rufinamide-for-

preventing-seizures

lNATIONAL FUNDING/ACCESS DECISIONS

Scottish Medicines Consortium (SMC) Decisions

TheScottish Medicines Consortiumhas advised (October

2008 ) that rufinamide (Inovelon®) is accepted for restricted

use within NHS Scotland as adjunctive therapy in the

treatment of seizures associated with Lennox-Gastaut

syndrome in patients 4 years and above. It is restricted for

use when alternative traditional antiepileptic drugs are

unsatisfactory.

lMEDICINAL FORMS

There can be variation in the licensing of different medicines

containing the same drug.

Oral suspension

CAUTIONARY AND ADVISORY LABELS8, 21

EXCIPIENTS:May contain Propylene glycol

▶Inovelon(Eisai Ltd)

Rufinamide 40 mg per 1 mlInovelon 40 mg/ml oral suspension

sugar-free| 460 mlP£ 94. 71 DT = £ 94. 71

Tablet

CAUTIONARY AND ADVISORY LABELS8, 21

▶Inovelon(Eisai Ltd)

Rufinamide 100 mgInovelon 100 mg tablets| 10 tabletP£ 5. 15

Rufinamide 200 mgInovelon 200 mg tablets| 60 tabletP

£ 61. 77

Rufinamide 400 mgInovelon 400 mg tablets| 60 tabletP

£ 102. 96

Sodium valproate 24-Apr-2018

lINDICATIONS AND DOSE

All forms of epilepsy

▶BY MOUTH USING IMMEDIATE-RELEASE MEDICINES

▶Neonate:Initially 20 mg/kg once daily; maintenance

10 mg/kg twice daily.

▶Child 1 month–11 years:Initially 10 – 15 mg/kg daily in

1 – 2 divided doses (max. per dose 600 mg);

maintenance 25 – 30 mg/kg daily in 2 divided doses,

doses up to 60 mg/kg daily in 2 divided doses may be

used in infantile spasms; monitor clinical chemistry

and haematological parameters if dose exceeds

40 mg/kg daily

▶Child 12–17 years:Initially 600 mg daily in 1 – 2 divided

doses, increased in steps of 150 – 300 mg every 3 days;

maintenance 1 – 2 g daily in 2 divided doses; maximum

2. 5 g per day

▶BY RECTUM

▶Neonate:Initially 20 mg/kg once daily; maintenance

10 mg/kg twice daily.

▶Child 1 month–11 years:Initially 10 – 15 mg/kg daily in

1 – 2 divided doses (max. per dose 600 mg);

maintenance 25 – 30 mg/kg daily in 2 divided doses,

doses up to 60 mg/kg daily in 2 divided doses may be

used in infantile spasms; monitor clinical chemistry

and haematological parameters if dose exceeds

40 mg/kg daily

▶Child 12–17 years:Initially 600 mg daily in 1 – 2 divided

doses, increased in steps of 150 – 300 mg every 3 days;

maintenance 1 – 2 g daily in 2 divided doses; maximum

2. 5 g per day

Initiation of valproate treatment

▶INITIALLY BY INTRAVENOUS INJECTION

▶Neonate: 10 mg/kg twice daily.

▶Child 1 month–11 years:Initially 10 mg/kg, then (by

intravenous infusion or by intravenous injection)

increased to 20 – 40 mg/kg daily in 2 – 4 divided doses,

alternatively (by continuous intravenous infusion)

increased to 20 – 40 mg/kg daily, monitor clinical

chemistry and haematological parameters if dose

exceeds 40 mg/kg daily

▶Child 12–17 years:Initially 10 mg/kg, followed by (by

intravenous infusion or by intravenous injection) up to

2. 5 g daily in 2 – 4 divided doses, alternatively (by

continuous intravenous infusion) up to 2. 5 g daily; (by

intravenous injection or by intravenous infusion or by

continuous intravenous infusion) usual dose 1 – 2 g

daily, alternatively (by intravenous injection or by

intravenous infusion or by continuous intravenous

infusion) usual dose 20 – 30 mg/kg daily, intravenous

injection to be administered over 3 – 5 minutes

Continuation of valproate treatment

▶BY INTRAVENOUS INJECTION, OR BY INTRAVENOUS INFUSION,

OR BY CONTINUOUS INTRAVENOUS INFUSION

▶Child:If switching from oral therapy to intravenous

therapy give the same dose as current oral daily dose,

give over 3 – 5 minutes by intravenous injectionorin

2 – 4 divided doses by intravenous infusion

EPILIM CHRONOSPHERE®

All forms of epilepsy

▶BY MOUTH

▶Child:Total daily dose to be given in 1 – 2 divided doses

(consult product literature)

EPILIM CHRONO®

All forms of epilepsy

▶BY MOUTH

▶Child (body-weight 20 kg and above):Total daily dose to

be given in 1 – 2 divided doses (consult product

literature)

EPISENTA®CAPSULES

All forms of epilepsy

▶BY MOUTH

▶Child:Total daily dose to be given in 1 – 2 divided doses

(consult product literature)

EPISENTA®GRANULES

All forms of epilepsy

▶BY MOUTH

▶Child:Total daily dose to be given in 1 – 2 divided doses

(consult product literature)

EPIVAL®

All forms of epilepsy

▶BY MOUTH

▶Child:Total daily dose to be given in 1 – 2 divided doses

(consult product literature)

IMPORTANT SAFETY INFORMATION

MHRA/CHM ADVICE: VALPROATE MEDICINES: CONTRA-INDICATED

IN WOMEN AND GIRLS OF CHILDBEARING POTENTIAL UNLESS

CONDITIONS OF PREGNANCY PREVENTION PROGRAMME ARE MET

(APRIL 2018)

Valproate is highly teratogenic and evidence supports

that use in pregnancy leads to neurodevelopmental

disorders (approx. 30 – 40 % risk) and congenital

malformations (approx. 10 % risk).

Valproate must not be used in women and girls of

childbearing potential unless the conditions of the

Pregnancy Prevention Programme are met (see

Conception and contraception) and only if other

208 Epilepsy and other seizure disorders BNFC 2018 – 2019

Nervous system

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