fatigue.increased risk of infection.insomnia.irritability.
nausea.vertigo.vomiting
▶UncommonAggression.psychotic disorder
lPREGNANCYManufacturer advises avoid unless potential
benefit outweighs risk—limited information available.
lBREAST FEEDINGManufacturer advises avoid—present in
milk inanimalstudies.
lHEPATIC IMPAIRMENT
Dose adjustmentsManufacturer advises consider a starting
dose of 25 mg twice daily in chronic liver disease; max.
maintenance dose 75 mg twice daily in all stages of
impairment.
lTREATMENT CESSATIONManufacturer advises avoid abrupt
withdrawal—reduce daily dose in steps of 50 mg at weekly
intervals, then reduce to 20 mg daily for afinal week.
lDIRECTIONS FOR ADMINISTRATION
▶With intravenous useFor intermittentintravenous infusion,
manufacturer advises dilute in Glucose 5 %orSodium
Chloride 0. 9 %orLactated Ringer’s solution; give over
15 minutes.
▶With oral useManufacturer advises oral solution can be
diluted in water or juice shortly before swallowing.
lPRESCRIBING AND DISPENSING INFORMATION
Manufacturer advises if switching between oral therapy
and intravenous therapy (for those temporarily unable to
take oral medication), the total daily dose and the
frequency of administration should be maintained.
lPATIENT AND CARER ADVICE
Missed dosesManufacturer advises if one or more doses
are missed, a single dose should be taken as soon as
possible and the next dose should be taken at the usual
time.
Driving and skilled tasksManufacturer advises patients and
carers should be cautioned on the effects on driving and
performance of skilled tasks—increased risk of dizziness.
lNATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) Decisions
TheScottish Medicines Consortiumhas advised (July 2016 )
that brivaracetam (Briviact®) is accepted for restricted use
within NHS Scotland as adjunctive therapy in the
treatment of partial-onset seizures with or without
secondary generalisation in patients with refractory
epilepsy. Treatment should be initiated by physicians who
have appropriate experience in the treatment of epilepsy.
All Wales Medicines Strategy Group (AWMSG) Decisions
TheAll Wales Medicines Strategy Grouphas advised
(October 2016 ) that Brivaracetam (Briviact®)is
recommended as an option for restricted use within NHS
Wales. Brivaracetam (Briviact®) should be restricted to use
in the treatment of patients with refractory epilepsy, who
remain uncontrolled with, or are intolerant to, other
adjunctive anti-epileptic medicines, within its licensed
indication as adjunctive therapy in the treatment of
partial-onset seizures (POS) with or without secondary
generalisation in adult and adolescent patients from
16 years of age with epilepsy. Brivaracetam (Briviact®)is
not recommended for use within NHS Wales outside of
this subpopulation.lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Solution for injection
CAUTIONARY AND ADVISORY LABELS 2
ELECTROLYTES:May contain Sodium
▶Briviact(UCB Pharma Ltd)A
Brivaracetam 10 mg per 1 mlBriviact 50 mg/ 5 ml solution for
injection vials| 10 vialP£ 222. 75Oral solution
CAUTIONARY AND ADVISORY LABELS2, 8
EXCIPIENTS:May contain Sorbitol
ELECTROLYTES:May contain Sodium
▶Briviact(UCB Pharma Ltd)A
Brivaracetam 10 mg per 1 mlBriviact 10 mg/ml oral solution sugar-
free| 300 mlP£ 115. 83 DT = £ 115. 83
Tablet
CAUTIONARY AND ADVISORY LABELS2, 8, 25
▶Briviact(UCB Pharma Ltd)A
Brivaracetam 10 mgBriviact 10 mg tablets| 14 tabletP£ 34. 64
Brivaracetam 25 mgBriviact 25 mg tablets| 56 tabletP
£ 129. 64
Brivaracetam 50 mgBriviact 50 mg tablets| 56 tabletP
£ 129. 64
Brivaracetam 75 mgBriviact 75 mg tablets| 56 tabletP
£ 129. 64
Brivaracetam 100 mgBriviact 100 mg tablets| 56 tabletP
£ 129. 64Carbamazepine
lINDICATIONS AND DOSE
Trigeminal neuralgia
▶BY MOUTH USING IMMEDIATE-RELEASE MEDICINES
▶Child 1 month–11 years:Initially 5 mg/kg once daily, dose
to be taken at night, alternatively initially 2. 5 mg/kg
twice daily, then increased in steps of 2. 5 – 5 mg/kg
every 3 – 7 days as required; maintenance 5 mg/kg
2 – 3 times a day, increased if necessary up to 20 mg/kg
daily
▶Child 12–17 years:Initially 100 – 200 mg 1 – 2 times a day,
then increased to 200 – 400 mg 2 – 3 times a day,
increased if necessary up to 1. 8 g daily, dose should be
increased slowly
Prophylaxis of bipolar disorder
▶BY MOUTH USING IMMEDIATE-RELEASE MEDICINES
▶Child 1 month–11 years:Initially 5 mg/kg once daily, dose
to be taken at night, alternatively initially 2. 5 mg/kg
twice daily, then increased in steps of 2. 5 – 5 mg/kg
every 3 – 7 days as required; maintenance 5 mg/kg
2 – 3 times a day, increased if necessary up to 20 mg/kg
daily
▶Child 12–17 years:Initially 100 – 200 mg 1 – 2 times a day,
then increased to 200 – 400 mg 2 – 3 times a day,
increased if necessary up to 1. 8 g daily, dose should be
increased slowly
Focal and generalised tonic-clonic seizures
▶BY MOUTH USING IMMEDIATE-RELEASE MEDICINES
▶Child 1 month–11 years:Initially 5 mg/kg once daily, dose
to be taken at night, alternatively initially 2. 5 mg/kg
twice daily, then increased in steps of 2. 5 – 5 mg/kg
every 3 – 7 days as required; maintenance 5 mg/kg
2 – 3 times a day, increased if necessary up to 20 mg/kg
daily
▶Child 12–17 years:Initially 100 – 200 mg 1 – 2 times a day,
then increased to 200 – 400 mg 2 – 3 times a day,
increased if necessary up to 1. 8 g daily, dose should be
increased slowly
▶BY RECTUM
▶Child:Up to 250 mg up to 4 times a day, to be used for
short-term use (max. 7 days) when oral therapy
temporarily not possible, use approx. 25 % more than
the oral dose
DOSE EQUIVALENCE AND CONVERSION
▶Suppositories of 125 mg may be considered to be
approximately equivalent in therapeutic effect to
tablets of 100 mg butfinal adjustment should always
depend on clinical response (plasma concentration
monitoring recommended).196 Epilepsy and other seizure disorders BNFC 2018 – 2019
Nervous system4