lSIDE-EFFECTS
▶Common or very commonAggression.agitation.appetite
decreased.drowsiness.irritability.movement disorders.
muscle tone decreased.nausea.neutropenia.sleep
disorder.vomiting.weight decreased
▶UncommonFatigue.photosensitivity reaction.skin
reactions
lALLERGY AND CROSS-SENSITIVITYAntiepileptic
hypersensitivity syndrome theoretically associated with
stiripentol. 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 FEEDINGPresent in milk inanimalstudies.
lHEPATIC IMPAIRMENTAvoid—no information available.
lRENAL IMPAIRMENTAvoid—no information available.
lMONITORING REQUIREMENTS
▶Perform full blood count and liver function tests prior to
initiating treatment and every 6 months thereafter.
▶Monitor growth.
lDIRECTIONS FOR ADMINISTRATIONDo not take with milk,
dairy products, carbonated drinks, fruit juice, or with food
or drinks that contains caffeine.
lPATIENT AND CARER ADVICE
Medicines for Children leaflet: Stiripentol for preventing
seizureswww.medicinesforchildren.org.uk/stiripentol-for-
preventing-seizures
lNATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) Decisions
TheScottish Medicines Consortiumhas advised (September
2017 ) that stiripentol (Diacomit®) is accepted for use
within NHS Scotland in conjunction with clobazam and
valproate as adjunctive therapy of refractory generalised
tonic-clonic seizures in patients with severe myoclonic
epilepsy in infancy whose seizures are not adequately
controlled with clobazam and valproate.
All Wales Medicines Strategy Group (AWMSG) Decisions
TheAll Wales Medicines Strategy Grouphas advised
(November 2017 ) that stiripentol (Diacomit®)is
recommended for use within NHS Wales for use in
conjunction with clobazam and valproate as adjunctive
therapy of refractory generalized tonic-clonic seizures in
patients with severe myoclonic epilepsy in infancy (SMEI,
Dravet syndrome) whose seizures are not adequately
controlled with clobazam and valproate.lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Powder
CAUTIONARY AND ADVISORY LABELS1, 8, 13, 21
EXCIPIENTS:May contain Aspartame
▶Diacomit(Alan Pharmaceuticals)
Stiripentol 250 mgDiacomit 250 mg oral powder sachets|
60 sachetP£ 284. 00 DT = £ 284. 00
Stiripentol 500 mgDiacomit 500 mg oral powder sachets|
60 sachetP£ 493. 00
Capsule
CAUTIONARY AND ADVISORY LABELS1, 8, 21
▶Diacomit(Alan Pharmaceuticals)
Stiripentol 250 mgDiacomit 250 mg capsules| 60 capsuleP
£ 284. 00 DT = £ 284. 00
Stiripentol 500 mgDiacomit 500 mg capsules| 60 capsuleP
£ 493. 00
Tiagabine
lINDICATIONS AND DOSE
Adjunctive treatment for focal seizures with or without
secondary generalisation that are not satisfactorily
controlled by other antiepileptics (with enzyme-inducing
drugs)
▶BY MOUTH
▶Child 12–17 years:Initially 5 – 10 mg daily in 1 – 2 divided
doses, then increased in steps of 5 – 10 mg/ 24 hours
every week; maintenance 30 – 45 mg daily in
2 – 3 divided doses
Adjunctive treatment for focal seizures with or without
secondary generalisation that are not satisfactorily
controlled by other antiepileptics (without enzyme-
inducing drugs)
▶BY MOUTH
▶Child 12–17 years:Initially 5 – 10 mg daily in 1 – 2 divided
doses, then increased in steps of 5 – 10 mg/ 24 hours
every week; maintenance 15 – 30 mg daily in
2 – 3 divided doseslCAUTIONSAvoid in Acute porphyrias p. 603
CAUTIONS, FURTHER INFORMATIONTiagabine should be
avoided in absence, myoclonic, tonic and atonic seizures
due to risk of seizure exacerbation.
lINTERACTIONS→Appendix 1 : antiepileptics
lSIDE-EFFECTS
▶Common or very commonAbdominal pain.behaviour
abnormal.concentration impaired.depression.diarrhoea
.dizziness.emotional lability.fatigue.gait abnormal.
insomnia.nausea.nervousness.speech disorder.tremor.
vision disorders.vomiting
▶UncommonDrowsiness.psychosis.skin reactions
▶Rare or very rareDelusions.hallucination
lPREGNANCY
MonitoringThe dose should be monitored carefully during
pregnancy and after birth, and adjustments made on a
clinical basis.
lHEPATIC IMPAIRMENTAvoid in severe impairment.
Dose adjustmentsIn mild to moderate impairment reduce
dose, prolong the dose interval, or both.
lPATIENT AND CARER ADVICE
Medicines for Children leaflet: Tiagibine for preventing
seizureswww.medicinesforchildren.org.uk/tiagabine-for-
preventing-seizures
Driving and skilled tasksMay impair performance of skilled
tasks (e.g. driving).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
Tablet
CAUTIONARY AND ADVISORY LABELS 21
▶Gabitril(Teva UK Ltd)
Tiagabine (as Tiagabine hydrochloride monohydrate)
5mgGabitril 5 mg tablets| 100 tabletP£ 52. 04
Tiagabine (as Tiagabine hydrochloride monohydrate)
10 mgGabitril 10 mg tablets| 100 tabletP£ 104. 09
Tiagabine (as Tiagabine hydrochloride monohydrate)
15 mgGabitril 15 mg tablets| 100 tabletP£ 156. 13BNFC 2018 – 2019 Epilepsy and other seizure disorders 211
Nervous system4