lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug. Forms available from special-order
manufacturers include: capsule, oral suspension
Tablet
CAUTIONARY AND ADVISORY LABELS2, 8
▶Primidone (Non-proprietary)
Primidone 50 mgPrimidone 50 mg tablets| 100 tabletP
£ 110. 00 – £ 112. 37 DT = £ 111. 58
Primidone 250 mgPrimidone 250 mg tablets| 100 tabletP
£ 99. 65 – £ 121. 94 DT = £ 114. 51HYPNOTICS, SEDATIVES AND
ANXIOLYTICS›BENZODIAZEPINESBenzodiazepines f
lCONTRA-INDICATIONSAcute pulmonary insufficiency.
marked neuromuscular respiratory weakness.sleep
apnoea syndrome.unstable myasthenia gravis
lCAUTIONSAvoid prolonged use (and abrupt withdrawal
thereafter).history of alcohol dependence or abuse.
history of drug dependence or abuse.myasthenia gravis.
personality disorder (within the fearful group—dependent,
avoidant, obsessive-compulsive) may increase risk of
dependence.respiratory disease
CAUTIONS, FURTHER INFORMATION
▶Paradoxical effectsA paradoxical increase in hostility and
aggression may be reported by patients taking
benzodiazepines. The effects range from talkativeness and
excitement to aggressive and antisocial acts. Adjustment
of the dose (up or down) sometimes attenuates the
impulses. Increased anxiety and perceptual disorders are
other paradoxical effects.
lSIDE-EFFECTS
▶Common or very commonAlertness decreased.anxiety.
ataxia.confusion.depression.dizziness.drowsiness.
dysarthria.fatigue.gastrointestinal disorder.headache.
hypotension.mood altered.muscle weakness.nausea.
sleep disorders.suicidal ideation.tremor.vertigo.vision
disorders.withdrawal syndrome
▶UncommonAgitation.anterograde amnesia.behaviour
abnormal.hallucination.libido disorder.rash.urinary
disorders
▶Rare or very rareAggression.blood disorder.delusions.
jaundice.paradoxical drug reaction.psychosis.
respiratory depression (particularly with high dose and
intravenous use - facilities for its treatment are essential).
restlessness (with sedative and peri-operative use)
▶Frequency not knownDrug dependence
OverdoseBenzodiazepines taken alone cause drowsiness,
ataxia, dysarthria, nystagmus, and occasionally respiratory
depression, and coma. For details on the management of
poisoning, see Benzodiazepines, under Emergency
treatment of poisoning p. 832.
lPREGNANCYRisk of neonatal withdrawal symptoms when
used during pregnancy. Avoid regular use and use only if
there is a clear indication such as seizure control. High
doses administered during late pregnancy or labour may
cause neonatal hypothermia, hypotonia, and respiratory
depression.
lRENAL IMPAIRMENTIncreased cerebral sensitivity to
benzodiazepines.
lPATIENT AND CARER ADVICE
Driving and skilled tasksDrowsiness may persist the next
day and affect performance of skilled tasks (e.g. driving);
effects of alcohol enhanced.
For information on 2015 legislation regarding driving
whilst taking certain controlled drugs, including
benzodiazepines, seeDrugs and drivingunder Guidance on
prescribing p. 1.eiiiiFaboveClobazam 07-Feb-2018
lINDICATIONS AND DOSE
Adjunct in epilepsy
▶BY MOUTH
▶Child 1 month–5 years:Initially 125 micrograms/kg twice
daily, dose to be increased if necessary every 5 days,
maintenance 250 micrograms/kg twice daily (max. per
dose 500 micrograms/kg twice daily); maximum 30 mg
per day
▶Child 6–17 years:Initially 5 mg daily, dose to be
increased if necessary at intervals of 5 days,
maintenance 0. 3 – 1 mg/kg daily, daily doses of up to
30 mg may be given as a single dose at bedtime, higher
doses should be divided; maximum 60 mg per day
Monotherapy for catamenial (menstruation) seizures
(usually for 7 – 10 days each month, just before and
during menstruation) (under expert supervision)|
Cluster seizures
▶BY MOUTH
▶Child 1 month–5 years:Initially 125 micrograms/kg twice
daily, dose to be increased if necessary every 5 days,
maintenance 250 micrograms/kg twice daily (max. per
dose 500 micrograms/kg twice daily); maximum 30 mg
per day
▶Child 6–17 years:Initially 5 mg daily, dose to be
increased if necessary at intervals of 5 days,
maintenance 0. 3 – 1 mg/kg daily, daily doses of up to
30 mg may be given as a single dose at bedtime, higher
doses should be divided; maximum 60 mg per daylUNLICENSED USENot licensed for use in children under
6 years. Not licensed as monotherapy.IMPORTANT SAFETY INFORMATION
SAFE PRACTICE
Clobazam has been confused with clonazepam; care
must be taken to ensure the correct drug is prescribed
and dispensed.lCONTRA-INDICATIONSHyperkinesis.obsessional states.
phobic states.respiratory depression
lCAUTIONSMuscle weakness.organic brain changes
CAUTIONS, FURTHER INFORMATIONThe effectiveness of
clobazam may decrease significantly after weeks or
months of continuous therapy.
lINTERACTIONS→Appendix 1 : clobazam
lSIDE-EFFECTSAppetite decreased.consciousness
impaired.constipation.drug abuse.dry mouth.fall.fine
tremor.gait unsteady.libido loss.movement disorders.
muscle spasms.nystagmus.psychotic disorder.
respiratory disorder.severe cutaneous adverse reactions
(SCARs).skin reactions.speech impairment.vision
disorder.weight increased
lBREAST FEEDINGBenzodiazepines are present in milk, and
should be avoided if possible during breast-feeding.
MonitoringAll infants should be monitored for sedation,
feeding difficulties, adequate weight gain, and
developmental milestones.
lHEPATIC IMPAIRMENTCan precipitate coma. Avoid in
severe impairment.
Dose adjustmentsStart with smaller initial doses or reduce
dose.
lRENAL IMPAIRMENT
Dose adjustmentsStart with small doses in severe
impairment.
lMONITORING REQUIREMENTSRoutine measurement of
plasma concentrations of antiepileptic drugs is not usually
justified, because the target concentration ranges are218 Epilepsy and other seizure disorders BNFC 2018 – 2019
Nervous system4