Topiramate 25-Jan-2018
lINDICATIONS AND DOSE
Monotherapy of generalised tonic-clonic seizures or focal
seizures with or without secondary generalisation
▶BY MOUTH
▶Child 6–17 years:Initially 0. 5 – 1 mg/kg once daily (max.
per dose 25 mg) for 1 week, dose to be taken at night,
then increased in steps of 250 – 500 micrograms/kg
twice daily, dose to be increased by a maximum of
25 mg twice daily at intervals of 1 – 2 weeks; usual dose
50 mg twice daily (max. per dose 7. 5 mg/kg twice daily),
if child cannot tolerate titration regimens
recommended above then smaller steps or longer
interval between steps may be used; maximum 500 mg
per day
Adjunctive treatment of generalised tonic-clonic seizures
or focal seizures with or without secondary
generalisation|Adjunctive treatment for seizures
associated with Lennox-Gastaut syndrome
▶BY MOUTH
▶Child 2–17 years:Initially 1 – 3 mg/kg once daily (max.
per dose 25 mg) for 1 week, dose to be taken at night,
then increased in steps of 0. 5 – 1. 5 mg/kg twice daily,
dose to be increased by a maximum of 25 mg twice
daily at intervals of 1 – 2 weeks; usual dose
2. 5 – 4. 5 mg/kg twice daily (max. per dose 7. 5 mg/kg
twice daily), if child cannot tolerate recommended
titration regimen then smaller steps or longer interval
between steps may be used; maximum 400 mg per day
Migraine prophylaxis
▶BY MOUTH
▶Child 16–17 years:Initially 25 mg once daily for 1 week,
dose to be taken at night, then increased in steps of
25 mg every week; usual dose 50 – 100 mg daily in
2 divided doses, if child cannot tolerate recommended
titration regimen then smaller steps or longer interval
between steps may be used; maximum 200 mg per daylUNLICENSED USENot licensed for use in children for
migraine prophylaxis.
lCAUTIONSAvoid in Acute porphyrias p. 603 .risk of
metabolic acidosis.risk of nephrolithiasis—ensure
adequate hydration (especially in strenuous activity or
warm environment)
lINTERACTIONS→Appendix 1 : antiepileptics
lSIDE-EFFECTS
▶Common or very commonAlopecia.anaemia.anxiety.
appetite abnormal.asthenia.behaviour abnormal.
cognitive impairment.concentration impaired.confusion
.constipation.cough.depression.diarrhoea.dizziness.
drowsiness.dry mouth.dyspnoea.ear discomfort.eye
disorders.feeling abnormal.fever.gait abnormal.
gastrointestinal discomfort.gastrointestinal disorders.
haemorrhage.hearing impairment.hypersensitivity.joint
disorders.malaise.memory loss.mood altered.
movement disorders.muscle complaints.muscle
weakness.nasal complaints.nasopharyngitis.nausea.
oral disorders.pain.seizures.sensation abnormal.skin
reactions.sleep disorders.speech impairment.taste
altered.tremor.urinary disorders.urolithiases.vertigo.
vision disorders.vomiting.weight changes
▶UncommonAbnormal sensation in eye.anhidrosis.
arrhythmias.aura.cerebellar syndrome.consciousness
impaired.crying.drooling.dry eye.dysgraphia.
dysphonia.eosinophilia.facial swelling.hallucinations.
hyperthermia.hypokalaemia.hypotension.influenza like
illness.learning disability.leucopenia.lymphadenopathy
.metabolic acidosis.musculoskeletal stiffness.
palpitations.pancreatitis.paranasal sinus hypersecretion
.peripheral coldness.peripheral neuropathy.polydipsia.psychotic disorder.renal pain.sexual dysfunction.smell
altered.suicidal tendencies.syncope.thinking abnormal.
thirst.thrombocytopenia.vasodilation
▶Rare or very rareEye inflammation.face oedema.
glaucoma.hepatic disorders.limb discomfort.
neutropenia.Raynaud’s phenomenon.renal tubular
acidosis.severe cutaneous adverse reactions (SCARs).
unresponsive to stimuli
SIDE-EFFECTS, FURTHER INFORMATIONTopiramate has
been associated with acute myopia with secondary angle-
closure glaucoma, typically occurring within 1 month of
starting treatment. Choroidal effusions resulting in
anterior displacement of the lens and iris have also been
reported. If raised intra-ocular pressure occurs: seek
specialist ophthalmological advice; use appropriate
measures to reduce intra-ocular pressure and stop
topiramate as rapidly as feasible.
lCONCEPTION AND CONTRACEPTIONManufacturer advises
perform pregnancy test before the initiation of
treatment—a highly effective contraceptive method is
advised in women of child-bearing potential; patients
should be fully informed of the risks related to the use of
topiramate during pregnancy.
lPREGNANCYIncreased risk of major congenital
malformations following exposure during thefirst
trimester.For migraine prophylaxismanufacturer advises
avoid.For epilepsymanufacturer advises consider
alternative treatment options.
MonitoringManufacturer advises in case of administration
duringfirst trimester, careful prenatal monitoring should
be performed.
It is recommended that the fetal growth should be
monitored.
The dose should be monitored carefully during
pregnancy and after birth, and adjustments made on a
clinical basis.
lBREAST FEEDINGManufacturer advises avoid—present in
milk.
lHEPATIC IMPAIRMENTUse with caution in moderate to
severe impairment—clearance may be reduced.
lRENAL IMPAIRMENTUse with caution.
Dose adjustmentsHalf usual starting and maintenance
dose if estimated glomerularfiltration less than
70 mL/minute/ 1. 73 m^2 —reduced clearance and longer time
to steady-state plasma concentration.
lDIRECTIONS FOR ADMINISTRATIONTopamax®Sprinkle
capsules can either be swallowed whole or the contents of
the capsule can be sprinkled on soft food and swallowed
immediately without chewing.
TOPAMAX®CAPSULESSwallow whole or sprinkle contents
of capsule on soft food and swallow immediately without
chewing.
lPRESCRIBING AND DISPENSING INFORMATION
Switching between formulationsCare should be taken when
switching between oral formulations in the treatment of
epilepsy. 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.
Patients being treated for epilepsy may need to be
maintained on a specific manufacturer’s branded or
generic topiramate product.
lPATIENT AND CARER ADVICE
Medicines for Children leaflet: Topiramate for preventing
seizureswww.medicinesforchildren.org.uk/topiramate-for-
preventing-seizures
TOPAMAX®CAPSULESPatients or carers should be given
advice on how to administerTopamax®capsules.212 Epilepsy and other seizure disorders BNFC 2018 – 2019
Nervous system4