▶ With rectal use Dissolve contents of sachet in small amount
of water and administer rectally [unlicensed use].
l PATIENT AND CARER ADVICE Patients and their carers
should be warned to report any new visual symptoms that
Medicines for Children leaflet: Vigabatrin for preventing seizures
www.medicinesforchildren.org.uk/vigabatrin-preventingseizures
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug. Forms available
from special-order manufacturers include: oral solution
CAUTIONARY AND ADVISORY LABELS 3, 8, 13
Vigabatrin 500 mg Sabril 500mg oral powder sachets sugar-free | 50 sachet P £24.60 DT = £24.60
CAUTIONARY AND ADVISORY LABELS 3, 8
Vigabatrin 500 mg Sabril 500mg tablets | 100 tablet P £44.41
BNF 78 Epilepsy and other seizure disorders 333
Monotherapy for treatment of focal seizures with or
without secondary generalisation in adults with newly
▶ Adult: Initially 100 mg once daily for 2 weeks, then
increased in steps of 100 mg every 2 weeks, usual
maintenance dose 300 mg once daily; maximum
Adjunctive treatment for refractory focal seizures with or
without secondary generalisation
▶ Child 6–17 years (body-weight 20–54 kg): Initially 1 mg/kg
once daily for 7 days, then increased in steps of
1 mg/kg every 7 days, usual maintenance 6–8 mg/kg
once daily (max. per dose 500 mg once daily), dose to
be increased at 2-week intervals in patients who are
not receiving concomitant carbamazepine, phenytoin,
phenobarbital or other potent inducers of cytochrome
▶ Child 6–17 years (body-weight 55 kg and above): Initially
1 mg/kg once daily for 7 days, then increased in steps
of 1 mg/kg every 7 days, usual maintenance
300–500 mg once daily, dose to be increased at 2-week
intervals in patients who are not receiving
concomitant carbamazepine, phenytoin, phenobarbital
or other potent inducers of cytochrome P450 enzyme
▶ Adult: Initially 50 mg daily in 2 divided doses for
7 days, then increased to 100 mg daily in 2 divided
doses, then increased in steps of 100 mg every 7 days,
usual maintenance 300–500 mg daily in 1–2 divided
doses, dose to be increased at 2-week intervals in
patients who are not receiving concomitant
carbamazepine, phenytoin, phenobarbital or other
potent inducers of cytochrome P450 enzyme CYP3A4
l CAUTIONS Elderly . low body-weight or poor appetite—
monitor weight throughout treatment (fatal cases of
weight loss reported in children). metabolic acidosis—
monitor serum bicarbonate concentration in children and
those with other risk factors (consider dose reduction or
discontinuation if metabolic acidosis develops).risk
factors for renal stone formation (particularly
predisposition to nephrolithiasis)
CAUTIONS, FURTHER INFORMATION Avoid overheating and
ensure adequate hydration especially in children, during
strenuous activity or if in warm environment (fatal cases of
heat stroke reported in children).
l INTERACTIONS → Appendix 1: antiepileptics
▶ Common or very common Alopecia . anxiety . appetite
metabolic acidosis . myasthenic syndrome . neuroleptic
malignant syndrome . pancreatitis .renal failure .renal
tubular acidosis .rhabdomyolysis . severe cutaneous
adverse reactions (SCARs). urine abnormal
▶ Frequency not known Sudden unexplained death in
l ALLERGY AND CROSS-SENSITIVITY Contra-indicated in
Antiepileptic hypersensitivity syndrome theoretically
associated with zonisamide. See under Epilepsy p. 305 for
l CONCEPTION AND CONTRACEPTION Manufacturer advises
women of childbearing potential should use effective
contraception during treatment and for one month after
last dose—avoid in women of childbearing potential not
using effective contraception unless clearly necessary and
the potential benefit outweighs risk; patients should be
fully informed of the risks related to the use of zonisamide
l PREGNANCY Manufacturer advises use only if clearly
necessary and the potential benefit outweighs risk—
toxicity in animal studies; patients should be fully
informed of the risks related to the use of zonisamide
during pregnancy. See also Pregnancy in Epilepsy p. 305.
Monitoring The dose should be monitored carefully during
pregnancy and after birth, and adjustments made on a
l BREAST FEEDING Manufacturer advises avoid for 4 weeks
l HEPATIC IMPAIRMENT Avoid in severe impairment.
Dose adjustments Initially increase dose at 2-week
intervals if mild or moderate impairment.
Dose adjustments Initially increase dose at 2-week
intervals; discontinue if renal function deteriorates.
l TREATMENT CESSATION Avoid abrupt withdrawal (consult
product literature for recommended withdrawal regimens
l PRESCRIBING AND DISPENSING INFORMATION
Switching between formulations Care should be taken when
switching between oral formulations. 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 may need to be maintained on a specific
manufacturer’s branded or generic zonisamide product.
l PATIENT AND CARER ADVICE Children and their carers
should be made aware of how to prevent and recognise
Medicines for Children leaflet: Zonisamide for preventing seizures
www.medicinesforchildren.org.uk/zonisamide-preventingseizures
l NATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (March
2014) that zonisamide (Zonegran ®) is accepted for
restricted use within NHS Scotland as adjunctive
treatment of focal seizures, with or without secondary
generalisation, in adolescents and children aged 6 years
and above. It is restricted to use on advice from specialists
in paediatric neurology or epilepsy.
334 Epilepsy and other seizure disorders BNF 78
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug. Forms available
from special-order manufacturers include: oral suspension, oral
CAUTIONARY AND ADVISORY LABELS 3, 8, 10
▶ Zonisamide (Non-proprietary)
Zonisamide 25 mg Zonisamide 25mg capsules | 14 capsule P £8.82 DT = £6.45
Zonisamide 50 mg Zonisamide 50mg capsules | 56 capsule P £47.04 DT = £33.60
Zonisamide 100 mg Zonisamide 100mg capsules | 56 capsule P £62.72 DT = £4.74
Zonisamide 25 mg Zonegran 25mg capsules | 14 capsule P £8.82 DT = £6.45
Zonisamide 50 mg Zonegran 50mg capsules | 56 capsule P £47.04 DT = £33.60
Zonisamide 100 mg Zonegran 100mg capsules | 56 capsule P £62.72 DT = £4.74
All forms of epilepsy except typical absence seizures
▶ Child 1 month–11 years: Initially 1–1.5 mg/kg twice daily,
then increased in steps of 2 mg/kg daily as required;
maintenance 2.5–4 mg/kg 1–2 times a day
▶ Child 12–17 years: 60–180 mg once daily
▶ Adult: 60–180 mg once daily, dose to be taken at night
▶ Adult: 10 mg/kg (max. per dose 1 g), dose to be
administered at a rate not more than 100 mg/minute,
injection to be diluted 1 in 10 with water for injections
▶ BY SLOW INTRAVENOUS INJECTION
▶ Neonate: Initially 20 mg/kg, dose to be administered at a
rate no faster than 1 mg/kg/minute, then 2.5–5 mg/kg
▶ Child 1 month–11 years: Initially 20 mg/kg, dose to be
administered at a rate no faster than 1 mg/kg/minute,
then 2.5–5 mg/kg 1–2 times a day
▶ Child 12–17 years: Initially 20 mg/kg (max. per dose 1 g),
dose to be administered at a rate no faster than
1 mg/kg/minute, then 300 mg twice daily
DOSE EQUIVALENCE AND CONVERSION
▶ For therapeutic purposes phenobarbital and
phenobarbital sodium may be considered equivalent in
drug abuse .respiratory depression (avoid if severe)
CAUTIONS, FURTHER INFORMATION Consider vitamin D
supplementation in patients who are immobilised for long
periods or who have inadequate sun exposure or dietary
l INTERACTIONS → Appendix 1: antiepileptics
Agranulocytosis . anticonvulsant hypersensitivity
syndrome . behaviour abnormal . bone disorders . bone
loss . movement disorders . nystagmus .respiratory
reactions (SCARs).thrombocytopenia
Overdose For details on the management of poisoning, see
Active elimination techniques, under Emergency
treatment of poisoning p. 1359.
l ALLERGY AND CROSS-SENSITIVITY Antiepileptic
hypersensitivity syndrome associated with phenobarbital.
See under Epilepsy p. 305 for more information.
Monitoring The dose should be monitored carefully during
pregnancy and after birth, and adjustments made on a
l BREAST FEEDING Avoid if possible; drowsiness may occur.
l HEPATIC IMPAIRMENT Manufacturer advises caution in
mild to moderate impairment; avoid in severe impairment.
l RENAL IMPAIRMENT Use with caution.
▶ Plasma-phenobarbital concentration for optimum
response is 15–40 mg/litre (60–180 micromol/litre);
however, monitoring the plasma-drug concentration is
less useful than with other drugs because tolerance occurs.
l TREATMENT CESSATION Avoid abrupt withdrawal
(dependence with prolonged use).
l DIRECTIONS FOR ADMINISTRATION
▶ With oral use For administration by mouth, tablets may be
▶ With intravenous use in adults Solution for injection must be
diluted before intravenous administration.
▶ With intravenous use in children For intravenous injection,
dilute to a concentration of 20 mg/mL with Water for
Injections; give over 20 minutes (no faster than
l PRESCRIBING AND DISPENSING INFORMATION Some
hospitals supply alcohol-free formulations of varying
The RCPCH and NPPG recommend that, when a liquid
special of phenobarbital is required, the following strength
Switching between formulations Different formulations of oral
preparations may vary in bioavailability. Patients should
be maintained on a specific manufacturer’s product.
Medicines for Children leaflet: Phenobarbital for preventing
seizures www.medicinesforchildren.org.uk/phenobarbitalpreventing-seizures
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug. Forms available
from special-order manufacturers include: tablet, capsule, oral
CAUTIONARY AND ADVISORY LABELS 2, 8
▶ Phenobarbital (Non-proprietary)
Phenobarbital 15 mg Phenobarbital 15mg tablets | 28 tablet P £24.95 DT = £16.71c
Phenobarbital 30 mg Phenobarbital 30mg tablets | 28 tablet P £5.99 DT = £0.69c
Phenobarbital 60 mg Phenobarbital 60mg tablets | 28 tablet P £7.99 DT = £6.67c
EXCIPIENTS: May contain Propylene glycol
▶ Phenobarbital (Non-proprietary)
Phenobarbital sodium 30 mg per 1 ml Phenobarbital 30mg/1ml
solution for injection ampoules | 10 ampoule P £98.42 DT =
BNF 78 Epilepsy and other seizure disorders 335
Phenobarbital sodium 60 mg per 1 ml Phenobarbital 60mg/1ml
solution for injection ampoules | 10 ampoule P £103.84 DT =
Phenobarbital sodium 200 mg per 1 ml Phenobarbital 200mg/1ml
solution for injection ampoules | 10 ampoule P £84.66 DT =
CAUTIONARY AND ADVISORY LABELS 2, 8
EXCIPIENTS: May contain Alcohol
▶ Phenobarbital (Non-proprietary)
Phenobarbital 3 mg per 1 ml Phenobarbital 15mg/5ml elixir | 500 ml P £83.00–£83.01 DT = £83.01c
All forms of epilepsy except typical absence seizures
▶ Child 1 month–1 year: Initially 125 mg daily, dose to be
taken at bedtime, then increased in steps of 125 mg
every 3 days, adjusted according to response;
maintenance 125–250 mg twice daily
▶ Child 2–4 years: Initially 125 mg once daily, dose to be
taken at bedtime, then increased in steps of 125 mg
every 3 days, adjusted according to response;
maintenance 250–375 mg twice daily
▶ Child 5–8 years: Initially 125 mg once daily, dose to be
taken at bedtime, then increased in steps of 125 mg
every 3 days, adjusted according to response;
maintenance 375–500 mg twice daily
▶ Child 9–17 years: Initially 125 mg once daily, dose to be
taken at bedtime, then increased in steps of 125 mg
every 3 days, increased to 250 mg twice daily, then
increased in steps of 250 mg every 3 days (max. per
dose 750 mg twice daily), adjusted according to
▶ Adult: Initially 125 mg once daily, dose to be taken at
bedtime, then increased in steps of 125 mg every
3 days, increased to 500 mg daily in 2 divided doses,
then increased in steps of 250 mg every 3 days,
adjusted according to response; maintenance
0.75–1.5 g daily in 2 divided doses
▶ Adult: Initially 50 mg daily, then adjusted according to
response to up to 750 mg daily, dose to be increased
drug abuse .respiratory depression (avoid if severe)
CAUTIONS, FURTHER INFORMATION Consider vitamin D
supplementation in patients who are immobilised for long
periods or who have inadequate sun exposure or dietary
l INTERACTIONS → Appendix 1: antiepileptics
▶ Common or very common Apathy . ataxia . drowsiness . nausea . nystagmus . visual impairment
▶ Uncommon Dizziness . headache . hypersensitivity . skin
▶ Rare or very rare Arthralgia . blood disorder. bone
disorders .Dupuytren’s contracture . megaloblastic
anaemia (may be treated with folic acid) . personality
change . psychotic disorder. severe cutaneous adverse
reactions (SCARs). systemic lupus erythematosus (SLE)
▶ Frequency not known Bone fracture
l ALLERGY AND CROSS-SENSITIVITY Antiepileptic
hypersensitivity syndrome associated with primidone. See
under Epilepsy p. 305 for more information.
Monitoring The dose should be monitored carefully during
pregnancy and after birth, and adjustments made on a
l HEPATIC IMPAIRMENT May precipitate coma.
l RENAL IMPAIRMENT Use with caution.
▶ Monitor plasma concentrations of derived phenobarbital;
plasma concentration for optimum response is
15–40 mg/litre (60–180 micromol/litre).
l TREATMENT CESSATION Avoid abrupt withdrawal
(dependence with prolonged use).
l PRESCRIBING AND DISPENSING INFORMATION
Switching between formulations Different formulations of oral
preparations may vary in bioavailability. Patients being
treated for epilepsy should be maintained on a specific
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug. Forms available
from special-order manufacturers include: capsule, oral
CAUTIONARY AND ADVISORY LABELS 2, 8
Primidone 50 mg Primidone 50mg tablets | 100 tablet P £110.00–£112.37 DT = £111.58
Primidone 250 mg Primidone 250mg tablets | 100 tablet P £99.65–£121.94 DT = £114.51
▶ 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
▶ Adult: 20–30 mg daily, then increased if necessary up
▶ Adult: 20–30 mg daily in divided doses, alternatively
20–30 mg once daily, dose to be taken at bedtime;
increased if necessary up to 60 mg daily in divided
doses, dose only increased in severe anxiety (in
hospital patients), for debilitated patients, use elderly
▶ In children Not licensed as monotherapy.
Clobazam has been confused with clonazepam; care
must be taken to ensure the correct drug is prescribed
with depression (in adults). obsessional states . phobic
states .respiratory depression
l CAUTIONS Muscle weakness . organic brain changes
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