l BREAST FEEDING Manufacturer advises avoid—present in
l HEPATIC IMPAIRMENT Manufacturer advises caution (risk
Dose adjustments Manufacturer advises consider initial
dose of 25 mg twice daily; max. maintenance dose of 75 mg
twice daily (limited information available).
l TREATMENT CESSATION Manufacturer advises avoid abrupt
withdrawal—reduce daily dose in steps of 50 mg at weekly
intervals, then reduce to 20 mg daily for a final week.
l DIRECTIONS FOR ADMINISTRATION
▶ With intravenous use For intermittent intravenous infusion,
manufacturer advises dilute in Glucose 5% or Sodium
Chloride 0.9% or Lactated Ringer’s solution; give over
▶ With oral use Manufacturer advises oral solution can be
diluted in water or juice shortly before swallowing.
l PRESCRIBING 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.
Missed doses Manufacturer 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
Driving and skilled tasks Manufacturer advises patients and
carers should be cautioned on the effects on driving and
performance of skilled tasks—increased risk of dizziness.
l NATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has 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 from 16 years of age
with refractory epilepsy. Treatment should be initiated by
physicians who have appropriate experience in the
All Wales Medicines Strategy Group (AWMSG) decisions
The All Wales Medicines Strategy Group has advised
(December 2018) that brivaracetam (Briviact ®) is
recommended as an option for restricted use within NHS
Wales. Brivaracetam (Briviact ®) should be restricted for
310 Epilepsy and other seizure disorders BNF 78
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 with or without secondary
generalisation in patients from 4 years of age with
epilepsy. Brivaracetam (Briviact ®) is not recommended for
use within NHS Wales outside of this subpopulation.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 2
ELECTROLYTES: May contain Sodium
Brivaracetam 10 mg per 1 ml Briviact 50mg/5ml solution for
injection vials | 10 vial P £222.75
CAUTIONARY AND ADVISORY LABELS 2, 8
EXCIPIENTS: May contain Sorbitol
ELECTROLYTES: May contain Sodium
Brivaracetam 10 mg per 1 ml Briviact 10mg/ml oral solution sugarfree | 300 ml P £115.83 DT = £115.83
CAUTIONARY AND ADVISORY LABELS 2, 8, 25
Brivaracetam 10 mg Briviact 10mg tablets | 14 tablet P £34.64
Brivaracetam 25 mg Briviact 25mg tablets | 56 tablet P £129.64 DT = £129.64
Brivaracetam 50 mg Briviact 50mg tablets | 56 tablet P £129.64 DT = £129.64
Brivaracetam 75 mg Briviact 75mg tablets | 56 tablet P £129.64 DT = £129.64
Brivaracetam 100 mg Briviact 100mg tablets | 56 tablet P £129.64 DT = £129.64
Focal and secondary generalised tonic-clonic seizures |
Primary generalised tonic-clonic seizures
▶ BY MOUTH USING IMMEDIATE-RELEASE MEDICINES
▶ Adult: Initially 100–200 mg 1–2 times a day, increased
in steps of 100–200 mg every 2 weeks; usual dose
0.8–1.2 g daily in divided doses; increased if necessary
up to 1.6–2 g daily in divided doses
▶ Elderly: Reduce initial dose
▶ Adult: Up to 1 g daily in 4 divided doses for up to
7 days, for short-term use when oral therapy
▶ BY MOUTH USING IMMEDIATE-RELEASE MEDICINES
▶ Adult: Initially 100 mg 1–2 times a day, some patients
may require higher initial dose, increase gradually
according to response; usual dose 200 mg 3–4 times a
day, increased if necessary up to 1.6 g daily
Prophylaxis of bipolar disorder unresponsive to lithium
▶ BY MOUTH USING IMMEDIATE-RELEASE MEDICINES
▶ Adult: Initially 400 mg daily in divided doses, increased
until symptoms controlled; usual dose 400–600 mg
Adjunct in acute alcohol withdrawal
▶ BY MOUTH USING IMMEDIATE-RELEASE MEDICINES
▶ Adult: Initially 800 mg daily in divided doses, then
reduced to 200 mg daily for usual treatment duration of
7–10 days, dose to be reduced gradually over 5 days
▶ BY MOUTH USING IMMEDIATE-RELEASE MEDICINES
▶ Adult: Initially 100 mg 1–2 times a day, increased
gradually according to response; usual dose 200 mg
3–4 times a day, increased if necessary up to 1.6 g daily
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
▶ 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
DOSE EQUIVALENCE AND CONVERSION
▶ Suppositories of 125 mg may be considered to be
approximately equivalent in therapeutic effect to
tablets of 100 mg but final adjustment should always
depend on clinical response (plasma concentration
Focal and secondary generalised tonic-clonic seizures |
Primary generalised tonic-clonic seizures
▶ Adult: Initially 100–400 mg daily in 1–2 divided doses,
increased in steps of 100–200 mg every 2 weeks, dose
should be increased slowly; usual dose 0.8–1.2 g daily
in 1–2 divided doses, increased if necessary up to
1.6–2 g daily in 1–2 divided doses
▶ Elderly: Reduce initial dose
▶ Adult: Initially 100–200 mg daily in 1–2 divided doses,
some patients may require higher initial dose, increase
gradually according to response; usual dose
600–800 mg daily in 1–2 divided doses, increased if
necessary up to 1.6 g daily in 1–2 divided doses
Prophylaxis of bipolar disorder unresponsive to lithium
▶ Adult: Initially 400 mg daily in 1–2 divided doses,
increased until symptoms controlled; usual dose
400–600 mg daily in 1–2 divided doses; maximum 1.6 g
Focal and generalised tonic-clonic seizures | Prophylaxis of
▶ Child 5–11 years: Initially 5 mg/kg daily in 1–2 divided
doses, then increased in steps of 2.5–5 mg/kg every
3–7 days as required, dose should be increased slowly;
maintenance 10–15 mg/kg daily in 1–2 divided doses,
increased if necessary up to 20 mg/kg daily in
▶ Child 12–17 years: Initially 100–400 mg daily in
1–2 divided doses, then increased to 400–1200 mg
daily in 1–2 divided doses, increased if necessary up to
1.8 g daily in 1–2 divided doses, dose should be
Focal and secondary generalised tonic-clonic seizures |
Primary generalised tonic-clonic seizures
▶ Adult: Initially 100–400 mg daily in 2 divided doses,
increased in steps of 100–200 mg every 2 weeks, dose
should be increased slowly; usual dose 0.8–1.2 g daily
in 2 divided doses, increased if necessary up to 1.6–2 g
daily in 2 divided doses continued→
BNF 78 Epilepsy and other seizure disorders 311
▶ Elderly: Reduce initial dose
Focal and generalised tonic-clonic seizures | Prophylaxis of
▶ Child 5–11 years: Initially 5 mg/kg daily in 2 divided
doses, then increased in steps of 2.5–5 mg/kg every
3–7 days as required; maintenance 10–15 mg/kg daily
in 2 divided doses, increased if necessary up to
20 mg/kg daily in 2 divided doses
▶ Child 12–17 years: Initially 100–400 mg daily in 2 divided
doses, dose should be increased slowly; maintenance
400–1200 mg daily in 2 divided doses, increased if
necessary up to 1.8 g daily in 2 divided doses
▶ Adult: Initially 100–200 mg daily in 2 divided doses,
some patients may require higher initial dose. After
initial dose, increase according to response; usual dose
600–800 mg daily in 2 divided doses, increased if
necessary up to 1.6 g daily in 2 divided doses, dose
Prophylaxis of bipolar disorder unresponsive to lithium
▶ Adult: Initially 400 mg daily in 2 divided doses,
increased until symptoms controlled; usual dose
400–600 mg daily in 2 divided doses; maximum 1.6 g
▶ In children Not licensed for use in trigeminal neuralgia or
prophylaxis of bipolar disorder.
▶ In adults Not licensed for use in acute alcohol withdrawal.
Use in diabetic neuropathy is an unlicensed indication.
l CONTRA-INDICATIONS Acute porphyrias p. 1058 .AV
conduction abnormalities (unless paced). history of bonemarrow depression
l CAUTIONS Cardiac disease . history of haematological
reactions to other drugs . may exacerbate absence and
myoclonic seizures . skin reactions . susceptibility to
CAUTIONS, FURTHER INFORMATION Consider vitamin D
supplementation in patients who are immobilised for long
periods or who have inadequate sun exposure or dietary
▶ Blood, hepatic, or skin disorders Carbamazepine should be
withdrawn immediately in cases of aggravated liver
dysfunction or acute liver disease. Leucopenia that is
severe, progressive, or associated with clinical symptoms
requires withdrawal (if necessary under cover of a suitable
l INTERACTIONS → Appendix 1: antiepileptics
▶ Common or very common Dizziness . drowsiness . dry
reactions .thrombocytopenia . vision disorders . vomiting . weight increased
▶ Uncommon Constipation . diarrhoea . eye disorders .tic . tremor
disease aggravated . depression . dyspnoea . embolism and
anaemia . hallucinations . hearing impairment. hepatic
disorders . hirsutism . hyperacusia . hyperhidrosis .
tubulointerstitial . nervous system disorder. neuroleptic
(SCARs). sexual dysfunction . speech impairment. spermatogenesis abnormal . syncope . systemic lupus
erythematosus (SLE) .taste altered .tinnitus . urinary
disorders . vanishing bile duct syndrome . vasculitis
▶ Frequency not known Bone fracture . colitis . human
herpesvirus 6 infection reactivation . memory loss . nail
SIDE-EFFECTS, FURTHER INFORMATION Some side-effects
(such as headache, ataxia, drowsiness, nausea, vomiting,
blurring of vision, dizziness and allergic skin reactions) are
dose-related, and may be dose-limiting. These side-effects
are more common at the start of treatment and in the
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 carbamazepine.
See under Epilepsy p. 305 for more information. Caution—
cross-sensitivity reported with oxcarbazepine and with
l PREGNANCY See Pregnancy in Epilepsy p. 305.
Monitoring Doses should be adjusted on the basis of
plasma-drug concentration monitoring.
l BREAST FEEDING Amount probably too small to be
Monitoring Monitor infant for possible adverse reactions.
l HEPATIC IMPAIRMENT Manufacturer advises caution and
close monitoring—no information available.
l RENAL IMPAIRMENT Use with caution.
l PRE-TREATMENT SCREENING Test for HLA-B*1502 allele in
individuals of Han Chinese or Thai origin (avoid unless no
alternative—risk of Stevens-Johnson syndrome in
presence of HLA-B*1502 allele).
▶ Plasma concentration for optimum response 4–12 mg/litre
(20–50 micromol/litre) measured after 1–2 weeks.
▶ Manufacturer recommends blood counts and hepatic and
renal function tests (but evidence of practical value
l TREATMENT CESSATION When stopping treatment with
carbamazepine for bipolar disorder, reduce the dose
gradually over a period of at least 4 weeks.
l DIRECTIONS FOR ADMINISTRATION
▶ In children Oral liquid has been used rectally—should be
retained for at least 2 hours (but may have laxative effect).
TEGRETOL ® PROLONGED RELEASE Tegretol ® Prolonged
Release tablets can be halved but should not be chewed.
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
Blood, hepatic, or skin disorders Patients or their carers
should be told how to recognise signs of blood, liver, or
skin disorders, and advised to seek immediate medical
attention if symptoms such as fever, rash, mouth ulcers,
bruising, or bleeding develop.
312 Epilepsy and other seizure disorders BNF 78
Medicines for Children leaflet: Carbamazepine (oral) for preventing
seizures www.medicinesforchildren.org.uk/carbamazepineoral-preventing-seizures-0
l PROFESSION SPECIFIC INFORMATION
Dental practitioners’ formulary
Carbamazepine Tablets may be prescribed.
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, 25
Carbamazepine 200 mg Carbagen SR 200mg tablets | 56 tablet P £4.16 DT = £5.20
Carbamazepine 400 mg Carbagen SR 400mg tablets | 56 tablet P £8.20 DT = £10.24
▶ Tegretol Retard (Novartis Pharmaceuticals UK Ltd)
Carbamazepine 200 mg Tegretol Prolonged Release 200mg tablets
| 56 tablet P £5.20 DT = £5.20
Carbamazepine 400 mg Tegretol Prolonged Release 400mg tablets
| 56 tablet P £10.24 DT = £10.24
CAUTIONARY AND ADVISORY LABELS 3, 8
▶ Tegretol (Novartis Pharmaceuticals UK Ltd)
Carbamazepine 100 mg Tegretol 100mg tablets | 84 tablet P £2.07 DT = £2.07
Carbamazepine 200 mg Tegretol 200mg tablets | 84 tablet P £3.83 DT = £3.83
Carbamazepine 400 mg Tegretol 400mg tablets | 56 tablet P £5.02 DT = £5.02
CAUTIONARY AND ADVISORY LABELS 3, 8
▶ Carbamazepine (Non-proprietary)
Carbamazepine 125 mg Carbamazepine 125mg suppositories |
5 suppository P £120.00 DT = £120.00
Carbamazepine 250 mg Carbamazepine 250mg suppositories | 5 suppository P £140.00 DT = £140.00
CAUTIONARY AND ADVISORY LABELS 3, 8
▶ Carbamazepine (Non-proprietary)
Carbamazepine 20 mg per 1 ml Carbamazepine 100mg/5ml oral
suspension sugar free sugar-free | 300 ml P £8.25 DT = £8.04
▶ Tegretol (Novartis Pharmaceuticals UK Ltd)
Carbamazepine 20 mg per 1 ml Tegretol 100mg/5ml liquid sugarfree | 300 ml P £6.12 DT = £8.04
Eslicarbazepine acetate 20-Nov-2018
Monotherapy of focal seizures with or without secondary
▶ Adult: Initially 400 mg once daily for 1–2 weeks, then
increased to 800 mg once daily, then increased if
necessary to 1.2 g once daily (max. per dose 1.6 g)
▶ Elderly: Initially 400 mg once daily for 1–2 weeks, then
increased to 800 mg once daily (max. per dose 1.2 g)
Adjunctive therapy of focal seizures with or without
▶ Adult: Initially 400 mg once daily for 1–2 weeks, then
increased to 800 mg once daily (max. per dose 1.2 g)
l CONTRA-INDICATIONS Second- or third-degree AV block
l CAUTIONS Elderly . hyponatraemia . PR-interval
l INTERACTIONS → Appendix 1: antiepileptics
disorders . vertigo . vision disorders . vomiting
in extremity . palpitations . peripheral coldness . peripheral
impairment.tinnitus .toothache . weight decreased
l ALLERGY AND CROSS-SENSITIVITY Antiepileptic
hypersensitivity syndrome theoretically associated with
eslicarbazepine. See under Epilepsy p. 305 for more
l PREGNANCY Manufacturer advises minimum effective
doses and monotherapy if possible—reproductive toxicity
Monitoring The dose should be monitored carefully during
pregnancy and after birth, and adjustments made on a
l BREAST FEEDING Manufacturer advises avoid—present in
l HEPATIC IMPAIRMENT Manufacturer advises caution in
mild to moderate impairment—limited information; avoid
in severe impairment—no information available.
l RENAL IMPAIRMENT Manufacturer advises avoid if
creatinine creatinine clearance less than 30 mL/minute.
Dose adjustments Manufacturer advises reduce initial dose
to 200 mg once daily or 400 mg every other day for 2 weeks,
then increase to 400 mg once daily if creatinine clearance
30–60 mL/minute. The dose may be further increased
l PRE-TREATMENT SCREENING Test for HLA-B*1502 allele in
individuals of Han Chinese or Thai origin (avoid unless no
alternative— risk of Stevens-Johnson syndrome in
presence of HLA-B*1502 allele).
l MONITORING REQUIREMENTS Monitor plasma-sodium
concentration in patients at risk of hyponatraemia and
discontinue treatment if hyponatraemia occurs.
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.
Driving and skilled tasks Manufacturer advises patients and
carers should be cautioned on the effects on driving and
performance of skilled tasks—increased risk of dizziness,
somnolence and visual disorders.
l NATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (November
2010) that eslicarbazepine (Zebinix ®) is accepted for
restricted use within NHS Scotland as adjunctive therapy
in adults with focal seizures with or without secondary
generalisation. It is restricted for use in refractory epilepsy
BNF 78 Epilepsy and other seizure disorders 313
in patients who have been heavily pre-treated and remain
uncontrolled with existing anti-epileptic drugs. This
advice is contingent upon the continuing availability of
the patient access scheme in Scotland.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 8
Eslicarbazepine acetate 50 mg per 1 ml Zebinix 50mg/1ml oral
suspension sugar-free | 200 ml P £56.67
CAUTIONARY AND ADVISORY LABELS 8
Eslicarbazepine acetate 200 mg Zebinix 200mg tablets | 60 tablet P £68.00 DT = £68.00
Eslicarbazepine acetate 800 mg Zebinix 800mg tablets | 30 tablet P £136.00 DT = £136.00
Absence seizures | Atypical absence seizures (adjunct)|
▶ Child 1 month–5 years: Initially 5 mg/kg twice daily
(max. per dose 125 mg), dose to be increased every
5–7 days; maintenance 10–20 mg/kg twice daily (max.
per dose 500 mg), total daily dose may rarely be given
▶ Child 6–17 years: Initially 250 mg twice daily, then
increased in steps of 250 mg every 5–7 days; usual dose
500–750 mg twice daily, increased if necessary up to
▶ Adult: Initially 500 mg daily in 2 divided doses, then
increased in steps of 250 mg every 5–7 days; usual dose
1–1.5 g daily in 2 divided doses, increased if necessary
l CAUTIONS Avoid in Acute porphyrias p. 1058
l INTERACTIONS → Appendix 1: antiepileptics
l SIDE-EFFECTS Aggression . agranulocytosis . appetite
haemorrhage . vision disorders . vomiting . weight
SIDE-EFFECTS, FURTHER INFORMATION Blood counts
required if features of fever, sore throat, mouth ulcers,
l 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 Present in milk. Hyperexcitability and
l HEPATIC IMPAIRMENT Use with caution.
l RENAL IMPAIRMENT Use with caution.
Blood disorders Patients or their carers should be told how
to recognise signs of blood disorders, and advised to seek
immediate medical attention if symptoms such as fever,
mouth ulcers, bruising, or bleeding develop.
Medicines for Children leaflet: Ethosuximide for preventing
seizures www.medicinesforchildren.org.uk/ethosuximidepreventing-seizures
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 8
▶ Ethosuximide (Non-proprietary)
Ethosuximide 50 mg per 1 ml Ethosuximide 250mg/5ml syrup |
CAUTIONARY AND ADVISORY LABELS 8
▶ Ethosuximide (Non-proprietary)
Ethosuximide 250 mg Ethosuximide 250mg capsules | 56 capsule P £173.00 DT = £173.00
Fosphenytoin sodium 23-Jul-2018
l DRUG ACTION Fosphenytoin is a pro-drug of phenytoin.
▶ Adult: Initially 20 mg(PE)/kg, dose to be administered
at a rate of 100–150 mg(PE)/minute, then 4–5 mg
(PE)/kg daily in 1–2 divided doses, dose to be
administered at a rate of 50–100 mg(PE)/minute, dose
to be adjusted according to response and trough
plasma-phenytoin concentration
▶ Elderly: Consider 10–25% reduction in dose or infusion
Prophylaxis or treatment of seizures associated with
▶ BY INTRAMUSCULAR INJECTION, OR BY INTRAVENOUS INFUSION
▶ Adult: Initially 10–15 mg(PE)/kg, intravenous infusion
to be administered at a rate of 50–100 mg(PE)/minute,
then 4–5 mg(PE)/kg daily in 1–2 divided doses,
intravenous infusion to be administered at a rate of
50–100 mg(PE)/minute, dose to be adjusted according
to response and trough plasma-phenytoin
▶ Elderly: Consider 10–25% reduction in dose or infusion
Temporary substitution for oral phenytoin
▶ BY INTRAMUSCULAR INJECTION, OR BY INTRAVENOUS INFUSION
▶ Adult: Same dose and same dosing frequency as oral
phenytoin therapy, intravenous infusion to be
administered at a rate of 50–100 mg(PE)/minute
▶ Elderly: Consider 10–25% reduction in dose or infusion
DOSE EQUIVALENCE AND CONVERSION
▶ Doses are expressed as phenytoin sodium equivalent
(PE); fosphenytoin sodium 1.5 mg : phenytoin sodium
l UNLICENSED USE Fosphenytoin sodium doses in BNF may
differ from those in product literature.
l CAUTIONS Heart failure . hypotension . injection solutions
alkaline (irritant to tissues).respiratory depression . resuscitation facilities must be available
l INTERACTIONS → Appendix 1: antiepileptics
314 Epilepsy and other seizure disorders BNF 78
taste altered .tinnitus .tremor. vasodilation . vertigo . vision disorders . vomiting
disorders .reflexes abnormal . severe cutaneous adverse
reactions (SCARs). systemic lupus erythematosus (SLE). thinking abnormal
disorders . hyperglycaemia . hypersensitivity . insomnia . leucopenia . lymphadenopathy . nephritis
SIDE-EFFECTS, FURTHER INFORMATION Fosphenytoin has
been associated with severe cardiovascular reactions
including asystole, ventricular fibrillation, and cardiac
arrest. Hypotension, bradycardia, and heart block have
also been reported. The following are recommended:
monitor heart rate, blood pressure, and respiratory
function for duration of infusion; observe patient for at
least 30 minutes after infusion; if hypotension occurs,
reduce infusion rate or discontinue; reduce dose or
infusion rate in elderly, and in renal or hepatic
l ALLERGY AND CROSS-SENSITIVITY Cross-sensitivity
l PREGNANCY See also Pregnancy in Epilepsy p. 305.
Monitoring Changes in plasma-protein binding make
interpretation of plasma-phenytoin concentrations
difficult—monitor unbound fraction.
The dose should be monitored carefully during
pregnancy and after birth, and adjustments made on a
l BREAST FEEDING Small amounts present in milk, but not
l HEPATIC IMPAIRMENT Manufacturer advises caution—
monitor free plasma-phenytoin concentration (rather than
total plasma-phenytoin concentration) in hepatic
impairment or hypoalbuminaemia and in
Dose adjustments Manufacturer advises consider a 10–25%
reduction in dose or infusion rate (except in the treatment
of status epilepticus) in hepatic impairment or
Dose adjustments Consider 10–25% reduction in dose or
infusion rate (except initial dose for status epilepticus).
l PRE-TREATMENT SCREENING HLA-B* 1502 allele in
individuals of Han Chinese or Thai origin—avoid unless
essential (increased risk of Stevens-Johnson syndrome).
▶ Manufacturer recommends blood counts (but evidence of
▶ With intravenous use Monitor heart rate, blood pressure,
ECG, and respiratory function for during infusion.
l DIRECTIONS FOR ADMINISTRATION For intermittent
intravenous infusion (Pro-Epanutin ®), give in Glucose 5% or
Sodium chloride 0.9%; dilute to a concentration of
1.5–25 mg (phenytoin sodium equivalent (PE))/mL.
l PRESCRIBING AND DISPENSING INFORMATION
Prescriptions for fosphenytoin sodium should state the
dose in terms of phenytoin sodium equivalent (PE);
fosphenytoin sodium 1.5 mg : phenytoin sodium 1 mg.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
ELECTROLYTES: May contain Phosphate
Fosphenytoin sodium 75 mg per 1 ml Pro-Epanutin 750mg/10ml
concentrate for solution for injection vials | 10 vial P £400.00
Adjunctive treatment of focal seizures with or without
▶ Child 6–11 years: 10 mg/kg once daily (max. per dose
300 mg) on day 1, then 10 mg/kg twice daily (max. per
dose 300 mg) on day 2, then 10 mg/kg 3 times a day
(max. per dose 300 mg) on day 3; usual dose
25–35 mg/kg daily in 3 divided doses, some children
may not tolerate daily increments; longer intervals (up
to weekly) may be more appropriate, daily dose
maximum to be given in 3 divided doses; maximum
▶ Child 12–17 years: Initially 300 mg once daily on day 1,
then 300 mg twice daily on day 2, then 300 mg 3 times
a day on day 3, alternatively initially 300 mg 3 times a
day on day 1, then increased in steps of 300 mg every
2–3 days in 3 divided doses, adjusted according to
response; usual dose 0.9–3.6 g daily in 3 divided doses
(max. per dose 1.6 g 3 times a day), some children may
not tolerate daily increments; longer intervals (up to
weekly) may be more appropriate
▶ Adult: Initially 300 mg once daily on day 1, then
300 mg twice daily on day 2, then 300 mg 3 times a day
on day 3, alternatively initially 300 mg 3 times a day on
day 1, then increased in steps of 300 mg every 2–3 days
in 3 divided doses, adjusted according to response;
usual dose 0.9–3.6 g daily in 3 divided doses (max. per
Monotherapy for focal seizures with or without secondary
▶ Child 12–17 years: Initially 300 mg once daily on day 1,
then 300 mg twice daily on day 2, then 300 mg 3 times
a day on day 3, alternatively initially 300 mg 3 times a
day on day 1, then increased in steps of 300 mg every
2–3 days in 3 divided doses, adjusted according to
response; usual dose 0.9–3.6 g daily in 3 divided doses
(max. per dose 1.6 g 3 times a day), some children may
not tolerate daily increments; longer intervals (up to
weekly) may be more appropriate
▶ Adult: Initially 300 mg once daily on day 1, then
300 mg twice daily on day 2, then 300 mg 3 times a day
on day 3, alternatively initially 300 mg 3 times a day on
day 1, then increased in steps of 300 mg every 2–3 days
in 3 divided doses, adjusted according to response;
usual dose 0.9–3.6 g daily in 3 divided doses (max. per
▶ Adult: Initially 300 mg once daily on day 1, then
300 mg twice daily on day 2, then 300 mg 3 times a day
on day 3, alternatively initially 300 mg 3 times a day on
day 1, then increased in steps of 300 mg continued→
BNF 78 Epilepsy and other seizure disorders 315
every 2–3 days in 3 divided doses, adjusted according
to response; maximum 3.6 g per day
▶ Adult: Initially 300 mg daily, then increased to up to
2.4 g daily in divided doses, adjusted according to
Menopausal symptoms, particularly hot flushes, in women
▶ Adult: 300 mg 3 times a day, initial dose should be
lower and titrated up over three days
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