per dose 300 mg), then increased in steps of up to

5 mg/kg twice daily, adjusted according to response,

dose to be adjusted at weekly intervals; maintenance

15 mg/kg twice daily; maximum 46 mg/kg per day

▶ Adult: Initially 300 mg twice daily, then increased in

steps of up to 600 mg daily, adjusted according to

response, dose to be adjusted at weekly intervals; usual

dose 0.6–2.4 g daily in divided doses

Treatment of primary generalised tonic-clonic seizures

▶ BY MOUTH

▶ Adult: Initially 300 mg twice daily, then increased in

steps of up to 600 mg daily, adjusted according to

response, dose to be increased at weekly intervals;

usual dose 0.6–2.4 g daily in divided doses

DOSE ADJUSTMENTS DUE TO INTERACTIONS

▶ In adjunctive therapy, the dose of concomitant

antiepileptics may need to be reduced when using high

doses of oxcarbazepine.

l UNLICENSED USE

▶ In adults Not licensed for the treatment of primary

generalised tonic-clonic seizures.

l CAUTIONS Avoid in Acute porphyrias p. 1058 . cardiac

conduction disorders . heart failure . hyponatraemia

l INTERACTIONS → Appendix 1: antiepileptics

l SIDE-EFFECTS

▶ Common or very common Abdominal pain . agitation . alopecia . asthenia . ataxia . concentration impaired . constipation . depression . diarrhoea . dizziness . drowsiness . emotional lability . headache . hyponatraemia . nausea . nystagmus . skin reactions . vertigo . vision

disorders . vomiting

▶ Uncommon Leucopenia

▶ Rare or very rare Angioedema . arrhythmia . atrioventricular block . hepatitis . hypothyroidism . pancreatitis . severe cutaneous adverse reactions (SCARs). systemic lupus erythematosus (SLE).thrombocytopenia

▶ Frequency not known Agranulocytosis . bone disorders . bone marrow disorders . hypertension . inappropriate

antidiuretic hormone secretion like-syndrome . neutropenia . speech impairment

l ALLERGY AND CROSS-SENSITIVITY Caution in patients with

hypersensitivity to carbamazepine. Antiepileptic

hypersensitivity syndrome associated with oxcarbazepine.

See under Epilepsy p. 305 for more information.

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

clinical basis.

l BREAST FEEDING Amount probably too small to be

harmful but manufacturer advises avoid.

l HEPATIC IMPAIRMENT Manufacturer advises caution in

severe impairment (no information available).

l RENAL IMPAIRMENT

Dose adjustments ▶ In adults Halve initial dose if eGFR less

than 30 mL/minute/1.73 m2

; increase according to

response at intervals of at least 1 week.

▶ In children Halve initial dose if estimated glomerular

filtration rate less than 30 mL/minute/1.73 m2

, increase

according to response at intervals of at least 1 week.

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).

BNF 78 Epilepsy and other seizure disorders 321

Nervous system

4

l MONITORING REQUIREMENTS

▶ Monitor plasma-sodium concentration in patients at risk

of hyponatraemia.

▶ Monitor body-weight in patients with heart failure.

l PRESCRIBING AND DISPENSING INFORMATION Patients

may need to be maintained on a specific manufacturer’s

branded or generic oxcarbazepine product.

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.

l PATIENT AND CARER ADVICE

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 lethargy, confusion,

muscular twitching, fever, rash, blistering, mouth ulcers,

bruising, or bleeding develop.

Medicines for Children: Oxcarbazepine for preventing seizures

www.medicinesforchildren.org.uk/oxcarbazepine-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 suspension

Oral suspension

CAUTIONARY AND ADVISORY LABELS 3, 8

EXCIPIENTS: May contain Propylene glycol

▶ Trileptal (Novartis Pharmaceuticals UK Ltd)

Oxcarbazepine 60 mg per 1 ml Trileptal 60mg/ml oral suspension

sugar-free | 250 ml P £48.96 DT = £48.96

Tablet

CAUTIONARY AND ADVISORY LABELS 3, 8

▶ Oxcarbazepine (Non-proprietary)

Oxcarbazepine 150 mg Oxcarbazepine 150mg tablets | 50 tablet P £11.14 DT = £8.37

Oxcarbazepine 300 mg Oxcarbazepine 300mg tablets |

50 tablet P £22.61 DT = £5.86

Oxcarbazepine 600 mg Oxcarbazepine 600mg tablets | 50 tablet P £45.19 DT = £38.71

▶ Trileptal (Novartis Pharmaceuticals UK Ltd)

Oxcarbazepine 150 mg Trileptal 150mg tablets | 50 tablet P £12.24 DT = £8.37

Oxcarbazepine 300 mg Trileptal 300mg tablets | 50 tablet P £24.48 DT = £5.86

Oxcarbazepine 600 mg Trileptal 600mg tablets | 50 tablet P £48.96 DT = £38.71

Perampanel 28-May-2019

l INDICATIONS AND DOSE

Adjunctive treatment of focal seizures with or without

secondary generalised seizures

▶ BY MOUTH

▶ Child 12–17 years: Initially 2 mg once daily, dose to be

taken before bedtime, then increased, if tolerated, in

steps of 2 mg at intervals of at least every 2 weeks,

adjusted according to response; maintenance 4–8 mg

once daily; maximum 12 mg per day

▶ Adult: Initially 2 mg once daily, dose to be taken before

bedtime, then increased, if tolerated, in steps of 2 mg

at intervals of at least every 2 weeks, adjusted

according to response; maintenance 4–8 mg once

daily; maximum 12 mg per day

Adjunctive treatment of primary generalised tonic-clonic

seizures

▶ BY MOUTH

▶ Child 12–17 years: Initially 2 mg once daily, dose to be

taken before bedtime, then increased, if tolerated, in

steps of 2 mg at intervals of at least every 2 weeks,

adjusted according to response, maintenance up to

8 mg once daily; maximum 12 mg per day

▶ Adult: Initially 2 mg once daily, dose to be taken before

bedtime, then increased, if tolerated, in steps of 2 mg

at intervals of at least every 2 weeks, adjusted

according to response, maintenance up to 8 mg once

daily; maximum 12 mg per day

DOSE ADJUSTMENTS DUE TO INTERACTIONS

▶ Titrate at intervals of at least 1 week with concomitant

carbamazepine, fosphenytoin, oxcarbazepine, or

phenytoin.

l INTERACTIONS → Appendix 1: antiepileptics

l SIDE-EFFECTS

▶ Common or very common Anxiety . appetite abnormal . back pain . behaviour abnormal . confusion . dizziness . drowsiness . dysarthria . fatigue . gait abnormal . irritability . movement disorders . nausea . vertigo . vision disorders . weight increased

l PREGNANCY Manufacturer advises avoid. See also

Pregnancy in Epilepsy p. 305.

Monitoring The dose should be monitored carefully during

pregnancy and after birth, and adjustments made on a

clinical basis.

l BREAST FEEDING Avoid—present in milk in animal studies.

l HEPATIC IMPAIRMENT Manufacturer advises caution in

mild to moderate impairment; avoid in severe impairment.

Dose adjustments Manufacturer advises maximum 8 mg

per day in mild to moderate impairment.

l RENAL IMPAIRMENT Avoid in moderate or severe

impairment.

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 perampanel product.

l PATIENT AND CARER ADVICE

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

and drowsiness.

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 suspension

CAUTIONARY AND ADVISORY LABELS 3, 8

EXCIPIENTS: May contain Sorbitol

▶ Fycompa (Eisai Ltd)

Perampanel 500 microgram per 1 ml Fycompa 0.5mg/ml oral

suspension sugar-free | 340 ml P £127.50

Tablet

CAUTIONARY AND ADVISORY LABELS 3, 8, 25

▶ Fycompa (Eisai Ltd)

Perampanel 2 mg Fycompa 2mg tablets | 7 tablet P £35.00 DT =

£35.00 | 28 tablet P £140.00 DT = £140.00

Perampanel 4 mg Fycompa 4mg tablets | 28 tablet P £140.00

DT = £140.00

Perampanel 6 mg Fycompa 6mg tablets | 28 tablet P £140.00

DT = £140.00

Perampanel 8 mg Fycompa 8mg tablets | 28 tablet P £140.00

DT = £140.00

Perampanel 10 mg Fycompa 10mg tablets | 28 tablet P £140.00 DT = £140.00

Perampanel 12 mg Fycompa 12mg tablets | 28 tablet P £140.00

DT = £140.00

322 Epilepsy and other seizure disorders BNF 78

Nervous system

4

Phenytoin 19-Apr-2017

l INDICATIONS AND DOSE

Tonic-clonic seizures | Focal seizures

▶ BY MOUTH

▶ Child 1 month–11 years: Initially 1.5–2.5 mg/kg twice

daily, then adjusted according to response to

2.5–5 mg/kg twice daily (max. per dose 7.5 mg/kg twice

daily), dose also adjusted according to plasmaphenytoin concentration; maximum 300 mg per day

▶ Child 12–17 years: Initially 75–150 mg twice daily, then

adjusted according to response to 150–200 mg twice

daily (max. per dose 300 mg twice daily), dose also

adjusted according to plasma-phenytoin concentration

Tonic-clonic seizures | Focal seizures | Prevention and

treatment of seizures during or following neurosurgery

or severe head injury

▶ BY MOUTH

▶ Adult: Initially 3–4 mg/kg daily, alternatively

150–300 mg once daily, alternatively 150–300 mg daily

in 2 divided doses; usual maintenance 200–500 mg

daily, to be taken preferably with or after food, dose to

be increased gradually as necessary (with plasmaphenytoin concentration monitoring), exceptionally,

higher doses may be used

Prevention and treatment of seizures during or following

neurosurgery or severe head injury

▶ BY MOUTH

▶ Child: Initially 2.5 mg/kg twice daily, then adjusted

according to response to 4–8 mg/kg daily, dose also

adjusted according to plasma-phenytoin

concentration; maximum 300 mg per day

Status epilepticus | Acute symptomatic seizures associated

with head trauma or neurosurgery

▶ INITIALLY BY SLOW INTRAVENOUS INJECTION, OR BY

INTRAVENOUS INFUSION

▶ Child 1 month–11 years: Loading dose 20 mg/kg, then (by

slow intravenous injection or by intravenous infusion)

2.5–5 mg/kg twice daily

▶ Child 12–17 years: Loading dose 20 mg/kg, then (by

intravenous infusion or by slow intravenous injection)

up to 100 mg 3–4 times a day

▶ Adult: Loading dose 20 mg/kg (max. per dose 2 g), then

(by intravenous infusion or by slow intravenous

injection or by mouth) maintenance 100 mg every

6–8 hours adjusted according to plasma-concentration

monitoring

DOSE EQUIVALENCE AND CONVERSION

▶ Preparations containing phenytoin sodium are not

bioequivalent to those containing phenytoin base

(such as Epanutin Infatabs ® and Epanutin ®

suspension); 100 mg of phenytoin sodium is

approximately equivalent in therapeutic effect to

92 mg phenytoin base. The dose is the same for all

phenytoin products when initiating therapy. However,

if switching between these products the difference in

phenytoin content may be clinically significant. Care is

needed when making changes between formulations

and plasma-phenytoin concentration monitoring is

recommended.

l UNLICENSED USE

▶ With oral use in children Licensed for use in children (age

range not specified by manufacturer).

▶ With intravenous use Phenytoin doses in BNF publications

may differ from those in product literature.

IMPORTANT SAFETY INFORMATION

NHS IMPROVEMENT PATIENT SAFETY ALERT: RISK OF DEATH AND

SEVERE HARM FROM ERROR WITH INJECTABLE PHENYTOIN

(NOVEMBER 2016)

Use of injectable phenytoin is error-prone throughout

the prescribing, preparation, administration and

monitoring processes; all relevant staff should be made

aware of appropriate guidance on the safe use of

injectable phenytoin to reduce the risk of error.

l CONTRA-INDICATIONS

GENERAL CONTRA-INDICATIONS Acute porphyrias p. 1058

SPECIFIC CONTRA-INDICATIONS

▶ With intravenous use Second- and third-degree heart block . sino-atrial block . sinus bradycardia . Stokes-Adams

syndrome

l CAUTIONS

GENERAL CAUTIONS Enteral feeding (interrupt feeding for

2 hours before and after dose; more frequent monitoring

may be necessary)

SPECIFIC CAUTIONS

▶ With intravenous use Heart failure . hypotension . injection

solutions alkaline (irritant to tissues).respiratory

depression .resuscitation facilities must be available

CAUTIONS, FURTHER INFORMATION Consider vitamin D

supplementation in patients who are immobilised for long

periods or who have inadequate sun exposure or dietary

intake of calcium.

Intramuscular phenytoin should not be used (absorption

is slow and erratic).

l INTERACTIONS → Appendix 1: antiepileptics

l SIDE-EFFECTS

GENERAL SIDE-EFFECTS

Agranulocytosis . bone disorders . bone fracture . bone

marrow disorders . cerebrovascular insufficiency . coarsening of the facial features . confusion . constipation . dizziness . drowsiness .Dupuytren’s contracture . dysarthria . eosinophilia . fever. gingival hyperplasia

(maintain good oral hygiene). granulocytopenia . hair

changes . headache . hepatic disorders . hypersensitivity . insomnia . joint disorders . leucopenia . lip swelling . lymphatic abnormalities . macrocytosis . megaloblastic

anaemia . movement disorders . muscle twitching . nausea . neoplasms . nephritis tubulointerstitial . nervousness . nystagmus . paraesthesia . Peyronie’s disease . polyarteritis

nodosa . pseudolymphoma . sensory peripheral

polyneuropathy . severe cutaneous adverse reactions

(SCARs). skin reactions . systemic lupus erythematosus

(SLE) .taste altered .thrombocytopenia .tremor. vertigo . vomiting

SPECIFIC SIDE-EFFECTS

▶ With oral use Electrolyte imbalance . pneumonitis . vitamin

D deficiency

▶ With parenteral use Arrhythmias . atrial conduction

depression (more common if injection too rapid). cardiac

arrest. extravasation necrosis . hypotension . injection site

necrosis . purple glove syndrome .respiratory arrest (more

common if injection too rapid).respiratory disorders . tonic seizure (more common if injection too rapid). ventricular conduction depression (more common if

injection too rapid). ventricular fibrillation (more common

if injection too rapid)

SIDE-EFFECTS, FURTHER INFORMATION Rash Discontinue;

if mild re-introduce cautiously but discontinue

immediately if recurrence.

BNF 78 Epilepsy and other seizure disorders 323

Nervous system

4

Bradycardia and hypotension With intravenous use;

reduce rate of administration if bradycardia or

hypotension occurs.

Overdose Symptoms of phenytoin toxicity include

nystagmus, diplopia, slurred speech, ataxia, confusion,

and hyperglycaemia.

l ALLERGY AND CROSS-SENSITIVITY Cross-sensitivity

reported with carbamazepine. Antiepileptic

hypersensitivity syndrome associated with phenytoin. See

under Epilepsy p. 305 for more information.

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.

Doses should be adjusted on the basis of plasma-drug

concentration monitoring.

l BREAST FEEDING Small amounts present in milk, but not

known to be harmful.

l HEPATIC IMPAIRMENT Manufacturer advises caution

(increased risk of accumulation and toxicity due to

decreased protein binding in hepatic impairment,

hypoalbuminaemia, or hyperbilirubinaemia).

Dose adjustments ▶ With oral use Manufacturer advises

consider dose reduction.

▶ With intravenous use Manufacturer advises consider

maintenance dose reduction.

l PRE-TREATMENT SCREENING HLAB* 1502 allele in

individuals of Han Chinese or Thai origin—avoid unless

essential (increased risk of Stevens- Johnson syndrome).

l MONITORING REQUIREMENTS

▶ Blood counts Manufacturer recommends blood counts (but

evidence of practical value uncertain).

▶ In adults The usual total plasma-phenytoin concentration

for optimum response is 10–20 mg/litre (or

40–80 micromol/litre). In pregnancy, the elderly, and

certain disease states where protein binding may be

reduced, careful interpretation of total plasma-phenytoin

concentration is necessary; it may be more appropriate to

measure free plasma-phenytoin concentration.

▶ In children Therapeutic plasma-phenytoin concentrations

reduced in first 3 months of life because of reduced protein

binding. Trough plasma concentration for optimum

response: neonate–3 months, 6–15 mg/litre

(25–60 micromol/litre); child 3 months–18 years,

10–20 mg/litre (40–80 micromol/litre).

▶ With intravenous use Monitor ECG and blood pressure.

l DIRECTIONS FOR ADMINISTRATION Manufacturer advises

each injection or infusion should be preceded and followed

by an injection of Sodium Chloride 0.9% through the same

needle or catheter to avoid local venous irritation.

▶ With intravenous use in children g For intravenous

injection, give into a large vein at a rate not exceeding

1 mg/kg/minute (max. 50 mg/minute). k Manufacturer

advises for intravenous infusion, dilute to a concentration

not exceeding 10 mg/mL with Sodium Chloride 0.9% and

give into a large vein through an in-line filter

(0.22–0.50 micron).g Give at a rate not exceeding

1 mg/kg/minute (max. 50 mg/minute). k Complete

administration within 1 hour of preparation.

▶ With intravenous use in adults Manufacturer advises for

intravenous injection, give into a large vein at a rate not

exceeding 50 mg/minute; rate of 25 mg/minute or lower

may be more appropriate in some patients (including the

elderly and those with heart disease). Manufacturer

advises for intravenous infusion, dilute in 50–100 mL

Sodium Chloride 0.9% (final concentration not to exceed

10 mg/mL) and give into a large vein through an in-line

filter (0.22–0.50 micron) at a rate not exceeding

50 mg/minute; rate of 25 mg/minute or lower may be more

appropriate in some patients (including the elderly and

those with heart disease). Complete administration within

1 hour of preparation.

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

manufacturer’s product.

l PATIENT AND CARER ADVICE

Blood or skin disorders Patients or their carers should be told

how to recognise signs of blood or skin disorders, and

advised to seek immediate medical attention if symptoms

such as fever, rash, mouth ulcers, bruising, or bleeding

develop. Leucopenia that is severe, progressive, or

associated with clinical symptoms requires withdrawal (if

necessary under cover of a suitable alternative).

Medicines for Children leaflet: Phenytoin for preventing seizures

www.medicinesforchildren.org.uk/phenytoin-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 suspension, oral

solution

Tablet

CAUTIONARY AND ADVISORY LABELS 8

▶ Phenytoin (Non-proprietary)

Phenytoin sodium 100 mg Phenytoin sodium 100mg tablets |

28 tablet P £30.00 DT = £11.03

Solution for injection

EXCIPIENTS: May contain Alcohol, propylene glycol

ELECTROLYTES: May contain Sodium

▶ Phenytoin (Non-proprietary)

Phenytoin sodium 50 mg per 1 ml Phenytoin sodium 250mg/5ml

solution for injection ampoules | 5 ampoule P £24.40 (Hospital

only)

▶ Epanutin (Pfizer Ltd)

Phenytoin sodium 50 mg per 1 ml Epanutin Ready-Mixed

Parenteral 250mg/5ml solution for injection ampoules |

10 ampoule P £48.79 (Hospital only)

Oral suspension

CAUTIONARY AND ADVISORY LABELS 8

▶ Epanutin (Pfizer Ltd)

Phenytoin 6 mg per 1 ml Epanutin 30mg/5ml oral suspension | 500 ml P £4.27 DT = £4.27

Chewable tablet

CAUTIONARY AND ADVISORY LABELS 8, 24

▶ Epanutin (Pfizer Ltd)

Phenytoin 50 mg Epanutin Infatabs 50mg chewable tablets | 200 tablet P £13.18 DT = £13.18

Capsule

CAUTIONARY AND ADVISORY LABELS 8

▶ Phenytoin (Non-proprietary)

Phenytoin sodium 25 mg Phenytoin sodium 25mg capsules | 28 capsule P £7.24 DT = £7.24

Phenytoin sodium 50 mg Phenytoin sodium 50mg capsules | 28 capsule P £7.07 DT = £7.07

Phenytoin sodium 100 mg Phenytoin sodium 100mg capsules |

84 capsule P £67.50 DT = £8.36

Phenytoin sodium 300 mg Phenytoin sodium 300mg capsules | 28 capsule P £9.11 DT = £9.11

Pregabalin 22-May-2019

l INDICATIONS AND DOSE

Peripheral and central neuropathic pain

▶ BY MOUTH

▶ Adult: Initially 150 mg daily in 2–3 divided doses, then

increased if necessary to 300 mg daily in 2–3 divided

doses, dose to be increased after 3–7 days, then

increased if necessary up to 600 mg daily in 2–3 divided

doses, dose to be increased after 7 days

324 Epilepsy and other seizure disorders BNF 78

Nervous system

4

Adjunctive therapy for focal seizures with or without

secondary generalisation

▶ BY MOUTH

▶ Adult: Initially 25 mg twice daily, then increased in

steps of 50 mg daily, dose to be increased at 7 day

intervals, increased to 300 mg daily in 2–3 divided

doses for 7 days, then increased if necessary up to

600 mg daily in 2–3 divided doses

Generalised anxiety disorder

▶ BY MOUTH

▶ Adult: Initially 150 mg daily in 2–3 divided doses, then

increased in steps of 150 mg daily if required, dose to

be increased at 7 day intervals, increased if necessary

up to 600 mg daily in 2–3 divided doses

l UNLICENSED USE Pregabalin doses in BNF may differ from

those in product literature.

IMPORTANT SAFETY INFORMATION

MHRA/CHM ADVICE: PREGABALIN (LYRICA ®) AND RISK OF ABUSE

AND DEPENDENCE: NEW SCHEDULING REQUIREMENTS FROM 1

APRIL (APRIL 2019)

Following concerns about abuse, pregabalin has been

reclassified as a Class C controlled substance and is now

a Schedule 3 drug, but is exempt from safe custody

requirements. Healthcare professionals should evaluate

patients carefully for a history of drug abuse before

prescribing pregabalin, and observe patients for signs of

abuse and dependence. Patients should be informed of

the potentially fatal risks of interactions between

pregabalin and alcohol, and with other medicines that

cause CNS depression, particularly opioids.

l CAUTIONS Conditions that may precipitate

encephalopathy . history of substance abuse . severe

congestive heart failure

l INTERACTIONS → Appendix 1: antiepileptics

l SIDE-EFFECTS

▶ Common or very common Abdominal distension . appetite

abnormal . asthenia . cervical spasm . concentration

impaired . confusion . constipation . diarrhoea . dizziness . drowsiness . dry mouth . feeling abnormal . gait abnormal . gastrointestinal disorders . headache . increased risk of

infection . joint disorders . memory loss . mood altered . movement disorders . muscle complaints . nausea . oedema . pain . sensation abnormal . sexual dysfunction . sleep

disorders . speech impairment. vertigo . vision disorders . vomiting . weight changes

▶ Uncommon Aggression . anxiety . arrhythmias . atrioventricular block . breast abnormalities . chest

tightness . chills . consciousness impaired . cough . depression . dry eye . dyspnoea . epistaxis . eye discomfort. eye disorders . eye inflammation .fever. hallucination . hyperacusia . hypertension . hypoglycaemia . hypotension . malaise . menstrual cycle irregularities . nasal complaints . neutropenia . oral disorders . peripheral coldness . psychiatric disorders .reflexes decreased . skin reactions . snoring . sweat changes . syncope .taste loss .thirst. urinary disorders . vasodilation

▶ Rare or very rare Altered smell sensation . ascites . dysgraphia . dysphagia . gynaecomastia . hepatic disorders . pancreatitis . QT interval prolongation .renal impairment .rhabdomyolysis . Stevens-Johnson syndrome .throat

tightness

▶ Frequency not known Drug use disorders

l PREGNANCY Manufacturer advises avoid unless potential

benefit outweighs risk — toxicity in animal studies. See

also Pregnancy in Epilepsy p. 305.

l BREAST FEEDING See Breast-feeding in Epilepsy p. 305.

l RENAL IMPAIRMENT

Dose adjustments Initially 75 mg daily and maximum

300 mg daily if eGFR 30–60 mL/minute/1.73 m2

.

Initially 25–50 mg daily and maximum 150 mg daily in

1–2 divided doses if eGFR 15–30 mL/minute/1.73 m2

.

Initially 25 mg once daily and maximum 75 mg once

daily if eGFR less than 15 mL/minute/1.73 m2

.

l MONITORING REQUIREMENTS Monitor for signs of

pregabalin abuse.

l TREATMENT CESSATION Avoid abrupt withdrawal (taper

over at least 1 week).

l PRESCRIBING AND DISPENSING INFORMATION Flavours of

oral liquid formulations may include strawberry.

l PATIENT AND CARER ADVICE

Patient leaflet NHS England has produced a patient leaflet

with information on the reclassification of pregabalin.

l NATIONAL FUNDING/ACCESS DECISIONS

Scottish Medicines Consortium (SMC) decisions

The Scottish Medicines Consortium has advised (July 2007)

that pregabalin (Lyrica ®) is not recommended for the

treatment of central neuropathic pain.

The Scottish Medicines Consortium has advised (April

2009) that pregabalin (Lyrica ®) is accepted for restricted

use within NHS Scotland for the treatment of peripheral

neuropathic pain in adults who have not achieved

adequate pain relief with, or have not tolerated, first- or

second-line treatments; discontinue treatment if sufficient

benefit is not achieved within 8 weeks of reaching the

maximum tolerated dose.

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

solution

Oral solution

CAUTIONARY AND ADVISORY LABELS 3, 8

▶ Pregabalin (Non-proprietary)

Pregabalin 20 mg per 1 ml Pregabalin 20mg/ml oral solution sugar

free sugar-free | 473 ml P £99.48 DT = £99.48c | 500 ml

P £75.00–£105.16c ▶ Lyrica (Pfizer Ltd)

Pregabalin 20 mg per 1 ml Lyrica 20mg/ml oral solution sugar-free

| 473 ml P £99.48 DT = £99.48c

Capsule

CAUTIONARY AND ADVISORY LABELS 3, 8

▶ Pregabalin (Non-proprietary)

Pregabalin 25 mg Pregabalin 25mg capsules | 56 capsule P £64.40 DT = £2.98c | 84 capsule P £4.47–£96.60c

Pregabalin 50 mg Pregabalin 50mg capsules | 56 capsule P £8.96c | 84 capsule P £96.60 DT = £3.40c

Pregabalin 75 mg Pregabalin 75mg capsules | 14 capsule P £3.21c | 56 capsule P £64.40 DT = £2.83c

Pregabalin 100 mg Pregabalin 100mg capsules | 84 capsule P £96.60 DT = £4.27c

Pregabalin 150 mg Pregabalin 150mg capsules | 56 capsule P £64.40 DT = £3.67c

Pregabalin 200 mg Pregabalin 200mg capsules | 84 capsule P £96.60 DT = £5.21c

Pregabalin 225 mg Pregabalin 225mg capsules | 56 capsule P £64.40 DT = £3.99c

Pregabalin 300 mg Pregabalin 300mg capsules | 56 capsule P £64.40 DT = £4.92c ▶ Alzain (Dr Reddy’s Laboratories (UK) Ltd)

Pregabalin 25 mg Alzain 25mg capsules | 56 capsule P £4.99 DT

= £2.98c

Pregabalin 50 mg Alzain 50mg capsules | 56 capsule P £5.99c | 84 capsule P £6.99 DT = £3.40c

Pregabalin 75 mg Alzain 75mg capsules | 56 capsule P £5.99 DT

= £2.83c

Pregabalin 100 mg Alzain 100mg capsules | 84 capsule P £6.99

DT = £4.27c

Pregabalin 150 mg Alzain 150mg capsules | 56 capsule P £6.99

DT = £3.67c

Pregabalin 200 mg Alzain 200mg capsules | 84 capsule P £8.99

DT = £5.21c

BNF 78 Epilepsy and other seizure disorders 325

Nervous system

4

Pregabalin 225 mg Alzain 225mg capsules | 56 capsule P £7.99

DT = £3.99c

Pregabalin 300 mg Alzain 300mg capsules | 56 capsule P £8.99

DT = £4.92c ▶ Axalid (Kent Pharmaceuticals Ltd)

Pregabalin 25 mg Axalid 25mg capsules | 56 capsule P £19.95

DT = £2.98c

Pregabalin 50 mg Axalid 50mg capsules | 56 capsule P £19.95c

Pregabalin 75 mg Axalid 75mg capsules | 56 capsule P £19.95

DT = £2.83c

Pregabalin 100 mg Axalid 100mg capsules | 56 capsule P £19.95c

Pregabalin 150 mg Axalid 150mg capsules | 56 capsule P £19.95 DT = £3.67c

Pregabalin 200 mg Axalid 200mg capsules | 56 capsule P £19.95c

Pregabalin 225 mg Axalid 225mg capsules | 56 capsule P £19.95 DT = £3.99c

Pregabalin 300 mg Axalid 300mg capsules | 56 capsule P £19.95 DT = £4.92c ▶ Lecaent (Actavis UK Ltd)

Pregabalin 25 mg Lecaent 25mg capsules | 56 capsule P £64.39

DT = £2.98c | 84 capsule P £96.59c

Pregabalin 50 mg Lecaent 50mg capsules | 84 capsule P £96.59 DT = £3.40c

Pregabalin 75 mg Lecaent 75mg capsules | 56 capsule P £64.39

DT = £2.83c

Pregabalin 100 mg Lecaent 100mg capsules | 84 capsule P £96.59 DT = £4.27c

Pregabalin 150 mg Lecaent 150mg capsules | 56 capsule P £64.39 DT = £3.67c

Pregabalin 200 mg Lecaent 200mg capsules | 84 capsule P £96.59 DT = £5.21c

Pregabalin 225 mg Lecaent 225mg capsules | 56 capsule P £64.39 DT = £3.99c

Pregabalin 300 mg Lecaent 300mg capsules | 56 capsule P £64.39 DT = £4.92c ▶ Lyrica (Pfizer Ltd)

Pregabalin 25 mg Lyrica 25mg capsules | 56 capsule P £64.40

DT = £2.98c | 84 capsule P £96.60c

Pregabalin 50 mg Lyrica 50mg capsules | 84 capsule P £96.60

DT = £3.40c

Pregabalin 75 mg Lyrica 75mg capsules | 56 capsule P £64.40

DT = £2.83c

Pregabalin 100 mg Lyrica 100mg capsules | 84 capsule P £96.60 DT = £4.27c

Pregabalin 150 mg Lyrica 150mg capsules | 56 capsule P £64.40 DT = £3.67c

Pregabalin 200 mg Lyrica 200mg capsules | 84 capsule P £96.60 DT = £5.21c

Pregabalin 225 mg Lyrica 225mg capsules | 56 capsule P £64.40 DT = £3.99c

Pregabalin 300 mg Lyrica 300mg capsules | 56 capsule P £64.40 DT = £4.92c

Rufinamide 15-May-2019

l INDICATIONS AND DOSE

Adjunctive treatment of seizures in Lennox-Gastaut

syndrome without valproate (initiated by a specialist)

▶ BY MOUTH

▶ Child 1–3 years: Initially 5 mg/kg twice daily, then

increased in steps of up to 5 mg/kg twice daily (max.

per dose 22.5 mg/kg twice daily), adjusted according to

response, dose to be increased at intervals of not less

than 3 days to the target dose (maximum dose), each

dose should be given to the nearest 0.5 mL

▶ Child 4–17 years (body-weight up to 30 kg): Initially

100 mg twice daily, then increased in steps of 100 mg

twice daily (max. per dose 500 mg twice daily), adjusted

according to response, dose to be increased at intervals

of not less than 3 days

▶ Child 4–17 years (body-weight 30–50 kg): Initially 200 mg

twice daily, then increased in steps of 200 mg twice

daily (max. per dose 900 mg twice daily), adjusted

according to response, dose to be increased at intervals

of not less than 2 days

▶ Child 4–17 years (body-weight 50.1–70 kg): Initially 200 mg

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