▶ In adults Not licensed for migraine prophylaxis.g Not

licensed for menopausal symptoms. h

IMPORTANT SAFETY INFORMATION

The levels of propylene glycol, acesulfame K and

saccharin sodium may exceed the recommended WHO

daily intake limits if high doses of gabapentin oral

solution (Rosemont brand) are given to adolescents or

adults with low body-weight (39–50 kg)—consult

product literature.

MHRA/CHM ADVICE: GABAPENTIN (NEURONTIN ®): RISK OF

SEVERE RESPIRATORY DEPRESSION (OCTOBER 2017)

Gabapentin has been associated with a rare risk of severe

respiratory depression even without concomitant opioid

medicines. Patients with compromised respiratory

function, respiratory or neurological disease, renal

impairment, concomitant use of central nervous system

(CNS) depressants, and elderly people might be at higher

risk of experiencing severe respiratory depression and

dose adjustments may be necessary in these patients.

MHRA/CHM ADVICE: GABAPENTIN (NEURONTIN ®) AND RISK OF

ABUSE AND DEPENDENCE: NEW SCHEDULING REQUIREMENTS

FROM 1 APRIL (APRIL 2019)

Following concerns about abuse, gabapentin 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 gabapentin, and observe patients for signs of

abuse and dependence. Patients should be informed of

the potentially fatal risks of interactions between

gabapentin and alcohol, and with other medicines that

cause CNS depression, particularly opioids.

l CAUTIONS Diabetes mellitus . elderly (in adults). high

doses of oral solution in adolescents and adults with low

body-weight. history of psychotic illness . history of

substance abuse . mixed seizures (including absences)

l INTERACTIONS → Appendix 1: antiepileptics

l SIDE-EFFECTS

▶ Common or very common Anxiety . appetite abnormal . arthralgia . asthenia . behaviour abnormal . confusion . constipation . cough . depression . diarrhoea . dizziness . drowsiness . dry mouth . dysarthria . dyspnoea . emotional

lability . flatulence . gait abnormal . gastrointestinal

discomfort. headache . hypertension . increased risk of

infection . insomnia . leucopenia . malaise . movement

disorders . muscle complaints . nausea . nystagmus . oedema . pain .reflexes abnormal . seizure (in children). sensation abnormal . sexual dysfunction . skin reactions . thinking abnormal .tooth disorder.tremor. vasodilation . vertigo . visual impairment. vomiting

▶ Uncommon Cognitive impairment. palpitations

▶ Frequency not known Acute kidney injury . alopecia . angioedema . breast enlargement. drug use disorders . gynaecomastia . hallucination . hepatic disorders .

hyponatraemia . pancreatitis .rhabdomyolysis . severe

cutaneous adverse reactions (SCARs).thrombocytopenia . tinnitus . urinary incontinence

l PREGNANCY Manufacturer advises avoid unless benefit

outweighs risk — toxicity reported. See also Pregnancy in

Epilepsy p. 305.

l BREAST FEEDING Present in milk—manufacturer advises

use only if potential benefit outweighs risk. See also

Breast-feeding in Epilepsy p. 305.

l RENAL IMPAIRMENT

Dose adjustments ▶ In adults Manufacturer advises reduce

dose to 600–1800 mg daily in 3 divided doses if creatinine

clearance 50–79 mL/minute. Manufacturer advises reduce

dose to 300–900 mg daily in 3 divided doses if creatinine

clearance 30–49 mL/minute. Manufacturer advises reduce

dose to 150–600 mg daily in 3 divided doses if creatinine

clearance 15–29 mL/minute (150 mg daily dose to be given

as 300 mg in 3 divided doses on alternate days).

Manufacturer advises reduce dose to 150–300 mg daily in

3 divided doses if creatinine clearance is less than

15 mL/minute (150 mg daily dose to be given as 300 mg in

3 divided doses on alternate days)—further dose

reductions may be required in proportion to creatinine

clearance, consult product literature.

▶ In children Reduce dose if estimated glomerular filtration

rate less than 80 mL/minute/1.73 m2

; consult product

literature.

l MONITORING REQUIREMENTS Monitor for signs of

gabapentin abuse.

l EFFECT ON LABORATORY TESTS False positive readings

with some urinary protein tests.

l DIRECTIONS FOR ADMINISTRATION Capsules can be

opened but the bitter taste is difficult to mask.

l PATIENT AND CARER ADVICE

Medicines for Children leaflet: Gabapentin for neuropathic pain

www.medicinesforchildren.org.uk/gabapentin-neuropathic-pain

Medicines for Children leaflet: Gabapentin for preventing seizures

www.medicinesforchildren.org.uk/gabapentin-preventingseizures

Patient leaflet NHS England has produced a patient leaflet

with information on the reclassification of gabapentin.

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 3, 5, 8, 25

▶ Gabapentin (Non-proprietary)

Gabapentin 600 mg Gabapentin 600mg tablets | 100 tablet P £106.00 DT = £5.99c

Gabapentin 800 mg Gabapentin 800mg tablets | 100 tablet P £78.00 DT = £25.96c ▶ Neurontin (Pfizer Ltd)

Gabapentin 600 mg Neurontin 600mg tablets | 100 tablet P £84.80 DT = £5.99c

Gabapentin 800 mg Neurontin 800mg tablets | 100 tablet P £98.13 DT = £25.96c

Oral solution

CAUTIONARY AND ADVISORY LABELS 3, 5, 8

EXCIPIENTS: May contain Propylene glycol

ELECTROLYTES: May contain Potassium, sodium

▶ Gabapentin (Non-proprietary)

Gabapentin 50 mg per 1 ml Gabapentin 50mg/ml oral solution sugar

free sugar-free | 150 ml P £69.00 DT = £66.05c

Capsule

CAUTIONARY AND ADVISORY LABELS 3, 5, 8, 25

▶ Gabapentin (Non-proprietary)

Gabapentin 100 mg Gabapentin 100mg capsules |

100 capsule P £18.29 DT = £1.81c

Gabapentin 300 mg Gabapentin 300mg capsules | 100 capsule P £42.40 DT = £3.15c

Gabapentin 400 mg Gabapentin 400mg capsules | 100 capsule P £49.06 DT = £3.86c

316 Epilepsy and other seizure disorders BNF 78

Nervous system

4

▶ Neurontin (Pfizer Ltd)

Gabapentin 100 mg Neurontin 100mg capsules | 100 capsule P £18.29 DT = £1.81c

Gabapentin 300 mg Neurontin 300mg capsules | 100 capsule P £42.40 DT = £3.15c

Gabapentin 400 mg Neurontin 400mg capsules | 100 capsule P £49.06 DT = £3.86c

Lacosamide 22-Feb-2018

l INDICATIONS AND DOSE

Monotherapy of focal seizures with or without secondary

generalisation

▶ BY MOUTH, OR BY INTRAVENOUS INFUSION

▶ Child (body-weight 50 kg and above): Initially 50 mg twice

daily, then increased to 100 mg twice daily, after one

week, alternatively initially 100 mg twice daily;

increased in steps of 50 mg twice daily (max. per dose

300 mg twice daily) if necessary and if tolerated, dose

to be increased at weekly intervals

▶ Child 4–17 years (body-weight up to 50 kg): (consult

product literature)

▶ Adult: Initially 50 mg twice daily, then increased to

100 mg twice daily, after one week, alternatively

initially 100 mg twice daily; increased in steps of 50 mg

twice daily (max. per dose 300 mg twice daily) if

necessary and if tolerated, dose to be increased at

weekly intervals

Monotherapy of focal seizures with or without secondary

generalisation (alternative loading dose regimen when it

is necessary to rapidly attain therapeutic plasma

concentrations) (under close medical supervision)

▶ BY MOUTH, OR BY INTRAVENOUS INFUSION

▶ Child (body-weight 50 kg and above): Loading dose

200 mg, followed by 100 mg twice daily, to be given

12 hours after initial dose; increased in steps of 50 mg

twice daily (max. per dose 300 mg twice daily) if

necessary and if tolerated, dose to be increased at

weekly intervals

▶ Adult: Loading dose 200 mg, followed by 100 mg twice

daily, to be given 12 hours after initial dose; increased

in steps of 50 mg twice daily (max. per dose 300 mg

twice daily) if necessary and if tolerated, dose to be

increased at weekly intervals

Adjunctive treatment of focal seizures with or without

secondary generalisation

▶ BY MOUTH, OR BY INTRAVENOUS INFUSION

▶ Child (body-weight 50 kg and above): Initially 50 mg twice

daily, then increased to 100 mg twice daily, after one

week; increased in steps of 50 mg twice daily (max. per

dose 200 mg twice daily) if necessary and if tolerated,

dose to be increased at weekly intervals

▶ Child 4–17 years (body-weight up to 50 kg): (consult

product literature)

▶ Adult: Initially 50 mg twice daily, then increased to

100 mg twice daily, after one week; increased in steps

of 50 mg twice daily (max. per dose 200 mg twice daily)

if necessary and if tolerated, dose to be increased at

weekly intervals

Adjunctive treatment of focal seizures with or without

secondary generalisation (alternative loading dose

regimen when it is necessary to rapidly attain

therapeutic plasma concentrations) (under close

medical supervision)

▶ BY MOUTH, OR BY INTRAVENOUS INFUSION

▶ Child (body-weight 50 kg and above): Loading dose

200 mg, followed by 100 mg twice daily, to be given

12 hours after initial dose; increased in steps of 50 mg

twice daily (max. per dose 200 mg twice daily) if

necessary and if tolerated, dose to be increased at

weekly intervals

▶ Adult: Loading dose 200 mg, followed by 100 mg twice

daily, to be given 12 hours after initial dose; increased

in steps of 50 mg twice daily (max. per dose 200 mg

twice daily) if necessary and if tolerated, dose to be

increased at weekly intervals

l CONTRA-INDICATIONS Second- or third-degree AV block

l CAUTIONS Conduction problems . elderly (in adults).risk

of PR-interval prolongation . severe cardiac disease

l INTERACTIONS → Appendix 1: antiepileptics

l SIDE-EFFECTS

▶ Common or very common Asthenia . concentration

impaired . confusion . constipation . depression . diarrhoea . dizziness . drowsiness . dry mouth . dysarthria . dyspepsia . flatulence . gait abnormal . headache . insomnia . mood

altered . movement disorders . muscle spasms . nausea . nystagmus . sensation abnormal . skin reactions .tinnitus . vertigo . vision disorders . vomiting

▶ Uncommon Aggression . agitation . angioedema . arrhythmias . atrioventricular block . hallucination . psychotic disorder. suicidal tendencies . syncope

▶ Frequency not known Agranulocytosis

l ALLERGY AND CROSS-SENSITIVITY Antiepileptic

hypersensitivity syndrome associated with lacosamide. 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 Manufacturer advises avoid—present in

milk in animal studies.

l HEPATIC IMPAIRMENT Manufacturer advises caution (risk

of increased exposure), particularly in severe impairment

(no information available).

Dose adjustments Manufacturer advises consider dose

reduction—consult product literature.

l RENAL IMPAIRMENT Consult product literature.

l DIRECTIONS FOR ADMINISTRATION

▶ With intravenous use For intermittent intravenous infusion,

manufacturer advises give undiluted or dilute with Glucose

5% or Sodium Chloride 0.9% or Lactated Ringer’s Solution;

give over 15–60 minutes—give doses greater than 200 mg

over at least 30 minutes.

l PRESCRIBING AND DISPENSING INFORMATION Flavours of

syrup may include strawberry.

l PATIENT AND CARER ADVICE

Medicines for Children leaflet: Lacosamide for preventing seizures

www.medicinesforchildren.org.uk/lacosamide-preventingseizures

l NATIONAL FUNDING/ACCESS DECISIONS

Scottish Medicines Consortium (SMC) decisions

SMC No. 532/09

The Scottish Medicines Consortium has advised (February

2009) that lacosamide (Vimpat ®) is accepted for restricted

use within NHS Scotland as adjunctive treatment for focal

seizures with or without secondary generalisation in

patients from 16 years. It is restricted for specialist use in

refractory epilepsy.

SMC No. 1301/18

The Scottish Medicines Consortium has advised (February

2018) that lacosamide (Vimpat ®) is accepted for restricted

use within NHS Scotland as adjunctive treatment for focal

seizures with or without secondary generalisation in

adolescents and children from 4 years of age with epilepsy.

It is restricted for specialist use in refractory epilepsy.

All Wales Medicines Strategy Group (AWMSG) decisions

AWMSG No. 3343

The All Wales Medicines Strategy Group has advised (March

2018) that lacosamide (Vimpat ®) is recommended as an

option for use within NHS Wales as adjunctive therapy in

BNF 78 Epilepsy and other seizure disorders 317

Nervous system

4

the treatment of focal seizures with or without secondary

generalisation in children from 4 years of age up to

15 years of age with epilepsy.

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Solution for infusion

ELECTROLYTES: May contain Sodium

▶ Vimpat (UCB Pharma Ltd)

Lacosamide 10 mg per 1 ml Vimpat 200mg/20ml solution for

infusion vials | 1 vial P £29.70

Oral solution

CAUTIONARY AND ADVISORY LABELS 8

EXCIPIENTS: May contain Aspartame, propylene glycol

ELECTROLYTES: May contain Sodium

▶ Vimpat (UCB Pharma Ltd)

Lacosamide 10 mg per 1 ml Vimpat 10mg/ml syrup sugar-free | 200 ml P £25.74 DT = £25.74

Tablet

CAUTIONARY AND ADVISORY LABELS 8

▶ Vimpat (UCB Pharma Ltd)

Lacosamide 50 mg Vimpat 50mg tablets | 14 tablet P £10.81

DT = £10.81

Lacosamide 100 mg Vimpat 100mg tablets | 14 tablet P £21.62

| 56 tablet P £86.50 DT = £86.50

Lacosamide 150 mg Vimpat 150mg tablets | 14 tablet P £32.44

| 56 tablet P £129.74 DT = £129.74

Lacosamide 200 mg Vimpat 200mg tablets | 56 tablet P £144.16 DT = £144.16

Lamotrigine 01-Aug-2018

l INDICATIONS AND DOSE

Monotherapy of focal seizures |Monotherapy of primary

and secondary generalised tonic-clonic seizures |

Monotherapy of seizures associated with LennoxGastaut syndrome

▶ BY MOUTH

▶ Child 12–17 years: Initially 25 mg once daily for 14 days,

then increased to 50 mg once daily for further 14 days,

then increased in steps of up to 100 mg every

7–14 days; maintenance 100–200 mg daily in

1–2 divided doses; increased if necessary up to 500 mg

daily, dose titration should be repeated if restarting

after interval of more than 5 days

▶ Adult: Initially 25 mg once daily for 14 days, then

increased to 50 mg once daily for further 14 days, then

increased in steps of up to 100 mg every 7–14 days;

maintenance 100–200 mg daily in 1–2 divided doses;

increased if necessary up to 500 mg daily, dose titration

should be repeated if restarting after interval of more

than 5 days

Adjunctive therapy of focal seizures with valproate |

Adjunctive therapy of primary and secondary

generalised tonic-clonic seizures with valproate |

Adjunctive therapy of seizures associated with LennoxGastaut syndrome with valproate

▶ BY MOUTH

▶ Child 2–11 years (body-weight up to 13 kg): Initially 2 mg

once daily on alternate days for first 14 days, then

300 micrograms/kg once daily for further 14 days, then

increased in steps of up to 300 micrograms/kg every

7–14 days; maintenance 1–5 mg/kg daily in

1–2 divided doses, dose titration should be repeated if

restarting after interval of more than 5 days; maximum

200 mg per day

▶ Child 2–11 years (body-weight 13 kg and above): Initially

150 micrograms/kg once daily for 14 days, then

300 micrograms/kg once daily for further 14 days, then

increased in steps of up to 300 micrograms/kg every

7–14 days; maintenance 1–5 mg/kg daily in

1–2 divided doses, dose titration should be repeated if

restarting after interval of more than 5 days; maximum

200 mg per day

▶ Child 12–17 years: Initially 25 mg once daily on alternate

days for 14 days, then 25 mg once daily for further

14 days, then increased in steps of up to 50 mg every

7–14 days; maintenance 100–200 mg daily in

1–2 divided doses, dose titration should be repeated if

restarting after interval of more than 5 days

▶ Adult: Initially 25 mg once daily on alternate days for

14 days, then 25 mg once daily for further 14 days, then

increased in steps of up to 50 mg every 7–14 days;

maintenance 100–200 mg daily in 1–2 divided doses,

dose titration should be repeated if restarting after

interval of more than 5 days

Adjunctive therapy of focal seizures (with enzyme

inducing drugs) without valproate | Adjunctive therapy of

primary and secondary generalised tonic-clonic seizures

(with enzyme inducing drugs) without valproate |

Adjunctive therapy of seizures associated with LennoxGastaut syndromes (with enzyme inducing drugs)

without valproate

▶ BY MOUTH

▶ Child 2–11 years: Initially 300 micrograms/kg twice daily

for 14 days, then 600 micrograms/kg twice daily for

further 14 days, then increased in steps of up to

1.2 mg/kg every 7–14 days; maintenance 5–15 mg/kg

daily in 1–2 divided doses, dose titration should be

repeated if restarting after interval of more than

5 days; maximum 400 mg per day

▶ Child 12–17 years: Initially 50 mg once daily for 14 days,

then 50 mg twice daily for further 14 days, then

increased in steps of up to 100 mg every 7–14 days;

maintenance 200–400 mg daily in 2 divided doses,

increased if necessary up to 700 mg daily, dose titration

should be repeated if restarting after interval of more

than 5 days

▶ Adult: Initially 50 mg once daily for 14 days, then

50 mg twice daily for further 14 days, then increased in

steps of up to 100 mg every 7–14 days; maintenance

200–400 mg daily in 2 divided doses, increased if

necessary up to 700 mg daily, dose titration should be

repeated if restarting after interval of more than 5 days

Adjunctive therapy of focal seizures (without enzyme

inducing drugs) without valproate | Adjunctive therapy of

primary and secondary generalised tonic-clonic seizures

(without enzyme inducing drugs) without valproate |

Adjunctive therapy of seizures associated with LennoxGastaut syndromes (without enzyme inducing drugs)

without valproate

▶ BY MOUTH

▶ Child 2–11 years: Initially 300 micrograms/kg daily in

1–2 divided doses for 14 days, then 600 micrograms/kg

daily in 1–2 divided doses for further 14 days, then

increased in steps of up to 600 micrograms/kg every

7–14 days; maintenance 1–10 mg/kg daily in

1–2 divided doses, dose titration should be repeated if

restarting after interval of more than 5 days; maximum

200 mg per day

▶ Child 12–17 years: Initially 25 mg once daily for 14 days,

then increased to 50 mg once daily for further 14 days,

then increased in steps of up to 100 mg every

7–14 days; maintenance 100–200 mg daily in

1–2 divided doses, dose titration should be repeated if

restarting after interval of more than 5 days

▶ Adult: Initially 25 mg once daily for 14 days, then

increased to 50 mg once daily for further 14 days, then

increased in steps of up to 100 mg every 7–14 days;

maintenance 100–200 mg daily in 1–2 divided doses,

dose titration should be repeated if restarting after

interval of more than 5 days

318 Epilepsy and other seizure disorders BNF 78

Nervous system

4

Monotherapy or adjunctive therapy of bipolar disorder

(without enzyme inducing drugs) without valproate

▶ BY MOUTH

▶ Adult: Initially 25 mg once daily for 14 days, then

50 mg daily in 1–2 divided doses for further 14 days,

then 100 mg daily in 1–2 divided doses for further

7 days; maintenance 200 mg daily in 1–2 divided doses,

patients stabilised on lamotrigine for bipolar disorder

may require dose adjustments if other drugs are added

to or withdrawn from their treatment regimens—

consult product literature, dose titration should be

repeated if restarting after interval of more than

5 days; maximum 400 mg per day

Adjunctive therapy of bipolar disorder with valproate

▶ BY MOUTH

▶ Adult: Initially 25 mg once daily on alternate days for

14 days, then 25 mg once daily for further 14 days, then

50 mg daily in 1–2 divided doses for further 7 days;

maintenance 100 mg daily in 1–2 divided doses,

patients stabilised on lamotrigine for bipolar disorder

may require dose adjustments if other drugs are added

to or withdrawn from their treatment regimens—

consult product literature, dose titration should be

repeated if restarting after interval of more than

5 days; maximum 200 mg per day

Adjunctive therapy of bipolar disorder (with enzyme

inducing drugs) without valproate

▶ BY MOUTH

▶ Adult: Initially 50 mg once daily for 14 days, then

50 mg twice daily for further 14 days, then increased to

100 mg twice daily for further 7 days, then increased to

150 mg twice daily for further 7 days; maintenance

200 mg twice daily, patients stabilised on lamotrigine

for bipolar disorder may require dose adjustments if

other drugs are added to or withdrawn from their

treatment regimens—consult product literature, dose

titration should be repeated if restarting after interval

of more than 5 days

IMPORTANT SAFETY INFORMATION

SAFE PRACTICE

Do not confuse the different combinations or

indications.

l CAUTIONS Myoclonic seizures (may be exacerbated). Parkinson’s disease (may be exacerbated)(in adults)

l INTERACTIONS → Appendix 1: antiepileptics

l SIDE-EFFECTS

▶ Common or very common Aggression . agitation . arthralgia . diarrhoea . dizziness . drowsiness . dry mouth . fatigue . headache . irritability . nausea . pain .rash . sleep disorders .tremor. vomiting

▶ Uncommon Alopecia . movement disorders . vision

disorders

▶ Rare or very rare Confusion . conjunctivitis . disseminated

intravascular coagulation . face oedema . fever. hallucination . hepatic disorders . lupus-like syndrome . lymphadenopathy . meningitis aseptic . multi organ failure . nystagmus . seizure . severe cutaneous adverse reactions

(SCARs).tic

SIDE-EFFECTS, FURTHER INFORMATION Serious skin

reactions including Stevens-Johnson syndrome and toxic

epidermal necrolysis have developed (especially in

children); most rashes occur in the first 8 weeks. Rash is

sometimes associated with hypersensitivity syndrome and

is more common in patients with history of allergy or rash

from other antiepileptic drugs. Consider withdrawal if rash

or signs of hypersensitivity syndrome develop. Factors

associated with increased risk of serious skin reactions

include concomitant use of valproate, initial lamotrigine

dosing higher than recommended, and more rapid dose

escalation than recommended.

l ALLERGY AND CROSS-SENSITIVITY Antiepileptic

hypersensitivity syndrome associated with lamotrigine.

See under Epilepsy p. 305 for more information.

l PREGNANCY See also Pregnancy in Epilepsy p. 305.

Monitoring Doses should be adjusted on the basis of

plasma-drug concentration monitoring.

l BREAST FEEDING Present in milk, but limited data suggest

no harmful effect on infant.

l HEPATIC IMPAIRMENT Manufacturer advises caution in

moderate to severe impairment.

Dose adjustments Manufacturer advises dose reduction of

approx. 50% in moderate impairment, and approx. 75% in

severe impairment; adjust according to response.

l RENAL IMPAIRMENT Caution in renal failure; metabolite

may accumulate.

Dose adjustments Consider reducing maintenance dose in

significant impairment.

l TREATMENT CESSATION Avoid abrupt withdrawal (taper off

over 2 weeks or longer) unless serious skin reaction occurs.

l PRESCRIBING AND DISPENSING INFORMATION Patients

being treated for epilepsy may need to be maintained on a

specific manufacturer’s branded or generic lamotrigine

product.

Switching between formulations Care 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.

l PATIENT AND CARER ADVICE

Skin reactions Warn patients and carers to see their doctor

immediately if rash or signs or symptoms of

hypersensitivity syndrome develop.

Blood disorders Patients and their carers should be alert for

symptoms and signs suggestive of bone-marrow failure,

such as anaemia, bruising, or infection. Aplastic anaemia,

bone-marrow depression, and pancytopenia have been

associated rarely with lamotrigine.

Medicines for Children leaflet: Lamotrigine for preventing seizures

www.medicinesforchildren.org.uk/lamotrigine-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

Dispersible tablet

CAUTIONARY AND ADVISORY LABELS 8, 13

▶ Lamotrigine (Non-proprietary)

Lamotrigine 5 mg Lamotrigine 5mg dispersible tablets sugar free

sugar-free | 28 tablet P £15.00 DT = £6.86

Lamotrigine 25 mg Lamotrigine 25mg dispersible tablets sugar free

sugar-free | 56 tablet P £20.00 DT = £2.20

Lamotrigine 100 mg Lamotrigine 100mg dispersible tablets sugar

free sugar-free | 56 tablet P £58.68 DT = £3.99

▶ Lamictal (GlaxoSmithKline UK Ltd)

Lamotrigine 2 mg Lamictal 2mg dispersible tablets sugar-free | 30 tablet P £18.81 DT = £18.81

Lamotrigine 5 mg Lamictal 5mg dispersible tablets sugar-free | 28 tablet P £9.38 DT = £6.86

Lamotrigine 25 mg Lamictal 25mg dispersible tablets sugar-free |

56 tablet P £23.53 DT = £2.20

Lamotrigine 100 mg Lamictal 100mg dispersible tablets sugar-free

| 56 tablet P £69.04 DT = £3.99

Tablet

CAUTIONARY AND ADVISORY LABELS 8

▶ Lamotrigine (Non-proprietary)

Lamotrigine 25 mg Lamotrigine 25mg tablets | 56 tablet P £8.80 DT = £4.25

BNF 78 Epilepsy and other seizure disorders 319

Nervous system

4

Lamotrigine 50 mg Lamotrigine 50mg tablets | 56 tablet P £10.24 DT = £6.25

Lamotrigine 100 mg Lamotrigine 100mg tablets | 56 tablet P £16.89 DT = £11.45

Lamotrigine 200 mg Lamotrigine 200mg tablets | 56 tablet P £53.46 DT = £15.01

▶ Lamictal (GlaxoSmithKline UK Ltd)

Lamotrigine 25 mg Lamictal 25mg tablets | 56 tablet P £23.53

DT = £4.25

Lamotrigine 50 mg Lamictal 50mg tablets | 56 tablet P £40.02

DT = £6.25

Lamotrigine 100 mg Lamictal 100mg tablets | 56 tablet P £69.04 DT = £11.45

Lamotrigine 200 mg Lamictal 200mg tablets | 56 tablet P £117.35 DT = £15.01

Levetiracetam 03-Apr-2018

l INDICATIONS AND DOSE

Monotherapy of focal seizures with or without secondary

generalisation

▶ BY MOUTH, OR BY INTRAVENOUS INFUSION

▶ Child 16–17 years: Initially 250 mg once daily for 1 week,

then increased to 250 mg twice daily, then increased in

steps of 250 mg twice daily (max. per dose 1.5 g twice

daily), adjusted according to response, dose to be

increased every 2 weeks

▶ Adult: Initially 250 mg once daily for 1–2 weeks, then

increased to 250 mg twice daily, then increased in steps

of 250 mg twice daily (max. per dose 1.5 g twice daily),

adjusted according to response, dose to be increased

every 2 weeks

Adjunctive therapy of focal seizures with or without

secondary generalisation

▶ BY MOUTH

▶ Child 1–5 months: Initially 7 mg/kg once daily, then

increased in steps of up to 7 mg/kg twice daily (max.

per dose 21 mg/kg twice daily), dose to be increased

every 2 weeks

▶ Child 6 months–17 years (body-weight up to 50 kg):

Initially 10 mg/kg once daily, then increased in steps of

up to 10 mg/kg twice daily (max. per dose 30 mg/kg

twice daily), dose to be increased every 2 weeks

▶ Child 12–17 years (body-weight 50 kg and above): Initially

250 mg twice daily, then increased in steps of 500 mg

twice daily (max. per dose 1.5 g twice daily), dose to be

increased every 2–4 weeks

▶ Adult: Initially 250 mg twice daily, then increased in

steps of 500 mg twice daily (max. per dose 1.5 g twice

daily), dose to be increased every 2–4 weeks

▶ BY INTRAVENOUS INFUSION

▶ Child 4–17 years (body-weight up to 50 kg): Initially

10 mg/kg once daily, then increased in steps of up to

10 mg/kg twice daily (max. per dose 30 mg/kg twice

daily), dose to be increased every 2 weeks

▶ Child 12–17 years (body-weight 50 kg and above): Initially

250 mg twice daily, then increased in steps of 500 mg

twice daily (max. per dose 1.5 g twice daily), dose to be

increased every 2 weeks

▶ Adult: Initially 250 mg twice daily, then increased in

steps of 500 mg twice daily (max. per dose 1.5 g twice

daily), dose to be increased every 2–4 weeks

Adjunctive therapy of myoclonic seizures and tonic-clonic

seizures

▶ BY MOUTH, OR BY INTRAVENOUS INFUSION

▶ Child 12–17 years (body-weight up to 50 kg): Initially

10 mg/kg once daily, then increased in steps of up to

10 mg/kg twice daily (max. per dose 30 mg/kg twice

daily), dose to be increased every 2 weeks

▶ Child 12–17 years (body-weight 50 kg and above): Initially

250 mg twice daily, then increased in steps of 500 mg

twice daily (max. per dose 1.5 g twice daily), dose to be

increased every 2 weeks

▶ Adult: Initially 250 mg twice daily, then increased in

steps of 500 mg twice daily (max. per dose 1.5 g twice

daily), dose to be increased every 2–4 weeks

l UNLICENSED USE g Initial dosing recommendations for

levetiracetam lin BNF Publications differ from product

licence.

▶ With oral use in children Manufacturer advises granules not

licensed for use in children under 6 years, for initial

treatment in children with body-weight less than 25 kg, or

for the administration of doses below 250 mg—oral

solution should be used.

l INTERACTIONS → Appendix 1: antiepileptics

l SIDE-EFFECTS

▶ Common or very common Anxiety . appetite decreased . asthenia . behaviour abnormal . cough . depression . diarrhoea . dizziness . drowsiness . gastrointestinal

discomfort. headache . increased risk of infection . insomnia . mood altered . movement disorders . nausea . skin reactions . vertigo . vomiting

▶ Uncommon Alopecia . concentration impaired . confusion . hallucination . leucopenia . muscle weakness . myalgia . paraesthesia . psychotic disorder. suicidal tendencies . thrombocytopenia . vision disorders . weight changes

▶ Rare or very rare Acute kidney injury . agranulocytosis . hepatic disorders . hyponatraemia . neutropenia . pancreatitis . pancytopenia . personality disorder. rhabdomyolysis . severe cutaneous adverse reactions

(SCARs).thinking abnormal

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.

It is recommended that the fetal growth should be

monitored.

l BREAST FEEDING Present in milk—manufacturer advises

avoid.

l HEPATIC IMPAIRMENT

Dose adjustments ▶ In adults Halve dose in severe hepatic

impairment if eGFR less than 60 mL/minute/1.73 m2

.

▶ In children Halve dose in severe hepatic impairment if

estimated glomerular filtration rate less than

60 mL/minute/1.73 m2

.

l RENAL IMPAIRMENT

Dose adjustments ▶ In children Reduce dose if estimated

glomerular filtration rate less than 80 mL/minute/1.73 m2

(consult product literature).

▶ In adults Maximum 2 g daily if eGFR

50–80 mL/minute/1.73 m2

. Maximum 1.5 g daily if eGFR

30–50 mL/minute/1.73 m2

. Maximum 1 g daily if eGFR less

than 30 mL/minute/1.73 m2

.

l DIRECTIONS FOR ADMINISTRATION

▶ With intravenous use For intravenous infusion (Keppra ®),

dilute requisite dose with at least 100 mL Glucose 5% or

Sodium Chloride 0.9%; give over 15 minutes.

▶ With oral use For administration of oral solution, requisite

dose may be diluted in a glass of water.

l PRESCRIBING AND DISPENSING INFORMATION If switching

between oral therapy and intravenous therapy (for those

temporarily unable to take oral medication), the

intravenous dose should be the same as the established

oral dose.

l PATIENT AND CARER ADVICE

Medicines for Children leaflet: Levetiracetam for preventing

seizures www.medicinesforchildren.org.uk/levetiracetampreventing-seizures

320 Epilepsy and other seizure disorders BNF 78

Nervous system

4

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

Granules

CAUTIONARY AND ADVISORY LABELS 8

▶ Desitrend (Desitin Pharma Ltd)

Levetiracetam 250 mg Desitrend 250mg granules sachets sugar-free

| 60 sachet P £22.41 DT = £22.41

Levetiracetam 500 mg Desitrend 500mg granules sachets sugarfree | 60 sachet P £39.46 DT = £39.46

Levetiracetam 1 gram Desitrend 1000mg granules sachets sugarfree | 60 sachet P £76.27 DT = £76.27

Tablet

CAUTIONARY AND ADVISORY LABELS 8

▶ Levetiracetam (Non-proprietary)

Levetiracetam 250 mg Levetiracetam 250mg tablets | 60 tablet P £26.86 DT = £3.27

Levetiracetam 500 mg Levetiracetam 500mg tablets | 60 tablet P £47.31 DT = £5.30

Levetiracetam 750 mg Levetiracetam 750mg tablets |

60 tablet P £84.02 DT = £7.87

Levetiracetam 1 gram Levetiracetam 1g tablets | 60 tablet P £93.09 DT = £8.33

▶ Keppra (UCB Pharma Ltd)

Levetiracetam 250 mg Keppra 250mg tablets | 60 tablet P £28.01 DT = £3.27

Levetiracetam 500 mg Keppra 500mg tablets | 60 tablet P £49.32 DT = £5.30

Levetiracetam 750 mg Keppra 750mg tablets | 60 tablet P £84.02 DT = £7.87

Levetiracetam 1 gram Keppra 1g tablets | 60 tablet P £95.34

DT = £8.33

Solution for infusion

ELECTROLYTES: May contain Sodium

▶ Levetiracetam (Non-proprietary)

Levetiracetam 100 mg per 1 ml Levetiracetam 500mg/5ml

concentrate for solution for infusion vials | 10 vial P £127.31 DT =

£127.31 | 10 vial P £114.57–£127.31 DT = £127.31 (Hospital only)

▶ Desitrend (Desitin Pharma Ltd)

Levetiracetam 100 mg per 1 ml Desitrend 500mg/5ml concentrate

for solution for infusion ampoules | 10 ampoule P £127.31 DT =

£127.31

▶ Keppra (UCB Pharma Ltd)

Levetiracetam 100 mg per 1 ml Keppra 500mg/5ml concentrate for

solution for infusion vials | 10 vial P £127.31 DT = £127.31

Oral solution

CAUTIONARY AND ADVISORY LABELS 8

▶ Levetiracetam (Non-proprietary)

Levetiracetam 100 mg per 1 ml Levetiracetam 100mg/ml oral

solution sugar free sugar-free | 150 ml P £27.00 sugar-free | 300 ml P £60.26 DT = £28.94

▶ Keppra (UCB Pharma Ltd)

Levetiracetam 100 mg per 1 ml Keppra 100mg/ml oral solution

sugar-free | 150 ml P £33.48 sugar-free | 300 ml P £66.95

DT = £28.94

Oxcarbazepine

l INDICATIONS AND DOSE

Monotherapy for the treatment of focal seizures with or

without secondary generalised tonic-clonic seizures

▶ BY MOUTH

▶ Child 6–17 years: Initially 4–5 mg/kg twice daily (max.

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; 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

Adjunctive therapy for the treatment of focal seizures

with or without secondary generalised tonic-clonic

seizures

▶ BY MOUTH

▶ Child 6–17 years: Initially 4–5 mg/kg twice daily (max.

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