Gabapentin 19-Jul-2017
lINDICATIONS AND DOSE
Adjunctive treatment of focal seizures with or without
secondary generalisation
▶BY MOUTH
▶Child 2–5 years: 10 mg/kg once daily on day 1 , then
10 mg/kg twice daily on day 2 , then 10 mg/kg 3 times a
day on day 3 , then increased to 30 – 70 mg/kg daily in
3 divided doses, adjusted according to response, some
children may not tolerate daily increments; longer
intervals (up to weekly) may be more appropriate
▶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
70 mg/kg per day
▶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
Monotherapy for focal seizures with or without secondary
generalisation
▶BY MOUTH
▶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 appropriatelUNLICENSED USENot licensed for use in children under
6 years. Not licensed at doses over 50 mg/kg daily in
children under 12 years.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, and concomitant use of central nervous
system (CNS) depressants might be at higher risk of
experiencing severe respiratory depression and dose
adjustments may be necessary in these patients.lCAUTIONSDiabetes mellitus.high doses of oral solution
in adolescents and adults with low body-weight.history of
psychotic illness.mixed seizures (including absences)
lINTERACTIONS→Appendix 1 : antiepilepticslSIDE-EFFECTS
▶Common or very commonAnxiety.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.sensation
abnormal.sexual dysfunction.skin reactions.thinking
abnormal.tooth disorder.tremor.vasodilation.vertigo.
visual impairment.vomiting
▶UncommonCognitive impairment.palpitations
▶Frequency not knownAcute kidney injury.alopecia.
angioedema.breast enlargement.gynaecomastia.
hallucination.hepatic disorders.hyponatraemia.
pancreatitis.rhabdomyolysis.severe cutaneous adverse
reactions (SCARs).thrombocytopenia.tinnitus.urinary
incontinence
lPREGNANCY
MonitoringThe dose should be monitored carefully during
pregnancy and after birth, and adjustments made on a
clinical basis.
lBREAST FEEDINGPresent in milk—manufacturer advises
use only if potential benefit outweighs risk.
lRENAL IMPAIRMENT
Dose adjustmentsReduce dose if estimated glomerular
filtration rate less than 80 mL/minute/ 1. 73 m^2 ; consult
product literature.
lEFFECT ON LABORATORY TESTSFalse positive readings
with some urinary protein tests.
lDIRECTIONS FOR ADMINISTRATIONCapsules can be
opened but the bitter taste is difficult to mask.
lPATIENT AND CARER ADVICE
Medicines for Children leaflet: Gabapentin for preventing
seizureswww.medicinesforchildren.org.uk/gabapentin-for-
preventing-seizureslMEDICINAL 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 LABELS3, 5, 8, 25
▶Gabapentin (Non-proprietary)
Gabapentin 600 mgGabapentin 600 mg tablets| 100 tabletP
£ 106. 00 DT = £ 6. 45
Gabapentin 800 mgGabapentin 800 mg tablets| 100 tabletP
£ 98. 13 DT = £ 29. 85
▶Neurontin(Pfizer Ltd)
Gabapentin 600 mgNeurontin 600 mg tablets| 100 tabletP
£ 84. 80 DT = £ 6. 45
Gabapentin 800 mgNeurontin 800 mg tablets| 100 tabletP
£ 98. 13 DT = £ 29. 85
Oral solution
CAUTIONARY AND ADVISORY LABELS3, 5, 8
EXCIPIENTS:May contain Propylene glycol
ELECTROLYTES:May contain Potassium, sodium
▶Gabapentin (Non-proprietary)
Gabapentin 50 mg per 1 mlGabapentin 50 mg/ml oral solution sugar
free| 150 mlP£ 69. 00 DT = £ 69. 00
Capsule
CAUTIONARY AND ADVISORY LABELS3, 5, 8, 25
▶Gabapentin (Non-proprietary)
Gabapentin 100 mgGabapentin 100 mg capsules|
100 capsuleP£ 18. 29 DT = £ 2. 41
Gabapentin 300 mgGabapentin 300 mg capsules|
100 capsuleP£ 42. 40 DT = £ 8. 09
Gabapentin 400 mgGabapentin 400 mg capsules|
100 capsuleP£ 49. 06 DT = £ 5. 94
▶Neurontin(Pfizer Ltd)
Gabapentin 100 mgNeurontin 100 mg capsules| 100 capsuleP
£ 18. 29 DT = £ 2. 41200 Epilepsy and other seizure disorders BNFC 2018 – 2019
Nervous system4