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Area Prescribing Committee Formulary  
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 Formulary Chapter 4: Central nervous system - Full Chapter
04.08.01  Expand sub section  Control of epilepsy
 note 

The MHRA recommend that patients on certain antiepileptic drugs remain on the same brand where possible. In order to help decide which anti-epileptics may or may not be switched the MHRA have classified anti-epileptics in to 3 categories.

Category 1 - the patient should be maintained on a specific manufacturer’s product (carbamazepine, phenobarbital and phenytoin)

Category 2 - the need for continued supply of a particular manufacturer’s product should be based on clinical judgement and consultation with patient and/or carer, taking into account factors such as seizure frequency and treatment history (clobazam, clonazepam, eslicarbazepine acetate, lamotrigine, oxcarbazepine, perampanel, retigabine, rufinamide, sodium valproate, topiramate, and zonisamide).

Category 3 - usually unnecessary to ensure that patients are maintained on a specific manufacturer’s product unless there are specific reasons such as patient anxiety and risk of confusion or dosing errors (acetazolamide, brivaracetam, ethosuximide, gabapentin, lacosamide, levetiracetam, pregabalin, stiripentol, and vigabatrin).

Acetazolamide
(Category 3)
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Formulary
Green
 
   
Brivaracetam
(Category 3)
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Formulary
Green plus
  • Approved for use as adjunctive therapy in patients with severe/intractable partial onset seizures e.g. a sezuire frequency of 1 per week following failure of first-line adjunctive therapy. Response must be assessed within 3-6 months before transferring prescribing to primary or stopping treatment, as appropriate.
 
   
Carbamazepine
(Category 1)
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Formulary
Green
  • Carbamazepine 200mg and 400mg MR tablets (Tegretol® retard) are available on consultant request for those in whom conventional carbamazepine has been shown to be unsuitable Green Traffic Light
 
   
Clobazam
(Category 2)
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Formulary
Green plus
 
   
Clonazepam
(Catergory 2)
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Formulary
Green
  • Clonazepam 500microgram in 5ml sugar-free oral solution is also approved unlicensedunlicensed
 
   
Eslicarbazepine
(Category 2)
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Formulary
Green plus
  • Approved for use by specialists only in those patients for whom intolerance of carbamazepine is a major concern and when use of this agent is more cost effective than alternatives available.
 
   
Ethosuximide
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Formulary
Green
 
   
Gabapentin
(Category 3)
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Green
  • Note: gabapentin 250mg in 5ml is also approved unlicensedunlicensed.
 
   
Lacosamide
(Category 3)
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Formulary
Green plus
  • Only approved on advice from consultant neurologists, in patients that are refractory to treatment with other drugs.
 
   
Lamotrigine
(Category 2)
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Formulary
Green
 
   
Levetiracetam
(Category 3)
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Formulary
Green plus
 
   
Oxcarbazepine
(Category 2)
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Formulary
Green
 
   
Perampanel
(Category 2)
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Formulary
Green
  • NETAG approved for partial (focal) seizure epilepsy only when other treatment  options recommended by NICE have been tried or fully considered.
 
Link  NETAG - Perampanel (Fycompa®) for focal epilepsy
   
Controlled Drug Phenobarbital
(Category 1)
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Formulary
Green
 
   
Phenytoin
(Category 1)
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Formulary
Green
  • Note: phenytoin 30mg in 5ml suspension (base) – 90mg (15ml) is equivalent to one 100mg phenytoin sodium capsule 250mg in 5ml injection (sodium salt).
 
   
Pregabalin
(Category 3)
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Formulary
Green plus
  • Approved for specialist advice in the management of treatment resistant epilepsy. 
  • Also approved as a second line agent for General Anxiety Disorder. Although treatment can be given 2-3 times daily, it is more cost effective to give as a twice daily dose. 
 
   
Retigabine
(Category 2)
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Formulary
Green plus
  • Only approved for use in accordance with NICE guidance. 
 
Link  NICE TA232: Retigabine for the adjunctive treatment of adults with partial onset seizures in epilepsy with and without secondary generalisation
   
Rufinamide
(Category 2)
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Formulary
Red
  • Approved for limited use as a second or third-line treatment in patients with Lennox-Gastaut syndrome and related encephalopathies.
  • Should only be used on the advice of paediatric neurologists and other neurologists specialising in the treatment of epilepsy.
 
   
Sodium Valproate
(Category 2)
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Formulary
Green
  • Note: sodium valproate 500mg & 1000mg MR granules (Episenta®) - for possible use in those who have difficulty swallowing sodium valproate tablets. May be more convenient to use than large volumes of liquid formulations.
 
Link  Valproate medicines: Pregnancy Prevention Programme materials
   
Stiripentol
(Category 3)
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Formulary
Green plus
  • For use as adjunctive therapy of refractory generalised tonicclonic seizures in children with severe myoclonic epilepsy in infancy.
 
   
Topiramate
(Category 2)
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Formulary
Green plus
 
   
Vigabatrin
(Category 3)
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Formulary
Amber
 
Link  Shared Care Guidance Vigabatrin
   
Zonisamide
(Category 2)
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Formulary
Green
  • For specialist use only in patients that are refractory to treatment with other drugs
  • Use in children is unlicensedunlicensed.
 
   
04.08.01  Expand sub section  Partial seizures with or without secondary generalisation
04.08.01  Expand sub section  Generalised seizures
04.08.01  Expand sub section  Carbamazepine and Oxcarbazepine
04.08.01  Expand sub section  Ethosuximide to top
04.08.01  Expand sub section  Gabapentin and pregabalin
04.08.01  Expand sub section  Lacosamide
04.08.01  Expand sub section  Lamotrigine
04.08.01  Expand sub section  Levetiracetam
04.08.01  Expand sub section  Perampanel to top
04.08.01  Expand sub section  Phenobarbital and other barbiturates
04.08.01  Expand sub section  Phenytoin
04.08.01  Expand sub section  Retigaine
04.08.01  Expand sub section  Rufinamide
04.08.01  Expand sub section  Rufinamide to top
04.08.01  Expand sub section  Tiagabine
04.08.01  Expand sub section  Topiramate
04.08.01  Expand sub section  Valproate
04.08.01  Expand sub section  Vigabatrin
04.08.01  Expand sub section  Zonisamide to top
04.08.01  Expand sub section  Benzodiazepines
04.08.01  Expand sub section  Other Drugs
 ....
Key
note Notes
Section Title Section Title (top level)
Section Title Section Title (sub level)
First Choice Item First Choice item
Non Formulary Item Non Formulary section
Restricted Drug
Restricted Drug
Unlicensed Drug
Unlicensed
Track Changes
Display tracking information
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Link to adult BNF
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Link to children's BNF
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Link to SPCs
SMC
Scottish Medicines Consortium
Cytotoxic Drug
Cytotoxic Drug
CD
Controlled Drug
High Cost Medicine
High Cost Medicine
Cancer Drugs Fund
Cancer Drugs Fund
NHSE
NHS England
Homecare
Homecare
CCG
CCG

Traffic Light Status Information

Status Description

Red

Drugs for hospital use only. The responsibility for initiation and monitoring treatment should rest with an appropriate hospital clinician and the drug should be supplied through the hospital throughout the duration of treatment. In some very exceptional circumstances (e.g. due to distance from the hospital, storage, supply or mobility/transport problems) it may be appropriate for the GP to be asked to prescribe a Red drug. This should be negotiated on an individual patient basis and should only be done with the GP’s prior informed agreement where the roles of the GP and hospital services are clearly defined and agreed. The GP should not feel under pressure to prescribe in these circumstances.   

Amber

Drugs initiated by hospital specialist, but where continuing treatment by GPs may be appropriate under a shared care arrangement. The specialist should send the GP a copy of the shared care agreement to sign. The GP should sign the shared care agreement, or indicate they do not want to be part of such an agreement, and return a copy back to the specialist. Shared care guidelines are available or are being developed for most of the drugs listed as Amber. If no shared care guideline is available, the hospital specialist should provide the patient’s GP with sufficient information and support to allow treatment to be continued and managed safely in primary care.  

Green plus

Drugs normally recommended or initiated by hospital specialist, but where the provision of an information leaflet may be appropriate to facilitate continuing treatment by GPs. Many of these information sheets are in the process of development.  

Green

Drugs where prescribing by GPs is appropriate. Drugs not classified as Red, Amber or Green Plus (formerly blue in North of Tyne) are generally classified as ‘Green’ by default. The Green drugs listed here include those products normally initiated by hospital specialists where there was a need for discussion and debate as to the category in which they should be placed.  

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