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 Formulary Chapter 4: Central nervous system - Full Chapter
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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 plus
 
 
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.
 
 
Controlled Drug Cannabidiol (Epidyolex®)
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Formulary
Red
High Cost Medicine
NHS England
  • 100mg/1mL oral solution
    • Approved for use in combination with clobazam for treating seizuires associated with Dravet syndrome in people aged 2 years and older
    • Approved for use in combination with clobazam for treating seizures associated with Lennox-Gastaut syndrome
    • Approved as an add-on treatment option for seizures caused by tuberous sclerosis complex in people aged 2 years and over - in line with NICE TA873.
 
Link  NICE TA614: Cannabidiol with clobazam for treating seizures associated with Dravet syndrome
Link  NICE TA615: Cannabidiol with clobazam for treating seizures associated with Lennox–Gastaut syndrome
Link  NICE TA873: Cannabidiol for treating seizures caused by tuberous sclerosis complex
 
Carbamazepine
(Category 1)
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Formulary
Green plus
  • 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
 
 
Carbamazepine Suppositories
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Formulary
Red
 
 
Clobazam
(Category 2)
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Formulary
Green plus
 
 
Clonazepam
(Catergory 2)
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Green
  • Clonazepam 500microgram in 5ml sugar-free oral solution is also approved unlicensedunlicensed
 
 
Eslicarbazepine
(Category 2)
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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 plus
 
 
FenfluramineBlack Triangle (Fintepla®)
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Formulary
Red
High Cost Medicine
NHS England

Oral solution: 2.2mg/mL

 
Link  NICE TA808: Fenfluramine for treating seizures associated with Dravet syndrome
 
Gabapentin
(Category 3)
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Formulary
Green plus
  • Note: gabapentin 250mg in 5ml is also approved unlicensedunlicensed.
 
Link  MHRA Drug Safety Alert (Oct 2017): Gabapentin (Neurontin): risk of severe respiratory depression
 
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 plus
 
 
Levetiracetam
(Category 3)
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Formulary
Green plus
 
 
Oxcarbazepine
(Category 2)
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Formulary
Green plus
 
 
Perampanel
(Category 2)
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Formulary
Green plus
  • NETAG approved for partial (focal) seizure epilepsy only when other treatment  options recommended by NICE have been tried or fully considered.
 
Link  NTAG - Perampanel (Fycompa®) for epilepsy
 
Controlled Drug Phenobarbital
(Category 1)
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Formulary
Green plus
 
 
Phenobarbital INJECTION
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Formulary
Red
 
 
Phenytoin
(Category 1)
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Formulary
Green plus
  • Note: phenytoin 30mg in 5ml suspension (base) – 90mg (15ml) is equivalent to one 100mg phenytoin sodium capsule 250mg in 5ml injection (sodium salt).
 
 
Piracetam
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Formulary
Green plus
 
 
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. 
 
Link  MHRA Drug Safety Update (Apr 2022): Pregabalin (Lyrica): findings of safety study on risks during pregnancy
Link  MHRA Drug Safety Update (Feb 2021): Pregabalin (Lyrica): reports of severe respiratory depression
 
Primidone 
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Formulary
Green plus
 
 
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 plus
  • 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.
  • Valproate▼ must no longer be prescribed to women and girls of childbearing potential unless there is no alternative and they are on the Pregnancy Prevention Programme (PPP) Amber

▼ BLACK TRIANGLE IN FEMALES

Valproate must no longer be prescribed to women and girls of
childbearing potential unless there is no alternative and they are on the
Pregnancy Prevention Programme (PPP)

For information relating to alerts regarding valproate, including Drug Safety Updates and links to PPP materials, please use the following link:

MHRA Drug Safety Updates (valproate)

 
Link  Valproate medicines: Pregnancy Prevention Programme materials
Link  Local Shared Care guideline in TEWV to support Valproate Pregnancy Prevention Programme
 
Sodium Valproate▼ Injection
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Formulary
Red

Valproate must no longer be prescribed to women and girls of
childbearing potential unless there is no alternative and they are on the
Pregnancy Prevention Programme (PPP)

For information relating to alerts regarding valproate, including Drug Safety Updates and links to PPP materials, please use the following link:

MHRA Drug Safety Updates (valproate)

 
 
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.
 
 
Tiagabine
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Formulary
Green plus
 
 
Topiramate
(Category 2)
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Formulary
Green plus
 
 
Vigabatrin
(Category 3)
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Formulary
Amber
 
Link  North of Tyne, Gateshead and North Cumbria - Vigabatrin Shared Care Guideline
 
Zonisamide
(Category 2)
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Formulary
Green plus

 

    • For use only in patients that are refractory to treatment with other drugs on the recommendation of a specialist

 

    • 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
Cenobamate (Ontozry®)
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Formulary
Green plus

  • 12.5mg, 25mg, 50mg, 100mg, 150mg and 200mg tablets

  • Approved for treating focal onset seizure in epilepsy in line with NICE

    • Patients will be stabilised by the epilepsy specialist prior to transfer to the GP for continuation. This will usually be after 3 months of treatment.



 
Link  NICE TA753: Cenobamate for treating focal onset seizures in epilepsy
 
 ....
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
click to search medicines.org.uk
Link to adult BNF
click to search medicines.org.uk
Link to children's BNF
click to search medicines.org.uk
Link to SPCs
Cytotoxic Drug
Cytotoxic Drug
CD
Controlled Drug
High Cost Medicine
High Cost Medicine
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. For all RED drugs automatically added to the formulary in response to a positive NICE TA: Prescribers need to ensure that local Trust new drug governance procedures and pharmacy processes are followed before any prescribing.  

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 a specialist (hospital or GP with an extended role https://www.rcgp.org.uk/gpwer), but can be safely maintained in primary care with very little or no monitoring required. In some cases there may be a further restriction for use outlined - these will be defined in each case. Provision of additional information, or an information leaflet, may be appropriate in some cases to facilitate continuing treatment by GPs.  

Green

Drugs where prescribing by GPs is appropriate. Can be initiated and prescribed in all care settings, and if appropriate, discontinued without recourse to secondary care.  

Black

NOT APPROVED: Drugs that have been considered by NTAG or the NENC ICB Medicines Subcommittee (or other approved body) and are not approved for prescribing within the North East and North Cumbria.   

Brown

UNDER REVIEW: drugs whose current formulary status or RAG status is currently under review.  

Not Recomended

NOT REVIEWED: Drugs that haven not been reviewed yet. This usually means that an application is in progress. These drugs are not normally considered appropriate for prescribing in the North East and North Cumbria until such time that a decision is taken on their formulary status.  

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