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Birmingham, Sandwell, Solihull and environs APC Formulary
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 Formulary Chapter 4: Central nervous system - Full Chapter
04.08.01  Expand sub section  Control of epilepsy
 note 

Category

Antiepileptic drugs

MHRA Advice

1

phenytoin, carbamazepine, phenobarbital, primidone

For these drugs, doctors are advised to ensure that their patient is maintained on a specific manufacturer’s product

2

valproate, lamotrigine, perampanel, retigabine, rufinamide, clobazam, clonazepam, oxcarbazepine, eslicarbazepine, zonisamide, topiramate

For these drugs, 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

3

levetiracetam, lacosamide, tiagabine, gabapentin, pregabalin, ethosuximide, vigabatrin  

For these drugs, it is 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

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
Carbamazepine
View adult BNF View SPC online View childrens BNF
Formulary
Green
  • Tablets
  • M/R tablets
  • SF liquid
  • Suppositories

    MHRA Advice
    Patients being treated for epilepsy should be maintained on a specific manufacturer's product- APC preferred brand is TEGRETOL 
  • Link  UKMI Q&A: Why is there a limit on the dose and duration of use for carbamazepine suppositories?
       
    Eslicarbazepine
    View adult BNF View SPC online View childrens BNF
    Formulary
    Amber
    • Supported by an ESCA
     
    Link  ESCA: Eslicarbazepine
       
    Oxcarbazepine
    View adult BNF View SPC online View childrens BNF
    Formulary
    Amber
  • Tablets
  • Oral suspension

    MHRA Advice
    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 patient and/or carer, taking into account factors such as seizure frequency and treatment history. 
  •    
    04.08.01  Expand sub section  Ethosuximide to top
    Ethosuximide capsules
    View adult BNF View SPC online View childrens BNF
    Formulary
    Amber
    MHRA Advice
    When prescribing for epilepsy, the potential for clinically relevant differences to exist between different manufacturers’ products is considered to be extremely low. However, consider other patient/carer-related factors, such as negative perceptions about alternative products and/or other issues related to the patient such co-morbid autism, mental health issues, or learning disability.
     
       
    04.08.01  Expand sub section  Gabapentin and pregabalin
    Gabapentin
    View adult BNF View SPC online View childrens BNF
    Formulary
    Amber
    • Capsules
    • Tablets £££

      MHRA Advice
      It is 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

    Schedule 3 Controlled Drug as of 01/04/2019

     
    Link  NHS England: Rescheduling of Gabapentin and Pregabalin as Schedule 3 Controlled Drugs
       
    Pregabalin
    View adult BNF View SPC online View childrens BNF
    Formulary
    Amber
    • Capsules

      MHRA Advice
      For patients being treated for epilepsy, it is 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.

    Schedule 3 Controlled Drug as of 01/04/2019

     
    Link  NHS England: Rescheduling of Gabapentin and Pregabalin as Schedule 3 Controlled Drugs
       
    04.08.01  Expand sub section  Lacosamide
    Lacosamide
    View adult BNF View SPC online View childrens BNF
    Formulary
    Amber
  • Tablets
  • Syrup

  • Supported by an ESCA, see link below. 
  • Link  ESCA: Lacosamide.
       
    04.08.01  Expand sub section  Lamotrigine
    Lamotrigine
    View adult BNF View SPC online View childrens BNF
    Formulary
    Amber
  • Tablets
  • Dispersible tablets

    MHRA Advice
    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 patient and/or carer, taking into account factors such as seizure frequency and treatment history.
     
  •    
    04.08.01  Expand sub section  Levetiracetam
    Levetiracetam
    View adult BNF View SPC online View childrens BNF
    Formulary
    Amber
  • Tablets
  • SF oral solution
  • Coated granules in sachets (see Desitrend®)

    MHRA Advice
    It is 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
     
  •    
    Levetiracetam (Desitrend®)
    (coated granules in sachets)
    View adult BNF View SPC online View childrens BNF
    Formulary
    Amber
  • Paediatrician initiation.
  • For patients up to and including 16 years of age unable to swallow tablets and in whom the liquid formulation is not appropriate or tolerated.

    MHRA Advice
    It is 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
     
  •    
    04.08.01  Expand sub section  Perampanel to top
    Perampanel tablets
    View adult BNF View SPC online View childrens BNF
    Formulary
    Amber
  • Supported by an ESCA, see link below.

    MHRA Advice
    When prescribing for epilepsy the patient should be assessed to make a clinical judgement if the same manufacturer’s product/brand is necessary taking into account factors such as seizure frequency and treatment history. Also take into account patient/carer-related factors such as their negative perceptions about alternative products and/or other issues related to the patient such co-morbid autism, mental health issues, or learning disability.

     
  • Link  ESCA: Perampanel.
    Link  NICE CG137: The epilepsies: the diagnosis and management of the epilepsies in adults and children in primary and secondary care
       
    04.08.01  Expand sub section  Phenobarbital and other barbiturates
    Controlled Drug Phenobarbital
    View adult BNF View SPC online View childrens BNF
    Formulary
    Amber
  • Tablets
  • Elixir

    MHRA Advice
    Patients being treated for epilepsy should be maintained on a specific manufacturer's product. 
  •    
    Primidone
    View adult BNF View SPC online View childrens BNF
    Formulary
    Amber
  • Tablets

    MHRA Advice
    Patients being treated for epilepsy should be maintained on a specific manufacturer's product. 
  •    
    04.08.01  Expand sub section  Phenytoin
    Phenytoin
    View adult BNF View SPC online View childrens BNF
    Formulary
    Amber
  • Capsules
  • Suspension

    MHRA Advice
    Patients being treated for epilepsy should be maintained on a specific manufacturer's product. 
  •    
    04.08.01  Expand sub section  Retigabine
     note 
    04.08.01  Expand sub section  Rufinamide
    Rufinamide
    View adult BNF View SPC online View childrens BNF
    Formulary
    Amber
  • Tablets
  • Supported by an ESCA, see link below.

    MHRA advises that when prescribing for epilepsy the patient should be assessed to make a clinical judgement if the same manufacturer’s product/brand is necessary taking into account factors such as seizure frequency and treatment history. Also take into account patient/carer-related factors such as their negative perceptions about alternative products and/or other issues related to the patient such co-morbid autism, mental health issues, or learning disability.
     
  • Link  ESCA: Rufinamide.
       
    04.08.01  Expand sub section  Tiagabine to top
    04.08.01  Expand sub section  Topiramate
    Topiramate
    View adult BNF View SPC online View childrens BNF
    Formulary
    Amber
  • Tablets

    MHRA Advice
    When prescribing for epilepsy the patient should be assessed to make a clinical judgement if the same manufacturer’s product/brand is necessary taking into account factors such as seizure frequency and treatment history. Also take into account patient/carer-related factors such as their negative perceptions about alternative products and/or other issues related to the patient such co-morbid autism, mental health issues, or learning disability.
     
  •    
    04.08.01  Expand sub section  Valproate
    Sodium Valproate
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    Formulary
    Amber
    • E/C tablets
    • M/R tablets
    • Crushable tablets
    • SF liquid
    • M/R granules see Episenta®
      MHRA Advice
      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 patient and/or carer, taking into account factors such as seizure frequency and treatment history.

    Contraindicated in women of childbearing potential unless part of the Pregnancy Prevention Programme.  See MHRA guidance

     
    Link  Women of childbearing potential: Educational Risk Minimisation Materials
    Link  Medicines related to valproate: risk of abnormal pregnancy outcomes
       
    Sodium Valproate (Episenta®)
    (M/R granules in capsules or sachets)
    View adult BNF View SPC online View childrens BNF
    Formulary
    Amber
    • Paediatrician initiation.
    • For patients with epilepsy aged up to and including 16 years of age unable to swallow tablets and who require a modified release formulation in whom other formulations are more expensive or not appropriate.
      MHRA Advice
      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 patient and/or carer, taking into account factors such as seizure frequency and treatment history.

    Contraindicated in women of childbearing potential unless part of the Pregnancy Prevention Programme.  See MHRA guidance

     
    Link  Medicines related to valproate: risk of abnormal pregnancy outcomes
    Link  Women of childbearing potential: Educational Risk Minimisation Materials
       
    04.08.01  Expand sub section  Vigabatrin
    Vigabatrin
    View adult BNF View SPC online View childrens BNF
    Formulary
    Amber
  • Tablets
  • Supported by an ESCA, see link below. 
  • Link  ESCA: Vigabatrin.
       
    04.08.01  Expand sub section  Zonisamide
    Zonisamide
    View adult BNF View SPC online View childrens BNF
    Formulary
    Amber
  • Capsules
  • Supported by an ESCA, see link below.

    MHRA Advice
    When prescribing for epilepsy the patient should be assessed to make a clinical judgement if the same manufacturer’s product/brand is necessary taking into account factors such as seizure frequency and treatment history. Also take into account patient/carer-related factors such as their negative perceptions about alternative products and/or other issues related to the patient such co-morbid autism, mental health issues, or learning disability.
     
  • Link  ESCA: Zonisamide.
       
    04.08.01  Expand sub section  Benzodiazepines to top
    Clobazam
    View adult BNF View SPC online View childrens BNF
    Formulary
    Amber
    MHRA Advice
    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 patient and/or carer, taking into account factors such as seizure frequency and treatment history.
     
       
    Clonazepam tablets
    View adult BNF View SPC online View childrens BNF
    Formulary
    Amber
    MHRA Advice
    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 patient and/or carer, taking into account factors such as seizure frequency and treatment history.
     
       
    04.08.01  Expand sub section  Other Drugs
    BrivaracetamBlack Triangle (Briviact®)
    (oral formulations)
    View adult BNF View SPC online View childrens BNF
    Formulary
    Amber
    • Initiation by Tertiary Epilepsy Specialist only.
    • For adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adult and adolescent patients from 16 years of age with severe refractory epilepsy warranting tertiary specialist input for patients who have tried three or more AEDs. The patient has used levetiracetam and has documentation of intolerance and patient is using a third line agent (perampanel, zonisamide, lacosamide, eslicarbazepine) which would be replaced by brivaracetam.
    • Supported by an ESCA
     
       
    Brivaracetam (Briviact ®)
    (injection)
    View adult BNF View SPC online View childrens BNF
    Formulary
    Red
     
       
    Stiripentol (Diacomit®)
    (250mg capsules, sachets, 500mg capsules)
    View adult BNF View SPC online View childrens BNF
    Formulary
    Red
    Severe myoclonic epilepsy in infancy (Dravet syndrome)
    APC supports use in Adults: for continuation of therapy started in childhood. (Note Off Label use in adults) 
       
     ....
     Non Formulary Items
    Acetazolamide

    View adult BNF View SPC online View childrens BNF
    Non Formulary
     
    Retigabine
    (Tablets)

    View adult BNF View SPC online View childrens BNF
    Non Formulary
    Black
  • Advance notification of retigabine discontinuation from June 2017. Advice to healthcare professionals.
    Click here
  • Link  NICE TA232: Retigabine for the adjunctive treatment of adults with partial onset seizures in epilepsy with and without secondary generalisation
     
    Tiagabine  (Gabitril®)

    View adult BNF View SPC online View childrens BNF
    Non Formulary
     
      
    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
    Cancer Drugs Fund
    Cancer Drugs Fund
    NHSE
    NHS England
    Homecare
    Homecare
    CCG
    CCG

    Traffic Light Status Information

    Status Description

    Prescribing in children

    The APC notes that the informed use of unlicensed medicines or of licensed medicines for unlicensed applications (‘off-label’ use) is often necessary in paediatric practice.

    The APC advises GPs to consider specialist prescribing recommendations for Green and Amber medicines that are not subject to ESCAs or RICaDs in combination with the information provided in the BNFC which goes beyond that of marketing authorisations. The BNFC has been designed for rapid reference and the information presented has been carefully selected to aid decisions on prescribing.

      

    Green

    Medicines which are suitable for initiation and maintenance prescribing by primary and secondary care clinicians. These medicines should be initiated and prescribed within their licensed indications.  

    Amber

    Initiation and maintenance of prescribing by Specialists and transfer to Primary Care prescribing when appropriate, or initiation and maintenance of prescribing in Primary Care following recommendation from a Specialist.

    Some amber medicines require agreement with the local (internal) medicines committee prior to initiation; others may require a framework to support safe transfer and maintenance of care such as a RICaD or ESCA. The Formulary will be annotated to reflect these requirements.   

    Red

    Medicines for initiation and maintenance prescribing by Specialists only  

    Black

    Non-formulary medicines- medicines not recommended for routine primary care prescribing.  

    Grey

    Positive NICE TA and /or awaiting local clarification on place in therapy ; Please contact your Medicines Optimisation team for more information.  

    netFormulary