| Formulary Chapter 4: Central nervous system - Full Chapter
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 Administration of depot antipsychotic injections during COVID-19 in stable adult patients |
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| 04.08 |
Antiepileptics |
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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 |
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| 04.08.01 |
Control of epilepsy |
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Partial seizures with or without secondary generalisation |
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Generalised seizures |
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Carbamazepine and Oxcarbazepine |
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Carbamazepine
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Formulary
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Tablets
M/R tablets
SF liquid
Suppositories
Tegretol is the preferred brand for new patients however please ensure that existing patients are maintained on a specific manufacturers brand
MHRA Advice
Patients being treated for epilepsy should be maintained on a specific manufacturer's product
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NICE CG 137: The epilepsies: the diagnosis and management of the epilepsies in adults and children in primary and secondary care
 UKMI Q&A: Why is there a limit on the dose and duration of use for carbamazepine suppositories?
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Eslicarbazepine
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Formulary
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Should only be considered following referral to a tertiary care specialists and after oxcarbazepine has been tried
Supported by an ESCA
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ESCA: Eslicarbazepine
NICE CG 137: The epilepsies: the diagnosis and management of the epilepsies in adults and children in primary and secondary care
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Oxcarbazepine
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Formulary
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Tablets
Oral suspension
On specialist advice
MHRA Advice
Care should be taken when switching between oral formulations. The need for continued supply of a particluar 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
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NICE CG137: The epilepsies: the diagnosis and management of the epilepsies in adults and children in primary and secondary care
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Ethosuximide |
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Ethosuximide
(capsules)
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Formulary
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On specialist advice
MHRA Advice
When prescribing for epilepsy, the potential for clinically relevant differences to exist between different manufacturers' product is considered to be extremely low. However, consider otherpatient / 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
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NICE CG137: The epilepsies: the diagnosis and management of the epilepsies in adults and children in primary and secondary care
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| 04.08.01 |
Gabapentin and pregabalin |
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Gabapentin
(capsules)
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Formulary
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On advice of specialist
MHRA Advice
It is usually unnecessary to ensure that patients are maintained on a specific maufacturer's product unless there are specific reasons such as patient anxiety and risk of confusion or dosing errors
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NHS England: (Schedule 3 Controlled Drugs) Patient Leaflet; Are you taking gabapentin or pregabalin? (Lyrica, Alzain, Neurontin)
NICE CG137: The epilepsies: the diagnosis and management of the epilepsies in adults and children in primary and secondary care
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Gabapentin
(tablets)
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Formulary
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On advice of specialist
Tablets £££££, capsules are more cost effective
MHRA Advice
For patients being treated for epilepsy , it is usually unnecessary to ensure that patiemts are maintained on a specific manufacturer's product unless there are specific reasons such as patient anxiety and risk of confusion or dosing errors
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NHS England: (Schedule 3 Controlled Drugs) Patient Leaflet; Are you taking gabapentin or pregabalin? (Lyrica, Alzain, Neurontin)
NICE CG137: The epilepsies: the diagnosis and management of the epilepsies in adults and children in primary and secondary care
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Pregabalin
(capsules)
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Formulary
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On advice of specialist
Please follow Optimise Rx for most cost effective brand
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NHS England: (Schedule 3 Controlled Drugs) Patient Leaflet; Are you taking gabapentin or pregabalin? (Lyrica, Alzain, Neurontin)
NICE CG137: The epilepsies: the diagnosis and management of the epilepsies in adults and children in primary and secondary care
UKMI Q&A: Gabapentin and pregabalin - are they safe whilst breast feeding?
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| 04.08.01 |
Lacosamide |
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Lacosamide
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Formulary
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Tablets
Syrup
Supported by an ESCA
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ESCA: Lacosamide
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| 04.08.01 |
Lamotrigine |
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Lamotrigine
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Formulary
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Tablets
Dispersible tablets
On specialist advice
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
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NICE CG137: The epilepsies: the diagnosis and management of the epilepsies in adults and children in primary and secondary care
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| 04.08.01 |
Levetiracetam |
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Levetiracetam
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Formulary
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Tablets
SF oral solution
Coated granules in sachets (see Desitrend®)
On specialist advice
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 riak of confusion or dosing errors
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NICE CG137: Epilepsies: diagnosis and management
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Levetiracetam (Desitrend®)
(coated granules in sachets)
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Formulary
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Paediatrician initiation
For patients up to and including 16 years of age who are 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 maufacturer's product unless there are specific reasons such as patient anxiety and risk of confusion or dosing errors
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NICE CG137: Epilepsies: diagnosis and management
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| 04.08.01 |
Perampanel |
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Perampanel (Fycompa®)
(Tablets)
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Formulary
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On specialist advice with an ESCA
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 as co-morbid autism, mental health issues or learning disability
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ESCA: Perampanel
NICE CG137: The epilepsies: the diagnosis and management of the epilepsies in adults and children in primary and secondary care
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| 04.08.01 |
Phenobarbital and other barbiturates |
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Phenobarbital
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Formulary
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Tablets
Elixir
On specialist advice
MHRA Advice
Patients being treated for epilepsy should be maintained on a specific manufacturer's product
Safety Information
Prescriptions for Phenobarbital for children should be prescribed as "unlicensed phenobarbital oral solution 50mg in 5ml (alcohol free)" APC descision September 2021
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NICE CG137: The epilepsies: the diagnosis and management of the epilepsies in adults and children in primary and secondary care
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Primidone
(Tablets)
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Formulary
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On specialist advice
MHRA Advice
Patients being treated for epilepsy should be maintained on a specific manufacturer's product
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NICE CG137: The epilepsies: the diagnosis and management of the epilepsies in adults and children in primary and secondary care
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| 04.08.01 |
Phenytoin |
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Phenytoin
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Formulary
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Capsules
Suspension
On specialist advice
MHRA Advice
Patients being treated for epilepsy should be maintained on a specific manufacturer's product
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NICE CG137: The epilepsies: the diagnosis and management of the epilepsies in adults and children in primary and secondary care
UKMI Q&A: Information on change of phenytoin capsules to tablets and vice versa
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| 04.08.01 |
Retigaine |
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| 04.08.01 |
Rufinamide |
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Rufinamide
(Tablets)
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Formulary
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For Lennox-Gastaut syndrome only
Supported by an ESCA
MHRA Advice
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 as co-morbid autism, mental health issues or learning disability
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ESCA: Rufinamide
NICE CG137: The epilepsies: the diagnosis and management of the epilepsies in adults and children in primary and secondary care
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| 04.08.01 |
Tiagabine |
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| 04.08.01 |
Topiramate |
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Topiramate
(tablets)
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Formulary
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On specialist advice
MHRA Advice
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 as co-morbid autism, mental health issues or learning disability
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NICE CG137: The epilepsies: the diagnosis and management of the epilepsies in adults and children in primary and secondary care
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| 04.08.01 |
Valproate |
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Sodium Valproate
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Formulary
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E/C tablets
M/R tablets
Crushable tablets
SF liquid
M/R granules see Episenta®
On specialist advice
 Use in men and women of non-child bearing potential
 Use in women and girls of childbearing potential (all indications).
Contraindicated in women of childbearing potential unless part of the Pregnancy Prevention Programme. See MHRA guidance
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
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 MHRA: Valproate Pregnancy Prevention Programme: temporary advice for management during coronavirus (COVID-19) pandemic
Guidance Document on Valproate Use in Women and Girls of Childbearing Years (March 2019)
Valproate form: Annual Risk Acknowledgement form (March 2019)
Medicines related to valproate: risk of abnormal pregnancy outcomes
MHRA : Valproate use in women and girls (August 2018)
NICE CG137: Epilepsies: diagnosis and management
Women of childbearing potential: Educational Risk Minimisation Materials
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Sodium valproate prolonged release (Episenta®)
(M/R granules in capsules or sachets)
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Formulary
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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
Contraindicated in women of childbearing potential unless part of the Pregnancy Prevention Programme. See MHRA guidance
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
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MHRA: Valproate Pregnancy Prevention Programme: temporary advice for management during coronavirus (COVID-19) pandemic
Guidance Document on Valproate Use in Women and Girls of Childbearing Years (March 2019)
Valproate form: Annual Risk Acknowledgement form (March 2019)
Medicines related to valproate: risk of abnormal pregnancy outcomes
MHRA: Valproate use in women and girls (August 2018)
NICE CG137: Epilepsies: diagnosis and management
Women of childbearing potential: Educational Risk Minimisation Materials
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Vigabatrin |
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Vigabatrin
(tablets)
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Formulary
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On specialist advice with an ESCA
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ESCA: Vigabatrin
NICE CG137: The epilepsies: the diagnosis and management of the epilepsies in adults and children in primary and secondary care
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| 04.08.01 |
Zonisamide |
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Zonisamide (Zonegran®)
(capsules)
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Formulary
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On specialist advice with an ESCA
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 as co-morbid autism, mental health issues or learning disability
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ESCA: Zonisamide
NICE CG137: The epilepsies: the diagnosis and management of the epilepsies in adults and children in primary and secondary care
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| 04.08.01 |
Benzodiazepines |
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Clobazam
(tablets)
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Formulary
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On specialist advice
MHRA Advice
Care should be taken when switching between oral formulations. The need for continued supply of a particluar 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
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Clonazepam
(tablets)
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Formulary
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On specialist advice
MHRA Advice
Care should be taken when switching between oral formulations. The need for continued supply of a particluar 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
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Other Drugs |
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Brivaracetam (Briviact®)
(oral formulations)
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Formulary
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•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
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Brivaracetam (Briviact ®)
(injection)
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Formulary
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Cannabidiol (Epidyolex®)
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Formulary
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In line with NICE
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NICE TA614: Cannabidiol with clobazam for treating seizures associated with Dravet syndrome
NICE TA615: Cannabidiol with clobazam for treating seizures associated with Lennox–Gastaut syndrome
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Cenobamate (Ontozry®)
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Formulary
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In line with NICE
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NICE TA753: Cenobamate for treating focal onset seizures in epilepsy
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Stiripentol (Diacomit®)
(250mg capsules, sachets. 500mg capsules)
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Formulary
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Severe myoclonic epilepsy of infancy (Dravet syndrome)
APC supports use in Adults: for continuation of therapy started in childhood. (Note Off Label use in adults)
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| 04.08.02 |
Drugs used in status epilepticus |
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Diazepam (Rectal tubes)
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Formulary
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Midazolam (Buccolam®)
(Buccal liquid)
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Formulary
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On specialist advice
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Paraldehyde
(rectal solution 50% in olive oil 10ml)
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Formulary
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| 04.08.03 |
Febrile convulsions |
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| Non Formulary Items |
Acetazolamide
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Non Formulary
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Clonazepam
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Non Formulary
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Diazepam
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Non Formulary
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Fosphenytoin Sodium (Pro-Epanutin®)
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Non Formulary
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Midazolam 10mg in 1ml oromucosal solution (Epistatus®)
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Non Formulary
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Non-formulary Medicines which APC/Trust DTC has actively reviewed and do not recommend for use. (September 2021) |
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Paracetamol
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Non Formulary
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Retigabine
(Tablets)
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Non Formulary
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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
Prescribe in accordance with NICE TA232
Prescribing restrictions imposed by the MHRA July 2013. Monitor for ocular side effects and complete yellow cards as appropriate.
To be discontinued from June 2017 (see link below) |
GlaxoSmithKline: Advance notification of Retigabine (Trobalt) discontinuation
MHRA safety update on pigmentation July 2013
MHRA: Letters sent to healthcare professionals in September 2016, including retigabine withdrawal
NICE TA232: Retigabine for the adjunctive treatment of adults with partial onset seizures in epilepsy with and without secondary generalisation
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Tiagabine (Gabitril®)
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Non Formulary
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Key |
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Restricted Drug |
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Unlicensed |
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Link to adult BNF
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Link to children's BNF
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Link to SPCs
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Cytotoxic Drug |
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Controlled Drug |
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High Cost Medicine |
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Cancer Drugs Fund |
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NHS England |
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Homecare |
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ICB |
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Low carbon footprint |
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Medium carbon footprint |
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High carbon footprint |
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| Status |
Description |
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All Settings
Suitable for initiation, ongoing prescribing, and discontinuation in both primary and secondary care settings. They are generally familiar, frequently used therapies that can be started within their licensed indications without specialist oversight. |
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Specialist only
Designated for initiation, ongoing prescribing, monitoring, exclusively by a specialists either in a hospital or as part of a specialist service (to note this could be in a non-hospital setting). Primary care should neither start nor continue these treatments except as part of a specialist service. A specialist could be either a medical or non-medical prescriber. |
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Specialist advice
Prescribers in primary care should seek advice and a recommendation from a specialists prior to initiating a medicine. Once agreed with a specialist, medicines can be initiated, prescribed and monitored in primary care without a formal shared-care agreement. |
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Specialist initiation
Medicines in this category require a specialist to start therapy, titrate dosage, and assess initial efficacy or tolerability. Once stabilised, prescribing responsibility may transfer to primary care without the need for a formal shared-care agreement. |
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Shared care agreement
Prescribing responsibility can be shared across health settings and between specialists and GPs only when formal shared care arrangement has been made. For example, there may be extensive and complex monitoring requirements or significant safety concerns (note would need a national policy on this to define the criteria for requiring a formal SCA), this will be produced once nationally. |
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Do not prescribe
Not approved for routine prescribing in primary or secondary care. For example, because they are agents classified in the BNF as “not NHS” or “Drugs of Low Clinical Value”, or they are products on NICE’s “do not do” list or NHS England’s “should not routinely prescribe” list. |
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Self Care
Not for routine prescribed in primary or secondary care unless as part of care for a long term condition. Instead, patients should be encouraged to self care with support from community pharmacy. |
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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 |
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Amber Specialist Initiation: Initiation and maintenance of prescribing by Specialists and transfer to Primary Care prescribing when appropriate. This may be supported by a RICaD, annotated within the formulary entry. |
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Amber Shared Care: Initiation and maintenance of prescribing by Specialists and transfer to Primary Care prescribing, in accordance with an ESCA, annotated within the formulary entry. |
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Amber Specialist Recommendation: Initiation and maintenance of prescribing in Primary Care following recommendation from a specialist. |
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Medicines for initiation and maintenance prescribing by Specialists (hospital or GPs with Special Interest) only |
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Positive NICE TA and /or awaiting local clarification on place in therapy; Please contact your Medicines Optimisation team for more information. |
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Non-formulary Medicines which APC/Trust DTC has actively reviewed and do not recommend for use. |
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