4.6 Seizures
| First line drugs | Second line drugs | Specialist drugs | Secondary care drugs |
Traffic light status explained:
- Green: Routine prescribing within licensed indication
- Amber 1: specialist recommendation followed by GP initiation and continuation
- Amber 2: specialist or GP initiation in line with local guideline after 1st line failure followed by GP continuation
- Amber 3: specialist initiation and stabilisation followed by GP continuation
- Amber SCG: specialist initiation and stabilisation followed by GP continuation in line with an agreed shared care guideline
- Red: Hospital or specialist prescribing only
4.6.1 Epilepsy
National Guideline:
- Drug Safety Update - Antiepileptic drugs: updated advice on switching between different manufacturers' products (November 2017)
Categories of AEDs
Three categories of AEDs are identified to help prescribers and patients decide whether it is necessary to keep using a supply of a specific manufacturer’s product, based on therapeutic index (a comparison of the amount of a therapeutic agent that causes the therapeutic effect to the amount that causes toxicity), solubility and absorption.
Category 1 – Phenytoin, carbamazepine, phenobarbital, primidone. For these drugs, doctors are advised to ensure that their patient is maintained on a specific manufacturer’s product.
Category 2 – Valproate, lamotrigine, perampanel, 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.
Category 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 concerns such as patient anxiety, and risk of confusion or dosing errors.
Antiepileptics
Brivaracetam (Amber 3)
- Tablets 10mg, 25mg, 50mg, 75mg, 100mg
- Oral solution 10mg/mL
- Intravenous injection 10mg/mL (Hosp only)
Note:
- Restricted. Only used when all other options have been tried or when prescribed by a specialist in epilepsy
Carbamazepine (MHRA Category 1)
- Tablet 100mg, 200mg, 400mg
- Modified Release tablet 200mg, 400mg
- Chewable tablet 100mg
- Oral suspension Sugar Free 100mg in 5mL
- Suppository 125mg, 250mg
Gabapentin CD (Amber 2)(MHRA Category 3)
- Capsule 100mg, 300mg, 400mg
- Tablets 600mg, 800mg
Lamotrigine (Amber 2) (MHRA Category 2)
- Tablets 25mg, 50mg, 100mg, 200mg
- Dispersible tablets 5mg, 25mg, 100mg
Note:
- The CSM has advised prescribers to be alert for symptoms and signs suggestive of bone-marrow failure such as anaemia, bruising or infection.
Levetiracetam (Amber 3) (MHRA Category 3)
- Tablets 250mg, 500mg, 750mg, 1g
- Oral solution 100mg/mL
- Intravenous infusion 100mg/mL (Hosp only)
Oxcarbazepine (Amber 3) (MHRA Category 2)
- Tablets f/c 150mg, 300mg, 600mg
- Trileptal® Oral Suspension 60mg/mL
Perampanel (Amber 3) (MHRA Category 2)
- Tablets f/c 2mg, 4mg, 6mg, 8mg, 10mg, 12mg
Notes:
1. Perampanel is licensed and anticipated to be used as a 2nd line adjunctive therapy after adjunctive administration of topiramate, levetiracetam, and other formulary antiepileptic drugs, where the patient has still not achieved adequate seizure control. (This means it will be used after 3 or 4 other agents)
2. Perampanel should be initiated in secondary care by: (1) Consultant Neurologist (2) Consultant Paediatrician with a special interest in epilepsy in line with common practice and the manufacturer’s advice.
3. Secondary Care will provide initial supply and continue to supply until the patient is stabilised on a maintenance. Subsequent to this, the GP will be advised in writing of the required dose and will be asked to take over prescribing.
Phenytoin (Amber 2) (MHRA Category 1)
- Capsules 25mg, 50mg, 100mg, 300mg
- Chewable tablets 50mg
- Suspension 30mg in 5mL
Notes:
- Tablets are not included in the formulary as they are more than 10 times more expensive than the capsules.
- Phenytoin has a narrow therapeutic index and the relationship between dose and plasma concentration is non-linear; a small dose increase in some patients may produce large rises in plasma concentration with acute toxic side effects.
- On the basis of single dose tests, there are no clinically relevant differences in bioavailablity between available phenytoin sodium tablets and capsules, but there may be a pharmacokinetic basis for maintaining the same brand in some patients.
- 90mg of phenytoin suspension is considered to be equivalent to 100mg of phenytoin sodium (capsules or tablets), so care is needed if patients are transferred from one preparation to another.
Primidone (Amber 2) (MHRA Category 1)
- Tablet 50mg, 250mg
Valproate
Sodium Valproate (Amber 2) (MHRA Category 2)
- Crushable tablets 100mg
- E/C tablets 200mg, 500mg
- Episenta® Modified Release capsules 150mg, 300mg (More cost effective than m/r tablets)
- Epilim Chrono® Modified Release tablets 200mg, 300mg, 500mg
- Oral solution sugar Free 200mg in 5mL
- Intravenous injection 400mg (Hospital only)
Notes:
- Guidance for prescribers. Withdrawal of, and alternatives to, valproate-containing medicines in girls and women of childbearing potential who have a psychiactric illness (Dec 2018)
- MHRA Guidance. Valproate use by women and girls (March 2018)
- MHRA Drug Safety Update (December 2018) Valproate medicines: are you in acting in compliance with the pregnancy prevention measures?
- MHRA Drug Safety Update (September 2018) Valproate Pregnancy Prevention Programme: actions required now from GPs, specialists, and dispensers
- MHRA Drug Safety Update (May 2018) Valproate medicines (Epilim▼, Depakote▼): Pregnancy Prevention Programme materials online
- MHRA Drug Safety Update (April 2018) Valproate medicines (Epilim▼, Depakote▼): contraindicated in women and girls of childbearing potential unless conditions of Pregnancy Prevention Programme are met
Topiramate (Amber 2) (MHRA Category 2)
- Tablets 25mg
- Tablets 50mg
- Tablets 100mg
- Tablets 200mg
- Capsules 15mg
- Capsules 25mg
- Capsules 50mg
Vigabatrin (MHRA Category 3)
- Tablets 500mg
- Oral powder sachet 500mg
Management of epilepsy in pregnancy:
- All women of child bearing potential should be offered folic acid 5mg per day with their AED treatment.
- Doses of AEDs should not be increased routinely in pregnancy but should only be adjusted on clinical grounds. The usual oral dose of AED medication should be continued during labour and post-natally. In women unable to tolerate oral medicine AEDs can be given by other routes.
Barbiturates
Phenobarbital CD (Amber 1) (MHRA Category 1)
- Tablets 15mg, 30mg, 60mg
- Elixir 15mg in 5mL
- Intravenous injection 30mg/mL, 200mg/mL
Benzodiazepines
Clobazam (Amber 2) (MHRA Category 2)
- Tablets 10mg
Note:
- NHS Restriction - Clobazam is not prescribable under the NHS exept for epilepsy and endorsed 'SLS'
Clonazepam (Amber 2) (MHRA Category 2)
- Tablet 500microgram, 2mg
- Intravenous injection 1mg/mL or infusion of 1mg
4.6.2 Status epilepticus
Barbiturates
Phenobarbital CD (Amber 1) (MHRA Category 1)
- As above
Benzodiazepines
Diazepam
- Tablets 2mg, 5mg, 10mg
- Solution for injection 10mg/2ml
- Oral suspension2mg/5ml
- Oral solution 2mg/5ml
- Enema 2.5mg tubes, 5mg tubes, 10mg tubes
Lorazepam
- Tablets 1mg, 2.5mg
Lorazepam
- Intravenous injection 4mg in 1mL (Hospital only)
Notes:
- Pfizer, the sole licensed UK supplier of Ativan (lorazepam 4mg/ml injection), are experiencing supply issues and there may be limited supply and stock restrictions until late October 2018.
Midazolam
Important notice
- There are two formulations of buccal midazolam
- Always prescribe by brand to ensure that the correct product is supplied.
- There is a high risk of harm if patients receive the incorrect brand and strength of buccal midazolam.
- The products (Buccolam and Epistatus below) are not interchangeable:
Buccolam® (Amber 1)
- Oromucosal solution - midazolam (as hydrochloride) 5 mg/mL
- 2.5mg in 0.5ml prefilled oral syringe
- 5 mg in 1ml prefillled oral syringe
- 7.5 mg in 1.5ml prefilled oral syringe
- 10 mg in 2ml prefilled oral syringe.
Notes:
Click here for information on how to administer Buccolam solution
Epistatus®
- Buccal solution - midazolam (as maleate) 10mg/mL
- oromucosal soln in prefilled oral syringe
Note:
- For use in hospital emergency trays only
Others
Everolimus
- Votubia 2.5mg, 5mg, 10mg
- Votubia dispersible 2mg, 3mg, 5mg
Notes:
- Use as per Clinical Commissioning Policy:Everolimus for refractory focal onset seizures associated with tuberous sclerosis complex (ages 2 years and above) Dec 2018
- Use must be registered on the Blueteq system and use is only via a shared care agreement with Nottingham University Hospitals
Traffic light status (TLS) explained:
- Green: Routine prescribing within licensed indication
- Amber 1: specialist recommendation followed by GP initiation and continuation
- Amber 2: specialist or GP initiation in line with local guideline after 1st line failure followed by GP continuation
- Amber 3: specialist initiation and stabilisation followed by GP continuation
- Amber SCG: specialist initiation and stabilisation followed by GP continuation in line with an agreed shared care guideline
- Red: Hospital or specialist prescribing only
Return to Chapter: 4. Nervous System
Last updated by: Sheila Wood on 05-06-2019 15:45
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BNF
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NICE
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Summary of product characteristics
