4.8.1 Control of epilepsy |
|
All patients with epilepsy need specialist assessment, generally before therapy is started. Use of newer agents should follow NICE |
guidance. |
|
Updated advice on brand prescribing in the treatment of epilepsy (Nov 2013)/Drug Safety Update November 2017 |
The Medicines and Healthcare Products Regulatory Agency (MHRA) has issued new guidance to prescribers, pharmacists and |
patients in relation to anti-epileptic drugs (AEDs). This follows a review by the Commission on Human Medicines (CHM) which |
looked at the evidence on patients switching between different manufacturers' products of particular AEDs. CHM concluded that |
whilst there was no clear evidence of harm associated with switching products, an effect in some drugs, for some drugs, could not |
be completely ruled out. |
The potential effects of switching may include a loss of seizure control or the occurrence of side effects, or both. These risks can |
be associated with switching between a branded originator and a generic product, and between different generic products. |
CHM advised that AEDs could be classified into three categories. These categories aim to help prescribers and patients whether it |
is necessary to maintain continuity of supply of a specific manufacturer's product |
|
Category 1 |
For these drugs doctors are advised to ensure that their patient is maintained on a specific manufacturer's product. |
The AEDs in this category are: phenytoin, carbamazepine, phenobarbital, primidone |
|
Category 2 |
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. |
The AEDs in this category are: valproate, lamotrigine, perampanel, retigabine, rufinamide, clobazam, clonazepam, |
oxcarbazepine, eslicarbazepine, zonisamide, topiramate. |
|
Category 3 |
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. |
The AEDs in this category are: levetiracetam, lacosamide, tigabine, gabapentin, pregabalin, ethosuximide, vigabatrin |
|
When evaluating whether continuity of supply should be maintained for category 2 or 3 medicines, it would be appropriate to |
consider: |
> perception by patients of differences in supply, for example differences in product presentations |
> co-morbid autism, mental health issues or special education needs. |
|
It is clinically appropriate to maintain an individual on a specific manufacturers' product, prescribe either by specifying brand |
name or by using the generic drug name and name of manufacturer. |
|
The newer antiepileptic drugs gabapentin, lamotrigine, levetiracetam, topiramate and zonisamide, within their licensed |
indications, are recommended for the management of epilepsy in people who have not benefited from treatment with the |
older antiepileptic drugs such as carbamazepine or sodium valproate, or for whom the older antiepileptic drugs are |
unsuitable because: |
> there are contraindications to the drugs |
> they could interact with other drugs the person is taking (notably oral contraceptives) |
> they are already known to be poorly tolerated by the individual |
> the person is a woman of childbearing potential |
|
Careful adjustment of dose is needed, starting low and increasing gradually until seizures are controlled or there are adverse |
effects. therapy with two or more antiepileptics concurrently should only be used when monotherapy with several alternative |
drugs has proved ineffective. |
|
Sodium Valproate - Risk of abnormal pregnancy outcomes- MHRA alert Jan 2015 |
https://www.gov.uk/drug-safety-update/medicines-related-to-valproate-risk-of-abnormal-pregnancy-outcomes |
Link to Valproate Safety Implementation Group (VSIG) |
[link to resources and recent updates] |
Valproate is associated with a dose-dependent risk of abnormal pregnancy outcomes, whether taken alone or in combination |
with other medicines. Data suggest that when valproate is taken for epilepsy with other medicines, the risk of abnormal |
pregnancy outcomes is greater than when valproate is taken alone. |
The risk of congenital malformations is approximately 10 % while studies in preschool children exposed in utero to valproate |
show that up to 30-40% experience delays in their early development. |
Given these risks, valproate for the treatment of epilepsy or bipolar disorder should not be used during pregnancy and in |
women of child-bearing potential unless clearly necessary ie in situations where other treatments are ineffective or not |
tolerated. |
|
Carefully balance the benefits of valproate treatment against the risks when prescribing valproate for the first time, at routine |
treatment reviews, when a female child reaches puberty and when a woman plans a pregnancy or becomes pregnant. If you |
decide to prescribe valproate to a woman of child-bearing potential, she must use effective contraception during treatment |
and be fully informed of the risks for the unborn child if she becomes pregnant during treatment with valproate. |
|
Older anti-epileptics |
AMBER Carbamazepine (Tegretol®) |
tablets 100mg, 200mg, 400mg to reach stable dose |
then convert to tablets m/r 200mg, 400mg |
liquid 100mg/5mL |
suppositories 125 mg |
AMBER Clobazam (only for epilepsy, endorse script SLS) : |
tablets 10mg |
AMBER Clonazepam (Rivotril®) tablets 500mcg |
Clonazepam 0.5mg/5mL oral suspension (Rosemont) |
AMBER Ethosuximide capsules 250mg (Epesri®) [PRESCRIBE BY BRAND] |
oral syrup 250mg/5mL (Emeside®) [paediatric use only] [PRESCRIBE BY BRAND] |
AMBER Phenytoin (Epanutin®) : |
tablets chewable 50mg |
suspension 30mg/5mL |
AMBER Phenytoin Sodium (Flynn Hardcaps®) |
capsules 25mg, 50mg, 100mg |
AMBER Sodium valproate (Epilim®) |
tablets e/c 200mg, 500mg |
tablets m/r 200mg, 300mg, 500mg |
tablets crushable 100mg |
liquid 200 mg/5mL |
RED Sodium Valproate injection 400mg |
|
Episenta® |
Episenta® capsules (prolonged release sodium valproate) are also available for use, and are especially helpful for those patients |
with swallowing difficulties. They are given once daily as capsules or sachets which can be opened and put on soft food if |
required, without chewing. Like other valproate preparations when used for epilepsy, they should be prescribed by brand name. |
AMBER Sodium valproate (Episenta ® ) : capsules m/r 150mg, 300mg |
AMBER Phenobarbital tablets 15mg, 30mg, 60mg |
RED Phenobarbital elixir [all strengths] |
|
Newer anti-epileptics |
AMBER Gabapentin Capsules 100mg, 300mg, 400mg |
AMBER Lamotrigine tablets 25mg, 50mg, 100mg |
AMBER Lamotrigine chewable/dispersible tablets 2mg, 5mg, 25mg,100mg (paediatric use only) |
AMBER Levetiracetam (prescribe generically): |
tablets 250mg, 500mg, 1g |
oral solution (sugar free) 100mg/mlL |
RED Levetiracetam Conc for solution for injection 500mg/5ml [Keppra®] [Epilepsy] |
AMBER Levetiracetam Conc for solution for injection 500mg/5ml [Keppra®] Specialist Palliative Care use |
A list of Community Pharmacies who stock specialist palliative care drugs can be accessed here |
AMBER Topiramate [generic prescribing only] |
tablets 25mg, 50mg, 100mg, 200mg |
sprinkle capsules 15mg, 25mg, 50mg |
Topiramate oral suspension 20mg/mL - paediatric use only [Rosemont pharmaceuticals] |
AMBER Zonisamide (Zonegran®) |
capsules 25mg, 50mg, 100mg |
AMBER Zonisamide oral solution 100mg/5mL [paediatric use only] |
AMBER Lacosamide (Vimpat®): |
tablets 50mg, 100mg, 150mg 200mg |
syrup 10mg/mL |
RED Lacosamide Intravenous infusion 10mg/mL |
AMBER Oxcarbazepine (Trileptal®) |
tablets f/c 150mg . 300mg, 400mg |
suspension 300mg/5mL |
|
Brivaracetam |
Adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adult, adolescent and |
children from 4 years of age with epilepsy. |
AMBER Brivaracetam (Briviact®) |
tablets 10mg, 25mg, 50mg, 75mg, 100mg |
AMBER Brivaracetam (Briviact®) |
oral solution 10mg/1ml Please note: Unlicensed use in children under the age of 4 years - initiated on advise of specialist or tertiary centre. |
RED Brivaracetam (Briviact®) |
tablets 10mg, 25mg, 50mg, 75mg, 100mg |
RED Brivaracetam (Briviact®) |
oral solution 10mg/1ml |
|
RED Cannabidiol with clobazam [Epidyolex®] |
NICE TA614 - Cannabidiol with clobazam is recommended as an option for treating seizures associated with Dravet syndrome in people aged 2 years and older, only if: |
> the frequency of convulsive seizures is checked every 6 months, and cannabidiol is topped if the frequency has not |
fallen by at least 30% compared with the 6 months before starting treatment. |
> the company provides cannabidiol according to the commercial arrangement NHS England Commisioned |
|
NICE TA615 - Cannabidiol with clobazam is recommended as an option for treating seizures associated with Lennox-Gastaut syndrome in people aged 2 years and older, only if: |
> the frequency of drop seizures is checked every 6 months, and cannabidiol is stopped if the frequency has not |
fallen by at least 30%compared with the 6 months before starting treatment |
> the company provides cannabidiol according to the commercial arrangement NHS England Commisioned |
RED Cenobamate [Ontozry®: tablets 100mg, 150mg, 25mg, 50mg] |
NICE TA753 Recommended as an option for treating focal onset seizures with or without secondary seizures in adults with |
drug-resistant epilepsy that has not been adequately controlled with at least w anti-seizure medicines. It is only |
recommended if: |
> it is used as an add-on treatment, after at least 1 other add-on treatment has not controlled seizures, and |
> treatment is started in a tertiary epilepsy service |
Eslicarbazepine actetate |
|
For adjunctive therapy in adults with focal (partial onset) seizures with or without secondary generalisation, only for refractory |
patients in whom standard adjunctive treatment is inefffective or not tolerated. Treatment should only be considered following |
referral to or discussion with a tertiary care specialist. |
AMBER Eslicarbazepine acetate (Zebininx®) |
tablets 800mg |
|
Perampanel |
For use only as an option when other treatment options recommended by NICE CG137 have been tried or fully considered in the |
treatment of partial-onset seizures with or without secondarily generalised seizures in people with epilepsy aged 12 years and |
over. |
AMBER Perampanel (Fycompa®) |
tablets f/c 2 mg, 4 mg, 6 mg, 8 mg,10 mg, 12 mg |
|
Rufinamide |
Rufinamide should only be initiated or recommended by a specialist in the management of Lennox-Gastaut Syndrome (LGS) and |
other forms of epilepsy, after which prescribing may be passed to the primary care prescriber. Adequate advice on dose titration |
should be provided in every case. It should be used as a fourth line adjunctive therapy, usually in a combination with one or |
more of the following medicines; sodium valproate (unlicensed), topiramate or lamotrigine. |
Women of child-bearing potential taking rufinamide should be advised to use two forms of safe and effective contraception. |
Hypersensitivity syndrome - Serious hypersensitivity syndrome has developed especially in children and upon initiation of |
therapy; consider withdrawal if rash or signs or symptoms of hypersensitivity syndrome develop. Warn patients to seek immediate medical attention if signs or symptoms of hypersensitivity develop. |
AMBER Rufinamide (Inovelon®) |
tablets 100mg, 200mg, 400mg |
|
Infantile Spasms |
AMBER Vigabatrin sachets 500mg |
|
Stiripentol to treating Dravet Syndrome in combination with Sodium Valproate and clobazam. For use under specialist advice only |
RED Stiripentol (Diacomit®) |
250mg, 500mg capsules |
|
Stirpentol as adjunctive therapy of refractory generalised tonic-clonic seizures in patients over the age of 18 years who were |
previously diagnosed with severe myoclonic epilepsy in infancy (Dravet syndrome) whose seizures are not adequately controlled |
with clobazam and valproate. |
RED* Stiripentol (Diacomit®) |
250mg, 500mg capsules |
* Red Traffic Light (for all ages) for continuation of treatment of patients who have previously received the drug during childhood |
under the NHSE standard contract for paediatric neurosciences - neurology. |
NOT to be newly initiated in adults. |
Medicine to be supplied by the hospital for the duration of the treatment course. |
Primary care initiation or continuation of treatment is not recommended. |
|
Fenfluramine for treating seizures associated with Dravet syndrome |
NICE TA808 Fenfluramine is recommended as an add-on to other ant-seizure medicines for treating seizures associated with |
Dravet syndrome in people aged 2 years and older, only if: |
> seizures have not been controlled after trying 2 or more antiseizure medicines |
> the frequency of convulsive seizures is checked every 6 months, and fenfluramine is stopped if it has not fallen by |
at least 30% compared with the 6 months before starting treatment |
> the company provides fenfluramine according to the commercial arrangement. |
RED Fenfluramine [Fintepla] 2.2mg/mL oral solution |
NHS England Commissioned |
|
4.8.2 Drugs used in status epilepticus |
Guidelines for the management of status epilepticus - see Appendix 2 |
Lorazepam is the drug of choice for initial use. |
RED Clonazepam (specialist use) |
injection 1mg/1mL |
GREEN Diazepam |
injection (emulsion) 5mg/mL |
rectal tubes 5mg, 10mg |
RED Lorazepam injection 4mg/mL |
AMBER Midazolam buccal liquid 5mg/mL (Buccolam®) (prefilled oral syringes) |
AMBER *Midazolam maleate oromucosal solution 10mg/mL (Epistatus®) Pre-filled syringe [1mL] |
*(licensed for use in children and adolescents aged 10 to less than 18 years) |
|
Transfer to new Licensed Buccal Midazolam 5mg/ml (Buccolam▼): Guidance for Practitioners is available here |
|
RED Paraldehyde injection (intramuscular or rectal use) |
RED Phenytoin sodium injection 250mg/5mL |
|
|
|
All material in this section is aimed at health care professionals, but is information currently held in the public domain, members of the |
public seeking advice on medicine-related matters are advised to speak with their GP, pharmacist, nurse or contact NHS111 Service |
Email: info.elmmb@nhs.net |
|
Copyright© 2016 - 2020 East Lancashire Medicines Management Board |
All rights reserved. Disclaimer/Terms and conditions |
|
|
|
|
|
|
|
|
|
|
|
|