| 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
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| guidance. |
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Updated advice on brand prescribing in the treatment of epilepsy (Nov 2013)/Drug Safety Update November 2017
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The Medicines and Healthcare Products Regulatory Agency (MHRA) has issued new guidance to prescribers, pharmacists
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| 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,
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| 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.
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| 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. |
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Category 1
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For these drugs doctors are advised to ensure that their patient is maintained on a specific manufacturer's product.
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The AEDs in this category are: phenytoin, carbamazepine, phenobarbital, primidone
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Category 2
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For these drugs the need for continued supply of a particular manufacturer's product should be based on clinical judgement and
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| 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,
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| clonazepam, oxcarbazepine, eslicarbazepine, zonisamide, topiramate. |
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Category 3
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For these drugs it is usually unnecessary to ensure that patients are maintained on a specific manufacturer's product unless there
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are specific concerns such as patient anxiety, and risk of confusion or dosing errors.
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The AEDs in this category are: levetiracetam, lacosamide, tigabine, gabapentin, pregabalin, ethosuximide, vigabatrin
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When evaluating whether continuity of supply should be maintained for category 2 or 3 medicines, it would be appropriate to
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| 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
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| name or by using the generic drug name and name of manufacturer. |
The newer antiepileptic drugs gabapentin, lamotrigine, levetiracetam, topiramate and zonisamide, within their
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| 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
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| adverse effects. therapy with two or more antiepileptics concurrently should only be used when monotherapy with several |
| alternative drugs has proved ineffective. |
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Sodium Valproate - Risk of abnormal pregnancy outcomes- MHRA alert Jan 2015
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https://www.gov.uk/drug-safety-update/medicines-related-to-valproate-risk-of-abnormal-pregnancy-outcomes
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| 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
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| 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
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in women of child-bearing potential unless clearly necessary ie in situations where other treatments are ineffective or
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| not tolerated. |
Carefully balance the benefits of valproate treatment against the risks when prescribing valproate for the first time, at
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| 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
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| treatment and be fully informed of the risks for the unborn child if she becomes pregnant during treatment with valproate. |
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Older anti-epileptics
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AMBER Carbamazepine (Tegretol®)
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| 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) :
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| tablets 10mg |
AMBER Clonazepam (Rivotril®) tablets 500mcg
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| Clonazepam 0.5mg/5mL oral suspension (Rosemont) |
AMBER Ethosuximide capsules 250mg (Epesri®) [PRESCRIBE BY BRAND]
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| oral syrup 250mg/5mL (Emeside®) [paediatric use only] [PRESCRIBE BY BRAND] |
AMBER Phenytoin (Epanutin®) :
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| tablets chewable 50mg |
| suspension 30mg/5mL |
AMBER Phenytoin Sodium (Flynn Hardcaps®)
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| capsules 25mg, 50mg, 100mg |
AMBER Sodium valproate (Epilim®)
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| tablets e/c 200mg, 500mg |
| tablets m/r 200mg, 300mg, 500mg |
| tablets crushable 100mg |
| liquid 200 mg/5mL |
RED Sodium Valproate injection 400mg
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Episenta®
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Episenta® capsules (prolonged release sodium valproate) are also available for use, and are especially helpful for those
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| 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.
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Like other valproate preparations when used for epilepsy, they should be prescribed by brand name.
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AMBER Sodium valproate (Episenta ® ) : capsules m/r 150mg, 300mg
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AMBER Phenobarbital tablets 15mg, 30mg, 60mg
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| RED Phenobarbital elixir [all strengths] |
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Newer anti-epileptics
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AMBER Gabapentin Capsules 100mg, 300mg, 400mg
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AMBER Lamotrigine tablets 25mg, 50mg, 100mg
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| AMBER Lamotrigine chewable/dispersible tablets 2mg, 5mg, 25mg,100mg (paediatric use only) |
AMBER Levetiracetam (prescribe generically):
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| tablets 250mg, 500mg, 1g |
| oral solution (sugar free) 100mg/mlL |
| See Levetiracetam (Keppra) prescribing - bioequivalence and antiepileptic drugs Position Statement |
| |
| 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
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| A list of Community Pharmacies who stock specialist palliative care drugs can be accessed here |
AMBER Topiramate [generic prescribing only]
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| tablets 25mg, 50mg, 100mg, 200mg |
| sprinkle capsules 15mg, 25mg, 50mg |
Topiramate oral suspension 20mg/mL - paediatric use only [Rosemont pharmaceuticals]
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AMBER Zonisamide (Zonegran®)
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| capsules 25mg, 50mg, 100mg |
| AMBER Zonisamide oral solution 100mg/5mL [paediatric use only] |
AMBER Lacosamide (Vimpat®):
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| tablets 50mg, 100mg, 150mg 200mg |
| syrup 10mg/mL |
RED Lacosamide Intravenous infusion 10mg/mL
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AMBER Oxcarbazepine (Trileptal®)
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| tablets f/c 150mg . 300mg, 400mg |
| suspension 300mg/5mL |
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Brivaracetam
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Adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adult, adolescent and
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children from 4 years of age with epilepsy.
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AMBER Brivaracetam (Briviact®)
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| tablets 10mg, 25mg, 50mg, 75mg, 100mg |
AMBER Brivaracetam (Briviact®)
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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®)
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| tablets 10mg, 25mg, 50mg, 75mg, 100mg |
RED Brivaracetam (Briviact®)
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| oral solution 10mg/1ml |
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Back to Main chapter
RED Cannabidiol with clobazam [Epidyolex®] |
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| 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 Commissioned |
NICE TA615 - Cannabidiol with clobazam is recommended as an option for treating seizures associated with Lennox-Gastaut
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| 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 Commissioned |
AMBER Cenobamate [Ontozry®: tablets 100mg, 150mg, 25mg, 50mg] ICS Commissioned
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| 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 |
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RED Cannabidiol [Epidyolex®] NHS England Commissioned |
| NICE TA873 Cannabidiol is recommended as an add-on treatment option for seizures caused by tuberous sclerosis complex in people aged 2 years and over, only if: |
| > their seizures are not controlled well enough by 2 or more antiseizure medications (either used alone or in |
combination) or these treatments were not tolerated
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| > seizure frequency 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
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| > the company provides cannabidiol according to the commercial arrangement. |
Eslicarbazepine actetate
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For adjunctive therapy in adults with focal (partial onset) seizures with or without secondary generalisation, only for
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| 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®)
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| tablets 800mg |
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Perampanel
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For use only as an option when other treatment options recommended by NICE NG217 have been tried or fully considered in
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| the treatment of partial-onset seizures with or without secondarily generalised seizures in people with epilepsy aged 12 years |
| and over. |
AMBER Perampanel (Fycompa®)
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| tablets f/c 2 mg, 4 mg, 6 mg, 8 mg,10 mg, 12 mg |
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Rufinamide
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Rufinamide should only be initiated or recommended by a specialist in the management of Lennox-Gastaut Syndrome (LGS) and
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| 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
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| 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
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| 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®)
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| tablets 100mg, 200mg, 400mg |
| liquid 40mg/mL oral suspension (Inovelon®) - Paediatrics use only |
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| Back to Main chapter |
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Infantile Spasms
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AMBER Vigabatrin sachets 500mg
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Stiripentol to treating Dravet Syndrome in combination with Sodium Valproate and clobazam. For use under specialist advice only
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RED Stiripentol (Diacomit®)
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| 250mg, 500mg capsules |
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| 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 |
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| Back to Main chapter |
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| 4.8.2 Drugs used in status epilepticus |
Guidelines for the management of status epilepticus - see Appendix 2
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Lorazepam is the drug of choice for initial use.
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RED Clonazepam (specialist use)
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| injection 1mg/1mL |
GREEN Diazepam
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| 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) |
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Transfer to new Licensed Buccal Midazolam 5mg/ml (Buccolam▼): Guidance for Practitioners is available here
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RED Paraldehyde injection (intramuscular or rectal use)
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RED Phenytoin sodium injection 250mg/5mL
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| Back to Main chapter |
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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
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Email: info.elmmb@nhs.net
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