Related guidance:
Epilepsy: treatment during pregnancy (SPS January 2022, updated December 2022)
Downloadable Factsheets (Epilepsy Society)
- Category 1 – Carbamazepine, Phenobarbital, Phenytoin, Primidone – Ensure that the patient is maintained on a specific manufacturer’s product.
- Category 2 – Clobazam, Clonazepam, Eslicarbazepine, Lamotrigine, Oxcarbazepine, Perampanel, Retigabine, Rufinamide, Topiramate, Valproate, Zonisamide – Base the need for continued supply of a particular manufacturer’s product on clinical judgement and consultation with patient and/or carer, taking into account factors such as seizure frequency and treatment history. Take into account patient/carer-related factors such as their negative perceptions about alternative products and/or other issues related to the patient should also be taken into account.
- Category 3 – Brivaracetam, Ethosuximide, Gabapentin, Lacosamide, Levetiracetam, Pregabalin, Tiagabine, Vigabatrin – 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.
- Not for use in pregnancy unless there is no effective alternative.
Medicines related to valproate: risk of abnormal pregnancy outcomes (MHRA January 2015)
- Children exposed in utero to valproate are at a high risk of serious developmental disorders (in up to 30-40% of cases) and/or congenital malformations (in approximately 10% of cases).
Valproate and risk of abnormal pregnancy outcomes: new communication materials (MHRA February 2016)
- Children exposed to valproate in utero are at high risk of developmental disorders and congenital malformations. Use the new communication materials below to discuss these risks with patients
Update on MHRA review into safe use of valproate (MHRA December 2022)
- No one should stop taking valproate without advice from their healthcare professional.
- Valproate is approved in the UK to treat epilepsy and bipolar disorder. Because of the known risk of birth defects and neurodevelopmental disorders following use of valproate in pregnancy, valproate should only be used in women of child-bearing potential if a Pregnancy Prevention Programme is in place, which includes a requirement to use effective contraception. Valproate should not be used in female children and women of childbearing potential unless other treatments are ineffective or not tolerated.
- The Commission on Human Medicines (CHM) has advised that no one under the age of 55 should be initiated on valproate unless two specialists independently consider and document that there is no other effective or tolerated treatment. Where possible, existing patients should be switched to another treatment unless two specialists independently consider and document that there is no other effective or tolerated treatment or the risks do not apply.
Safety of valproate – new study on risks in children of men taking valproate (MHRA August 2023)
- No action is currently needed from patients. No one should stop taking valproate without advice from their healthcare professional.
Collection Valproate safety measures (MHRA November 2023)
- Collection of information and guidance for patients and for healthcare professionals on the reproductive risks of valproate and new safety measures introduced to reduce these risks.
- Ask patients to attend any offered appointments to discuss their treatment plan and to talk to a healthcare professional if they are concerned.
- Ask clinicians to discuss the current warnings and upcoming measures relating to valproate with their patients and consider together how it affects the patient’s individual circumstances.
- No one should stop taking valproate without advice from a specialist. This is because epilepsy or bipolar disorder may become worse without treatment, which can be harmful.
- Other effective medicines are available for epilepsy and bipolar disorder and valproate should only be used if these don’t work or aren’t suitable for an individual patient.
- From January 2024, valproate must not be started in new patients (male or female) younger than 55 years, unless two specialists independently consider and document that there is no other effective or tolerated treatment, or unless there are compelling reasons that the reproductive risks do not apply. For the majority of patients, other effective treatment options are available.
- All women who could become pregnant and girls who are currently taking valproate will be reviewed at their next annual specialist review, using a revised valproate Annual Risk Acknowledgement Form, which will include the need for a second opinion’s signature if the patient is to continue with valproate.
- A similar system will be introduced later in 2024 for male patients currently taking valproate. This follows advice from an independent expert group of the Commission on Human Medicines, with representation from across the healthcare system, that the measures should be introduced in a phased manner to ensure ongoing patient care is not disrupted.
MHRA update on new study on risk in children born to men taking valproate (MHRA January 2024)
- The new safety measures being introduced in UK are for male and female patients.
- As a precaution, male patients on valproate who are planning a family in the next year should talk to their healthcare professional about their treatment.
- New safety and educational materials have been introduced for men and women and healthcare professionals to reduce the harms from valproate, including the significant risk of serious harm to the baby if taken during pregnancy and the risk of impaired fertility in males.
NHS Somerset Contraception formulary
NHS Somerset Contraception website
NHS Somerset Medicines used in pregnancy website
Antiepileptics: risk of suicidal thoughts and behaviour (MHRA December 2014)
- Antiepileptic treatment is associated with a small risk of suicidal thoughts and behaviour; available data suggest that the increased risk applies to all antiepileptics and is seen as early as 1 week after starting treatment.
- Patients should be alert to any mood changes, distressing thoughts, or feelings about suicide or harming themselves at any point during treatment -they should be advised to seek medical advice if they develop such thoughts or behaviour, and should be referred for appropriate treatment if necessary.
- The available evidence does not define whether the risk of suicidal thoughts and behaviour differs between antiepileptics – patients should not stop or switch treatment on the basis of this information and without speaking to a healthcare professional.
Antiepileptics: adverse effects on bone (MHRA December 2014)
- Data suggests that long-term use of carbamazepine, phenytoin, primidone, and sodium valproate is associated with decreased bone mineral density that may lead to osteopenia, osteoporosis, and increased fractures.
Vitamin D supplementation alone or with calcium does not reduce fracture incidence among community-dwelling adults without known vitamin D deficiency, osteoporosis, or prior fracture.
Bisphosphonates remain first line treatment option for people with osteoporosis or high risk of fractures.
NHS Somerset have approved the use of Bisphosphonates (off-label) to address significant unmet need for people with high risk of fracture such as those with a diagnosis of osteopenia.
NHS Somerset Bone metabolism disorders
NHS Somerset classify all drugs for epilepsy as Amber (initiated by specialist only) except cannabidiol and fenfluramine which are Red.
Epilepsies in children, young people and adults NICE guideline (NG217 April 2022)
Monitoring and review
- Arrange regular (at least annual) monitoring reviews for adults with epilepsy and any of the following:
• a learning disability
• drug-resistant epilepsy
• a high risk of sudden unexpected death in epilepsy
• a serious comorbidity, such as complex psychosocial, cognitive or mental health problems
• who are taking antiseizure medications associated with long-term side effects or drug interactions
• who are able to get pregnant and are taking valproate or any other high-risk teratogenic antiseizure medication. - Discuss monitoring reviews with children and young people with epilepsy and their families and carers if appropriate, and agree a frequency for regular reviews that is:
• individually tailored to the child or young person’s needs, preferences and the nature of their epilepsy and
• at least every 12 months. - Consider monitoring antiseizure medication levels in people with epilepsy and any of the following:
• uncontrolled seizures
• side effects from their medication
• a specific clinical condition needing closer supervision (such as pregnancy or renal failure)
• poor adherence to medication. - Explain to people with epilepsy and, if appropriate, their families and carers, that they can ask for a review of their care if they have concerns, need support or their care needs change, for example, to support medicines withdrawal, pregnancy planning or to review treatment if seizures recur. Provide contact details and information on how to access epilepsy services.
Discontinuing antiseizure medication
- For further guidance on managing withdrawal of benzodiazepines and gabapentinoids see
Generalised tonic-clonic seizures
- Offer sodium valproate as first line monotherapy for generalised tonic-clonic seizures in:
• boys and men
• girls aged under 10 years and who are unlikely to need treatment when they are old enough to have children
• women who are unable to have children. - Offer lamotrigine or levetiracetam as first line monotherapy for generalised tonic-clonic seizures in women and girls able to have children (including young girls who are likely to need treatment when they are old enough to have children). If the first choice is unsuccessful, offer the other of these options (off-label uses of lamotrigine in children under 13 years and levetiracetam in adults and children).
- If first line monotherapy with sodium valproate is unsuccessful for generalised tonic-clonic seizures, offer lamotrigine or levetiracetam as second-line monotherapy treatment. If the first choice is unsuccessful, try the other of these options (off-label uses of lamotrigine in children under 13 years and levetiracetam in adults and children).
- Do not offer sodium valproate monotherapy for generalised tonic-clonic seizures in women and girls able to have children (including young girls who are likely to need treatment when they are old enough to have children), unless:
• other treatment options are unsuccessful
• the risks and benefits have been fully discussed, including the risks to an unborn child
• the likelihood of pregnancy has been taken into account and a pregnancy prevention programme put in place, if appropriate. - If monotherapy is unsuccessful in people with generalised tonic-clonic seizures, consider 1 of the following first line add-on treatment options:
• clobazam
• lamotrigine
• levetiracetam
• perampanel
• sodium valproate, except in women and girls able to have children
• topiramate. - If the first choice is unsuccessful, consider the other first line add-on options (off-label uses of clobazam as add-on therapy in children under 6 months, lamotrigine in children under 2 years, levetiracetam in children under 12 years, perampanel in children under 7 years, and topiramate in children under 2 years).
- If first line add-on treatments tried are unsuccessful in people with generalised tonic-clonic seizures, consider 1 of the following second-line add-on treatment options:
• brivaracetam
• lacosamide
• phenobarbital
• primidone
• zonisamide. - If the first choice is unsuccessful, consider the other second line add-on options (off-label uses of brivaracetam in adults and children, lacosamide in children under 4 years, and zonisamide in adults and children).
- Do not offer sodium valproate as an add-on treatment for generalised tonic-clonic seizures in women and girls able to have children (including young girls who are likely to need treatment when they are old enough to have children), unless:
• other treatment options are unsuccessful
• the risks and benefits have been fully discussed, including the risks to an unborn child
• the likelihood of pregnancy has been taken into account and a pregnancy prevention programme put in place, if appropriate. - Be aware that the following antiseizure medications may exacerbate seizures in people with absence or myoclonic seizures, including in juvenile myoclonic epilepsy:
• carbamazepine
• gabapentin
• lamotrigine (for myoclonic seizures)
• oxcarbazepine
• phenytoin
• pregabalin
• tiagabine
• vigabatrin.
Focal seizures with or without evolution to bilateral tonic-clonic seizures
- Consider lamotrigine or levetiracetam as first line monotherapy for people with focal seizures. If the first choice is unsuccessful, consider the other of these options (off-label uses of lamotrigine in children under 13 years, and levetiracetam in children and young people under 16 years).
- If first line monotherapies are unsuccessful in people with focal seizures, consider 1 of the following second-line monotherapy options:
• carbamazepine
• oxcarbazepine
• zonisamide. - If the first choice is unsuccessful, consider the other second line monotherapy options (off-label uses of oxcarbazepine in children under 6 years, and zonisamide in children).
- If second line monotherapies tried are unsuccessful in people with focal seizures, consider lacosamide as third line monotherapy (off-label use of lacosamide in children under 4 years).
- If monotherapy is unsuccessful in people with focal seizures, consider 1 of the following first line add-on treatment options:
• carbamazepine
• lacosamide
• lamotrigine
• levetiracetam
• oxcarbazepine
• topiramate
• zonisamide. - If the first choice is unsuccessful, consider the other first line add-on options (off-label uses of lacosamide in children under 4 years, lamotrigine in children under 2 years, levetiracetam in children under 4 years, oxcarbazepine in children under 6 years, topiramate in children under 2 years, and zonisamide in children under 6 years).
- If first line add-on treatments tried are unsuccessful in people with focal seizures, consider 1 of the following second line add-on treatment options:
• brivaracetam
• cenobamate (in line with NICE’s TA guidance see below) NHS Somerset classified as amber following initiation at MDT in secondary care.
• eslicarbazepine acetate
• perampanel
• pregabalin
• sodium valproate, except in women and girls able to have children.
- If the first choice is unsuccessful, consider the other second line add-on options (off-label uses of brivaracetam in children under 4 years, eslicarbazepine acetate in children under 6 years, perampanel in children under 4 years, and pregabalin in children).
- If second line add-on treatments tried are unsuccessful in people with focal seizures, consider 1 of the following third line add-on treatment options:
• phenobarbital
• phenytoin
• tiagabine
• vigabatrin. - If the first choice is unsuccessful, consider the other third line add-on options (off-label use of tiagabine in children under 12 years).
- Do not offer sodium valproate as an add-on treatment for focal seizures in women and girls able to have children (including young girls who are likely to need treatment when they are old enough to have children), unless:
• other treatment options are unsuccessful
• the risks and benefits have been fully discussed, including the risks to an unborn child
• the likelihood of pregnancy has been taken into account and a pregnancy prevention programme put in place, if appropriate.
Absence seizures
- Offer ethosuximide as first line treatment for absence seizures.
- If first line treatment is unsuccessful, offer sodium valproate as second line monotherapy or add-on treatment for absence seizures in:
• boys of all ages
• girls aged under 10 years and who are unlikely to need treatment when they are old enough to have children
• women who are unable to have children. - If second line treatment is unsuccessful for absence seizures, consider lamotrigine or levetiracetam as a third line monotherapy or add-on treatment options. If the first choice is unsuccessful, consider the other of these options (off-label uses of lamotrigine in children under 2 years and levetiracetam in adults and children).
- Be aware that the following antiseizure medications may exacerbate seizures in people with absence seizures:
• carbamazepine
• gabapentin
• oxcarbazepine
• phenobarbital
• phenytoin
• pregabalin
• tiagabine
• vigabatrin.
Absence seizures with other seizure types
- Consider sodium valproate as first line treatment for absence seizures with other seizure types (or at risk of these) in:
• boys and men
• girls aged under 10 years and who are unlikely to need treatment when they are old enough to have children
• women who are unable to have children. - Consider lamotrigine or levetiracetam as first line treatment options in women and girls able to have children (including young girls who are likely to need treatment when they are old enough to have children) with absence seizures and other seizure types (or at risk of these).
- If the first choice is unsuccessful, consider the other of these options (off-label uses of levetiracetam as monotherapy for adults and children, and as an add-on therapy for children under 12 years).
- Do not offer sodium valproate for absence seizures with other seizure types (or at risk of these) in women and girls able to have children (including young girls who are likely to need treatment when they are old enough to have children), unless:
• other treatment options are unsuccessful
• the risks and benefits have been fully discussed, including the risks to an unborn child
• the likelihood of pregnancy has been taken into account and a pregnancy prevention programme put in place, if appropriate. - If first line treatments tried are unsuccessful for absence seizures and other seizure types (or at risk of these), consider:
• lamotrigine or levetiracetam as a second line monotherapy or add-on treatment options or
• ethosuximide as a second line add-on treatment. - If the first choice is unsuccessful, consider the other second line options (off-label uses of lamotrigine in children under 2 years, and levetiracetam in adults and children).
- Be aware that the following antiseizure medications may exacerbate seizures in people with absence seizures and other seizure types (or at risk of these):
• carbamazepine
• gabapentin
• oxcarbazepine
• phenobarbital
• phenytoin
• pregabalin
• tiagabine
• vigabatrin.
Myoclonic seizures
- Offer sodium valproate as first line treatment for myoclonic seizures in:
• boys and men
• girls aged under 10 years and who are unlikely to need treatment when they are old enough to have children
• women who are unable to have children. - Offer levetiracetam as first line treatment for myoclonic seizures in women and girls able to have children (including young girls who are likely to need treatment when they are old enough to have children). (off-label use of levetiracetam).
- If sodium valproate is unsuccessful as first line treatment for myoclonic seizures, offer levetiracetam as a second line monotherapy or add-on treatment (off-label uses of levetiracetam as monotherapy for adults and children, and as an add-on therapy for children under 12 years).
- If levetiracetam is unsuccessful for myoclonic seizures, consider 1 of the following as monotherapy or add-on treatment options:
• brivaracetam
• clobazam
• clonazepam
• lamotrigine
• phenobarbital
• piracetam
• topiramate
• zonisamide. - If the first choice is unsuccessful, consider any other of these options. (off-label uses for brivaracetam in adults and children, clobazam as monotherapy in adults and children, clobazam as add-on therapy in children under 6 months, clonazepam solution in children, lamotrigine as monotherapy for children under 13 years and add-on therapy for children under 2 years, piracetam in children, topiramate in adults and children, and zonisamide in adults and children).
- Do not offer sodium valproate for myoclonic seizures in women and girls able to have children (including young girls who are likely to need treatment when they are old enough to have children), unless:
• other treatment options are unsuccessful
• the risks and benefits have been fully discussed, including the risks to an unborn child
• the likelihood of pregnancy has been taken into account and a pregnancy prevention programme put in place, if appropriate.
Be aware that lamotrigine can occasionally exacerbate myoclonic seizures.
- Do not use any of the following antiseizure medications in people with myoclonic seizures because they may exacerbate seizures:
• carbamazepine
• gabapentin
• oxcarbazepine
• phenytoin
• pregabalin
• tiagabine
• vigabatrin.
Tonic or atonic seizures
- Offer sodium valproate as first line treatment for tonic or atonic seizures in:
• boys and men
• girls aged under 10 years and who are unlikely to need treatment when they are old enough to have children
• women who are unable to have children. - Consider lamotrigine as first line treatment for tonic or atonic seizures in women and girls able to have children (including young girls who are likely to need treatment when they are old enough to have children). (off-label use of lamotrigine in children under 13 years).
- If sodium valproate is unsuccessful as first line treatment for tonic or atonic seizures, consider lamotrigine as a second line monotherapy or add-on treatment. (off-label use of lamotrigine as monotherapy in children under 13 years and add-on therapy in children under 2 years).
- If lamotrigine is unsuccessful for treating tonic or atonic seizures, consider 1 of the following as monotherapy or add-on treatment options:
• clobazam
• rufinamide
• topiramate. - If the first choice is unsuccessful, consider any other of these options. (off-label uses for clobazam as monotherapy in adults and children, clobazam as add-on therapy in children under 6 months, rufinamide, and topiramate as monotherapy in children under 6 years, and topiramate as add-on therapy in children under 2 years).
- Do not offer sodium valproate for tonic or atonic seizures in women and girls able to have children (including young girls who are likely to need treatment when they are old enough to have children), unless:
• other treatment options are unsuccessful
• the risks and benefits have been fully discussed, including the risks to an unborn child
• the likelihood of pregnancy has been taken into account and a pregnancy prevention programme put in place, if appropriate. - If third line treatment is unsuccessful for tonic or atonic seizures in children, consider a ketogenic diet as an add-on treatment under the supervision of a ketogenic diet team.
- If all other treatment options for tonic or atonic seizures are unsuccessful, consider felbamate as an add-on treatment under the supervision of a neurologist with expertise in epilepsy (not licensed for use in the UK).
- Be aware that the following antiseizure medications may exacerbate seizures in people with tonic or atonic seizures:
• carbamazepine
• gabapentin
• oxcarbazepine
• pregabalin
• tiagabine
• vigabatrin.
Idiopathic generalised epilepsies
- Offer sodium valproate as first line treatment for idiopathic generalised epilepsies in:
• boys and men
• girls aged under 10 years and who are unlikely to need treatment when they are old enough to have children
• women who are unable to have children. - Offer lamotrigine or levetiracetam as first line treatment for idiopathic generalised epilepsies in women and girls able to have children (including young girls who are likely to need treatment when they are old enough to have children). If the first choice is unsuccessful, offer the other of these options (off-label uses of lamotrigine in children under 13 years, and levetiracetam in adults and children).
- If first line treatments are unsuccessful for idiopathic generalised epilepsies, consider lamotrigine or levetiracetam as a second line monotherapy or add-on treatment options. If the first choice is unsuccessful, consider the other of these options (off-label uses of lamotrigine as monotherapy in children under 13 years and add-on therapy for children under 2 years, and levetiracetam as monotherapy in adults and children and add-on therapy for children under 12 years).
- If second line treatments tried are unsuccessful for idiopathic generalised epilepsies, consider perampanel or topiramate as third line add-on treatment options. If the first choice is unsuccessful, consider the other of these options (off-label use of perampanel for children under 7 years).
- Do not offer sodium valproate for idiopathic generalised epilepsies in women and girls able to have children (including young girls who are likely to need treatment when they are old enough to have children), unless:
• other treatment options are unsuccessful
• the risks and benefits have been fully discussed, including the risks to an unborn child
• the likelihood of pregnancy has been taken into account and a pregnancy prevention programme put in place, if appropriate.
Treating childhood-onset epilepsies
Antiseizure medications for childhood-onset epilepsy syndromes are considered off-label unless they are authorised for the specific syndrome.
Dravet syndrome
- Consider sodium valproate as first line treatment for people with Dravet syndrome. Be aware that sodium valproate should be used with caution in women and girls, but it is recommended as first line treatment for Dravet syndrome because of the severity of the syndrome and the lack of evidence for other effective first-line treatment options.
- If sodium valproate first line monotherapy is started or continued for Dravet syndrome in women and girls able to have children (including young girls who are likely to need treatment when they are old enough to have children):
• discuss the potential risks and benefits of treatment, including the risks to an unborn child
• take into account the likelihood of pregnancy and put in place a pregnancy prevention programme, if appropriate. - If sodium valproate alone is unsuccessful as first line monotherapy for Dravet syndrome, consider triple therapy with stiripentol and clobazam as first line add-on therapy. Carefully titrate the additional drugs and review treatment frequently, including monitoring for adverse effects such as sedation (off-label uses of clobazam as add-on therapy in children under 6 months, and stiripentol when it is started in adults over 18 years).
- If triple therapy is unsuccessful for Dravet syndrome and the child is over 2 years, consider cannabidiol in combination with clobazam as a second line add-on treatment option in line with NICE’s technology appraisal guidance on cannabidiol with clobazam for treating seizures associated with Dravet syndrome.
NHS Somerset classify cannabidiol for seizures associated with Dravet syndrome as Red (specialist prescribing only) as per traffic light guidance.
- If triple therapy is unsuccessful for Dravet syndrome in a child aged under 2 years or second line treatment is unsuccessful in a child aged over 2 years, consider 1 of the following add-on options under the supervision of a ketogenic diet team or a neurologist with expertise in epilepsy, as appropriate:
• ketogenic diet
• levetiracetam
• topiramate.
If the first choice is unsuccessful, consider the other add-on options (off-label uses of levetiracetam and topiramate). - If all other treatment options for Dravet syndrome are unsuccessful, consider potassium bromide (named patient only) under the guidance of a neurologist with expertise in epilepsy (not licensed for use in the UK).
- Be aware that the following medications may exacerbate seizures in people with Dravet syndrome:
• carbamazepine
• gabapentin
• lacosamide
• lamotrigine
• oxcarbazepine
• phenobarbital
• pregabalin
• tiagabine
• vigabatrin.
NHS Somerset classify fenfluramine for seizures associated with Dravet syndrome as Red (specialist prescribing only) as per traffic light guidance.
Lennox–Gastaut syndrome
- Consider sodium valproate as first line treatment for people with Lennox–Gastaut syndrome. Be aware that sodium valproate should be used with caution in women and girls, but it is recommended as first line treatment for Lennox–Gastaut syndrome because of the severity of the syndrome and the lack of evidence for other effective first-line treatment options.
- If sodium valproate treatment is started or continued for Lennox–Gastaut syndrome in women and girls able to have children who are likely to need treatment when they are old enough to have children):
• discuss the risks and benefits of treatment, including the risks to an unborn child
• take into account the likelihood of pregnancy and put in place a pregnancy prevention programme, if appropriate. - If first line treatment is unsuccessful, consider lamotrigine as a second-line monotherapy or add-on treatment for people with Lennox–Gastaut syndrome (off-label as monotherapy in children under 13 years and add-on therapy for children under 2 years).
- If second line treatment is unsuccessful, consider the following as third-line add-on treatment options for people with Lennox–Gastaut syndrome:
• cannabidiol in combination with clobazam if the child is over 2 years, in line with NICE’s technology appraisal guidance on cannabidiol with clobazam for treating seizures associated with Lennox–Gastaut syndrome
• clobazam
• rufinamide
• topiramate.
(off-label uses of clobazam as add-on therapy in children under 6 months, rufinamide in children under 1 year, and topiramate in children under 2 years). - When starting an add-on treatment in people with Lennox–Gastaut syndrome, carefully titrate the additional medicine and review treatment frequently, including monitoring for adverse effects such as sedation.
- If seizures continue with third line treatments for Lennox–Gastaut syndrome, consider a ketogenic diet as an add-on treatment under the supervision of a ketogenic diet team.
- If all other treatment options for Lennox–Gastaut syndrome are unsuccessful, consider felbamate as add-on treatment under the supervision of a neurologist with expertise in epilepsy (not licensed for use in the UK).
- Be aware that the following medications may exacerbate seizures in people with Lennox–Gastaut syndrome:
• carbamazepine
• gabapentin
• lacosamide
• lamotrigine
• oxcarbazepine
• phenobarbital
• pregabalin
• tiagabine
• vigabatrin.
Infantile spasms syndrome
- Offer combination therapy with high-dose oral prednisolone and vigabatrin as first line treatment for infantile spasms that are not due to tuberous sclerosis, unless the child is at high risk of steroid-related side effects (off-label use of vigabatrin in combination with prednisolone).
- Consider vigabatrin alone as first-line treatment for infantile spasms in children at high risk of steroid-related side effects.
- Offer vigabatrin alone as first line treatment for infantile spasms due totuberous sclerosis. If vigabatrin is ineffective after 1 week, add high-dose oral prednisolone (off-label use of vigabatrin in combination with prednisolone).
- Before starting oral prednisolone for infantile spasms:
• discuss the possible side effects of steroid treatment with parents and carers
• test whether the child has antibodies to the varicella zoster virus
• give the parents and carers a steroid card and information about when to seek medical help for side effects. - When using oral prednisolone to treat infantile spasms, follow the advice in the BNF for children on prednisolone dosages. Monitor blood pressure and urinary glucose weekly during treatment.
- When using vigabatrin to treat infantile spasms, increase the dose as outlined in the BNF for children on vigabatrin. Discuss further dose increases with a tertiary paediatric neurologist if the spasms do not stop (clinically and on EEG).
- If first line treatment for infantile spasms is unsuccessful, discuss further treatment with a tertiary paediatric epilepsy specialist.
- Consider the following as a second line monotherapy or add-on treatment options for infantile spasms, guided by a ketogenic diet team or tertiary paediatric epilepsy specialist, as appropriate:
• ketogenic diet
• levetiracetam
• nitrazepam
• sodium valproate
• topiramate.
If the first choice is unsuccessful, consider the other second line options (off-label uses of levetiracetam, nitrazepam and topiramate).
Self-limited epilepsy with centrotemporal spikes
- Consider lamotrigine or levetiracetam as first line treatment for self-limited epilepsy with centrotemporal spikes. If either lamotrigine or levetiracetam is unsuccessful, try the other of these options (off-label uses of lamotrigine in children under 13 years, and levetiracetam in children under 16 years).
- If first line treatments for self-limited epilepsy with centrotemporal spikes are unsuccessful, consider the following as second line monotherapy treatment options:
• carbamazepine
• oxcarbazepine
• zonisamide.
If the first choice is unsuccessful, consider the other second line monotherapy options (off-label uses for oxcarbazepine in children under 6 years, and zonisamide in adults and children). - If second line treatments tried are unsuccessful for self-limited epilepsy with centrotemporal spikes, consider sulthiame as monotherapy or add-on treatment, but only after discussion with a tertiary paediatric neurologist (not licensed for use in the UK).
- Be aware that carbamazepine, oxcarbazepine and lamotrigine may rarely exacerbate seizures or the development of another epilepsy syndrome, or affect cognitive performance, in a small number of children and young people with self-limited epilepsy with centrotemporal spikes.
- If there is concern about the school performance of a child or young person having antiseizure medication, seek guidance from an epilepsy specialist and consider:
• sleep electroencephalogram (EEG) to exclude exacerbation of epileptic activity (electrical status epilepticus during sleep) and
• neuropsychology assessment to review academic performance. - If a child or young person having antiseizure medication treatment develops other seizure types, consider a sleep EEG to exclude exacerbation of epileptic activity (developmental epileptic encephalopathy with spike-wave activation in sleep).
- Offer follow up at a frequency and with a healthcare professional appropriate to the child or young person’s individual needs. Discuss discontinuing treatment if a child or young person with self-limited epilepsy with centrotemporal spikes is seizure-free for at least 2 years or at age 14 years.
Epilepsy with myoclonic-atonic seizures (Doose syndrome)
- Consider levetiracetam or sodium valproate as first line treatments for epilepsy with myoclonic-atonic seizures. If either levetiracetam or sodium valproate is unsuccessful, try the other of these options (off-label use of levetiracetam).
- If sodium valproate is started or continued for epilepsy with myoclonic-atonic seizures in girls or women able to have children (including young girls who are likely to need treatment when they are old enough to have children):
• discuss the risks and benefits of treatment, including the risks to an unborn child
• take into account the likelihood of pregnancy and put in place a pregnancy prevention programme, if appropriate. - If first line treatments for epilepsy with myoclonic-atonic seizures are unsuccessful, consider a ketogenic diet as a second line monotherapy or add-on treatment, under the supervision of a ketogenic diet team.
- If second line treatment for epilepsy with myoclonic-atonic seizures is unsuccessful, consider the following as third line monotherapy or add-on treatment options:
• clobazam
• ethosuximide
• topiramate
• zonisamide.
If the first choice is unsuccessful, consider the other third line options (off-label uses of clobazam as monotherapy in adults and children, and add-on therapy in children under 6 months, and topiramate and zonisamide in adults and children). - Do not use any of the following medications because they may exacerbate seizures in people with epilepsy with myoclonic-atonic seizures:
• carbamazepine
• gabapentin
• oxcarbazepine
• phenytoin
• pregabalin
• vigabatrin. - Consider discontinuing antiseizure medication treatment in children with epilepsy with myoclonic-atonic seizures who are seizure-free for 2 years.
| Therapeutic Area | Formulary Choices | Cost for 28 (unless otherwise stated) | Rationale for decision / comments |
|---|---|---|---|
| Antiepileptics | |||
| Sodium valproate | as Epival® | 300mg modified-release tablet: £3.40 (30) | NHS Somerset classify as an Amber drug for bipolar disorder as per traffic light guidance. First line monotherapy for generalised tonic-clonic seizures except girls that are likely to continue treatment and women of children bearing age. First line add-on if monotherapy is unsuccessful in people with generalised tonic-clonic seizures except in women and girls able to have children. Second line add-on in people with focal seizures except in women and girls able to have children. Second line monotherapy or add-on for absence seizures in except girls that are likely to continue treatment and women of children bearing age. First line for absence seizures with other seizure types except girls that are likely to continue treatment and women of children bearing age. First line for myoclonic seizures except girls that are likely to continue treatment and women of children bearing age. First line monotherapy for for tonic or atonic seizures except girls that are likely to continue treatment and women of children bearing age. First line for idiopathic generalised epilepsies except girls that are likely to continue treatment and women of children bearing age. First line for Dravet syndrome. First line for Lennox–Gastaut syndrome. Second line monotherapy or add-on for infantile spasms. First line for epilepsy with myoclonic-atonic seizures. Contraindicated in women and girls of childbearing potential unless conditions of Pregnancy Prevention Programme are met. |
| 500mg modified-release tablet: £5.67 (30) | |||
| as Epilim® | 100mg crushable tablet: £1.68 (30) | ||
| 200mg gastro-resistant tablet: £2.46 (30), £8.21 (100) | |||
| 500mg gastro-resistant tablet: £5.96 (30) | |||
| 200mg/5ml oral solution sugar free: £8.39 (300ml) | |||
| as Epilim Chrono® | 200mg modified-release tablet: £3.50 (30) | ||
| 300mg modified-release tablet: £5.24 (30) | |||
| 500mg modified-release tablet: £8.73 (30) | |||
| as Episenta® | 150mg modified-release capsule: £2.76 (30) | ||
| 300mg modified-release capsule: £4.56 (30) | |||
| Lamotrigine | 25mg tablet: £1.48 (56) | NHS Somerset classify as an Amber drug for monotherapy or adjunctive therapy of bipolar disorder. First line monotherapy for generalised tonic-clonic seizures in women and girls able to have children including young girls who are likely to need treatment when they are old enough to have children. Second line monotherapy for generalised tonic-clonic seizures. First line add-on if monotherapy is unsuccessful in people with generalised tonic-clonic seizures. First line monotherapy for people with focal seizures. First line add-on in people with focal seizures. Third line monotherapy or add-on for absence seizures. First line for absence seizures and other seizure types in women and girls able to have children including young girls who are likely to need treatment when they are old enough to have children. Second line monotherapy or add-on for absence seizures and other seizure types. First line for absence seizures and other seizure types in women and girls able to have children including young girls who are likely to need treatment when they are old enough to have children. Second line monotherapy or add-on tonic or atonic seizures. First line for idiopathic generalised epilepsies in women and girls able to have children including young girls who are likely to need treatment when they are old enough to have children. Second line monotherapy or add-on for idiopathic generalised epilepsies. Second line monotherapy or add-on for Lennox–Gastaut syndrome. First line for self-limited epilepsy with centrotemporal spikes. May exacerbate seizures in people with myoclonic seizures, including in juvenile myoclonic epilepsy, Dravet syndrome and Lennox–Gastaut syndrome. May rarely exacerbate seizures or the development of another epilepsy syndrome, or affect cognitive performance, in a small number of children and young people with self-limited epilepsy with centrotemporal spikes. |
|
| 50mg tablet: £1.76 (56) | |||
| 100mg tablet: £1.93 (56) | |||
| 200mg tablet: £2.31 (56) | |||
| 25mg dispersible tablet sugar free: £7.87 (56) | |||
| 25mg dispersible tablet sugar free: £7.87 (56) | |||
| 100mg dispersible tablet sugar free: £13.90 (56) | |||
| Levetiracetam | 250mg tablet: £1.96 (60) | Please prescribe as Levetiracetam as branded formulations are not cost effective and considered bioequivalent (except Desitrend®). First line monotherapy for generalised tonic-clonic seizures in women and girls able to have children including young girls who are likely to need treatment when they are old enough to have children. Second line monotherapy for generalised tonic-clonic seizures. First line add-on if monotherapy is unsuccessful in people with generalised tonic-clonic seizures. First line monotherapy for people with focal seizures. First line add-on in people with focal seizures. Third line monotherapy or add-on for absence seizures. First line for absence seizures and other seizure types in women and girls able to have children including young girls who are likely to need treatment when they are old enough to have children. Second line monotherapy or add-on for absence seizures and other seizure types. First line treatment for for tonic or atonic seizures in women and girls able to have children including young girls who are likely to need treatment when they are old enough to have children. Second line monotherapy or add-on for myoclonic seizures. First line for idiopathic generalised epilepsies in women and girls able to have children including young girls who are likely to need treatment when they are old enough to have children. Second line monotherapy or add-on for idiopathic generalised epilepsies. Add-on for Dravet syndrome. Second line monotherapy or add-on for infantile spasms. First line for self-limited epilepsy with centrotemporal spikes. First line for epilepsy with myoclonic-atonic seizures. |
|
| 500mg tablet: £3.18 (60) | |||
| 750mg tablet: £4.27 (60) | |||
| 1g tablet: £5.70 (60) | |||
| 100mg/ml oral solution sugar free: £5.66 (300ml) | |||
| as Desitrend® | 250mg granules sachet sugar free: £22.41 (60) | For patients with swallowing difficulty, or for children over 25kg unable to swallow tablets (including patients with learning difficulties). Can be taken with a small amount of liquid (10 mls) or mixed with food. For patients who are on a ketogenic diet (is carbohydrate free). For administration via a feeding tube (dissolve in 10 mls of water). |
|
| 500mg granules sachet sugar free: £39.46 (60) | |||
| 1g granules sachet sugar free: £76.27 (60) | |||
| Perampanel | as Fycompa® | 2mg tablet: £35.00 (7), £140.00 (28) | First line add-on if monotherapy is unsuccessful in people with generalised tonic-clonic seizures. Second line add-on in people with focal seizures. Third line add-on for idiopathic generalised epilepsies. |
| 4mg tablet: £140.00 (28) | |||
| 6mg tablet: £140.00 (28) | |||
| 8mg tablet: £140.00 (28) | |||
| 10mg tablet: £140.00 (28) | |||
| 12mg tablet: £140.00 (28) | |||
| Topiramate | 25mg tablet: £2.25 (60) | Adult: Migraine prophylaxis, initially 25mg once daily for 1 week, dose to be taken at night, then increased in steps of 25mg every week; usual dose 50-100mg daily in 2 divided doses; maximum 200mg per day. First line add-on if monotherapy is unsuccessful in people with generalised tonic-clonic seizures. Second line monotherapy for generalised tonic-clonic seizures. First line add-on in people with focal seizures. Third line or add-on for myoclonic seizures. Third line monotherapy or add-on for tonic or atonic seizures. Third line add-on for idiopathic generalised epilepsies. Add-on for Dravet syndrome. Third line add-on for Lennox–Gastaut syndrome. Second line monotherapy or add-on for infantile spasms. Third line monotherapy or add-on for epilepsy with myoclonic-atonic seizures. Associated with an increased risk of congenital malformations and effects on fetal growth if used during pregnancy, use effective contraception throughout use. |
|
| 50mg tablet: £2.89 (60) | |||
| 100mg tablet: £3.17 (60) | |||
| We have initiated a new safety review into topiramate as a result of an observational study reporting an increased risk of neurodevelopmental disabilities in children whose mothers took topiramate during pregnancy. Topiramate is known to be associated with an increased risk of congenital malformations and effects on fetal growth if used during pregnancy. Continue to counsel patients who can become pregnant on the known and emerging risks of topiramate for an unborn baby and on the need to use effective contraception throughout use. See MHRA Drug Safety Update (July 2022) for Topiramate (Topamax): start of safety review triggered by a study reporting an increased risk of neurodevelopmental disabilities in children with prenatal exposure. | |||
| Brivaracetam | as Briviact® | 25mg tablet: £129.64 (56) | Second line add-on in people with generalised tonic-clonic seizures. Second line add-on in people with focal seizures. Third line or add-on for myoclonic seizures. |
| 50mg tablet: £129.64 (56) | |||
| 75mg tablet: £129.64 (56) | |||
| 100mg tablet: £129.64 (56) | |||
| 50mg/5ml oral solution sugar free: £115.83 (300ml) | |||
| Lacosamide | as Vimpat® | 50mg tablet: £10.81 (14) | Second line add-on in people with generalised tonic-clonic seizures. Second line monotherapy in people with focal seizures. Third line monotherapy in people with focal seizures. First line add-on in people with focal seizures. May exacerbate seizures in people with Dravet syndrome and Lennox–Gastaut syndrome. |
| 100mg tablet: £21.62 (14), £86.50 (56) | |||
| 150mg tablet: £32.44 (14), £129.74 (56) | |||
| 200mg tablet: £144.16 (56) | |||
| 10mg/ml oral solution sugar free: £25.74 (200ml) | |||
| Zonisamide | 25mg capsule: £8.17 (14) | Second line add-on in people with generalised tonic-clonic seizures. Second line monotherapy in people with focal seizures. First line add-on in people with focal seizures. Third line or add-on for myoclonic seizures. Second line monotherapy for self-limited epilepsy with centrotemporal spikes. Third line monotherapy or add-on for epilepsy with myoclonic-atonic seizures. |
|
| 50mg capsule: £42.30 (56) | |||
| 100mg capsule: £34.31 (56) | |||
| Tiagabine | as Gabitril® | 5mg tablet: £52.04 (100) | Third line add-on in people with focal seizures. May exacerbate seizures in people with absence and with other types, tonic or atonic or myoclonic seizures, including in juvenile myoclonic epilepsy, Dravet syndrome and Lennox–Gastaut syndrome. Do not use as may exacerbate seizures in people with epilepsy with myoclonic seizures. |
| 10mg tablet: £104.09 (100) | |||
| 15mg tablet: £156.13 (100) | |||
| Vigabatrin | as Sabril® | 500mg tablet: £44.41 (100) | Third line add-on in people with focal seizures. First line for infantile spasms. May exacerbate seizures in people with absence and with other types, tonic or atonic or myoclonic seizures, including in juvenile myoclonic epilepsy, Dravet syndrome and Lennox–Gastaut syndrome. Do not use as may exacerbate seizures in people with epilepsy with myoclonic or myoclonic-atonic seizures. |
| 500mg oral powder sachets sugar free: £24.60 (50) | |||
| Cenobamate | as Ontozry® | 12.5mg tablet: £165.62 (28) | Second line add-on in people with focal seizures. NHS Somerset classified as amber following initiation at MDT in secondary care. |
| 25mg tablet: £165.62 (28) | |||
| 50mg tablet: £85.54 (14), £91.00 (28) | |||
| 150mg tablet: £89.18 (14), £182.00 (28) | |||
| 200mg tablet: £91.00 (14), £182.00 (28) | |||
| Carbamazepine | as Tegretol® | 100mg tablet: £2.07 (84) | Offer carbamazepine as initial treatment for trigeminal neuralgia. Second line monotherapy in people with focal seizures. First line add-on in people with focal seizures. Second line monotherapy for self-limited epilepsy with centrotemporal spikes. May exacerbate seizures in people with absence and with other types, tonic or atonic or myoclonic seizures, including in juvenile myoclonic epilepsy, Dravet syndrome and Lennox–Gastaut syndrome. May rarely exacerbate seizures or the development of another epilepsy syndrome, or affect cognitive performance, in a small number of children and young people with self-limited epilepsy with centrotemporal spikes. Do not use as may exacerbate seizures in people with epilepsy with myoclonic or myoclonic-atonic seizures. Be aware that carbamazepine and oxcarbazepine are associated with an increased risk of serious skin reactions in people of Han Chinese, Thai, European or Japanese family background. Ensure that the patient is maintained on a specific manufacturer’s product. |
| 200mg tablet: £3.83 (84) | |||
| 400mg tablet: £5.02 (56) | |||
| 200mg modified-release tablets: £5.20 (56) | |||
| 400mg modified-release tablets: £10.24 (56) | |||
| 100mg/5ml oral suspension sugar free: £10.08 (300ml) | |||
| Oxcarbazepine | 300mg tablet: £6.31 (50) | ||
| as Trileptal® | 60mg/ml oral suspension sugar free: £48.96 (250ml) | ||
| Eslicarbazepine | as Zebinix® | 200mg tablet: £68.00 (60) | Second line add-on in people with focal seizures. Be aware that eslicarbazepine is associated with an increased risk of serious skin reactions in people of Han Chinese, Thai, European or Japanese family background. |
| 800mg tablet: £136 (30) | |||
| 50mg/1ml oral suspension sugar free: £56.67 (200ml) | |||
| Pregabalin | 25mg capsule: £1.44 (56) | Please prescribe as Pregabalin as branded formulations are not cost effective and considered bioequivalent. Second line add on for people with focal seizures. Offer as initial treatment for neuropathic pain (except trigeminal neuralgia) in adults, for generalized anxiety disorder if SSRI and SNRI are not tolerated and second line for painful diabetic neuropathy adults as per traffic light guidance. For generalised anxiety disorder if the person cannot tolerate SSRIs or SNRIs. Adult: initially 150mg daily in 2-3 divided doses, then increased in steps of 150mg daily if required, dose to be increased at 7 day intervals, increased if necessary up to 600mg daily in 2-3 divided doses. May exacerbate seizures in people with absence and with other types, tonic or atonic or myoclonic seizures, including in juvenile myoclonic epilepsy, Dravet syndrome and Lennox–Gastaut syndrome. Do not use as may exacerbate seizures in people with epilepsy with myoclonic-atonic seizures. Avoid use in pregnancy unless clearly necessary; patients should continue to use effective contraception during treatment. |
|
| 50mg capsule: £1.77 (84) | |||
| 75mg capsule: £1.68 (56) | |||
| 100mg capsule: £2.38 (84) | |||
| 150mg capsule: £2.02 (56) | |||
| 200mg capsule: £3.04 (84) | |||
| 300mg capsule: £2.62 (56) | |||
| 20mg/ml oral solution sugar free: £85.22 (473ml) | |||
| Pregabalin has been associated with infrequent reports of severe respiratory depression, including some cases without the presence of concomitant opioid medicines. Patients with compromised respiratory function, respiratory or neurological disease, renal impairment; those using concomitant central nervous system (CNS) depressants; and people older than 65 years might be at higher risk of experiencing these events and adjustments in dose or dosing regimen may be necessary. See MHRA Drug Safety Update (February 2021) for Pregabalin: reports of severe respiratory depression. | |||
| A new study has suggested pregabalin may slightly increase the risk of major congenital malformations if used in pregnancy. Patients should continue to use effective contraception during treatment and avoid use in pregnancy unless clearly necessary. See MHRA Drug Safety Update (April 2022) for Pregabalin: findings of safety study on risks during pregnancy. | |||
| As of 1 April 2019, pregabalin and gabapentin are controlled under the Misuse of Drugs Act 1971 as Class C substances and scheduled under the Misuse of Drugs Regulations 2001 as Schedule 3. Evaluate patients carefully for a history of drug abuse before prescribing pregabalin and gabapentin and observe patients for development of signs of abuse and dependence. See MHRA Drug Safety Update (April 2019) for Pregabalin, gabapentin and risk of abuse and dependence: new scheduling requirements from 1 April. | |||
| Phenytoin | 25mg capsule: £7.24 (28) | Third line add-on in people with focal seizures. May exacerbate seizures in people with absence and with other types or myoclonic seizures, including in juvenile myoclonic epilepsy. Do not use as may exacerbate seizures in people with epilepsy with myoclonic or myoclonic-atonic seizures. Be aware that phenytoin is associated with an increased risk of serious skin reactions in people of Han Chinese or Thai family background. Ensure that the patient is maintained on a specific manufacturer’s product. Phenytoin sodium 100mg capsule = phenytoin 90mg suspension. |
|
| 50mg capsule: £7.07 (28) | |||
| 100mg capsule: £10.21 (84) | |||
| 300mg capsule: £9.11 (28) | |||
| as Epanutin® | 30mg/5ml oral suspension: £4.27 (500ml) | ||
| Ethosuximide | as Epesri® | 250mg capsule: £100.41 (56) | First line treatment for absence seizures. Second line add-on for absence seizures and other seizure types. Third line monotherapy or add-on for epilepsy with myoclonic-atonic seizures. |
| Rufinamide | as Inovelon® | 100mg tablet: £5.15 (10) | Third line monotherapy or add-on for tonic or atonic seizures. Third line add-on for Lennox–Gastaut syndrome. |
| 200mg tablet: £61.77 (60) | |||
| 400mg tablet: £102.96 (60) | |||
| 40mg/ml oral suspension sugar free: £94.71 (460ml) | |||
| Gabapentin | 100mg capsule: £3.38 (100) | Please prescribe as Gabapentin as branded formulations are not cost effective and considered bioequivalent. Offer as initial treatment for neuropathic pain (except trigeminal neuralgia) in adults. May exacerbate seizures in people with absence and with other types, tonic or atonic or myoclonic seizures, including in juvenile myoclonic epilepsy, Dravet syndrome and Lennox–Gastaut syndrome. Do not use as may exacerbate seizures in people with epilepsy with myoclonic or myoclonic-atonic seizures. |
|
| 300mg capsule: £3.12 (100) | |||
| 400mg capsule: £3.47 (100) | |||
| 50mg/ml oral solution sugar free: £65.24 (150ml) | |||
| Stiripentol | as Diacomit® | 250mg capsule: £284.00 (60) | First line add-on for Dravet syndrome as triple therapy with sodium valproate and clobazam. |
| 500mg capsule: £493.00 (60) | |||
| 250mg oral powder sachet: £284.00 (60) | |||
| 500mg oral powder sachet: £493.00 (60) | |||
| Potassium bromide | Not licensed for use in the UK. | Named patient only. If all other treatment options for Dravet syndrome are unsuccessful. | |
| Felbamate | Not licensed for use in the UK. | Named patient only. If all other treatment options for Lennox–Gastaut syndrome are unsuccessful. | |
| Sulthiame | Not licensed for use in the UK. | Named patient only. If all other treatment options for self-limited epilepsy with centrotemporal spikes are unsuccessful. | |
| CNS stimulant | |||
| Piracetam | as Nootropil® | 800mg tablet: £11.75 (90) | Third line or add-on for myoclonic seizures. |
| 1.2g tablet: £10.97 (60) | |||
| 333.3mg/ml oral solution sugar free: £16.31 (300ml) | |||
| NHS Somerset classify Cannabidiol oral solution as Epidyolex® a Red drug as per traffic light guidance (specialist prescribing only). | |||
| NHS Somerset classify fenfluramine as Fintepla® a Red drug as per traffic light guidance (specialist prescribing only). | |||
| Antiepileptics, Barbiturates | |||
| Phenobarbital | 30mg tablets: £0.88 (28) | Second line add-on in people with generalised tonic-clonic seizures. Third line add-on in people with focal seizures. Third line or add-on for myoclonic seizures. May exacerbate seizures in people with absence and with other types seizures, Dravet syndrome and Lennox–Gastaut syndrome. Ensure that the patient is maintained on a specific manufacturer’s product. |
|
| 15mg/5ml elixir: £83.01 (500ml) | |||
| Primidone | 50mg tablet: £119.82 (100) | Second line add-on in people with generalised tonic-clonic seizures. Ensure that the patient is maintained on a specific manufacturer’s product. |
|
| 250mg tablet: £101.23 (100) | |||
| Hypnotics, sedatives and anxiolytics, benzodiazepines | |||
| Clobazam | 10mg tablet: £6.43 (30) | First line add-on in people with generalised tonic-clonic seizures. Third line or add-on for myoclonic seizures. Third line monotherapy or add-on for tonic or atonic seizures. Third line add-on for Lennox–Gastaut syndrome. Third line monotherapy or add-on for epilepsy with myoclonic-atonic seizures. |
|
| 10mg/5ml oral suspension sugar free: £88.14 (150ml) | |||
| Clonazepam | 500mcg tablet: £24.47 (100) | Third line or add-on for myoclonic seizures. | |
| 1mg tablet: £41.95 (100) | |||
| 2mg tablet: £25.96 (100) | |||
| 500micrograms/5ml oral solution sugar free: £77.09 (150ml) | |||
| 2mg/5ml oral solution sugar free: £108.38 (150ml) | |||
| Nitrazepam | 2.5mg/5ml oral suspension: £145.00 (70ml) | Second line monotherapy or add-on treatment options for infantile spasms. | |
Status epilepticus
- Provide resuscitation and immediate emergency treatment for children, young people and adults who have convulsive status epilepticus (seizures lasting 5 minutes or more).
- If the person with convulsive status epilepticus has an individualised emergency management plan that is immediately available, administer medication as detailed in the plan.
- If the person with convulsive status epilepticus does not have an individualised emergency management plan immediately available:
• give a benzodiazepine (buccal midazolam or rectal diazepam) immediately as first-line treatment in the community or
• use intravenous lorazepam if intravenous access and resuscitation facilities are immediately available. - Be aware of the possible underlying causes of status epilepticus, including hypoglycaemia, eclampsia and alcohol withdrawal, which may need to be treated with additional medication.
- Be alert to non-adherence to antiseizure medication, which can also be a cause of status epilepticus.
- Be aware that non-epileptic seizures (dissociative seizures) can be similar in presentation to convulsive status epilepticus.
- If convulsive status epilepticus does not respond to the first dose of benzodiazepine:
• call emergency services in the community or
• seek expert guidance in hospital. - Continue to follow the person’s individualised emergency management plan, if this is immediately available, or give a second dose of benzodiazepine if the seizure does not stop within 5 to 10 minutes of the first dose.
- If convulsive status epilepticus does not respond to 2 doses of a benzodiazepine, give any of the following medicines intravenously as a second line treatment:
• levetiracetam
• phenytoin
• sodium valproate.
Take into account that levetiracetam may be quicker to administer and have fewer adverse effects than the alternative options (off-label use of levetiracetam). - If convulsive status epilepticus does not respond to a second line treatment, consider trying an alternative second line treatment option under expert guidance.
- If convulsive status epilepticus does not respond to the second line treatment options tried, consider the following third line options under expert guidance:
• phenobarbital or
• general anaesthesia. - After an episode of convulsive status epilepticus, agree an emergency management plan with the person if they do not already have one and there is concern that status epilepticus may recur.
Repeated seizures or cluster seizures
- Manage repeated or cluster seizures (typically 3 or more self-terminating seizures in 24 hours) as a medical emergency.
- If a person has repeated or cluster seizures:
• follow their individualised emergency management plan, if this is immediately available or
• consider giving a benzodiazepine, such as clobazam or midazolam, immediately if they do not have an individualised emergency management plan immediately available. - Seek expert guidance if the person has further episodes of repeated or cluster seizures.
- Agree an individualised emergency management plan with the person after repeated or cluster seizures if they do not have one already and there is concern that repeated or cluster seizures may recur.
Prolonged seizures
- For convulsive seizures that continue for 5 minutes or more, follow the recommendations in the section on status epilepticus.
- Manage prolonged convulsive seizures (any convulsive seizure that continues for more than 2 minutes longer than a person’s usual seizure) as a medical emergency.
- If a person has a prolonged convulsive seizure:
• follow their individualised emergency management plan if this is immediately available or
• consider giving a benzodiazepine, such as midazolam or clobazam, immediately if they do not have an individualised emergency management plan immediately available. - After a prolonged convulsive seizure, agree an emergency management plan with the person if they do not already have one and there is concern that prolonged convulsive seizures may recur.
- After a prolonged non-convulsive seizure (a non-convulsive seizure that continues for more than 2 minutes longer than a person’s usual seizure), agree an emergency management plan with the person if they do not already have one and there is concern that prolonged non-convulsive seizures may recur.
| Therapeutic Area | Formulary Choices | Cost for 28 (unless otherwise stated) | Rationale for decision / comments |
|---|---|---|---|
| Hypnotics, sedatives and anxiolytics, benzodiazepines | |||
| Midazolam | as Buccolam® | 2.5mg/0.5ml oromucosal solution pre-filled oral syringes sugar free: £82.00 (4) | First line treatment in the community for convulsive status epilepticus. Licensed in patients from 3 months to < 18 years. Caution when switching between different formulations as they may vary in strength and bioavailability. |
| 5mg/1ml oromucosal solution pre-filled oral syringes sugar free: £85.50 (4) | |||
| 7.5mg/1.5ml oromucosal solution pre-filled oral syringes sugar free: £89.00 (4) | |||
| 10mg/2ml oromucosal solution pre-filled oral syringes sugar free: £91.50 (4) | |||
| Care needed when transferring from unlicensed formulations. See MHRA Drug Safety Update (December 2014) for Buccal midazolam: new authorised medicine for paediatric use. | |||
| as Epistatus® | 10mg/1ml oromucosal solution pre-filled oral syringes sugar free: £45.76 (1) | First line treatment in the community for convulsive status epilepticus. Licensed in patients from in children and adolescents aged 10 to less than 18 years. Caution when switching between different formulations as they may vary in strength and bioavailability. |
|
| Diazepam | 5mg/2.5ml rectal solution tube: £5.85 (5) | Second line treatment in the community for convulsive status epilepticus based on previous use or if buccal midazolam is unavailable. Children under 10 kg (under 1 year): not recommended. Children 10 to 15 kg (1 to 3 years): 5 mg Children over 15 kg (over 3 years): 10 mg Adults: 20mg If no effect is seen after 10 minutes, the dose can be repeated. The dose can be repeated every 12 hours. In case of repeated administration respiration should be monitored. |
|
| 10mg/2.5ml rectal solution tube: £8.78 (5) | |||