Lacosamide oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations containing lacosamide.
Drugs List
Therapeutic Indications
Uses
Epilepsy - primary generalised tonic-clonic seizures - adjunctive
Epilepsy-partial seizures with/without secondary generalisation-adjunctive
Epilepsy-partial seizures with/without secondary generalisation-monotherapy
Dosage
Adults
Monotherapy
Initially 50mg twice a day, which should be increased to an initial therapeutic dose of 100mg twice a day after one week.
According to response and tolerability, increase the dose at weekly intervals by 50mg twice a day until optimum response is achieved. Maximum dose 300mg twice a day.
Alternatively, a higher initial dose of 100mg twice a day can be used where the need to reduce seizures outweighs the potentially higher risk of side effects.
Adjunctive therapy
Initially 50mg twice a day, which should be increased to an initial therapeutic dose of 100mg twice a day after one week.
According to response and tolerability, increase the dose at weekly intervals by 50mg twice a day until optimum response is achieved. Maximum dose 200mg twice a day.
Loading dose
Where rapid steady state plasma concentrations are required a single loading dose of 200mg can be used. Maintenance treatment should start approximately 12 hours later at an initial dose of 100mg twice a day, increased at weekly intervals as needed in line with standard dose advice for monotherapy/adjunctive therapy above.
This regimen carries a higher risk of central nervous system side effects and should be administered under close medical supervision.
Children
Children aged 4 years and above - weighing 50kg or more:
(See Dosage; Adult)
Children aged 4 years and above - weighing less than 50kg:
Monotherapy:
Initially 1mg/kg twice a day, which should be increased to an initial therapeutic dose of 2mg/kg twice a day after one week.
According to response and tolerability, increase the dose at weekly intervals by 1mg/kg twice a day until optimum response is achieved.
Maximum dose 5mg/kg twice a day for patients weighing 40kg to 50kg.
Maximum dose 6mg/kg twice a day for patients weighing less than 40kg.
Adjunctive therapy:
Initially 1mg/kg twice a day, which should be increased to an initial therapeutic dose of 2mg/kg twice a day after one week.
According to response and tolerability, increase the dose at weekly intervals by 1mg/kg twice a day until optimum response is achieved.
Maximum dose 4mg/kg twice a day for patients weighing 30kg to 50kg.
Maximum dose 5mg/kg twice a day for patients weighing 20kg to 30kg.
Maximum dose 6mg/kg twice a day for patients weighing less than 20kg.
Loading doses are not recommended in this patient group.
Patients with Renal Impairment
Creatinine clearance greater than 30ml/min
No dosage adjustments required.
If a loading dose is required, use caution if the maintenance dose is titrated above 100mg twice a day.
Creatinine clearance less than or equal to 30ml/min
Adults and children weighing 50kg or more:
Use caution when titrating the maintenance dose. Maximum dose 125mg twice a day.
If a loading dose is required, use a single dose of 100mg followed by a maintenance dose of 50mg twice a day.
Children weighing less than 50kg:
Use caution when titrating the maintenance dose. Reduce the maximum dose by 25%.
Patients requiring haemodialysis
Supplement of up to 50% of the divided daily dose directly after the end of haemodialysis is recommended.
Patients with Hepatic Impairment
Mild to moderate hepatic impairment
Adults and children weighing 50kg or more:
Use caution when titrating the maintenance dose. Maximum dose 150mg twice a day.
If a loading dose is required, use caution if the maintenance dose is titrated above 100mg twice a day.
Children weighing less than 50kg:
Use caution when titrating the maintenance dose. Reduce the maximum dose by 25%.
Severe hepatic impairment
Experience in this patient group is limited. Only use where expected therapeutic benefits outweigh any potential risks.
Additional Dosage Information
Missed dose
If a dose is missed the patient should be instructed to take the missed dose immediately, and then to take the next dose of lacosamide at the regularly scheduled time. If the patient notices the missed dose within 6 hours of the next one, they should be instructed to wait to take the next dose of lacosamide at the regularly scheduled time. Patients should not take a double dose.
Discontinuing therapy
A reduction of 200mg per week is suggested by the manufacturer.
Contraindications
Children under 4 years
Breastfeeding
Second degree atrioventricular block
Third degree atrioventricular block
Precautions and Warnings
Patients over 65 years
Restricted sodium intake
Cardiac conduction defects
Cardiac failure
Haemodialysis
Hepatic impairment
Hereditary fructose intolerance
History of myocardial infarction
Phenylketonuria
Pregnancy
Renal impairment - creatinine clearance below 30 ml/minute
Severe cardiac disorder
Sodium content of formulation may be significant
Some formulations contain aspartame - caution in phenylketonuria
Advise patient dizziness may affect ability to drive or operate machinery
Folic acid 5mg daily required pre-conception to end of 1st trimester
Oral liquid contains hydroxybenzoate: caution in hypersensitivity
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Monitor for signs of suicide ideation or behaviour
Perform ECG when increasing doses in patients with proarrhythmic conditions
Refer women considering pregnancy for specialist advice and monitoring
Advise patient to report any signs of cardiac arrhythmias
Advise pt to seek medical advice if AV block or atrial fibrillation occur
Counsel patients on symptoms of AV block or arrhythmias
May exacerbate myoclonic seizures
To discontinue, reduce dose gradually
Consider discontinuing therapy if serious cardiac arrhythmias occur
Discontinue if severe hypersensitivity reactions occur
Advise patient not to take St John's wort concurrently
Advise patient to avoid alcohol during treatment
Female: Ensure adequate contraception during treatment
Advise patient of increased risk of falls
Advise patient/carers to report signs of suicide ideation or behaviour
Antiepileptic drug hypersensitivity syndrome is a rare but potentially fatal syndrome associated with some antiepileptic drugs. Patients usually present with fever, rash, lymphadenopathy and other organ system involvement. Other possible symptoms include liver dysfunction, haematological, renal and pulmonary abnormalities, vasculitis and multi-organ failure. If signs or symptoms of hypersensitivity syndrome occur, the drug should be withdrawn immediately and expert advice sought.
Antiepileptic treatment is associated with a small increased risk of suicidal thoughts and behaviour; available data suggest that the increased risk applies to all antiepileptics and is seen as early as one 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.
Use caution in children experiencing partial-onset seizures with secondary generalisation as the safety and efficacy in this group is currently unknown.
Pregnancy and Lactation
Pregnancy
Use lacosamide with caution during pregnancy.
The manufacturer does not recommend using lacosamide during pregnancy. At the time of writing, there are no adequate data on the use of lacosamide in pregnant women. Animal studies have not indicated any teratogenic effects in rats or rabbits, but embryotoxicity was observed in rats and rabbits at maternal toxic doses. The potential risk for humans is not known.
Due to the lack of data and experience, use of lacosamide during pregnancy is not recommended unless absolutely necessary. However, adjusting or stopping any anti-epileptic medication during pregnancy should not be done without specialist advice, and the relative benefits and risks should be discussed carefully first. The risk of harm to the mother and unborn child from seizures outweighs any teratogenic risk. Pregnancy in epileptic women is associated with a higher risk of congenital abnormalities, which are mainly associated with the use of anti-epileptic drugs rather than the disease itself. This risk is increased when multiple drugs are used. Routine monitoring of antiepileptic drugs is not recommended, but may be useful in cases where seizures have increased or are likely to, in order to plan the extent of dose adjustment needed. It is recommend that folic acid 5mg daily should be prescribed to all women with epilepsy who are taking antiepileptic drugs, prior to conception and continued until the 12th week of pregnancy.
Lactation
Lacosamide is contraindicated during pregnancy.
The manufacturer does not recommend breastfeeding during treatment with lacosamide. Lacosamide is excreted in human breast milk. Mothers on anti-epileptic drugs are encouraged to breastfeed, except in rare circumstances, as it is generally considered safe. The risk of injury to the infant caused by a maternal seizure is low.
Side Effects
Abnormal liver function tests
Aggression
Agitation
Agranulocytosis
Angioedema
Asthenia
Ataxia
Atrial fibrillation
Atrial flutter
Atrioventricular block
Attention disturbances
Blurred vision
Bradycardia
Cardiac arrhythmias
Cognitive impairment
Confusion
Constipation
Contusion
Convulsions
Depression
Diarrhoea
Diplopia
Dizziness
Drowsiness
Drug rash with eosinophilia and systemic symptoms (DRESS)
Dry mouth
Dysarthria
Dyskinesia
Dyspepsia
Erythema
Euphoria
Falls
Fatigue
Feeling drunk
Flatulence
Gait abnormality
Hallucinations
Headache
Hypersensitivity reactions
Hypoaesthesia
Impaired co-ordination
Impaired memory
Increases in hepatic enzymes
Insomnia
Irritability
Laceration
Loss of balance
Muscle spasm
Myoclonus
Nausea
Nystagmus
Paraesthesia
Prolongation of PR interval
Pruritus
Psychotic disorder
Rash
Seizures
Somnolence
Stevens-Johnson syndrome
Suicidal tendencies
Syncope
Tinnitus
Toxic epidermal necrolysis
Tremor
Urticaria
Ventricular tachyarrhythmias
Vertigo
Vomiting
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: September 2014
Reference Sources
Summary of Product Characteristics: Eplaid 50mg, 100mg, 150mg and 200mg film coated tablets. Dr. Reddy's Laboratories Ltd. Revised August 2022.
Summary of Product Characteristics: Vimpat 50mg, 100mg, 150mg and 200mg film coated tablets. UCB Pharma Ltd. Revised June 2022.
Summary of Product Characteristics: Vimpat 10mg/ml syrup. UCB Pharma Ltd. Revised June 2022.
MHRA Drug Safety Update Vol 2, Issue 1, August 2008
Antiepileptics: risk of suicidal thoughts and behaviour
Available at: www.mhra.gov.uk/Publications/Safetyguidance/DrugSafetyUpdate/CON023078
Last accessed: 3 September 2008
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