Formulary
Lacosamide: Indications, Dosing, Side Effects and Interactions
Lacosamide clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 10 min read
Lacosamide: Indications, Dosing, Side Effects and Interactions
Lacosamide clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Monotherapy of focal seizures with or without secondary generalisation**
- **Child** (By Mouth, Or By Intravenous Infusion): 2-17 years (body-weight 40-49 kg) Initially 1 mg/kg twice daily, then increased to 2 mg/kg twice daily after 1 week; increased in steps of 1 mg/kg twice daily (max. per dose 5 mg/kg twice daily) if necessary and if tolerated, dose to be increased at weekly intervals.
- **Adult** (By Mouth, Or By Intravenous Infusion): Initially 50 mg twice daily, then increased to 100 mg twice daily after 1 week, alternatively initially 100 mg twice daily; increased in steps of 50 mg twice daily (max. per dose 300 mg twice daily) if necessary and if tolerated, dose to be increased at weekly intervals.
**Monotherapy of focal seizures with or without secondary generalisation (alternative loading dose regimen when it is necessary to rapidly attain therapeutic plasma concentrations) (under close medical supervision)**
- **Child** (By Mouth, Or By Intravenous Infusion): (body-weight 50 kg and above) Loading dose 200 mg, followed by 100 mg twice daily, to be given 12 hours after initial dose; increased in steps of 50 mg twice daily (max. per dose 300 mg twice daily) if necessary and if tolerated, dose to be increased at weekly intervals.
- **Adult** (By Mouth, Or By Intravenous Infusion): Loading dose 200 mg, followed by 100 mg twice daily, to be given 12 hours after initial dose; increased in steps of 50 mg twice daily (max. per dose 300 mg twice daily) if necessary and if tolerated, dose to be increased at weekly intervals.
**Adjunctive treatment of focal seizures with or without secondary generalisation**
- **Child** (By Mouth, Or By Intravenous Infusion): 2-17 years (body-weight 30-49 kg) Initially 1 mg/kg twice daily, then increased to 2 mg/kg twice daily after 1 week; increased in steps of 1 mg/kg twice daily (max. per dose 4 mg/kg twice daily) if necessary and if tolerated, dose to be increased at weekly intervals.
- **Adult** (By Mouth, Or By Intravenous Infusion): Initially 50 mg twice daily, then increased to 100 mg twice daily after 1 week; increased in steps of 50 mg twice daily (max. per dose 200 mg twice daily) if necessary and if tolerated, dose to be increased at weekly intervals.
**Adjunctive treatment of primary generalised tonic-clonic seizures**
- **Child** (By Mouth, Or By Intravenous Infusion): 4-17 years (body-weight 30-49 kg) Initially 1 mg/kg twice daily, then increased to 2 mg/kg twice daily after 1 week; increased in steps of 1 mg/kg twice daily (max. per dose 4 mg/kg twice daily) if necessary and if tolerated, dose to be increased at weekly intervals.
- **Adult** (By Mouth, Or By Intravenous Infusion): Initially 50 mg twice daily, then increased to 100 mg twice daily after 1 week; increased in steps of 50 mg twice daily (max. per dose 200 mg twice daily) if necessary and if tolerated, dose to be increased at weekly intervals.
**Adjunctive treatment of focal seizures with or without secondary generalisation (alternative loading dose regimen when it is necessary to rapidly attain therapeutic plasma concentrations) (under close medical supervision),Adjunctive treatment of primary generalised tonic-clonic seizures (alternative loading dose regimen when it is necessary to rapidly attain therapeutic plasma concentrations) (under close medical supervision)**
- **Child** (By Mouth, Or By Intravenous Infusion): (body-weight 50 kg and above) Loading dose 200 mg, followed by 100 mg twice daily, to be given 12 hours after initial dose; increased in steps of 50 mg twice daily (max. per dose 200 mg twice daily) if necessary and if tolerated, dose to be increased at weekly intervals.
- **Adult** (By Mouth, Or By Intravenous Infusion): Loading dose 200 mg, followed by 100 mg twice daily, to be given 12 hours after initial dose; increased in steps of 50 mg twice daily (max. per dose 200 mg twice daily) if necessary and if tolerated, dose to be increased at weekly intervals.
**Monotherapy of focal seizures with or without secondary generalisation for lacosamide**
- **Child (body-weight 50 kg and above)** (By mouth, or by intravenous infusion): Initially 50 mg twice daily, then increased to 100 mg twice daily after 1 week, alternatively initially 100 mg twice daily; increased in steps of 50 mg twice daily (max. per dose 300 mg twice daily) if necessary and if tolerated, dose to be increased at weekly intervals.
- **Child 2-17 years (body-weight 10-39 kg)** (By mouth, or by intravenous infusion): Initially 1 mg/kg twice daily, then increased to 2 mg/kg twice daily after 1 week; increased in steps of 1 mg/kg twice daily (max. per dose 6 mg/kg twice daily) if necessary and if tolerated, dose to be increased at weekly intervals.
- **Child 2-17 years (body-weight 40-49 kg)** (By mouth, or by intravenous infusion): Initially 1 mg/kg twice daily, then increased to 2 mg/kg twice daily after 1 week; increased in steps of 1 mg/kg twice daily (max. per dose 5 mg/kg twice daily) if necessary and if tolerated, dose to be increased at weekly intervals.
**Monotherapy of focal seizures with or without secondary generalisation (alternative loading dose regimen when it is necessary to rapidly attain therapeutic plasma concentrations) (under close medical supervision) for lacosamide**
- **Child (body-weight 50 kg and above)** (By mouth, or by intravenous infusion): Loading dose 200 mg, followed by 100 mg twice daily, to be given 12 hours after initial dose; increased in steps of 50 mg twice daily (max. per dose 300 mg twice daily) if necessary and if tolerated, dose to be increased at weekly intervals.
**Adjunctive treatment of focal seizures with or without secondary generalisation for lacosamide**
- **Child (body-weight 50 kg and above)** (By mouth, or by intravenous infusion): Initially 50 mg twice daily, then increased to 100 mg twice daily after 1 week; increased in steps of 50 mg twice daily (max. per dose 200 mg twice daily) if necessary and if tolerated, dose to be increased at weekly intervals.
- **Child 2-17 years (body-weight 10-19 kg)** (By mouth, or by intravenous infusion): Initially 1 mg/kg twice daily, then increased to 2 mg/kg twice daily after 1 week; increased in steps of 1 mg/kg twice daily (max. per dose 6 mg/kg twice daily) if necessary and if tolerated, dose to be increased at weekly intervals.
- **Child 2-17 years (body-weight 20-29 kg)** (By mouth, or by intravenous infusion): Initially 1 mg/kg twice daily, then increased to 2 mg/kg twice daily after 1 week; increased in steps of 1 mg/kg twice daily (max. per dose 5 mg/kg twice daily) if necessary and if tolerated, dose to be increased at weekly intervals.
- **Child 2-17 years (body-weight 30-49 kg)** (By mouth, or by intravenous infusion): Initially 1 mg/kg twice daily, then increased to 2 mg/kg twice daily after 1 week; increased in steps of 1 mg/kg twice daily (max. per dose 4 mg/kg twice daily) if necessary and if tolerated, dose to be increased at weekly intervals.
**Adjunctive treatment of primary generalised tonic-clonic seizures for lacosamide**
- **Child (body-weight 50 kg and above)** (By mouth, or by intravenous infusion): Initially 50 mg twice daily, then increased to 100 mg twice daily after 1 week; increased in steps of 50 mg twice daily (max. per dose 200 mg twice daily) if necessary and if tolerated, dose to be increased at weekly intervals.
- **Child 4-17 years (body-weight 10-19 kg)** (By mouth, or by intravenous infusion): Initially 1 mg/kg twice daily, then increased to 2 mg/kg twice daily after 1 week; increased in steps of 1 mg/kg twice daily (max. per dose 6 mg/kg twice daily) if necessary and if tolerated, dose to be increased at weekly intervals.
- **Child 4-17 years (body-weight 20-29 kg)** (By mouth, or by intravenous infusion): Initially 1 mg/kg twice daily, then increased to 2 mg/kg twice daily after 1 week; increased in steps of 1 mg/kg twice daily (max. per dose 5 mg/kg twice daily) if necessary and if tolerated, dose to be increased at weekly intervals.
- **Child 4-17 years (body-weight 30-49 kg)** (By mouth, or by intravenous infusion): Initially 1 mg/kg twice daily, then increased to 2 mg/kg twice daily after 1 week; increased in steps of 1 mg/kg twice daily (max. per dose 4 mg/kg twice daily) if necessary and if tolerated, dose to be increased at weekly intervals.
**Adjunctive treatment of focal seizures with or without secondary generalisation (alternative loading dose regimen when it is necessary to rapidly attain therapeutic plasma concentrations) (under close medical supervision), Adjunctive treatment of primary generalised tonic-clonic seizures (alternative loading dose regimen when it is necessary to rapidly attain therapeutic plasma concentrations) (under close medical supervision) for lacosamide**
- **Child (body-weight 50 kg and above)** (By mouth, or by intravenous infusion): Loading dose 200 mg, followed by 100 mg twice daily, to be given 12 hours after initial dose; increased in steps of 50 mg twice daily (max. per dose 200 mg twice daily) if necessary and if tolerated, dose to be increased at weekly intervals.
Cautions
Conduction problems; elderly (in adults); risk of PR-interval prolongation; seizures (may be exacerbated); severe cardiac disease Cautions, further information Seizure exacerbation Lacosamide may exacerbate seizures in patients with Dravet syndrome and Lennox-Gastaut syndrome. A
Contraindications
Second- or third-degree AV block
Side effects
Common or very common Asthenia; cognitive disorder; concentration impaired; confusion; constipation; depression; diarrhoea; dizziness; drowsiness; dry mouth; dysarthria; dyspepsia; feeling drunk; flatulence; gait abnormal; headache; insomnia; memory impairment; mood altered; movement disorders; muscle spasms; myoclonic seizure; nausea; nystagmus; sensation abnormal; skin reactions; tinnitus; tremor; vertigo; vision disorders; vomiting Uncommon Agitation; angioedema; arrhythmias; atrioventricular block; behaviour abnormal; hallucination; psychotic disorder; suicidal behaviours; syncope Frequency not known Agranulocytosis; appetite decreased (in children); fever (in children); increased risk of infection (in children); severe cutaneous adverse reactions (SCARs)
Interactions
**Severe interactions:**
- The CYP2C19 inhibitor omeprazole (40 mg once daily) did not give rise to a clinically significant change in lacosamide exposure.
- Antiepileptic medicinal products In interaction studies lacosamide did not significantly affect the plasma concentrations of carbamazepine and valproic acid.
**Other interactions (20):**
- Lacosamide should be used with caution in patients treated with medicinal products known to be associated with PR prolongation (including sodium channel blocking antiepileptic medicinal products)...
- However, subgroup analysis in clinical studies did not identify an increased magnitude of PR prolongation in patients with concomitant administration of carbamazepine or lamotrigine.
- In vitro data Data generally suggest that lacosamide has a low interaction potential.
- In vitro studies indicate that the enzymes CYP1A2, CYP2B6, and CYP2C9 are not induced and that CYP1A1, CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2D6, and CYP2E1 are not inhibited by lacosamide at...
- An in vitro study indicated that lacosamide is not transported by P-glycoprotein in the intestine.
- In vivo data Lacosamide does not inhibit or induce CYP2C19 and CYP3A4 to a clinically relevant extent.
Pregnancy
Important safety information For lacosamide MHRA/CHM advice: Antiepileptics: risk of suicidal thoughts and behaviour (August 2008) See Epilepsy . MHRA/CHM advice: Antiepileptic drugs: updated advice on switching between different manufacturers' products (November 2017) See Epilepsy . MHRA/CHM advice: Antiepileptic drugs in pregnancy: updated advice following comprehensive safety review (January 2021) See Epilepsy .
Breast feeding
Specialist sources indicate use with caution only if no suitable alternative-present in milk; monitor infant neurodevelopment and monitor infant for adverse effects.
Hepatic impairment
Manufacturer advises caution (risk of increased exposure), particularly in severe impairment (no information available). Dose adjustments Manufacturer advises consider dose reduction-consult product literature.
Renal impairment
Dose adjustments Dose reduction may be required (consult product literature). M
Medicinal forms
Tablet,Solution,Solution
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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