Dosing & Uses
Dosage Forms & Strengths
tablet: Schedule V
- 50mg
- 100mg
- 150mg
- 200mg
injectable solution: Schedule V
- 200mg/20mL
oral solution: Schedule V
- 10mg/mL
Partial Onset Seizures
Indicated as monotherapy or adjunctive therapy for partial onset seizures
Monotherapy
- 100 mg PO/IV q12hr initially, THEN, based on response and tolerability, increase dose at weekly intervals by 50 mg PO/IV BID; up to a recommended dose of 150-200 mg BID (300-400 mg/day) OR
- Alternate initial loading dose schedule: 200 mg PO/IV as a single loading dose, followed 12 hr later by 100 mg PO/IV BID; THEN increase dose at weekly intervals by 50 mg BID; up to a recommended dose of 150-200 mg BID (300-400 mg/day)
Adjunctive therapy
- Initial: 50 mg PO/IV q12hr
- Based on response and tolerability, increase dose at weekly intervals by 50 mg PO/IV BID; up to a recommended dose of 100-200 mg BID (200-400 mg/day)
Conversion from single AED to lacosamide monotherapy
- Maintain lacosamide at recommended maintenance dose for at least 3 days before initiating withdrawal of the previous AED
- Patients currently treated with a single antiepileptic (AED) who will convert to lacosamide monotherapy, withdrawal of the concomitant AED should not occur until the therapeutic dosage of lacosamide is achieved and has been administered for at least 3 days
- Gradual withdrawal of the initial AED over at least 6 weeks is recommended
- When discontinuing lacosamide, gradually withdraw treatment over at least 1 week is recommended
Primary Generalized Tonic-Clonic Seizures
Indicated as adjunctive therapy for primary generalized tonic-clonic seizures
Initial: 50 mg PO/IV q12hr
Based on response and tolerability, increase dose at weekly intervals by 50 mg PO/IV BID; up to a recommended dose of 100-200 mg BID (200-400 mg/day)
Dosage Modifications
Renal impairment
- Mild-to-moderate: no dose adjustment required
- Severe (CrCl <30 mL/min) or ESRD: Reduce maximum dosage by 25%
- Hemodialysis: Consider supplementing with up to 50% of dose after 4-hr dialysis session
- Coadministration with strong CYP3A4 or CYP2C9 inhibitors: Lacosamide systemic exposure may increase; consider dose reduction
Hepatic impairment
- Mild-to-moderate: No dose adjustment required
- Severe: Not recommended
- Coadministration with strong CYP3A4 or CYP2C9 inhibitors: Lacosamide systemic exposure may increase; consider dose reduction
Dosing Considerations
IV administration indicated as short-term replacement (up to 5 consecutive days) when PO administration is not feasible
Dosage Forms & Strengths
tablet: Schedule V
- 50mg
- 100mg
- 150mg
- 200mg
injectable solution: Schedule V
- 200mg/20mL
oral solution: Schedule V
- 10mg/mL
Partial Onset Seizures
Indicated as monotherapy or adjunctive therapy for partial-onset seizures in children aged ≥1 month
<1 month: Safety and efficacy not established
1 month to 17 years
-
<6 kg:
- Intravenous: 0.66 mg/kg TID, THEN, based on response and tolerability, increase dose at weekly intervals by 0.66 mg/kg TID; up to a recommended 2.5-5 mg/kg TID (7.5-15 mg/kg/day)
- Oral: 1 mg/kg BID (2 mg/kg/day), THEN, based on response and tolerability, increase dose at weekly intervals by 1 mg/kg BID (2 mg/kg/day), up to 3.75-7.5 mg/kg BID (7.5-15 mg/kg/day)
- 6 to <30 kg: 1 mg/kg PO/IV BID, THEN, based on response and tolerability, increase dose at weekly intervals by 1 mg/kg PO/IV BID, up to recommended 3-6 mg/kg PO/IV BID (6-12 mg/kg/day)
- 30 to <50 kg: 1 mg/kg PO/IV BID, THEN, based on response and tolerability, increase dose at weekly intervals by 1 mg/kg PO/IV BID, up to recommended 2-4 mg/kg PO BID (4-8 mg/kg/day)
- ≥50 kg: 50 mg PO/IV BID, THEN, based on response and tolerability, increase dose at weekly intervals by 50 mg PO/IV BID, up to recommended 150-200 mg PO/IV BID (300-400 mg/day) for monotherapy or 100-200 mg PO/IV BID (200-400 mg/day) for adjunctive therapy
Conversion from single AED to lacosamide monotherapy
- Maintain lacosamide at recommended maintenance dose for at least 3 days before initiating withdrawal of the previous AED
- Patients currently treated with a single antiepileptic (AED) who will convert to lacosamide monotherapy, withdrawal of the concomitant AED should not occur until the therapeutic dosage of lacosamide is achieved and has been administered for at least 3 days
- Gradual withdrawal of the initial AED over at least 6 weeks is recommended
- When discontinuing lacosamide, gradually withdraw treatment over at least 1 week is recommended
Primary Generalized Tonic-Clonic Seizures
Indicated as adjunctive therapy for primary generalized tonic-clonic seizures in patients aged ≥4 years with idiopathic generalized epilepsy
<4 years: Safety and efficacy not established
4-17 years
- 11 to <30 kg: 1 mg/kg PO/IV BID, THEN, based on response and tolerability, increase dose at weekly intervals by 1 mg/kg PO/IV BID, up to recommended 3-6 mg/kg PO/IV BID (6-12 mg/kg/day)
- 30 to <50 kg: 1 mg/kg PO/IV BID, THEN, based on response and tolerability, increase dose at weekly intervals by 1 mg/kg PO/IV BID, up to recommended 2-4 mg/kg PO/IV BID (4-8 mg/kg/day)
- ≥50 kg: 50 mg PO/IV BID, THEN, based on response and tolerability, increase dose at weekly intervals by 50 mg PO/IV BID, up to recommended 150-200 mg PO/IV BID (300-400 mg/day) for monotherapy or 100-200 mg PO/IV BID (200-400 mg/day) for adjunctive therapy
Dosage Modifications
Renal impairment
- Mild-to-moderate: no dose adjustment required
- Severe (CrCl <30 mL/min) or ESRD: Reduce maximum dosage by 25%
- Hemodialysis: Consider supplementing with up to 50% of dose after 4-hr dialysis session
- Coadministration with strong CYP3A4 or CYP2C9 inhibitors: Lacosamide systemic exposure may increase; consider dose reduction
Hepatic impairment
- Mild-to-moderate: No dose adjustment required
- Severe: Not recommended
- Coadministration with strong CYP3A4 or CYP2C9 inhibitors: Lacosamide systemic exposure may increase; consider dose reduction
Dosing Considerations
IV administration indicated as short-term replacement (up to 5 consecutive days) when PO administration is not feasible
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (9)
- abametapir
abametapir will increase the level or effect of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For 2 weeks after abametapir application, avoid taking drugs that are CYP3A4 substrates. If not feasible, avoid use of abametapir.
- apalutamide
apalutamide will decrease the level or effect of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. Avoid or substitute another drug for these medications when possible. Evaluate for loss of therapeutic effect if medication must be coadministered. Adjust dose according to prescribing information if needed.
- fexinidazole
fexinidazole will increase the level or effect of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Fexinidazole inhibits CYP3A4. Coadministration may increase risk for adverse effects of CYP3A4 substrates.
- idelalisib
idelalisib will increase the level or effect of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Idelalisib is a strong CYP3A inhibitor; avoid coadministration with sensitive CYP3A substrates
- ivosidenib
ivosidenib will decrease the level or effect of lacosamide by affecting hepatic enzyme CYP2C9/10 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of sensitive CYP2C9 substrates with ivosidenib or replace with alternate therapies. If coadministration is unavoidable, monitor patients for loss of therapeutic effect of these drugs.
- metoclopramide intranasal
lacosamide, metoclopramide intranasal. Either increases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Avoid use of metoclopramide intranasal or interacting drug, depending on importance of drug to patient.
- olopatadine intranasal
lacosamide and olopatadine intranasal both increase sedation. Avoid or Use Alternate Drug. Coadministration increases risk of CNS depression, which can lead to additive impairment of psychomotor performance and cause daytime impairment.
- tucatinib
tucatinib will increase the level or effect of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid concomitant use of tucatinib with CYP3A substrates, where minimal concentration changes may lead to serious or life-threatening toxicities. If unavoidable, reduce CYP3A substrate dose according to product labeling.
- voxelotor
voxelotor will increase the level or effect of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Voxelotor increases systemic exposure of sensitive CYP3A4 substrates. Avoid coadministration with sensitive CYP3A4 substrates with a narrow therapeutic index. Consider dose reduction of the sensitive CYP3A4 substrate(s) if unable to avoid.
Monitor Closely (59)
- alpelisib
alpelisib will decrease the level or effect of lacosamide by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely.
- apalutamide
apalutamide will decrease the level or effect of lacosamide by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Coadministration of apalutamide, a weak CYP2C9 inducer, with drugs that are CYP2C9 substrates can result in lower exposure to these medications. Evaluate for loss of therapeutic effect if medication must be coadministered.
- atazanavir
atazanavir increases effects of lacosamide by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of PR prolongation and cardiac arrhythmias.
atazanavir increases levels of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP3A4 inhibitors. - cannabidiol
cannabidiol will increase the level or effect of lacosamide by decreasing metabolism. Modify Therapy/Monitor Closely. Cannabidiol may potentially inhibit CYP2C9 activity. Consider reducing the dose when concomitantly using CYP2C9 substrates.
- capecitabine
capecitabine increases levels of lacosamide by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP2C9 inhibitors.
- carbamazepine
carbamazepine will decrease the level or effect of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- cenobamate
cenobamate will decrease the level or effect of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Increase dose of CYP3A4 substrate, as needed, when coadministered with cenobamate.
- clarithromycin
clarithromycin increases levels of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP3A4 inhibitors.
- conivaptan
conivaptan increases levels of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP3A4 inhibitors.
- daridorexant
lacosamide and daridorexant both increase sedation. Modify Therapy/Monitor Closely. Coadministration increases risk of CNS depression, which can lead to additive impairment of psychomotor performance and cause daytime impairment.
- darunavir
darunavir increases levels of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP3A4 inhibitors.
- deutetrabenazine
lacosamide and deutetrabenazine both increase sedation. Use Caution/Monitor.
- difelikefalin
difelikefalin and lacosamide both increase sedation. Use Caution/Monitor.
- elagolix
elagolix decreases levels of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Elagolix is a weak-to-moderate CYP3A4 inducer. Monitor CYP3A substrates if coadministered. Consider increasing CYP3A substrate dose if needed.
- elvitegravir/cobicistat/emtricitabine/tenofovir DF
elvitegravir/cobicistat/emtricitabine/tenofovir DF increases levels of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP3A4 inhibitors.
- eslicarbazepine acetate
eslicarbazepine acetate will increase the level or effect of lacosamide by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.
- fedratinib
fedratinib will increase the level or effect of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP3A4 substrates as necessary.
- fluconazole
fluconazole increases levels of lacosamide by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP2C9 inhibitors.
- fluorouracil
fluorouracil increases levels of lacosamide by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP2C9 inhibitors.
- flurbiprofen
flurbiprofen increases levels of lacosamide by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP2C9 inhibitors.
- fosamprenavir
fosamprenavir increases levels of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP3A4 inhibitors.
- fosphenytoin
fosphenytoin will decrease the level or effect of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- gemfibrozil
gemfibrozil increases levels of lacosamide by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP2C9 inhibitors.
- ibuprofen
ibuprofen increases levels of lacosamide by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP2C9 inhibitors.
- ibuprofen IV
ibuprofen IV increases levels of lacosamide by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP2C9 inhibitors.
- imatinib
imatinib increases levels of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP3A4 inhibitors.
- indinavir
indinavir increases levels of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP3A4 inhibitors.
- indomethacin
indomethacin increases levels of lacosamide by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP2C9 inhibitors.
- isoniazid
isoniazid increases levels of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP3A4 inhibitors.
- istradefylline
istradefylline will increase the level or effect of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of CYP3A4 substrates in clinical trials. This effect was not observed with istradefylline 20 mg/day. Consider dose reduction of sensitive CYP3A4 substrates.
- itraconazole
itraconazole increases levels of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP3A4 inhibitors.
- ketoconazole
ketoconazole increases levels of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Patients with renal or hepatic impairment who are taking strong CYP3A4 and CYP2C9 inhibitors may have a significant increase in exposure to lacosamide. Dose reduction may be necessary in these patients.
ketoconazole increases levels of lacosamide by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely. Patients with renal or hepatic impairment who are taking strong CYP3A4 and CYP2C9 inhibitors may have a significant increase in exposure to lacosamide. Dose reduction may be necessary in these patients. - levoketoconazole
levoketoconazole increases levels of lacosamide by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely. Patients with renal or hepatic impairment who are taking strong CYP3A4 and CYP2C9 inhibitors may have a significant increase in exposure to lacosamide. Dose reduction may be necessary in these patients.
levoketoconazole increases levels of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Patients with renal or hepatic impairment who are taking strong CYP3A4 and CYP2C9 inhibitors may have a significant increase in exposure to lacosamide. Dose reduction may be necessary in these patients. - lopinavir
lopinavir increases levels of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP3A4 inhibitors.
- lumacaftor/ivacaftor
lumacaftor/ivacaftor, lacosamide. affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. In vitro studies suggest that lumacaftor may induce and ivacaftor may inhibit CYP2C9 substrates. .
- mefenamic acid
mefenamic acid increases levels of lacosamide by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP2C9 inhibitors.
- methylphenidate transdermal
methylphenidate transdermal will increase the level or effect of lacosamide by decreasing metabolism. Modify Therapy/Monitor Closely. Consider decreasing the dose of these drugs when given coadministered with methylphenidate. Monitor for drug toxiticities when initiating or discontinuing methylphenidate.
- midazolam intranasal
midazolam intranasal, lacosamide. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Concomitant use of barbiturates, alcohol, or other CNS depressants may increase the risk of hypoventilation, airway obstruction, desaturation, or apnea and may contribute to profound and/or prolonged drug effect.
- mifepristone
mifepristone will increase the level or effect of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- mitotane
mitotane decreases levels of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Mitotane is a strong inducer of cytochrome P-4503A4; monitor when coadministered with CYP3A4 substrates for possible dosage adjustments.
- nefazodone
nefazodone increases levels of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP3A4 inhibitors.
- nelfinavir
nelfinavir, lacosamide. Either increases levels of the other by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP3A4 inhibitors.
- nicardipine
nicardipine, lacosamide. Either increases levels of the other by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP3A4 inhibitors.
nicardipine increases levels of lacosamide by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP2C9 inhibitors. - nitisinone
nitisinone will increase the level or effect of lacosamide by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Nitisinone inhibits CYP2C9. Caution if CYP2C9 substrate coadministered, particularly those with a narrow therapeutic index.
- orlistat
orlistat decreases levels of lacosamide by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Risk of convulsions.
- piroxicam
piroxicam increases levels of lacosamide by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP2C9 inhibitors.
- posaconazole
posaconazole, lacosamide. Either increases levels of the other by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP3A4 inhibitors.
- quinidine
quinidine, lacosamide. Either increases levels of the other by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP3A4 inhibitors.
- ritonavir
ritonavir increases levels of lacosamide by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Potential for increased toxicity. Use alternatives if available. Increased risk of PR prolongation and cardiac arrhythmias.
ritonavir, lacosamide. Either increases levels of the other by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP3A4 inhibitors. - saquinavir
saquinavir increases levels of lacosamide by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Potential for increased toxicity. Use alternatives if available. Increased risk of PR prolongation and cardiac arrhythmias.
saquinavir increases levels of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP3A4 inhibitors. - sevelamer
sevelamer decreases levels of lacosamide by increasing elimination. Use Caution/Monitor.
- stiripentol
stiripentol, lacosamide. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Stiripentol is a CYP3A4 inhibitor and inducer. Monitor CYP3A4 substrates coadministered with stiripentol for increased or decreased effects. CYP3A4 substrates may require dosage adjustment.
- sulfadiazine
sulfadiazine increases levels of lacosamide by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP2C9 inhibitors.
- sulfamethoxazole
sulfamethoxazole increases levels of lacosamide by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP2C9 inhibitors.
- tazemetostat
tazemetostat will decrease the level or effect of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- tecovirimat
tecovirimat will decrease the level or effect of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Tecovirimat is a weak CYP3A4 inducer. Monitor sensitive CYP3A4 substrates for effectiveness if coadministered.
- tipranavir
tipranavir increases levels of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP3A4 inhibitors.
- tolbutamide
tolbutamide increases levels of lacosamide by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP2C9 inhibitors.
- voriconazole
voriconazole increases levels of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP3A4 inhibitors.
voriconazole increases levels of lacosamide by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely. Consider decreasing lacosamide dose when coadministered with strong CYP2C9 inhibitors.
Minor (18)
- acetaminophen
lacosamide decreases levels of acetaminophen by increasing metabolism. Minor/Significance Unknown. Enhanced metabolism incr levels of hepatotoxic metabolites.
- acetaminophen IV
lacosamide decreases levels of acetaminophen IV by increasing metabolism. Minor/Significance Unknown. Enhanced metabolism incr levels of hepatotoxic metabolites.
- acetaminophen rectal
lacosamide decreases levels of acetaminophen rectal by increasing metabolism. Minor/Significance Unknown. Enhanced metabolism incr levels of hepatotoxic metabolites.
- atracurium
lacosamide decreases effects of atracurium by pharmacodynamic antagonism. Minor/Significance Unknown.
- biotin
lacosamide decreases levels of biotin by unspecified interaction mechanism. Minor/Significance Unknown. Biotin supplementation may be necessary.
- cisatracurium
lacosamide decreases effects of cisatracurium by pharmacodynamic antagonism. Minor/Significance Unknown.
- cyanocobalamin
lacosamide decreases levels of cyanocobalamin by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.
- dexmethylphenidate
dexmethylphenidate increases effects of lacosamide by decreasing metabolism. Minor/Significance Unknown.
- levocarnitine
lacosamide decreases levels of levocarnitine by unspecified interaction mechanism. Minor/Significance Unknown.
- onabotulinumtoxinA
lacosamide decreases effects of onabotulinumtoxinA by pharmacodynamic antagonism. Minor/Significance Unknown.
- pancuronium
lacosamide decreases effects of pancuronium by pharmacodynamic antagonism. Minor/Significance Unknown.
- rapacuronium
lacosamide decreases effects of rapacuronium by pharmacodynamic antagonism. Minor/Significance Unknown.
- ribociclib
ribociclib will increase the level or effect of lacosamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- rocuronium
lacosamide decreases effects of rocuronium by pharmacodynamic antagonism. Minor/Significance Unknown.
- sage
sage decreases effects of lacosamide by pharmacodynamic antagonism. Minor/Significance Unknown. Theoretical interaction; some species of sage may cause convulsions.
- serdexmethylphenidate/dexmethylphenidate
serdexmethylphenidate/dexmethylphenidate increases effects of lacosamide by decreasing metabolism. Minor/Significance Unknown.
- succinylcholine
lacosamide decreases effects of succinylcholine by pharmacodynamic antagonism. Minor/Significance Unknown.
- vecuronium
lacosamide decreases effects of vecuronium by pharmacodynamic antagonism. Minor/Significance Unknown.
Adverse Effects
>10%
Tablets and oral solution
- Dizziness (16-53%)
- Diplopia (6-16%)
- Blurred vision (2-16%)
- Nausea (7-17%)
- Vomiting (6-16%)
- Fatigue (7-15%)
- Ataxia (11-14%)
- Nystagmus (2-10%)
IV
- Fatigue (20-63%)
- Somnolence (26-34%)
- Headache (4-16%)
- Diplopia (4-20%)
- Nausea (14-24%)
- Dry mouth (6-12%)
- Vomiting (4-12%)
- Fatigue (12-18%)
- Chest pain (3-12%)
1-10%
Tablets and oral solution
- Nystagmus (2-10%)
- Memory impairment (1-6%)
- Balance disorder (1-6%)
- Diarrhea (3-5%)
- Gait disturbance (<1-4%)
- Asthenia (1-3%)
- Vertigo (1-4%)
- Pruritus (2-3%)
- Depression (2%)
IV
- Oral paresthesia (4-8%)
- Oral hypoesthesia (5-8%)
- Diarrhea (4-8%)
- Paresthesia (4-8%)
- Gait disturbance (2-8%)
- Hyperhidrosis (2-8%)
- Tremor (4-6%)
- Abnormal coordination (3-6%)
- Pruritus (4-6%)
Frequency Not Reported
Blood and lymphatic system disorders: Neutropenia, anemia
Cardiac disorders: Palpitations Ear and labyrinth disorders: Tinnitus
Gastrointestinal disorders: Constipation, dyspepsia, dry mouth, oral hypoaesthesia
General disorders and administration site conditions: Irritability, pyrexia, feeling drunk
Injury, poisoning, and procedural complications: Fall
Musculoskeletal and connective tissue disorders: Muscle spasms
Nervous system disorders: Paresthesia, cognitive disorder, hypesthesia, dysarthria, disturbance in attention, cerebellar syndrome
Psychiatric disorders: Confusional state, mood altered, depressed mood
Postmarketing Reports
Blood and lymphatic system disorders: Agranulocytosis
Psychiatric disorders: Aggression, agitation, hallucination, insomnia, psychotic disorder
Neurologic disorders: New or worsening seizures, dyskinesia
Skin and subcutaneous tissue disorders: Angioedema, rash, urticaria, Stevens-Johnson syndrome, toxic epidermal necrolysis
Warnings
Contraindications
None
Cautions
Increase the risk of suicidal thoughts or behavior; monitor for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior
Dizziness and ataxia reported; may impair ability to perform hazardous tasks
Blurred vision and diplopia may occur during therapy; consider increased monitoring in patients with preexisting ocular conditions or vision-related issues
Oral solution contains aspartame, a source of phenylalanine; 200 mg dose (20 mL) contains 0.32 mg of phenylalanine
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multi-organ hypersensitivity, reported with antiepileptic drugs; some of these events have been fatal or life- threatening; monitor for signs and symptoms of possible disparate manifestations associated with lymphatic hepatic, renal, and/or hematologic organ systems; may require gradual discontinuation and conversion to alternate therapy
Use caution in renal and hepatic impairment; dosage adjustments may be required
Withdraw gradually over 1 week; do not discontinue abruptly because of risk for increased frequency of seizures
Cardiac rhythm and conduction
- Both atrial fibrillation and atrial flutter reported in open label partial-onset seizure trials and in postmarketing experience; therapy may predispose to atrial arrhythmias (atrial fibrillation or flutter), especially in patients with diabetic neuropathy and/or cardiovascular diseaseCardiac arrhythmias reported, including bradycardia, AV block, and ventricular tachyarrhythmia, which have rarely resulted in asystole, cardiac arrest, and death
- Most, although not all, cases occurred in patients with underlying proarrhythmic conditions, or in those taking concomitant medications that affect cardiac conduction or prolong the PR interval
- Events occurred with both PO or IV administration and at prescribed doses, as well as in the setting of overdose
- Caution with underlying proarrhythmic conditions (eg, marked first-degree AV block, second-degree or higher AV block and sick sinus syndrome without pacemaker), severe cardiac disease, including myocardial ischemia or heart failure, or structural heart disease, and cardiac sodium disorders (eg, Brugada Syndrome)
Drug interactions overview
- Patients with renal or hepatic impairment who are taking strong CYP3A4 and CYP2C9 inhibitors may have a significant increase in exposure to lacosamide; dose reduction may be necessary
-
Concomitant medications that prolong PR interval
- Use with caution when administered concomitantly with medications that affect cardiac conduction, including sodium channel blockers, beta-blockers, calcium channel blockers, potassium channel blockers, and medications that prolong the PR interval; obtain an ECG before beginning therapy, and after titrating to steady-state maintenance dose, in such patients; closely monitor if intravenous route used to administer medication
- Obtain an ECG before initiating and after titrated to steady-state; additionally, monitor closely if administered IV
Pregnancy & Lactation
Pregnancy
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs); to enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/
Available data from NAAED pregnancy registry, a prospective cohort study, case reports, and a case series in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes
Lacosamide produced developmental toxicity (increased embryofetal and perinatal mortality, growth deficit) in rats following administration during pregnancy
Developmental neurotoxicity was observed in rats following administration during a period of postnatal development corresponding to the third trimester of human pregnancy
Lactation
Data from published literature indicate that lacosamide is present in human milk; there are reports of increased sleepiness in breastfed infants exposed to lacosamide; there is no information on effects of lacosamide on milk production
Studies in lactating rats have shown excretion of lacosamide and/or its metabolites in milk
Developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for lacosamide and any potential adverse effects on the breastfed infant from lacosamide or from the underlying maternal condition
Monitor infants exposed to drugs through breastmilk for excess sedation
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Antiepileptic effects unknown; may slowly inactivate voltage-gated Na channels
Binds to collapsin response mediator protein-2 (CRMP-2), a phosphoprotein that is expressed mainly in the nervous system and is involved in neuronal differentiation and control of axonal outgrowth
Absorption
Bioavailability: ~100%
Peak plasma time: 1-4 hr
Distribution
Protein bound: <15%
Vd: 0.6 L/kg
Metabolism
Predominantly by CYP isoenzymes 3A4 and 2C9; also 2C19
Major metabolite: O-desmethyl-lacosamide (inactive)
Elimination
Half-life: 13 hr
Primarily eliminated by renal excretion and biotransformation
Excretion: 95% urine; <5% feces
Dialyzable: Yes (hemodialysis)
Administration
IV Compatibility
0.9% NaCl, D5W, LR
IV Preparation
May be administered without dilution or diluted in compatible solutions; (see IV Compatibility)
Visually inspect for particulate matter and discoloration prior to administration, whenever solution and container permit
Product with particulate matter or discoloration should not be used
Vials is for single-dose only; discard any unused portion of lacosamide injection
IV Administration
IV lacosamide may cause bradycardia or AV bock in patients with underlying cardiac disease
Monitor infusion closely patients with known cardiac conduction problems, on concomitant medications that prolong PR interval, or with severe cardiac disease (eg, myocardial ischemia, heart failure)
Adults
- Administer by IV infusion over 30-60 minutes
- May administer as rapidly as 15 minutes if needed
Children
- Administer by IV infusion over 30-60 minutes
- Infusion duration <30 minutes not recommended
Oral Administration
Tablets or oral solution: Take with or without food
Swallow tablets whole with liquid; do not divide tablets
Oral solution
- Use calibrated measuring device to measure and deliver the prescribed dose accurately
- May be administered using a nasogastric tube or gastrostomy tube; discard any unused lacosamide oral solution remaining after 6 months of first opening the bottle
Storage
Tablet: Store at room temperature, 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F); do not freeze lacosamide oral solution
Oral solution: Store at room temperature, 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F); do not freeze lacosamide oral solution; discard any unused oral solution remaining after 6 months of first opening the bottle
Injection: Store at room temperature, 20-25°C (68-77°F); excursions are permitted between 15-30°C (59-86°F); do not freeze
Diluted IV solution: Store at room temperature, 20-25°C (68-77°F); for up to 4 hr
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Vimpat intravenous - | 200 mg/20 mL vial |  | |
| lacosamide oral - | 200 mg tablet |  | |
| lacosamide oral - | 50 mg tablet |  | |
| lacosamide oral - | 10 mg/mL solution |  | |
| lacosamide oral - | 200 mg tablet |  | |
| lacosamide oral - | 150 mg tablet |  | |
| lacosamide oral - | 100 mg tablet |  | |
| lacosamide oral - | 50 mg tablet |  | |
| Vimpat oral - | 100 mg tablet |  | |
| Vimpat oral - | 50 mg tablet |  | |
| Vimpat oral - | 150 mg tablet |  | |
| Vimpat oral - | 10 mg/mL solution |  | |
| Vimpat oral - | 10 mg/mL solution |  | |
| Vimpat oral - | 200 mg tablet |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
lacosamide intravenous
NO MONOGRAPH AVAILABLE AT THIS TIME
USES: Consult your pharmacist.
HOW TO USE: Consult your pharmacist.
SIDE EFFECTS: Consult your pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Consult your pharmacist.
DRUG INTERACTIONS: Consult your pharmacist.Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: No monograph available at this time.
MISSED DOSE: Consult your pharmacist.
STORAGE: Consult your pharmacist.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised July 2016. Copyright(c) 2022 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
