Vimpat

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Vimpat

Classes

Anticonvulsants, Miscellaneous

Administration

Administer loading doses with medical supervision due to possible increased risk of central nervous system or cardiovascular adverse reactions.

Oral Administration

May be administered without regard to meals.

Oral Solid Formulations

Immediate-release tablets: Swallow tablets whole with liquid. Do not divide the tablets.[34626]
Extended-release capsules: Swallow capsules whole with liquid. Do not open, chew, or crush the capsules.

Oral Liquid Formulations

Measure dosage with an oral syringe or calibrated measuring device.
May administer through a nasogastric or gastrostomy tube.
Storage: Do not freeze. Discard any unused solution remaining after 6 months of first opening the bottle.[34626]

Injectable Administration

Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.

Intravenous Administration

Intermittent IV Infusion
Administer undiluted or mixed with 0.9% Sodium Chloride Injection, 5% Dextrose Injection, or Lactated Ringer's Injection.
Infuse over 30 to 60 minutes (recommended). Infusions as rapid as 15 minutes can be administered in adults if needed.
Storage: Diluted solution can be stored for up to 4 hours at room temperature.[34626]
 
Intermittent IV Push†
NOTE: Lacosamide is not FDA-approved for administration via IV push.
Undiluted lacosamide has been administered IV in doses of up to 400 mg and at a rate of 40 to 80 mg/minute to patients in status epilepticus.
In a retrospective study of 48 patients (age: 17 to 95 years) in status epileptics, a median bolus dose of 200 mg (range 200 to 400 mg) was administered undiluted at a rate of 60 mg/minute. Two patients reported skin rash and pruritus.[65323]
In a retrospective study of 39 patients (age: 18 to 90 years) in status epilepticus, a median bolus dose of 400 mg (range 200 to 400 mg) was administered undiluted at a rate of 40 to 80 mg/minute. Adverse reactions reported were mild and thought to be due to other medications such as benzodiazepines or propofol (hypotension, sedation, and 1 allergic skin reaction).[65324]
A retrospective cohort study in patients (age: 49 to 69 years) receiving intravenous lacosamide (indication not specified) compared diluted lacosamide infused over 30 minutes (n = 88) to undiluted IV push lacosamide given at a rate of 80 mg/minute (n = 78). Hypotension (8% vs. 10.3%) and bradycardia (2.3% vs. 2.6%) were similar between the 2 groups; no infusion reactions occurred.[65325]

Adverse Reactions
Severe

atrial fibrillation / Early / 0.5-0.5
atrial flutter / Early / 0.5-0.5
AV block / Early / 0.4-0.5
seizures / Delayed / Incidence not known
acute cerebellar syndrome / Early / Incidence not known
suicidal ideation / Delayed / Incidence not known
asystole / Rapid / Incidence not known
ventricular tachycardia / Early / Incidence not known
bradycardia / Rapid / Incidence not known
cardiac arrest / Early / Incidence not known
angioedema / Rapid / Incidence not known
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) / Delayed / Incidence not known
proteinuria / Delayed / Incidence not known
myocarditis / Delayed / Incidence not known
agranulocytosis / Delayed / Incidence not known

Moderate

euphoria / Early / 6.0-25.0
blurred vision / Early / 2.0-16.0
ataxia / Delayed / 4.0-15.0
nystagmus / Delayed / 2.0-10.0
confusion / Early / 2.0-4.0
depression / Delayed / 2.0-2.0
elevated hepatic enzymes / Delayed / 0.7-0.7
erythema / Early / 0.5-0.5
dyskinesia / Delayed / Incidence not known
dysarthria / Delayed / Incidence not known
psychosis / Early / Incidence not known
hallucinations / Early / Incidence not known
constipation / Delayed / Incidence not known
orthostatic hypotension / Delayed / Incidence not known
loss of consciousness / Rapid / Incidence not known
PR prolongation / Rapid / Incidence not known
palpitations / Early / Incidence not known
hepatitis / Delayed / Incidence not known
neutropenia / Delayed / Incidence not known
anemia / Delayed / Incidence not known
psychological dependence / Delayed / Incidence not known

Mild

dizziness / Early / 16.0-53.0
drowsiness / Early / 5.0-17.0
nausea / Early / 7.0-17.0
vomiting / Early / 6.0-16.0
diplopia / Early / 6.0-16.0
fatigue / Early / 7.0-15.0
headache / Early / 11.0-14.0
tremor / Early / 4.0-12.0
vertigo / Early / 3.0-5.0
diarrhea / Early / 3.0-5.0
asthenia / Delayed / 2.0-4.0
gait disturbance / Delayed / 0-4.0
pruritus / Rapid / 2.0-3.0
syncope / Early / 1.2-1.2
hypoesthesia / Delayed / Incidence not known
insomnia / Early / Incidence not known
paresthesias / Delayed / Incidence not known
irritability / Delayed / Incidence not known
agitation / Early / Incidence not known
dyspepsia / Early / Incidence not known
xerostomia / Early / Incidence not known
injection site reaction / Rapid / Incidence not known
urticaria / Rapid / Incidence not known
rash / Early / Incidence not known
fever / Early / Incidence not known
tinnitus / Delayed / Incidence not known
muscle cramps / Delayed / Incidence not known

Common Brand Names

Vimpat

Dea Class

Rx, schedule V

Description

Oral and intravenous functionalized amino acid anticonvulsant
Used for partial onset and generalized tonic-clonic seizures
Clinical study experience of intravenous lacosamide limited to 5 days of consecutive treatment

Dosage And Indications
For the treatment of partial seizures. For the treatment of partial seizures as monotherapy. Oral dosage (immediate-release) Adults

100 mg PO twice daily or alternatively, 200 mg PO as a single dose, then 100 mg PO twice daily starting 12 hours later, initially. May increase the dose by 100 mg/day at weekly intervals based on response and tolerability. Usual dose: 150 to 200 mg PO twice daily. When discontinuing therapy, a gradual withdrawal over at least 1 week is recommended.

Adolescents 17 years

100 mg PO twice daily or alternatively, 200 mg PO as a single dose, then 100 mg PO twice daily starting 12 hours later, initially. May increase the dose by 100 mg/day at weekly intervals based on response and tolerability. Usual dose: 150 to 200 mg PO twice daily. When discontinuing therapy, a gradual withdrawal over at least 1 week is recommended.

Children and Adolescents 1 to 16 years weighing 50 kg or more

50 mg PO twice daily or alternatively, 200 mg PO as a single dose, then 100 mg PO twice daily starting 12 hours later, initially. May increase the dose by 100 mg/day at weekly intervals based on response and tolerability. Usual dose: 150 to 200 mg PO twice daily. When discontinuing therapy, a gradual withdrawal over at least 1 week is recommended.

Children and Adolescents 1 to 16 years weighing 30 to 49 kg

1 mg/kg/dose PO twice daily or alternatively, 4 mg/kg/dose PO as a single dose, then 2 mg/kg/dose PO twice daily starting 12 hours later, initially. May increase the dose by 2 mg/kg/day at weekly intervals based on response and tolerability. Usual dose: 2 to 4 mg/kg/dose PO twice daily. When discontinuing therapy, a gradual withdrawal over at least 1 week is recommended.

Infants, Children, and Adolescents 1 month to 16 years weighing 6 to 29 kg

1 mg/kg/dose PO twice daily or alternatively, 4.5 mg/kg/dose PO as a single dose, then 3 mg/kg/dose PO twice daily starting 12 hours later, initially. May increase the dose by 2 mg/kg/day at weekly intervals based on response and tolerability. Usual dose: 3 to 6 mg/kg/dose PO twice daily. When discontinuing therapy, a gradual withdrawal over at least 1 week is recommended.

Infants weighing less than 6 kg

1 mg/kg/dose PO twice daily or alternatively, 3.75 mg/kg/dose PO twice daily, initially. May increase the dose by 2 mg/kg/day at weekly intervals based on response and tolerability. Usual dose: 3.75 to 7.5 mg/kg/dose PO twice daily. When discontinuing therapy, a gradual withdrawal over at least 1 week is recommended.

Oral dosage (extended-release) Adults

200 mg PO once daily, initially. May increase the dose by 100 mg/day at weekly intervals based on response and tolerability. Usual dose: 300 mg to 400 mg PO once daily. When discontinuing therapy, a gradual withdrawal over at least 1 week is recommended.

Adolescents 17 years

200 mg PO once daily, initially. May increase the dose by 100 mg/day at weekly intervals based on response and tolerability. Usual dose: 300 mg to 400 mg PO once daily. When discontinuing therapy, a gradual withdrawal over at least 1 week is recommended.

Children and Adolescents weighing 50 kg or more

100 mg PO once daily, initially. May increase the dose by 100 mg/day at weekly intervals based on response and tolerability. Usual dose: 300 mg to 400 mg PO once daily. When discontinuing therapy, a gradual withdrawal over at least 1 week is recommended.

Intravenous dosage Adults

100 mg IV twice daily or alternatively, 200 mg IV as a single dose, then 100 mg IV twice daily starting 12 hours later, initially. May increase the dose by 100 mg/day at weekly intervals based on response and tolerability. Usual dose: 150 to 200 mg IV twice daily. When discontinuing therapy, a gradual withdrawal over at least 1 week is recommended. Clinical study experience is limited to 5 consecutive days of IV therapy.

Adolescents 17 years

100 mg IV twice daily or alternatively, 200 mg IV as a single dose, then 100 mg IV twice daily starting 12 hours later, initially. May increase the dose by 100 mg/day at weekly intervals based on response and tolerability. Usual dose: 150 to 200 mg IV twice daily. When discontinuing therapy, a gradual withdrawal over at least 1 week is recommended. Clinical study experience is limited to 5 consecutive days of IV therapy.

Children and Adolescents 1 to 16 years weighing 50 kg or more

50 mg IV twice daily or alternatively, 200 mg IV as a single dose, then 100 mg IV twice daily starting 12 hours later, initially. May increase the dose by 100 mg/day at weekly intervals based on response and tolerability. Usual dose: 150 to 200 mg IV twice daily. When discontinuing therapy, a gradual withdrawal over at least 1 week is recommended. Clinical study experience is limited to 5 consecutive days of IV therapy.

Children and Adolescents 1 to 16 years weighing 30 to 49 kg

1 mg/kg/dose IV twice daily or alternatively, 4 mg/kg/dose IV as a single dose, then 2 mg/kg/dose IV twice daily starting 12 hours later, initially. May increase the dose by 2 mg/kg/day at weekly intervals based on response and tolerability. Usual dose: 2 to 4 mg/kg/dose IV twice daily. When discontinuing therapy, a gradual withdrawal over at least 1 week is recommended. Clinical study experience is limited to 5 consecutive days of IV therapy.

Infants, Children, and Adolescents 1 month to 16 years weighing 6 to 29 kg

1 mg/kg/dose IV twice daily or alternatively, 4.5 mg/kg/dose IV as a single dose, then 3 mg/kg/dose IV twice daily starting 12 hours later, initially. May increase the dose by 2 mg/kg/day at weekly intervals based on response and tolerability. Usual dose: 3 to 6 mg/kg/dose IV twice daily. When discontinuing therapy, a gradual withdrawal over at least 1 week is recommended. Clinical study experience is limited to 5 consecutive days of IV therapy.

Infants weighing less than 6 kg

0.66 mg/kg/dose IV 3 times daily or alternatively, 2.5 mg/kg/dose IV 3 times daily, initially. May increase the dose by 2 mg/kg/day at weekly intervals based on response and tolerability. Usual dose: 2.5 to 5 mg/kg/dose IV 3 times daily. When discontinuing therapy, a gradual withdrawal over at least 1 week is recommended. Clinical study experience is limited to 5 consecutive days of IV therapy.

For the treatment of partial seizures as an adjunct. Oral dosage (immediate-release) Adults

50 mg PO twice daily or alternatively, 200 mg PO as a single dose, then 100 mg PO twice daily starting 12 hours later, initially. May increase the dose by 100 mg/day at weekly intervals based on response and tolerability. Usual dose: 100 to 200 mg PO twice daily. When discontinuing therapy, a gradual withdrawal over at least 1 week is recommended.

Adolescents 17 years

50 mg PO twice daily or alternatively, 200 mg PO as a single dose, then 100 mg PO twice daily starting 12 hours later, initially. May increase the dose by 100 mg/day at weekly intervals based on response and tolerability. Usual dose: 100 to 200 mg PO twice daily. When discontinuing therapy, a gradual withdrawal over at least 1 week is recommended.

Children and Adolescents 1 to 16 years weighing 50 kg or more

50 mg PO twice daily or alternatively, 200 mg PO as a single dose, then 100 mg PO twice daily starting 12 hours later, initially. May increase the dose by 100 mg/day at weekly intervals based on response and tolerability. Usual dose: 100 to 200 mg PO twice daily. When discontinuing therapy, a gradual withdrawal over at least 1 week is recommended.

Children and Adolescents 1 to 16 years weighing 30 to 49 kg

1 mg/kg/dose PO twice daily or alternatively, 4 mg/kg/dose PO as a single dose, then 2 mg/kg/dose PO twice daily starting 12 hours later, initially. May increase the dose by 2 mg/kg/day at weekly intervals based on response and tolerability. Usual dose: 2 to 4 mg/kg/dose PO twice daily. When discontinuing therapy, a gradual withdrawal over at least 1 week is recommended.

Infants, Children, and Adolescents 1 month to 16 years weighing 6 to 29 kg

1 mg/kg/dose PO twice daily or alternatively, 4.5 mg/kg/dose PO as a single dose, then 3 mg/kg/dose PO twice daily starting 12 hours later, initially. May increase the dose by 2 mg/kg/day at weekly intervals based on response and tolerability. Usual dose: 3 to 6 mg/kg/dose PO twice daily. When discontinuing therapy, a gradual withdrawal over at least 1 week is recommended.

Infants weighing less than 6 kg

1 mg/kg/dose PO twice daily or alternatively, 3.75 mg/kg/dose PO twice daily, initially. May increase the dose by 2 mg/kg/day at weekly intervals based on response and tolerability. Usual dose: 3.75 to 7.5 mg/kg/dose PO twice daily. When discontinuing therapy, a gradual withdrawal over at least 1 week is recommended.

Oral dosage (extended-release) Adults

100 mg PO once daily, initially. May increase the dose by 100 mg/day at weekly intervals based on response and tolerability. Usual dose: 200 to 400 mg PO once daily. When discontinuing therapy, a gradual withdrawal over at least 1 week is recommended.

Adolescents 17 years

100 mg PO once daily, initially. May increase the dose by 100 mg/day at weekly intervals based on response and tolerability. Usual dose: 200 to 400 mg PO once daily. When discontinuing therapy, a gradual withdrawal over at least 1 week is recommended.

Children and Adolescents weighing 50 mg or more

100 mg PO once daily, initially. May increase the dose by 100 mg/day at weekly intervals based on response and tolerability. Usual dose: 200 mg to 400 mg PO once daily. When discontinuing therapy, a gradual withdrawal over at least 1 week is recommended.

Intravenous dosage Adults

50 mg IV twice daily or alternatively, 200 mg IV as a single dose, then 100 mg IV twice daily starting 12 hours later, initially. May increase the dose by 100 mg/day at weekly intervals based on response and tolerability. Usual dose: 100 to 200 mg IV twice daily. When discontinuing therapy, a gradual withdrawal over at least 1 week is recommended. Clinical study experience is limited to 5 consecutive days of IV therapy.

Adolescents 17 years

50 mg IV twice daily or alternatively, 200 mg IV as a single dose, then 100 mg IV twice daily starting 12 hours later, initially. May increase the dose by 100 mg/day at weekly intervals based on response and tolerability. Usual dose: 100 to 200 mg IV twice daily. When discontinuing therapy, a gradual withdrawal over at least 1 week is recommended. Clinical study experience is limited to 5 consecutive days of IV therapy.

Children and Adolescents 1 to 16 years weighing 50 kg or more

50 mg IV twice daily or alternatively, 200 mg IV as a single dose, then 100 mg IV twice daily starting 12 hours later, initially. May increase the dose by 100 mg/day at weekly intervals based on response and tolerability. Usual dose: 100 to 200 mg IV twice daily. When discontinuing therapy, a gradual withdrawal over at least 1 week is recommended. Clinical study experience is limited to 5 consecutive days of IV therapy.

Children and Adolescents 1 to 16 years weighing 30 to 49 kg

1 mg/kg/dose IV twice daily or alternatively, 4 mg/kg/dose IV as a single dose, then 2 mg/kg/dose IV twice daily starting 12 hours later, initially. May increase the dose by 2 mg/kg/day at weekly intervals based on response and tolerability. Usual dose: 2 to 4 mg/kg/dose IV twice daily. When discontinuing therapy, a gradual withdrawal over at least 1 week is recommended. Clinical study experience is limited to 5 consecutive days of IV therapy.

Infants, Children, and Adolescents 1 month to 16 years weighing 6 to 29 kg

1 mg/kg/dose IV twice daily or alternatively, 4.5 mg/kg/dose IV as a single dose, then 3 mg/kg/dose IV twice daily starting 12 hours later, initially. May increase the dose by 2 mg/kg/day at weekly intervals based on response and tolerability. Usual dose: 3 to 6 mg/kg/dose IV twice daily. When discontinuing therapy, a gradual withdrawal over at least 1 week is recommended. Clinical study experience is limited to 5 consecutive days of IV therapy.

Infants weighing less than 6 kg

0.66 mg/kg/dose IV 3 times daily or alternatively, 2.5 mg/kg/dose IV 3 times daily, initially. May increase the dose by 2 mg/kg/day at weekly intervals based on response and tolerability. Usual dose: 2.5 to 5 mg/kg/dose IV 3 times daily. When discontinuing therapy, a gradual withdrawal over at least 1 week is recommended. Clinical study experience is limited to 5 consecutive days of IV therapy.

For the treatment of generalized tonic-clonic seizures as an adjunct. Oral dosage Adults

50 mg PO twice daily or alternatively, 200 mg PO as a single dose, then 100 mg PO twice daily starting 12 hours later, initially. May increase the dose by 100 mg/day at weekly intervals based on response and tolerability. Usual dose: 100 to 200 mg PO twice daily. When discontinuing therapy, a gradual withdrawal over at least 1 week is recommended.

Adolescents 17 years

50 mg PO twice daily or alternatively, 200 mg PO as a single dose, then 100 mg PO twice daily starting 12 hours later, initially. May increase the dose by 100 mg/day at weekly intervals based on response and tolerability. Usual dose: 100 to 200 mg PO twice daily. When discontinuing therapy, a gradual withdrawal over at least 1 week is recommended.

Children and Adolescents 4 to 16 years weighing 50 kg or more

50 mg PO twice daily or alternatively, 200 mg PO as a single dose, then 100 mg PO twice daily starting 12 hours later, initially. May increase the dose by 100 mg/day at weekly intervals based on response and tolerability. Usual dose: 100 to 200 mg PO twice daily. When discontinuing therapy, a gradual withdrawal over at least 1 week is recommended.

Children and Adolescents 4 to 16 years weighing 30 to 49 kg

1 mg/kg/dose PO twice daily or alternatively, 4 mg/kg/dose PO as a single dose, then 2 mg/kg/dose PO twice daily starting 12 hours later, initially. May increase the dose by 2 mg/kg/day at weekly intervals based on response and tolerability. Usual dose: 2 to 4 mg/kg/dose PO twice daily. When discontinuing therapy, a gradual withdrawal over at least 1 week is recommended.

Children and Adolescents 4 to 16 years weighing 11 to 29 kg

1 mg/kg/dose PO twice daily or alternatively, 4.5 mg/kg/dose PO as a single dose, then 3 mg/kg/dose PO twice daily starting 12 hours later, initially. May increase the dose by 2 mg/kg/day at weekly intervals based on response and tolerability. Usual dose: 3 to 6 mg/kg/dose PO twice daily. When discontinuing therapy, a gradual withdrawal over at least 1 week is recommended.

Intravenous dosage Adults

50 mg IV twice daily or alternatively, 200 mg IV as a single dose, then 100 mg IV twice daily starting 12 hours later, initially. May increase the dose by 100 mg/day at weekly intervals based on response and tolerability. Usual dose: 100 to 200 mg IV twice daily. When discontinuing therapy, a gradual withdrawal over at least 1 week is recommended. Clinical study experience is limited to 5 consecutive days of IV therapy.

Adolescents 17 years

50 mg IV twice daily or alternatively, 200 mg IV as a single dose, then 100 mg IV twice daily starting 12 hours later, initially. May increase the dose by 100 mg/day at weekly intervals based on response and tolerability. Usual dose: 100 to 200 mg IV twice daily. When discontinuing therapy, a gradual withdrawal over at least 1 week is recommended. Clinical study experience is limited to 5 consecutive days of IV therapy.

Children and Adolescents 4 to 16 years weighing 50 kg or more

50 mg IV twice daily or alternatively, 200 mg IV as a single dose, then 100 mg IV twice daily starting 12 hours later, initially. May increase the dose by 100 mg/day at weekly intervals based on response and tolerability. Usual dose: 100 to 200 mg IV twice daily. When discontinuing therapy, a gradual withdrawal over at least 1 week is recommended. Clinical study experience is limited to 5 consecutive days of IV therapy.

Children and Adolescents 4 to 16 years weighing 30 to 49 kg

1 mg/kg/dose IV twice daily or alternatively, 4 mg/kg/dose IV as a single dose, then 2 mg/kg/dose IV twice daily starting 12 hours later, initially. May increase the dose by 2 mg/kg/day at weekly intervals based on response and tolerability. Usual dose: 2 to 4 mg/kg/dose IV twice daily. When discontinuing therapy, a gradual withdrawal over at least 1 week is recommended. Clinical study experience is limited to 5 consecutive days of IV therapy.

Children and Adolescents 4 to 16 years weighing 11 to 29 kg

1 mg/kg/dose IV twice daily or alternatively, 4.5 mg/kg/dose IV as a single dose, then 3 mg/kg/dose IV twice daily starting 12 hours later, initially. May increase the dose by 2 mg/kg/day at weekly intervals based on response and tolerability. Usual dose: 3 to 6 mg/kg/dose IV twice daily. When discontinuing therapy, a gradual withdrawal over at least 1 week is recommended. Clinical study experience is limited to 5 consecutive days of IV therapy.

Dosing Considerations
Hepatic Impairment

A reduction of 25% of the maximum dosage is recommended for persons with mild to moderate hepatic impairment; use caution during dose titration. Lacosamide use is not recommended in persons with severe hepatic impairment. Additionally, persons with hepatic impairment who are taking strong inhibitors of CYP3A4 and CYP2C9 may have a significant increase in exposure to lacosamide; dosage reduction may be necessary.

Renal Impairment

CrCl 30 mL/minute or more (adults) or CrCl 30 mL/minute/1.73m2 or more (pediatrics): No dosage adjustments are needed; use caution during dose titration. Persons with renal impairment who are taking strong inhibitors of CYP3A4 and CYP2C9 may have a significant increase in exposure to lacosamide; dosage reduction may be necessary.
CrCl less than 30 mL/minute (adults) or CrCl less than 30 mL/minute/1.73m2 (pediatrics) or end-stage renal disease: A reduction of 25% of the maximum dosage is recommended; use caution during dose titration. Persons with renal impairment who are taking strong inhibitors of CYP3A4 and CYP2C9 may have a significant increase in exposure to lacosamide; additional dosage reduction may be necessary.
 
Intermittent hemodialysis
Lacosamide is removed by hemodialysis. After a 4-hour hemodialysis treatment, consider a supplemental dose of up to 50%.

Drug Interactions

Acebutolol: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as beta-blockers, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Alprazolam: (Moderate) Concomitant administration of alprazolam with CNS-depressant drugs, including anticonvulsants, can potentiate the CNS effects of either agent.
Amiodarone: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as Class III antiarrhythmics, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Amlodipine: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as calcium-channel blockers, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Amlodipine; Atorvastatin: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as calcium-channel blockers, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Amlodipine; Benazepril: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as calcium-channel blockers, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Amlodipine; Celecoxib: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as calcium-channel blockers, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Amlodipine; Olmesartan: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as calcium-channel blockers, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Amlodipine; Valsartan: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as calcium-channel blockers, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Amlodipine; Valsartan; Hydrochlorothiazide, HCTZ: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as calcium-channel blockers, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Atazanavir: (Moderate) Lacosamide causes PR interval prolongation in some patients. Caution is advised during coadministration of lacosamide with other drugs that cause PR prolongation, such as atazanavir, since further PR prolongation is possible. If concurrent use is necessary, an ECG is recommended prior to initiation of lacosamide and after the drug is titrated to the maintenence dose. Patients receiving intravenous lacosamide should be closely monitored due to the potential for profound bradycardia and AV block during coadministration.
Atazanavir; Cobicistat: (Moderate) Lacosamide causes PR interval prolongation in some patients. Caution is advised during coadministration of lacosamide with other drugs that cause PR prolongation, such as atazanavir, since further PR prolongation is possible. If concurrent use is necessary, an ECG is recommended prior to initiation of lacosamide and after the drug is titrated to the maintenence dose. Patients receiving intravenous lacosamide should be closely monitored due to the potential for profound bradycardia and AV block during coadministration.
Atenolol: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as beta-blockers, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Atenolol; Chlorthalidone: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as beta-blockers, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Beta-adrenergic blockers: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as beta-blockers, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Betaxolol: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as beta-blockers, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Bisoprolol: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as beta-blockers, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Bisoprolol; Hydrochlorothiazide, HCTZ: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as beta-blockers, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Bretylium: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as Class III antiarrhythmics, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Brimonidine; Timolol: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as beta-blockers, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Calcium-channel blockers: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as calcium-channel blockers, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Carbamazepine: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction including those that prolong PR interval, such as sodium channel blocking anticonvulsants (e.g., carbamazepine), because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Carteolol: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as beta-blockers, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Carvedilol: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as beta-blockers, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Class IA Antiarrhythmics: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as Class IA antiarrhythmics, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Class IB Antiarrhythmics: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as Class IB antiarrhythmics, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Class IC Antiarrhythmics: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as Class IC antiarrhythmics, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Class III Antiarrhythmics: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as Class III antiarrhythmics, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Clevidipine: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as calcium-channel blockers, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Delavirdine: (Moderate) Use caution during concurrent use of lacosamide and delavirdine, particularly in patients with renal or hepatic impairment. Lacosamide is a CYP3A4 substrate; delavirdine is a potent inhibitor of CYP3A4. Patients with renal or hepatic impairment may have significantly increased exposure to lacosamide if coadminsitered with a strong CYP3A4 inhibitor. Dosage reduction of lacosamide may be necessary in this population.
Dextromethorphan; Quinidine: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as Class IA antiarrhythmics, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Digoxin: (Moderate) Lacosamide causes PR interval prolongation in some patients. Caution is advised during coadministration of lacosamide with other drugs that cause PR prolongation, such as digoxin, since further PR prolongation is possible. If concurrent use is necessary, an ECG is recommended prior to initiation of lacosamide and after the drug is titrated to the maintenence dose. Patients receiving intravenous lacosamide should be closely monitored due to the potential for profound bradycardia and AV block during coadministration.
Diltiazem: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as calcium-channel blockers, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Disopyramide: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as Class IA antiarrhythmics, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Dofetilide: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as Class III antiarrhythmics, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Dorzolamide; Timolol: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as beta-blockers, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Dronedarone: (Moderate) Lacosamide causes PR interval prolongation in some patients. Caution is advised during coadministration of lacosamide with other drugs that cause PR prolongation, such as dronedarone, since further PR prolongation is possible. If concurrent use is necessary, an ECG is recommended prior to initiation of lacosamide and after the drug is titrated to the maintenence dose. Patients receiving intravenous lacosamide should be closely monitored due to the potential for profound bradycardia and AV block during coadministration.
Eslicarbazepine: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction including those that prolong PR interval, such as sodium channel blocking anticonvulsants (e.g., eslicarbazepine), because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Esmolol: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as beta-blockers, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Ethanol: (Major) Advise patients to avoid alcohol consumption while taking CNS depressants. Alcohol consumption may result in additive CNS depression.
Felbamate: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction including those that prolong PR interval, such as sodium channel blocking anticonvulsants (e.g., felbamate), because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Felodipine: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as calcium-channel blockers, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Fenofibric Acid: (Minor) At therapeutic concentrations, fenofibric acid is a weak inhibitor of CYP2C19. Concomitant use of fenofibric acid with CYP2C19 substrates, such as lacosamide, has not been formally studied. Fenofibric acid may theoretically increase plasma concentrations of CYP2C19 substrates and could lead to toxicity for drugs that have a narrow therapeutic range. Monitor the therapeutic effect of lacosamide during coadministration with fenofibric acid.
Flecainide: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as Class IC antiarrhythmics, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Fluconazole: (Moderate) Use caution during concurrent use of lacosamide and fluconazole, particularly in patients with renal or hepatic impairment. Patients with renal or hepatic impairment may have significantly increased exposure to lacosamide if coadministered with fluconazole. Dosage reduction of lacosamide may be necessary in this population. Lacosamide is a CYP3A4, CYP2C9, CYP2C19 substrate; fluconazole is a potent inhibitor of CYP2C19 and a moderate inhibitor of CYP3A4 and CYP2C9.
Food: (Major) Advise patients to avoid cannabis use while taking CNS depressants due to the risk for additive CNS depression and potential for other cognitive adverse reactions.
Fosphenytoin: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction including those that prolong PR interval, such as sodium channel blocking anticonvulsants (e.g., fosphenytoin), because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Hydroxychloroquine: (Moderate) Caution is warranted with the coadministration of hydroxychloroquine and antiepileptic drugs, such as lacosamide. Hydroxychloroquine can lower the seizure threshold; therefore, the activity of antiepileptic drugs may be impaired with concomitant use.
Ibutilide: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as Class III antiarrhythmics, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Indinavir: (Moderate) Use caution during concurrent use of lacosamide and indinavir, particularly in patients with renal or hepatic impairment. Lacosamide is a CYP3A4 substrate; indinavir is a potent inhibitor of CYP3A4. Patients with renal or hepatic impairment may have significantly increased exposure to lacosamide if coadminsitered with a strong CYP3A4 inhibitor. Dosage reduction of lacosamide may be necessary in this population.
Isradipine: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as calcium-channel blockers, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Itraconazole: (Moderate) Use caution during concurrent use of lacosamide and itraconazole, particularly in patients with renal or hepatic impairment. Lacosamide is a CYP3A4 substrate; itraconazole is a potent inhibitor of CYP3A4. Patients with renal or hepatic impairment may have significantly increased exposure to lacosamide if coadministered with a strong CYP3A4 inhibitor. Dosage reduction of lacosamide may be necessary in this population.
Ketoconazole: (Moderate) Use caution during concurrent use of lacosamide and ketoconazole, particularly in patients with renal or hepatic impairment. Lacosamide is a CYP3A4 substrate; ketoconazole is a potent inhibitor of CYP3A4. Patients with renal or hepatic impairment may have significantly increased exposure to lacosamide if coadminsitered with a strong CYP3A4 inhibitor. Dosage reduction of lacosamide may be necessary in this population.
Labetalol: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as beta-blockers, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Lamotrigine: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction including those that prolong PR interval, such as sodium channel blocking anticonvulsants (e.g., lamotrigine), because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Letermovir: (Moderate) The plasma concentration of lacosamide may be increased during concurrent use with letermovir. The magnitude of this interaction may be increased in patients who are also receiving cyclosporine. If lacosamide is administered to a patient with hepatic impairment receiving both letermovir and cyclosporine, a lacosamide dose reduction may be needed. Lacosamide is a CYP3A4 substrate. Letermovir is a moderate inhibitor of CYP3A4. However, when given with cyclosporine, the combined effect of letermovir and cyclosporine on a CYP3A4 substrate is similar to a strong CYP3A4 inhibitor.
Levamlodipine: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as calcium-channel blockers, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Levobunolol: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as beta-blockers, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Levoketoconazole: (Moderate) Use caution during concurrent use of lacosamide and ketoconazole, particularly in patients with renal or hepatic impairment. Lacosamide is a CYP3A4 substrate; ketoconazole is a potent inhibitor of CYP3A4. Patients with renal or hepatic impairment may have significantly increased exposure to lacosamide if coadminsitered with a strong CYP3A4 inhibitor. Dosage reduction of lacosamide may be necessary in this population.
Lopinavir; Ritonavir: (Moderate) Lacosamide causes PR interval prolongation in some patients. Caution is advised during coadministration of lacosamide with other drugs that cause PR prolongation, such as lopinavir, since further PR prolongation is possible. (Moderate) Use caution during concurrent use of lacosamide and ritonavir, particularly in patients with renal or hepatic impairment. Lacosamide is a CYP3A4 substrate; ritonavir is a potent inhibitor of CYP3A4. Patients with renal or hepatic impairment may have significantly increased exposure to lacosamide if coadministered with a strong CYP3A4 inhibitor. Dosage reduction of lacosamide may be necessary in this population.
Luliconazole: (Moderate) Theoretically, luliconazole may increase the side effects of lacosamide, which is a CYP2C19 and a CYP3A4 substrate. Monitor patients for adverse effects of lacosamide, such as PR prolongation. Patients with renal or hepatic impairment may be particularly affected. In vitro, therapeutic doses of luliconazole inhibit the activity of CYP2C19 and CYP3A4 and small systemic concentrations may be noted with topical application, particularly when applied to patients with moderate to severe tinea cruris. No in vivo drug interaction trials were conducted prior to the approval of luliconazole.
Maprotiline: (Moderate) Maprotiline, when used concomitantly with anticonvulsants, can increase CNS depression and may also lower the seizure threshold, leading to pharmacodynamic interactions. Monitor patients on anticonvulsants carefully when maprotiline is used concurrently. Because of the lowering of seizure threshold, an alternative antidepressant may be a more optimal choice for patients taking drugs for epilepsy.
Mefloquine: (Moderate) Coadministration of mefloquine and anticonvulsants may result in lower than expected anticonvulsant concentrations and loss of seizure control. Monitoring of the anticonvulsant serum concentration, if the drug is monitored via therapeutic drug monitoring, is recommended. Mefloquine may cause CNS side effects that may cause seizures or alter moods or behaviors. Some, but not all anticonvulsants, induce CYP3A4 and may increase the metabolism of mefloquine. Use of enzyme-inducing anticonvulsants can reduce the clinical efficacy of mefloquine, increasing the risk of Plasmodium falciparum resistance during treatment of malaria.
Metoprolol: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as beta-blockers, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Metoprolol; Hydrochlorothiazide, HCTZ: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as beta-blockers, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Molindone: (Moderate) Consistent with the pharmacology of molindone, additive effects may occur with other CNS active drugs such as anticonvulsants. In addition, seizures have been reported during the use of molindone, which is of particular significance in patients with a seizure disorder receiving anticonvulsants. Adequate dosages of anticonvulsants should be continued when molindone is added; patients should be monitored for clinical evidence of loss of seizure control or the need for dosage adjustments of either molindone or the anticonvulsant.
Nadolol: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as beta-blockers, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Nebivolol: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as beta-blockers, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Nebivolol; Valsartan: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as beta-blockers, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Nicardipine: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as calcium-channel blockers, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Nifedipine: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as calcium-channel blockers, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Nimodipine: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as calcium-channel blockers, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Nirmatrelvir; Ritonavir: (Moderate) Use caution during concurrent use of lacosamide and ritonavir, particularly in patients with renal or hepatic impairment. Lacosamide is a CYP3A4 substrate; ritonavir is a potent inhibitor of CYP3A4. Patients with renal or hepatic impairment may have significantly increased exposure to lacosamide if coadministered with a strong CYP3A4 inhibitor. Dosage reduction of lacosamide may be necessary in this population.
Nisoldipine: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as calcium-channel blockers, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Olmesartan; Amlodipine; Hydrochlorothiazide, HCTZ: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as calcium-channel blockers, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Oritavancin: (Moderate) Lacosamide is metabolized by CYP2C19; oritavancin is a weak CYP2C19 inhibitor. Coadministration may result in elevated lacosamide plasma concentrations. If these drugs are administered concurrently, monitor patients for signs of lacosamide toxicity, such as fainting or falling spells, low blood pressure, or changes in heart rate (fast, slow, or irregular).
Oxcarbazepine: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction including those that prolong PR interval, such as sodium channel blocking anticonvulsants (e.g., oxcarbazepine), because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Perindopril; Amlodipine: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as calcium-channel blockers, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Phentermine; Topiramate: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction including those that prolong PR interval, such as sodium channel blocking anticonvulsants (e.g., topiramate), because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Phenytoin: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction including those that prolong PR interval, such as sodium channel blocking anticonvulsants (e.g., phenytoin), because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Pindolol: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as beta-blockers, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Procainamide: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as Class IA antiarrhythmics, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Prochlorperazine: (Major) The phenothiazines, including prochlorperazine, can lower the seizure threshold. Adequate dosages of anticonvulsants should be continued when a phenothiazine is added; patients should be monitored for clinical evidence of loss of seizure control or the need for dosage adjustments of either the phenothiazine or the anticonvulsant.
Propafenone: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as Class IC antiarrhythmics, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Propranolol: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as beta-blockers, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Propranolol; Hydrochlorothiazide, HCTZ: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as beta-blockers, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Quinidine: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as Class IA antiarrhythmics, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Ritonavir: (Moderate) Use caution during concurrent use of lacosamide and ritonavir, particularly in patients with renal or hepatic impairment. Lacosamide is a CYP3A4 substrate; ritonavir is a potent inhibitor of CYP3A4. Patients with renal or hepatic impairment may have significantly increased exposure to lacosamide if coadministered with a strong CYP3A4 inhibitor. Dosage reduction of lacosamide may be necessary in this population.
Rufinamide: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction including those that prolong PR interval, such as sodium channel blocking anticonvulsants (e.g., rufinamide), because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Sotalol: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as Class III antiarrhythmics, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Telmisartan; Amlodipine: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as calcium-channel blockers, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Timolol: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as beta-blockers, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Tipranavir: (Moderate) Use caution during concurrent use of lacosamide and tipranavir, particularly in patients with renal or hepatic impairment. Lacosamide is a CYP3A4 substrate; tipranavir is a potent inhibitor of CYP3A4. Patients with renal or hepatic impairment may have significantly increased exposure to lacosamide if coadminsitered with a strong CYP3A4 inhibitor. Dosage reduction of lacosamide may be necessary in this population.
Topiramate: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction including those that prolong PR interval, such as sodium channel blocking anticonvulsants (e.g., topiramate), because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Trandolapril; Verapamil: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as calcium-channel blockers, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Tricyclic antidepressants: (Moderate) Tricyclic antidepressants (TCAs), when used concomitantly with anticonvulsants, can increase CNS depression and may also lower the seizure threshold, leading to pharmacodynamic interactions.
Valproic Acid, Divalproex Sodium: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction including those that prolong PR interval, such as sodium channel blocking anticonvulsants (e.g.,valproic acid), because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Verapamil: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction, such as calcium-channel blockers, because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.
Zonisamide: (Moderate) Use lacosamide with caution in patients taking concomitant medications that affect cardiac conduction including those that prolong PR interval, such as sodium channel blocking anticonvulsants (e.g., zonisamide), because of the risk of AV block, bradycardia, or ventricular tachyarrhythmia. If use together is necessary, obtain an ECG prior to lacosamide initiation and after treatment has been titrated to steady-state. In addition, monitor patients receiving lacosamide via the intravenous route closely.

How Supplied

Lacosamide/Vimpat Intravenous Inj Sol: 1mL, 10mg
Lacosamide/Vimpat Oral Sol: 1mL, 10mg
Lacosamide/Vimpat Oral Tab: 50mg, 100mg, 150mg, 200mg

Maximum Dosage
Adults

400 mg/day PO or IV.

Geriatric

400 mg/day PO or IV.

Adolescents

17 years: 400 mg/day PO or IV.
13 to 16 years weighing 50 kg or more: 400 mg/day PO or IV.
13 to 16 years weighing 30 to 49 kg: 8 mg/kg/day PO or IV. Safety and efficacy of the extended-release capsules have not been established.
13 to 16 years weighing 11 to 29 kg: 12 mg/kg/day PO or IV. Safety and efficacy of the extended-release capsules have not been established.

Children

Safety and efficacy of the extended-release capsules have not been established.
weighing 50 kg or more: 400 mg/day PO or IV.
weighing 30 to 49 kg: 8 mg/kg/day PO or IV.
weighing 6 to 29 kg: 12 mg/kg/day PO or IV.

Infants

Safety and efficacy of the extended-release capsules have not been established.
weighing 6 to 29 kg: 12 mg/kg/day PO or IV.
weighing less than 6 kg: 15 mg/kg/day PO or IV.

Neonates

Safety and efficacy have not been established.

Mechanism Of Action

The exact mechanism by which lacosamide exerts its anticonvulsant effects is unknown. In vitro, lacosamide enhances slow inactivation of voltage-gated sodium channels, with subsequent stabilization of hyperexcitable neuronal membranes and inhibition of repetitive neuronal firing. Additional in vitro data indicate that lacosamide interferes with the activity of collapsin response mediator protein-2 (CRMP-2), a phosphoprotein that is involved in neuronal differentiation and control of axonal growth. The role of CRMP-2 in the control of seizures is unknown.

Pharmacokinetics

Lacosamide is administered orally or intravenously. The Vd of lacosamide is 0.67 L/kg with no clinically relevant protein binding (less than 15%). The hepatic enzymes primarily responsible for the formation of the major metabolite (O-desmethyl-lacosamide) are CYP2C9, CYP2C19, and CYP3A4. O-desmethyl-lacosamide has no known pharmacologic activity and a plasma exposure that is 10% of the parent compound. Approximately 95% of a dose is excreted in the urine and 0.5% in the feces as unchanged lacosamide (40%), O-desmethyl-lacosamide (30%), and a structurally unknown polar fraction (20%). The elimination half-life of unchanged lacosamide is 13 hours while the elimination half-life of the metabolite is 15 to 23 hours.
 
Affected cytochrome P450 enzymes and drug transporters: CYP2C9, CYP2C19, CYP3A4
In vitro data suggest that lacosamide is a CYP2C9, CYP2C19, and CYP3A4 substrate, and has the potential to inhibit CYP2C19 at therapeutic concentrations. In vitro data also indicate that lacosamide does not induce CYP1A2, CYP2B6, CYP2C9, CYP2C19, or CYP3A4, and does not inhibit CYP1A1, CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2D6, CYP2E1, or CYP3A4/5.

Oral Route

After oral administration, lacosamide is completely absorbed with negligible first-pass effect with an absolute bioavailability of approximately 100%. Maximum lacosamide plasma concentrations occur approximately 1 to 4 hours after oral dosing with the immediate-release tablet; steady-state concentrations are achieved after 3 days of twice daily repeated administration. The oral tablet and oral solution are bioequivalent. In a multiple-dose pharmacokinetic study in healthy adults, at steady-state, the peak plasma lacosamide concentration after oral administration of extended-release lacosamide was reached in 7 hours; steady-state plasma concentrations are achieved after 4 days of once daily repeated administration. Food does not affect the rate or extent of absorption.

Intravenous Route

After intravenous administration, Cmax is reached at the end of the infusion. When administered intravenously over 30 or 60 minutes, the infusion is bioequivalent to an equivalent dose of the oral tablet. After a 15-minute infusion, bioequivalence was met for AUC, but Cmax was 20% higher than that of the oral tablet.

Pregnancy And Lactation
Pregnancy

Data with lacosamide in pregnancy are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Results from animal studies suggest that various fetal developmental toxicities are possible (e.g., increased embryofetal and perinatal mortality, growth deficit, developmental neurotoxicity). In addition, decreased brain weights and long-term neurobehavioral changes (i.e., altered open field performance, deficits in learning and memory) occurred in neonatal and juvenile rats receiving oral lacosamide. The early postnatal period in rats is thought to correspond to the brain development that occurs in late pregnancy in humans. In vitro data indicate that lacosamide interferes with the activity of collapsin response mediator protein-2, which is involved in neuronal differentiation and control of axonal growth. No adverse effects on male or female fertility or reproduction have been observed during animal studies. The effect of lacosamide on labor and delivery in humans is not known; there was a tendency toward prolonged gestation in lacosamide-treated rats in animal studies. There is a pregnancy exposure registry that monitors outcomes in pregnant patients exposed to lacosamide; information about the registry can be obtained at www.aedpregnancyregistry.org or by calling 1-888-233-2334.

Lacosamide is present in human milk. Monitor infants exposed to lacosamide during breast-feeding for excess sedation. Increased sleepiness has been reported in infants exposed to lacosamide through breast milk. The effects of lacosamide on milk production are unknown. Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for lacosamide and any potential adverse effects on the breast-fed infant from lacosamide or the underlying maternal condition.