LACOSAMIDE ORAL SOLUTION

Anticonvulsant

Brand names: Lacosamide Oral Solution

Oral

Mechanism of Action

12.1 Mechanism of Action The precise mechanism by which lacosamide oral solution exerts its antiepileptic effects in humans remains to be fully elucidated. In vitro electrophysiological studies have shown that lacosamide selectively enhances slow inactivation of voltage-gated sodium channels, resulting in stabilization of hyperexcitable neuronal membranes and inhibition of repetitive neuronal firing.

Indications

Inc.’s VIMPAT ® (lacosamide) oral solution. However

due to UCB

Inc.’s marketing exclusivity rights

this drug product is not labeled with that information.

Contraindications

• 4 CONTRAINDICATIONS None . None ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Monitor patients for suicidal behavior and ideation ( 5
1 Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including lacosamide oral solution, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication
Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1
The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting treatment with AEDs and persisted for the duration of treatment assessed

Known Side Effects

6 documented side effects by frequency

Drug Not Working

>10%

Dizziness

1-10%

Drowsiness

0.1-1%

Fatigue

0.1-1%

Falls

0.1-1%

Headache

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral