Lacosamide

What is Lacosamide?

• Lacosamide (Vimpat) is an amino acid derivative with a unique anticonvulsant activity that is used in combination with other agents as therapy of partial onset seizures and primary generalized tonic-clonic seizures.

What are the uses of this medicine?

Lacosamide (Vimpat) is a prescription medicine used:

• to treat partial-onset seizures in people 1 month of age and older.
• with other medicines to treat primary generalized tonic-clonic seizures in people 4 years of age and older.

How does this medicine work?

• Lacosamide (la koe' sa mide) is a functionalized amino acid derivative that appears to act by slow inactivation of voltage gated sodium channels in the central nervous system, which decreases the rate of neurotransmission and diminishes rapid, repetitive neuronal firing.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Patients with renal or hepatic impairment who are taking strong inhibitors of CYP3A4 and CYP2C9 may have a significant increase in exposure to VIMPAT. Dose reduction may be necessary in these patients.
• VIMPAT should be used with caution in patients on concomitant medications that affect cardiac conduction (sodium channel blockers, beta-blockers, calcium channel blockers, potassium channel blockers) including those that prolong PR interval (including sodium channel blocking AEDs), because of a risk of AV block, bradycardia, or ventricular tachyarrhythmia.

Is this medicine FDA approved?

• It was approved in the US on October 29, 2008.

How should this medicine be used?

Recommended dosage: Adults (17 years and older):

• Initial dosage for monotherapy for the treatment of partial-onset seizures is 100 mg twice daily.
• Initial dosage for adjunctive therapy for the treatment of partial-onset seizures or primary generalized tonic-clonic seizures is 50 mg twice daily.
• Maximum recommended dosage for monotherapy and adjunctive therapy is 200 mg twice daily.

Pediatric Patients 1 month to less than 17 years:

• The recommended dosage is based on body weight and is administered orally twice daily.
• Increase dosage based on clinical response and tolerability, no more frequently than once per week.

• Injection: for intravenous use only when oral administration is temporarily not feasible; the recommended dosage is based on body weight and is administered two or three times daily over 15 to 60 minutes; obtaining ECG before initiation is recommended in certain patients.

• Dose adjustment is recommended for severe renal impairment.
• Dose adjustment is recommended for mild or moderate hepatic impairment; use in patients with severe hepatic impairment is not recommended.

Administration:

• VIMPAT may be taken with or without food.
• Swallow VIMPAT tablets whole with liquid. Do not cut VIMPAT tablets.
• If your healthcare provider has prescribed VIMPAT oral solution, be sure to ask your pharmacist for a medicine dropper or medicine cup to help you measure the correct amount of VIMPAT oral solution. Do not use a household teaspoon. Ask your pharmacist for instructions on how to use the measuring device the right way.
• If you take too much VIMPAT, call your healthcare provider or local Poison Control Center right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• 50 mg, 100 mg, 150 mg, 200 mg tablets
• 200 mg/20 mL single-dose vial for intravenous use
• 10 mg/mL oral solution

This medicine is available in fallowing brand namesː

• VIMPAT

What side effects can this medication cause?

The most common side effects of this medicine include:

• double vision
• headache
• dizziness
• nausea
• sleepiness

VIMPAT may cause other serious side effects including:

• A serious allergic reaction
• suicidal thoughts or actions
• feel dizzy, have double vision, feel sleepy, or have problems with coordination and walking.
• irregular heartbeat

What special precautions should I follow?

• Antiepileptic drugs (AEDs), including VIMPAT, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Monitor patients for suicidal behavior and ideation.
• VIMPAT may cause dizziness and ataxia in adult and pediatric patients.
• Cardiac rhythm and conduction abnormalities have been observed. Obtaining ECG before beginning and after titration to steady-state maintenance is recommended in patients with underlying proarrhythmic conditions or on concomitant medications that affect cardiac conduction; closely monitor these patients.
• VIMPAT may cause syncope. The cause of syncope was not determined in most cases. However, several were associated with either changes in orthostatic blood pressure, atrial flutter/fibrillation (and associated tachycardia), or bradycardia.
• As with all AEDs, VIMPAT should be withdrawn gradually (over a minimum of 1 week) to minimize the potential of increased seizure frequency in patients with seizure disorders.
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multi-organ hypersensitivity, has been reported in patients taking antiepileptic drugs, including VIMPAT. Discontinue if no alternate etiology.
• Phenylalanine can be harmful in patients with phenylketonuria (PKU). VIMPAT oral solution contains aspartame, a source of phenylalanine. Before prescribing VIMPAT oral solution to a patient with PKU, consider the combined daily amount of phenylalanine from all sources, including VIMPAT oral solution.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• dizziness
• nausea
• seizures
• Cardiac conduction disorders
• confusion
• decreased level of consciousness
• cardiogenic shock
• cardiac arrest
• coma

• Fatalities have occurred following lacosamide overdoses of several grams.

Management of overdosage:

• There is no specific antidote for overdose with VIMPAT.
• Standard decontamination procedures should be followed.
• General supportive care of the patient is indicated including monitoring of vital signs and observation of the clinical status of patient.
• A Certified Poison Control Center should be contacted for up to date information on the management of overdose with VIMPAT.
• Standard hemodialysis procedures result in significant clearance of VIMPAT.

Can this medicine be used in pregnancy?

• There are no adequate data on the developmental risks associated with the use of VIMPAT in pregnant women.
• It is not known if VIMPAT can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking VIMPAT. You and your healthcare provider will decide if you should take VIMPAT while you are pregnant.
• If you become pregnant while taking VIMPAT, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy.

Can this medicine be used in children?

• It is not known if VIMPAT is safe and effective for partial-onset seizures in children under 1 month of age or for primary generalized tonic-clonic seizures in children under 4 years of age.

What are the active and inactive ingredients in this medicine?

• Active ingredient: lacosamide
• Tablet inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide and additional ingredients listed below:
• 50 mg tablets: red iron oxide, black iron oxide, FD&C Blue #2/indigo carmine aluminum lake
• 100 mg tablets: yellow iron oxide
• 150 mg tablets: yellow iron oxide, red iron oxide, black iron oxide
• 200 mg tablets: FD&C Blue #2/indigo carmine aluminum lake
• Injection inactive ingredients: sodium chloride (7.62 mg/mL), water for injection, hydrochloric acid (for pH adjustment)
• Oral solution inactive ingredients: purified water, sorbitol solution, glycerin, polyethylene glycol, carboxymethylcellulose sodium, acesulfame potassium, methylparaben, flavoring (including natural and artificial flavors, propylene glycol, aspartame, and maltol), anhydrous citric acid and sodium chloride.

Who manufactures and distributes this medicine?

Manufactured for: UCB, Inc. Smyrna, GA

What should I know about storage and disposal of this medication?

• Store VIMPAT at room temperature between 68ºF to 77ºF (20ºC to 25ºC).
• Do not freeze VIMPAT injection or oral solution.
• Throw away any unused VIMPAT oral solution 6 months after you first open the bottle.

• Dailymed label info on Lacosamide
• FDA Lacosamide

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