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Vimpat Dosage

Generic name: LACOSAMIDE 50mg
Dosage form: tablet, film coated; injection; oral solution

Medically reviewed on November 17, 2017.

Dosage Information

Monotherapy and Adjunctive Therapy

The recommended dosage for adults and pediatric patients 4 years to less than 17 years of age is included in Table 1. In pediatric patients 4 years to less than 17 years of age, the recommended dosing regimen is dependent upon body weight and is only recommended to be administered orally. Dosage should be increased based on clinical response and tolerability, no more frequently than once per week. Titration increments should not exceed those shown in Table 1.

Table 1: Recommended Dosage for Adults and Pediatric Patients 4 Years and Older *
Age and Body Weight Initial Dosage Titration Regimen Maintenance Dosage
*
when not specified, the dosage is the same for monotherapy and adjunctive therapy
Adults (17 years and older) Monotherapy:
100 mg twice daily
(200 mg per day)
Adjunctive Therapy:
50 mg twice daily
(100 mg per day)
Increase by 50 mg twice daily
(100 mg per day)
every week
Monotherapy:
150 mg to 200 mg twice daily
(300 mg to 400 mg per day)
Adjunctive Therapy:
100 mg to 200 mg twice daily
(200 mg to 400 mg per day)
Alternate Initial Dosage: 200 mg single loading dose, followed 12 hours later by 100 mg twice daily
Pediatric patients weighing 50 kg or more 50 mg twice daily
(100 mg per day)
Increase by 50 mg twice daily (100 mg per day) every week Monotherapy:
150 mg to 200 mg twice daily
(300 mg to 400 mg per day)
Adjunctive Therapy:
100 mg to 200 mg twice daily
(200 mg to 400 mg per day)
Pediatric patients weighing 30 kg to less than 50 kg 1 mg/kg twice daily
(2 mg/kg/day)
Increase by 1 mg/kg twice daily (2 mg/kg/day) every week 2 mg/kg to 4 mg/kg twice daily
(4 mg/kg/day to 8 mg/kg/day)
Pediatric patients weighing 11 kg to less than 30 kg 1 mg/kg twice daily
(2 mg/kg/day)
Increase by 1 mg/kg twice daily (2 mg/kg/day) every week 3 mg/kg to 6 mg/kg twice daily
(6 mg/kg/day to 12 mg/kg/day)

In adjunctive clinical trials in adult patients, a dosage higher than 200 mg twice daily (400 mg per day) was not more effective and was associated with a substantially higher rate of adverse reactions [ see Adverse Reactions (6.1) and Clinical Studies (14.2)].

VIMPAT Injection Dosage in Adult Patients (17 years and older)

VIMPAT injection may be used for adult patients when oral administration is temporarily not feasible [ see Dosage and Administration (2.6) and Warnings and Precautions (5.3)] . VIMPAT injection can be administered intravenously to adult patients with the same dosing regimens described for oral dosing, including the loading dose. The use of VIMPAT injection in pediatric patients has not been studied.

The clinical study experience of intravenous VIMPAT is limited to 5 days of consecutive treatment.

Loading Dose in Adult Patients (17 Years and Older)

VIMPAT and VIMPAT injection may be initiated in adult patients with a single loading dose of 200 mg, followed approximately 12 hours later by 100 mg twice daily (200 mg per day). This maintenance dose regimen should be continued for one week. VIMPAT can then be titrated as recommended in Table 1. The adult loading dose should be administered with medical supervision because of the increased incidence of CNS adverse reactions [ see Adverse Reactions (6.1), Clinical Pharmacology (12.3)].

The use of a loading dose in pediatric patients has not been studied.

Converting From a Single Antiepileptic (AED) to VIMPAT Monotherapy

For patients who are already on a single AED and will convert to VIMPAT monotherapy, withdrawal of the concomitant AED should not occur until the therapeutic dosage of VIMPAT is achieved and has been administered for at least 3 days. A gradual withdrawal of the concomitant AED over at least 6 weeks is recommended.

Dosage Information for Patients with Renal Impairment

For patients with mild to moderate renal impairment, no dosage adjustment is necessary.

For patients with severe renal impairment [creatinine clearance (CL CR) less than 30 mL/min as estimated by the Cockcroft-Gault equation for adults; CL CR less than 30 mL/min/1.73m 2 as estimated by the Schwartz equation for pediatric patients] or end-stage renal disease, a reduction of 25% of the maximum dosage is recommended.

In all patients with renal impairment, the dose titration should be performed with caution.

Hemodialysis

VIMPAT is effectively removed from plasma by hemodialysis. Following a 4-hour hemodialysis treatment, dosage supplementation of up to 50% should be considered.

Concomitant Strong CYP3A4 or CYP2C9 Inhibitors

Dose reduction may be necessary in patients with renal impairment who are taking strong inhibitors of CYP3A4 and CYP2C9 [ see Drug Interactions (7.1), Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

Dosage Information for Patients with Hepatic Impairment

For patients with mild or moderate hepatic impairment, a reduction of 25% of the maximum dosage is recommended. The dose titration should be performed with caution in patients with hepatic impairment.

VIMPAT use is not recommended in patients with severe hepatic impairment.

Concomitant Strong CYP3A4 and CYP2C9 Inhibitors

Dose reduction may be necessary in patients with hepatic impairment who are taking strong inhibitors of CYP3A4 and CYP2C9 [ see Drug Interactions (7.1), Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].

Administration Instructions for VIMPAT Tablets and Oral Solution

VIMPAT may be taken with or without food.

VIMPAT Oral Solution

A calibrated measuring device is recommended to measure and deliver the prescribed dose accurately. A household teaspoon or tablespoon is not an adequate measuring device.

VIMPAT oral solution may also be administered using a nasogastric tube or gastrostomy tube.

Discard any unused VIMPAT oral solution remaining after 7 weeks of first opening the bottle.

Preparation and Administration Information for VIMPAT Injection for Adult Patients

Preparation

VIMPAT injection can be administered intravenously without further dilution or may be mixed with diluents listed below. The diluted solution should not be stored for more than 4 hours at room temperature.

Diluents:

Sodium Chloride Injection 0.9% (w/v)
Dextrose Injection 5% (w/v)
Lactated Ringer's Injection

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Product with particulate matter or discoloration should not be used.

VIMPAT injection is for single-dose only. Any unused portion of VIMPAT injection should be discarded.

Administration

The recommended infusion rate is 30 to 60 minutes; however, infusions as rapid as 15 minutes can be administered if required [ see Adverse Reactions (6.1), Clinical Pharmacology (12.3)] .

Intravenous infusion of VIMPAT may cause bradycardia or AV blocks [ see Warnings and Precautions (5.3)]. Obtaining an ECG before beginning VIMPAT and after VIMPAT is titrated to steady-state maintenance dose is recommended in patients with known cardiac conduction problems, on concomitant medications that prolong PR interval, or with severe cardiac disease.

Storage and Stability

The diluted solution should not be stored for more than 4 hours at room temperature. Any unused portion of VIMPAT injection should be discarded.

Discontinuation of VIMPAT

When discontinuing VIMPAT, a gradual withdrawal over at least 1 week is recommended [ see Warnings and Precautions (5.5)].

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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