Vimpat 10 mg/mL
lacosamide · SOLUTION · UCB, Inc.
Vimpat is a solution containing lacosamide at 10 mg/mL, taken oral. Manufactured by UCB, Inc..
Key Facts
- Brand Name
- Vimpat
- Generic Name
- lacosamide
- NDC Code (Product)
0131-5410- Manufacturer
- UCB, Inc.
- Strength
- 10 mg/mL
- Dosage Form
- SOLUTION
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule V (Controlled)
- Application #
- NDA022255
- Marketing Start
- 04/20/2010
Recall History
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE VIMPAT is indicated for: Treatment of partial-onset seizures in patients 1 month of age and older ( 1.1 ) Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older ( 1.2 ) 1.1 Partial-Onset Seizures VIMPAT is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. 1.2 Primary Generalized Tonic-Clonic Seizures VIMPAT is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Adults (17 years and older): Initial dosage for monotherapy for the treatment of partial-onset seizures is 100 mg twice daily ( 2.1 ) Initial dosage for adjunctive therapy for the treatment of partial-onset seizures or primary generalized tonic-clonic seizures is 50 mg twice daily ( 2.1 ) Maximum recommended dosage for monotherapy and adjunctive therapy is 200 mg twice daily ( 2.1 ) Pediatric Patients 1 month to less than 17 years : The recommended dosage is based on body weight and is administered orally twice daily ( 2.1 ) Increase dosage based on clinical response and tolerability, no more frequently than once per week ( 2.1 ) 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 ( 2.7 , 5.3 ) Dose adjustment is recommended for severe renal impairment ( 2.4 , 12.3 ) Dose adjustment is recommended for mild or moderate hepatic impairment; use in patients with severe hepatic impairment is not recommended ( 2.5 , 12.3 ) 2.1 Dosage Informatio…
Contraindications
4 CONTRAINDICATIONS None . None ( 4 )
Drug Interactions
7 DRUG INTERACTIONS 7.1 Strong CYP3A4 or CYP2C9 Inhibitors 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. 7.2 Concomitant Medications that Affect Cardiac Conduction 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. In such patients, obtaining an ECG before beginning VIMPAT, and after VIMPAT is titrated to steady-state, is recommended. In addition, these patients should be closely monitored if they are administered VIMPAT through the intravenous route [see Warnings and Precautions (5.3) ] .
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: Suicidal Behavior and Ideation [see Warnings and Precautions (5.1) ] Dizziness and Ataxia [see Warnings and Precautions (5.2) ] Cardiac Rhythm and Conduction Abnormalities [see Warnings and Precautions (5.3) ] Syncope [see Warnings and Precautions (5.4) ] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity Reactions [see Warnings and Precautions (5.6) ] Adjunctive therapy: Most common adverse reactions in adults (≥10% and greater than placebo) are diplopia, headache, dizziness, nausea, and somnolence ( 6.1 ) Monotherapy: Most common adverse reactions are similar to those seen in adjunctive therapy studies ( 6.1 ) Pediatric patients: Adverse reactions are similar to those seen in adult patients ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact UCB, Inc. at 1-844-599-2273 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clini…
Frequently Asked Questions
What is Vimpat used for?
Vimpat contains lacosamide. It is a solution taken oral. Consult your doctor for specific uses.
Is Vimpat a controlled substance?
Yes, Vimpat is classified as CV under the DEA Controlled Substances Act.
What is the generic name for Vimpat?
The generic name for Vimpat is lacosamide. There are 12 other brand versions of lacosamide.
What is the NDC code for Vimpat 10 mg/mL?
The NDC (National Drug Code) for Vimpat 10 mg/mL is 0131-5410, listed by UCB, Inc..