Search for drugs:

LACOSAMIDE


DIR Classification


Classification:Ambiguous
Severity Score:1.0

Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF

  • CLINICAL PHARMACOLOGY
  • Pharmacodynamics
  • Cardiac electrophysiology
  • Electrocardiographic effects of VIMPAT were determined in a double-blind, randomized clinical pharmacology trial of 247 healthy subjects. Chronic oral doses of 400 and 800 mg/day were compared with placebo and a positive control (400 mg moxifloxacin). VIMPAT did not prolong QTc interval and did not have a dose-related or clinically important effect on QRS duration. VIMPAT produced a small, dose-related increase in mean PR interval. At steady-state, the time of the maximum observed mean PR interval corresponded with t max. The placebo-subtracted maximum increase in PR interval (at t max) was 7.3 ms for the 400 mg/day group and 11.9 ms for the 800 mg/day group. For patients who participated in the controlled trials, the placebo-subtracted mean maximum increase in PR interval for a 400 mg/day VIMPAT dose was 3.1 ms in patients with partial-onset seizures and 9.4 ms for patients with diabetic neuropathy.

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
QT Prolongation
26
24066
Other ADRs
26955
38354632

Odds Ratio = 1.538

Drug Property Information



ATC Code(s):
  • N03AX18 - lacosamide
    • N03AX - Other antiepileptics
    • N03A - ANTIEPILEPTICS
    • N03 - ANTIEPILEPTICS
    • N - NERVOUS SYSTEM
Active Ingredient:LACOSAMIDE
Active Ingredient UNII:563KS2PQY5
Drugbank ID:DB06218
PubChem Compound:219078
CTD ID:D000078334
PharmGKB:PA166160048
CAS Number:175481-36-4
Dosage Form(s):tablet, film coated
Route(s) Of Administrator:oral
Daily Dose:
  • 300.0 mg/day N03AX18
Chemical Structure:
SMILE Code:
COC[C@@H](NC(C)=O)C(=O)NCC1=CC=CC=C1

Reference

N/A

Disclaimer:

The content of this database of QT prolongation is intended for educational and scientific research purposes only. It is not intended as a substitute for professional medical advice, diagnosis or treatment.

Any mention of commercial products is for clarification and not intended as endorsement.