Worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in Monitor patients taking VIMPAT for the emergence or Suicidal Behavior and Ideation: Antiepileptic drugs (AEDs), including VIMPAT, increase the Adverse reactions with IV administration generally appeared similar to those observed with the oral formulation, although IV administration was associated with local adverse events, such as injection site pain or discomfort (2.5%), irritation (1%), and erythema (0.5%).Proarrhythmic conditions or on concomitant medications that affect cardiac Titrated to steady-state maintenance dose is recommended in patients with underlying Obtaining an ECG before beginning VIMPAT and after VIMPAT is Intravenous infusion of VIMPAT may cause bradycardia, AV blocks, and ventricular.Infusion durations less than 30 minutes are generally not recommended in pediatric patients.Infusions as rapid as 15 minutes can be administered in adults if required The recommended infusion duration is 30 to 60 minutes however,.For pediatric patients weighing less than 6 kg, VIMPAT injection may be initiated with a dose of 0.66 mg/kg three times daily. VIMPAT injection can be administered intravenously to adult and pediatric patients weighing 6 kg or more with the same dosing regimens described for oral dosing.Replacement when oral administration is not feasible. VIMPAT injection for intravenous use-indicated as VIMPAT is a Schedule V controlled substance. The adverse reactions most commonly reported wereĭizziness, somnolence, headache, and nausea. Seizures, the adverse reactions were generally similar to those that occurred in the
#TOP 10 I DOSER DOSES TRIAL#
In the adjunctive therapy placebo-controlled trial for primary generalized tonic-clonic
Primary Generalized Tonic-Clonic Seizures Pediatric adverse reactions were similar to those seen in adult patients. Placebo-controlled trials, with the exception of insomnia (observed at a higher rate of Generally similar to those observed and attributed to drug in adjunctive In the adult monotherapy clinical trial, adverse reactions were In the adult adjunctive placebo-controlled trials for partial-onset seizures, the mostĬommon adverse reactions (≥10% and greater than placebo) were dizziness, headache,
VIMPAT is associated with important warnings and precautions including suicidal behaviorĪnd ideation, dizziness and ataxia, cardiac rhythm and conduction abnormalities, syncope,Īnd Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as Treatment of partial-onset seizures in patients 1 month of age and olderĪdjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older.
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