WARNING: SERIOUS PSYCHIATRIC AND BEHAVIORAL REACTIONS WARNING: SERIOUS PSYCHIATRIC AND BEHAVIORAL REACTIONS Serious or life-threatening psychiatric and behavioral adverse reactions including aggression, hostility, irritability, anger, and homicidal ideation and threats have been reported in patients taking perampanel ( 5.1). These reactions occurred in patients with and without prior psychiatric history, prior aggressive behavior, or concomitant use of medications associated with hostility and aggression ( 5.1). Advise patients and caregivers to contact a healthcare provider immediately if any of these reactions or changes in mood, behavior, or personality that are not typical for the patient are observed while taking perampanel or after discontinuing perampanel ( 5.1). Closely monitor patients particularly during the titration period and at higher doses ( 5.1). Perampanel should be reduced if these symptoms occur and should be discontinued immediately if symptoms are severe or are worsening ( 5.1). WARNING: SERIOUS PSYCHIATRIC AND BEHAVIORAL REACTIONS See full prescribing information for complete boxed warning. Serious or life-threatening psychiatric and behavioral adverse reactions including aggression, hostility, irritability, anger, and homicidal ideation and threats have been reported in patients taking perampanel ( 5.1) Monitor patients for these reactions as well as for changes in mood, behavior, or personality that are not typical for the patient, particularly during the titration period and at higher doses ( 5.1) Perampanel should be reduced if these symptoms occur and should be discontinued immediately if symptoms are severe or are worsening ( 5.1)
Adult Dosing
partial-onset seizures
for partial-onset seizures: 8 mg to 12 mg once daily at bedtime Recommended maintenance dose in adjunctive therapy
primary generalized tonic-clonic seizures
for primary generalized tonic-clonic seizures: 8 mg once daily at bedtime Dosing in the presence of concomitant moderate or strong CYP3A4 inducers : see section 2.3 Specific Populations Mild and Moderate Hepatic Impairment: Maximum recommended daily dose is 6 mg (mild) and 4 mg (moderate) once daily at bedtime Severe Hepatic Impairment: Not recommended Severe Renal Impairment or on Hemodialysis: Not recommended Elderly: Increase dose no more frequently than every 2 weeks 2.1 Dosage for Partial-Onset Seizures Monotherapy or Adjunctive Therapy The recommended starting dosage of perampanel in adults and pediatric patients 4 years of age and older is 2 mg once daily taken orally at bedtime.
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