Nayzilam®

USA

In the U.S., Nayzilam® (midazolam) is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 12 years of age and older.

 

WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS

See full prescribing information for complete boxed warning.

  • Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death (5.1, 7.2) 
  • The use of benzodiazepines, including NAYZILAM, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Before prescribing NAYZILAM and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (5.2).
  • Although NAYZILAM is indicated only for intermittent use (1, 2), if used more frequently than recommended, abrupt discontinuation or rapid dosage reduction of NAYZILAM may precipitate acute withdrawal reactions, which can be life-threatening. For patients using NAYZILAM more frequently than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue NAYZILAM (5.3).
     

Prescribing information USA