WARNING: PERSONNEL AND EQUIPMENT FOR MONITORING AND RESUSCITATION AND RISKS FROM CONCOMITANT USE WITH OPIOID ANALGESICS AND OTHER SEDATIVE-HYPNOTICS

Personnel and Equipment for Monitoring and Resuscitation

• Only personnel trained in the administration of procedural sedation, and not involved in the conduct of the diagnostic or therapeutic procedure, should administer Midazolam in Sodium Chloride Injection.
• Administering personnel must be trained in the detection and management of airway obstruction, hypoventilation, and apnea, including the maintenance of a patent airway, supportive ventilation, and cardiovascular resuscitation.
• Resuscitative drugs, and age- and size-appropriate equipment for bag/valve/mask assisted ventilation must be immediately available during administration of Midazolam in Sodium Chloride Injection.
• Continuously monitor vital signs during sedation and during the recovery period.

Risks from Concomitant Use with Opioid Analgesics and Other Sedative Hypnotics

Concomitant use of benzodiazepines, including Midazolam in Sodium Chloride Injection, and opioids may result in profound sedation, respiratory depression, coma, and death. Continuously monitor patients for respiratory depression and depth of sedation.

Indications and Usage

Midazolam in Sodium Chloride Injection is indicated: 

• Continuous intravenous infusion for sedation of intubated and mechanically ventilated adult, pediatric, and neonatal patients as a component of anesthesia or during treatment in a critical care setting.

Important Dosage and Administration Instructions

• Midazolam in Sodium Chloride Injection should only be administered intravenously. Avoid intra-arterial injection or extravasation.
• Only personnel trained in the administration of procedural sedation, and not involved in the conduct of the diagnostic or therapeutic procedure, should administer Midazolam in Sodium Chloride Injection.
• Administering personnel must be trained in the detection and management of airway obstruction, hypoventilation, and apnea, including the maintenance of a patent airway, supportive ventilation, and cardiovascular resuscitation.
• Supplemental oxygen, resuscitative drugs, and age- and size-appropriate equipment for bag/valve/mask assisted ventilation must be immediately available during administration of Midazolam in Sodium Chloride Injection. A benzodiazepine reversal agent should be immediately available.
• Continuously monitor vital signs during sedation and through the recovery period.

Please see package insert for Full Prescribing Information, including Warnings, Precautions, and Important Safety Information.