Adult Dosing

• N/A

Pediatric Dosing

Preoperative sedation/anxiolysis/amnesia

• 0.25-1 mg/kg PO; Max: 20 mg
• Not intended for chronic administration

• Indicated for use in pediatric patients for sedation, anxiolysis and amnesia prior to diagnostic, therapeutic or endoscopic procedures or before induction of anesthesia

• Hypersensitivity to any of the ingredients of the product
• Patients with acute narrow-angle glaucoma
• Untreated open-angle glaucoma
• Not intended for chronic use

• Therapy has been associated with respiratory depression and respiratory arrest, especially when used for sedation in noncritical care settings
• There have been reports of respiratory depression, airway obstruction, desaturation, hypoxia, and apnea, most often when used concomitantly with other central nervous system depressants (eg, opioids)
• Midazolam should be used only in hospital or ambulatory care settings, including physicians' and dentists' offices that can provide with continuous respiratory and cardiac function monitoring, resuscitative drugs, appropriate ventilation/intubation equipment, and personnel skilled in airway management
• One dedicated person other than practitioner performing procedure should continuously monitor deeply sedated pediatric patients

Renal Dose Adjustment: (Based on CrCl)

• Renal impairment: Dose adjustments not defined, caution advised

Hepatic Dose Adjustment:

• Hepatic impairment: Dose adjustments not defined, caution advised

• Therapy has been associated with respiratory depression and respiratory arrest, especially when used for sedation in noncritical care settings [US black box warning]
• There have been reports of respiratory depression, airway obstruction, desaturation, hypoxia, and apnea, most often when used concomitantly with other central nervous system depressants (eg, opioids)[US black box warning]
• Midazolam should be used only in hospital or ambulatory care settings, including physicians' and dentists' offices that can provide with continuous respiratory and cardiac function monitoring, resuscitative drugs, appropriate ventilation/intubation equipment, and personnel skilled in airway management [US black box warning]
• One dedicated person other than practitioner performing procedure should continuously monitor deeply sedated pediatric patients [US black box warning]
• Serious respiratory adverse events have occurred after administration of oral midazolam, most often when was used in combination with other central nervous system depressants. These adverse events have included respiratory depression, airway obstruction, oxygen desaturation, apnea, and rarely, respiratory and/or cardiac arrest
• Closely monitor patients for early signs of hypoventilation, airway obstruction, or apnea with means for detection readily available (eg, pulse oximetry). Hypoventilation, airway obstruction, and apnea can lead to hypoxia and/or cardiac arrest unless effective countermeasures are taken immediately
• Because midazolam can depress respiration, especially when used concomitantly with opioid agonists and other sedatives, it should be used for sedation/anxiolysis/amnesia only in the presence of personnel skilled in early detection of hypoventilation, maintaining a patent airway, and supporting ventilation
• Episodes of oxygen desaturation, respiratory depression, apnea, and airway obstruction have been occasionally reported following premedication
• Adverse reactions such as agitation, involuntary movements (including tonic/clonic movements and muscle tremor), hyperactivity and combativeness have been reported
• Concomitant use of barbiturates, alcohol or other central nervous system depressants may increase the risk of hypoventilation, airway obstruction, desaturation, or apnea
• It is recommended that no patient operate hazardous machinery or a motor vehicle until the effects of the drug, such as drowsiness, have subsided or until one full day after anesthesia and surgery
• Risk of severe hypotension and seizure especially in neonates and with concomitant fentanyl administration

Pregnancy Category:D

Breastfeeding: An increased risk of congenital malformations associated with the use of benzodiazepine drugs (diazepam and chlordiazepoxide) have been suggested in several studies. If this drug is used during pregnancy, the patient should be apprised of the potential hazard to the fetus. According to manufacturer data, caution should be exercised when midazolam hydrochloride is administered to a nursing woman.

• CNS: Dysphoria, disinhibition, excitation, aggression, mood swings, hallucinations, adverse behavior, agitation, dizziness, confusion, ataxia, vertigo, dysarthria
• GI: Emesis, nausea
• RESP: Laryngospasm, hiccoughs, sneezing, hypoxia, respiratory depression, rhonchi, airway obstruction, apnea, hypercarbia, desaturation, stridor, arrest
• CV: Bradycardia, decreased systolic and diastolic blood pressure, increased heart rate, arrest
• DERM: Rash

• Benzodiazepine; enhances GABA effects by binding to benzodiazepine receptors
• Well absorbed following oral administration
• Absolute bioavailability: 36%
• Exclusively metabolized by the liver; CYP450: 3A4 substrate
• Excreted in urine
• Half-life: 2.2-6.8 hrs

US Trade Name(s)

• Only generic available

US Availability

midazolam (generic)

• SOLN: 2 mg/mL

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

Neurologic

Anxiolytics/Sedatives/Hypnotics

Benzodiazepines

Psychiatric

Anxiolytics/Sedatives/Hypnotics

Benzodiazepines