midazolam [Oral]

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

Dosing Adjustment ⬆ ⬇

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

Warnings/Precautions ⬆ ⬇

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/Breast Feeding ⬆ ⬇

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.

Adverse Reactions ⬆ ⬇

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

Clinical Pharmacology ⬆ ⬇