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Midazolam injection, USP is indicated for intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia; intravenously as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography, cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerations and other procedures either alone or in combination with other CNS depressants; intravenously for induction of general anesthesia, before administration of other anesthetic agents. With the use of narcotics premedication, induction of anesthesia can be attained within a relatively narrow dose range and in a short period of time. Intravenous midazolam can also be used as a component of intravenous supplementation of nitrous oxide and oxygen (balanced anesthesia); continuous intravenous infusion for sedation of intubated and mechanically ventilated patients as a component of anesthesia or during treatment in a critical care setting.

Important Safety Information

WARNING Adult and Pediatric: Intravenous midazolam has been associated with respiratory depression and respiratory arrest, especially when used for sedation in noncritical care settings. In some cases, where this was not recognized promptly and treated effectively, death or hypoxic encephalopathy has resulted. Intravenous midazolam should be used only in hospital or ambulatory care settings, including physicians and dental offices that provide for continuous monitoring of respiratory and cardiac function, i.e. pulse oximetry. Immediate availability of resuscitative drugs and age- and size-appropriate equipment for bag/valve/mask ventilation and intubation, and personnel trained in their use and skilled in airway management should be assured (see WARNINGS). For deeply sedated pediatric patients, a dedicated individual, other than the practitioner performing the procedure, should monitor the patient throughout the procedure.

Injectable midazolam is contraindicated in patients with a known hypersensitivity to the drug. Benzodiazepines are contraindicated in patients with acute narrow-angle glaucoma.

Other Significant Warnings for Midazolam include higher risk for adult and pediatric surgical patients, elderly patients and debilitated adult and pediatric patients require lower dosages, whether or not concomitant sedating medications have been administered.

Injectable midazolam should not be administered to adult or pediatric patients in shock or coma, or in acute alcohol intoxication with depression of vital signs.

Usage in Pregnancy: An increased risk of congenital malformations associated with the use of benzodiazepine drugs (diazepam and chlordiazepoxide) has been suggested in several studies.

Midazolam can cause serious cardiorespiratory adverse events, including respiratory depression, airway obstruction, oxygen desaturation, apnea, respiratory arrest, cardiac arrest, sometimes resulting in death or permanent neurologic injury.

Additional adverse reactions were reported subsequent to intravenous in adult patients including, hiccough, nausea, vomiting, coughing, oversedation, headache, drowsiness, local effects at the IV site.

The most common adverse effects of midazolam include fluctuations in vital signs following parenteral administration of midazolam in adults and included decreased tidal volume and/or respiratory rate decrease and apnea as well as variations in blood pressure and pulse rate.

Please see full prescribing information, including Boxed WARNING, for additional important safety information here.