List of non sedating
At the specified p H of the product, the solution may contain up to about 25% of the open-ring compound.At the physiologic conditions under which the product is absorbed (p H of 5 to 8) into the systemic circulation, any open-ring form present reverts to the physiologically active, lipophilic, closed-ring form (midazolam) and is absorbed as such.
The amount of open-ring form is dependent upon the p H of the solution.For deeply sedated pediatric patients, a dedicated individual, other than the practitioner performing the procedure, should monitor the patient throughout the procedure.Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.Midazolam hydrochloride is a water-soluble benzodiazepine available as a sterile, nonpyrogenic parenteral dosage form for intravenous or intramuscular injection.Each m L contains midazolam hydrochloride equivalent to 1 mg midazolam compounded with 0.8% sodium chloride and 0.01% edetate disodium; the p H is adjusted to 2.9 to 3.5 with hydrochloric acid and, if necessary, sodium hydroxide.Above p H 5, at least 99% of the mixture is present in the closed-ring form.
The effects of midazolam hydrochloride on the CNS are dependent on the dose administered, the route of administration, and the presence or absence of other medications.
Intravenous midazolam hydrochloride 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, e.g., 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).
Intravenous midazolam hydrochloride 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.
In one study of pediatric patients undergoing lumbar puncture or bone marrow aspiration, 88% of patients had impaired recall vs 9% of the placebo controls.