Midazolam (Pf) (midazolam HCl/PF)

Midazolam is commercially available as midazolam or the hydrochloride salt; dosage is expressed in terms of midazolam. Midazolam is a potent sedative that requires individualized dosing.

When midazolam is used for sedation or anesthesia, dosage must be carefully adjusted according to individual requirements and response, age, body weight, physical and clinical status, underlying pathologic condition(s), type and amount of premedication or concomitant medication, and the nature and duration of the surgical or other procedure; however, individual response to the drug also may vary independent of these factors. Titration should be more gradual in patients 60 years of age and older for procedural sedation, in those 55 years of age and older for induction of anesthesia, and in patients with chronic debilitating diseases. Excessive doses or rapid or single large IV injections may result in respiratory depression and/or arrest, particularly in geriatric or debilitated patients and in patients receiving other cardiorespiratory depressants concomitantly. The smallest effective dose should be used, especially in geriatric and/or debilitated patients.

It should be recognized that the depth of sedation/anxiolysis needed for pediatric patients depends on the type of procedure performed. For example, simple light sedation in the preoperative period is different from the deeper sedation required for a therapeutic or diagnostic procedure (e.g., endoscopy); therefore, there is a broad dosage range. For all pediatric patients, regardless of the indications for sedation/anxiolysis, it is vital to titrate the midazolam dose and the dose of other concomitant drugs slowly for the desired clinical effect. Unlike adults, pediatric patients generally receive increments of midazolam on a mg/kg basis; drug dose in obese pediatric patients should be calculated on the basis of ideal body weight. Pediatric patients generally require higher dosages of midazolam on a mg/kg basis than adults, and pediatric patients younger than 6 years of age generally require higher dosages on a mg/kg basis than older pediatric patients and may require closer monitoring.

When midazolam is used for sedation in geriatric patients, the initial dose should be reduced, since some degree of organ impairment frequently is present. Dosage requirements in this age group generally appear to decrease with increasing age, and the possibility of profound and/or prolonged effects should be considered in older and/or debilitated patients. Low doses of midazolam usually are required in high-risk surgical patients, debilitated patients, and geriatric patients when the drug is administered with or without premedication.

Midazolam hydrochloride is administered orally, by IM or slow IV injection, or by IV infusion. Midazolam also has been used in IV patient-controlled analgesia (PCA). Midazolam is administered intranasally. Midazolam also has been orally administered as the maleate salt+; however, midazolam maleate currently is not commercially available in the US.

Because serious and life-threatening adverse cardiorespiratory effects can occur during therapy with midazolam, provision should be made for monitoring, detecting, and correcting such effects in every patient in whom the drug is administered, regardless of age or health status.

When IV or oral midazolam is used for sedation or anesthesia, the drug should be administered in a hospital or ambulatory care setting equipped to provide continuous monitoring of cardiorespiratory function. Resuscitative equipment, drugs, and personnel for airway and ventilation management should be immediately available. For deeply sedated pediatric patients, a dedicated individual other than the clinician performing the procedure should monitor the patient throughout the procedure.

When IM midazolam is used for status epilepticus, the drug should be administered in a monitored setting that allows for immediate access to resuscitative drugs, and the patient's cardiorespiratory function should be continuously monitored until stabilized.

When midazolam nasal spray is used, consideration should be given to administering the drug under the supervision of a healthcare professional.

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There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

There is no enhanced messaging for this drug.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

There is no enhanced messaging for this drug.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

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No enhanced messaging available.

An increased risk of congenital malformations associated with the use of benzodiazepines (e.g., chlordiazepoxide, diazepam) during pregnancy has been suggested by several retrospective studies in humans. Midazolam has been shown to cross the placenta in humans. Reproduction studies in rabbits and rats using IV midazolam in doses up to 1.85 times the human induction dose have not revealed evidence of fetal malformation. If the drug is administered during pregnancy, the patient should be informed of the potential hazard to the fetus. Use of midazolam injection for obstetric procedures or during labor and delivery is not recommended, since such use has not been evaluated and use of other benzodiazepines during the last weeks of pregnancy has caused CNS depression in the neonate.

Based on animal data, repeated or prolonged use of general anesthetics and sedation drugs, including midazolam, during the third trimester of pregnancy may result in adverse neurodevelopmental effects in the fetus. The clinical relevance of these animal findings to humans is not known; the potential risk of adverse neurodevelopmental effects should be considered and discussed with pregnant women undergoing procedures requiring general anesthetics and sedation drugs.

Midazolam is distributed into milk in humans, and caution should be exercised when midazolam is administered to nursing women.

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