Midazolam (injection)
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]
Disclaimer
WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
Black Box Warning
|
BOXED WARNING
See full prescribing information for complete Boxed Warning.
Adults and Pediatric:
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. 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, ie., 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. The initial intravenous dose for sedation in adult patients may be as little as 1 mg, but should not exceed 2.5 mg in a normal healthy adult. Lower doses are necessary for older (over 60 years) or debilitated patients and in patients receiving concomitant narcotics or other central nervous system (CNS) depressants. The initial dose and all subsequent doses should always be titrated slowly; administer over at least 2 minutes and allow an additional 2 or more minutes to fully evaluate the sedative effect. The use of the 1 mg/mL formulation or dilution of the 1 mg/mL or 5 mg/mL formulation is recommended to facilitate slower injection. Doses of sedative medications in pediatric patients must be calculated on a mg/kg basis, and initial doses and all subsequent doses should always be titrated slowly. The initial pediatric dose of midazolam for sedation /anxiolysis/amnesia is age, procedure, and route dependent (see DOSAGE AND ADMINISTRATION for complete dosing information). Neonates: Midazolam should not be administered by rapid injection in the neonatal population. Severe hypotension and seizures have been reported following rapid IV administration, particularly with concomitant use of fentanyl (see DOSAGE AND ADMINISTRATION for complete information). |
Overview
Midazolam (injection) is a general anesthetic that is FDA approved for the {{{indicationType}}} of anxiety - induction of amnesia - preoperative sedation, induction of general anesthesia, procedural sedation, sedation for a mechanically ventilated patient.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include neurologic: excessive somnolence] (1.6%), [[]headache]] (1.3% to 1.5%), somnolence(1.2%), respiratory: hiccoughs (3.6% ).
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Midazolam (injection) FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information about Off-Label Guideline-Supported Use of Midazolam in adult patients.
Non–Guideline-Supported Use
There is limited information about Off-Label Non–Guideline-Supported Use of Midazolam in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Midazolam (injection) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information about Off-Label Guideline-Supported Use of Midazolam in pediatric patients.
Non–Guideline-Supported Use
There is limited information about Off-Label Non–Guideline-Supported Use of Midazolam in pediatric patients.
Contraindications
There is limited information regarding Midazolam (injection) Contraindications in the drug label.
Warnings
|
BOXED WARNING
See full prescribing information for complete Boxed Warning.
Adults and Pediatric:
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. 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, ie., 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. The initial intravenous dose for sedation in adult patients may be as little as 1 mg, but should not exceed 2.5 mg in a normal healthy adult. Lower doses are necessary for older (over 60 years) or debilitated patients and in patients receiving concomitant narcotics or other central nervous system (CNS) depressants. The initial dose and all subsequent doses should always be titrated slowly; administer over at least 2 minutes and allow an additional 2 or more minutes to fully evaluate the sedative effect. The use of the 1 mg/mL formulation or dilution of the 1 mg/mL or 5 mg/mL formulation is recommended to facilitate slower injection. Doses of sedative medications in pediatric patients must be calculated on a mg/kg basis, and initial doses and all subsequent doses should always be titrated slowly. The initial pediatric dose of midazolam for sedation /anxiolysis/amnesia is age, procedure, and route dependent (see DOSAGE AND ADMINISTRATION for complete dosing information). Neonates: Midazolam should not be administered by rapid injection in the neonatal population. Severe hypotension and seizures have been reported following rapid IV administration, particularly with concomitant use of fentanyl (see DOSAGE AND ADMINISTRATION for complete information). |
There is limited information regarding Midazolam (injection) Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Midazolam (injection) Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Midazolam (injection) Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Midazolam (injection) Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Midazolam (injection) in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Midazolam (injection) in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Midazolam (injection) during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Midazolam (injection) in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Midazolam (injection) in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Midazolam (injection) in geriatric settings.
Gender
There is no FDA guidance on the use of Midazolam (injection) with respect to specific gender populations.
Race
There is no FDA guidance on the use of Midazolam (injection) with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Midazolam (injection) in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Midazolam (injection) in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Midazolam (injection) in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Midazolam (injection) in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Midazolam (injection) Administration in the drug label.
Monitoring
There is limited information regarding Midazolam (injection) Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Midazolam (injection) and IV administrations.
Overdosage
There is limited information regarding Midazolam (injection) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Midazolam (injection) Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Midazolam (injection) Mechanism of Action in the drug label.
Structure
There is limited information regarding Midazolam (injection) Structure in the drug label.
Pharmacodynamics
There is limited information regarding Midazolam (injection) Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Midazolam (injection) Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Midazolam (injection) Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Midazolam (injection) Clinical Studies in the drug label.
How Supplied
There is limited information regarding Midazolam (injection) How Supplied in the drug label.
Storage
There is limited information regarding Midazolam (injection) Storage in the drug label.
Images
Drug Images
{{#ask: Page Name::Midazolam (injection) |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Midazolam (injection) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Midazolam (injection) Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Midazolam interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Midazolam (injection) Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Midazolam (injection) Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.