Label: MIDAZOLAM- midazolam hydrochloride injection, solution

  • NDC Code(s): 70860-601-05, 70860-601-10, 70860-601-41, 70860-601-42
  • Packager: Athenex Pharmaceutical Division, LLC.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CIV
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 25, 2019

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  • SPL UNCLASSIFIED SECTION
    NOT FOR USE IN NEONATES - CONTAINS BENZYL ALCOHOL - Athenex - Rx only
  • BOXED WARNING (What is this?)
    Personnel and Equipment for Monitoring and Resuscitation - Adults and Pediatrics: Intravenous midazolam hydrochloride has been associated with respiratory depression and respiratory arrest ...

    WARNINGS

    Personnel and Equipment for Monitoring and Resuscitation

    Adults and Pediatrics: 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 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). For deeply sedated pediatric patients, a dedicated individual, other than the practitioner performing the procedure, should monitor the patient throughout the procedure.

    Risks From Concomitant Use With Opioids

    Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Monitor patients for respiratory depression and sedation (see WARNINGS and PRECAUTIONS, Drug Interactions).

    Individualization of Dosage

    Midazolam hydrochloride must never be used without individualization of dosage. 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).

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  • DESCRIPTION
    Midazolam hydrochloride is a water-soluble benzodiazepine available as a sterile, nonpyrogenic parenteral dosage form for intravenous or intramuscular injection. Each mL contains midazolam ...
  • CLINICAL PHARMACOLOGY
    Midazolam is a short-acting benzodiazepine central nervous system (CNS) depressant. Pharmacodynamics - The effects of midazolam hydrochloride on the CNS are dependent on the dose administered ...
  • INDICATIONS AND USAGE
    Midazolam Injection, USP is indicated:   intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia;   intravenously as an agent for sedation/anxiolysis/amnesia prior to ...
  • CONTRAINDICATIONS
    Injectable midazolam hydrochloride is contraindicated in patients with a known hypersensitivity to the drug. Benzodiazepines are contraindicated in patients with acute narrow-angle glaucoma ...
  • WARNINGS
    Personnel and Equipment for Monitoring and Resuscitation - Prior to the intravenous administration of midazolam hydrochloride in any dose, the immediate availability of oxygen, resuscitative ...
  • PRECAUTIONS
    General - Intravenous doses of midazolam hydrochloride should be decreased for elderly and for debilitated patients (see WARNINGS and DOSAGE AND ADMINISTRATION). These patients will also ...
  • ADVERSE REACTIONS
    See WARNINGS concerning serious cardiorespiratory events and possible paradoxical reactions. Fluctuations in vital signs were the most frequently seen findings following parenteral administration ...
  • DRUG ABUSE AND DEPENDENCE
    Midazolam hydrochloride contains midazolam, a Schedule IV control substance. Midazolam was actively self-administered in primate models used to assess the positive reinforcing effects of ...
  • OVERDOSAGE
    Symptoms - The manifestations of midazolam overdosage reported are similar to those observed with other benzodiazepines, including sedation, somnolence, confusion, impaired coordination ...
  • DOSAGE AND ADMINISTRATION
    NOTE: CONTAINS BENZYL ALCOHOL (see WARNINGS and PRECAUTIONS, Pediatric Use). Midazolam injection is a potent sedative agent that requires slow administration and individualization of dosage ...
  • HOW SUPPLIED
    Midazolam Injection, USP is supplied as follows: NDCMidazolam Injection, USP (5 mg per mL)Package Factor - 70860-601-05 - 25 mg per 5 mL Multi-Dose Vial - 10 vials per carton - 70860-601-10 - 50 ...
  • ANIMAL TOXICOLOGY AND/OR PHARMACOLOGY
    Published studies in animals demonstrate that the use of anesthetic agents during the period of rapid brain growth or synaptogenesis results in widespread neuronal and oligodendrocyte cell loss in ...
  • PRINCIPAL DISPLAY PANEL
    PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label - NDC 70860-601-41 - Midazolam Injection, USP - CIV - 25 mg per 5 mL (5 mg per mL) Rx only - CONTAINS BENZYL ALCOHOL - For Intravenous or ...
  • PRINCIPAL DISPLAY PANEL
    PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label - NDC 70860-601-42 - Midazolam Injection, USP - CIV - 50 mg per 10 mL (5 mg per mL) Rx only - CONTAINS BENZYL ALCOHOL - For Intravenous or ...
  • INGREDIENTS AND APPEARANCE
    Product Information