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Midazolam

    DEA Class;  Rx

    Common Brand Names; Seizalam, Versed (DSC), Nayzilam

    • Antianxiety Agents; 
    • Anxiolytics, Benzodiazepines; 
    • Anticonvulsants, Benzodiazepine

    Oral/parenteral/intranasal short-acting benzodiazepine
    Used for sedation, anxiolysis, amnesia, and acutely for seizures
    Black-box warning describing risk of profound sedation and respiratory depression with concomitant opioid use

    Indicated for procedural sedation and amnesia induction and to control preoperative anxiety.

    For general anesthesia induction and general anesthesia maintenance.
    For the treatment of status epilepticus.

    Documented hypersensitivity

    Acute alcohol intoxication

    Acute narrow angle glaucoma

    Intrathecal/epidural use (formulations containing preservatives, such as, benzyl alcohol)

    Potent inhibitors of CYP3A4 including amprenavir, atazanavir, darunavir, indinavir, lopinavir, ritonavir, nelfinavir, ritonavir, saquinavir, tipranavir or oral or injectable midazolam with fosamprenavir

    • Decreased respiratory rate (23%)
    • Apnea (15%)
    • Drowsiness (1-5%)
    • Seizure-like activity (1%)
    • Nausea/vomiting (3%)
    • Cough (1%)
    • Pain at injection site (4-5%)
    • Headache
    • Sedation
    • Hiccoughs
    • Delirium
    • Euphoria

    Pediatric

    • Desaturation
    • Hypotension
    • Seizurelike activity
    • Nystagmus
    • Paradoxical reactions
    • Hiccoughs
    • Apnea

    Use caution in COPD, sleep apnea, renal/hepatic disease, open-angle glaucoma (questionable), depression, suicidal ideation, impaired gag reflex, heart failure, patients at risk of falls, or obese patients

    Anterograde amnesia reported with benzodiazepines

    Use caution in myasthenia gravis (allowable in limited circumstances)

    Use in narrow-angle glaucoma questionable

    May cause hypotension; may occur more frequently in patients receiving opioid analgesics

    Use caution in patient receiving other CNS depressants or psychoactive medications

    IV use in shock, coma, depressed respiration, patients who recently received other respiratory depressants not recommended

    Paradoxical reactions, including hyperactive or aggressive behavior reported

    Avoid extravasation of arterial formulation

    Does not protect against increases in heart rate or blood pressure

    May cause CNS depression and impair ability to perform hazardous tasks

    Not for use as antidepressant, analgesic, or antipsychotic agent

    Not for use in acute alcohol intoxication, shock, or coma

    Use of drug, particularly in patients at elevated risk of abuse, necessitates counseling about risks and proper use of drug along with monitoring for signs and symptoms of abuse, misuse, and addiction; do not exceed recommended dosing frequency

    There are no adequate and well-controlled studies of midazolam intranasal in pregnant women

    Midazolam is excreted in human milk

    Studies assessing effects in the breastfed infant or on milk production/excretion have not been performed

    Postmarketing experience suggests that breastfed infants of mothers taking benzodiazepines may experience lethargy, somnolence, and poor sucking

    Adults

    1 spray (5 mg)/dose intranasal up to 2 doses/episode for acute repetitive seizures; 10 mg IM for status epilepticus. Specific maximum dosage information for other routes or indications is not available; the dose required is dependent on route of administration, indication for therapy, and clinical response.

    Geriatric

    1 spray (5 mg)/dose intranasal up to 2 doses/episode for acute repetitive seizures; 10 mg IM for status epilepticus. Specific maximum dosage information for other routes or indications is not available; the dose required is dependent on route of administration, indication for therapy, and clinical response.

    Adolescents

    1 mg/kg (Max: 20 mg) PO total dose for procedural sedation; a total dose up to 10 mg IV may be necessary for amnesia induction; 1 spray (5 mg)/dose intranasal up to 2 doses/episode for acute repetitive seizures; specific maximum dosage information for other routes or indications is not available; the dose required is dependent on route of administration, indication, and clinical response.

    Children

    12 years: 1 mg/kg (Max: 20 mg) PO total dose for procedural sedation; a total dose up to 0.6 mg/kg (Max: 6 mg) IV may be necessary for amnesia induction; 1 spray (5 mg)/dose intranasal up to 2 doses/episode for acute repetitive seizures; specific maximum dosage information for other routes or indications is not available; the dose required is dependent on route of administration, indication, and clinical response.
    1 to 11 years: 1 mg/kg (Max: 20 mg) PO total dose for procedural sedation; a total dose up to 0.6 mg/kg (Max: 6 mg) IV may be necessary for amnesia induction; specific maximum dosage information for other routes or indications is not available; the dose required is dependent on route of administration, indication, and clinical response.

    Infants

    6 to 11 months: 1 mg/kg PO total dose for procedural sedation; a total dose up to 0.6 mg/kg IV may be necessary for amnesia induction; specific maximum dosage information for other routes or indications is not available; the dose required is dependent on route of administration, indication, and clinical response.
    1 to 5 months: Specific maximum dosage information is not available; the dose required is dependent on route of administration, indication, and clinical response.

    Neonates

    Specific maximum dosage information is not available; the dose required is dependent on route of administration, indication, and clinical response.

    Midazolam hydrochloride

    oral syrup: Schedule IV

    • 2mg/mL (generic)

    injectable solution: Schedule IV

    • 1mg/mL (generic)

    • 5mg/mL (generic, Seizalam)

    intranasal solution: Schedule IV

    • 5mg/0.1mL per single-dose spray