Midazolam

Adult dosing:

Anxiety – Induction of amnesia – Preoperative sedation
  • good-risk patients less than 60 years of age, 0.07 to 0.08 mg/kg IM (approximately 5 mg) up to 1 hour before surgery [2]
  • patients 60 years or older, patients with COPD, other higher-risk surgical patients, and patients who have received concomitant narcotics or other CNS depressants, 0.02 to 0.05 mg/kg IM (approximately 2 to 3 mg) 1 hour before surgery [2]
  • older patients when the anticipated intensity and duration of sedation is less critical, 1 mg IM 1 hour before surgery [2]
  • healthy adults less than 60 years of age, initial, 1 to 2.5 mg IV over at least 2 minutes, may titrate using small increments to desired level of sedation (allowing 2 additional minutes to evaluate full effect after each increment); reduce dose by 30% with narcotic premedication or other CNS depressants (MAX total dose: 5 mg) [2]
  • patients 60 years or older, and debilitated or chronically ill patients, initial, 1 to 1.5 mg IV over at least 2 minutes, may titrate by no more than 1-mg increments (allowing 2 additional minutes to evaluate full effect after each increment); reduce dose by 50% with narcotic premedication or other CNS depressants (MAX total dose: 3.5 mg) [2]
  • maintenance, additional doses of 25% of total initial dose required to achieved desired sedation may be administered IV if additional sedation is required [2]
Procedural sedation
  • healthy adults below 60 years of age, initial, 1 to 2.5 mg IV over at least 2 minutes, may titrate using small increments to desired level of sedation (allowing 2 additional minutes to evaluate full effect after each increment); reduce dose by 30% with narcotic premedication or other CNS depressants (MAX total dose: 5 mg) [2]
  • patients 60 years or older, and debilitated or chronically ill patients, initial, 1 to 1.5 mg IV over at least 2 minutes, may titrate by no more than 1-mg increments (allowing 2 additional minutes to evaluate full effect after each increment); reduce dose by 50% with narcotic premedication or other CNS depressants (MAX total dose: 3.5 mg) [2]
  • maintenance, additional doses of 25% of total initial dose required to achieved desired sedation may be administered IV if additional sedation is required [2]
Sedation for a mechanically ventilated patient
  • loading dose, 0.01 to 0.05 mg/kg IV administered over several minutes; may repeat at 10- to 15-minute intervals until adequate sedation is achieved [2].
  • maintenance, continuous IV infusion initiated at a rate of 0.02 to 0.1 mg/kg/hr; may adjust rate up or down by 25% to 50% of initial infusion rate to achieve adequate sedation [2].
Seizure
  • Refractory status epilepticus, 0.2 mg/kg IV (via slow bolus injection) followed by 0.75 to 10 mcg/kg/min maintenance infusion (study dose) [3][4]
  • 0.2 mg/kg IM (study dose) [5]
  • Individualized doses of buccal solution 10 mg/mL (mean total dose given, 15.5 mg) in a syringe administered by parting the patient’s lips and, without opening the jaws, placing fluid between teeth and cheek, with half of the dose on each side (study administration) [6]
  • 2 puffs INTRANASALLY in each nostril (total, 10 mg) of midazolam hydrochloride in a mixture of water, propylene glycol (pH 4), and benzyl alcohol 1% using an intranasal device that delivered 2.5 mg of midazolam per 90 mcL of spray (study dose) [7]

Pediatric dosing:

Anxiety – Induction of amnesia – Preoperative sedation
  • (6 months or older) 0.25 to 0.5 mg/kg ORALLY as a single dose; up to 1 mg/kg for younger (6 months to less than 6 years) or uncooperative patients (MAX dose: 20 mg) [1]
  • 0.1 to 0.15 mg/kg IM as a single dose; 0.5 mg/kg for more anxious patients (MAX total dose: 10 mg) [2]
  • (6 months to 5 years of age) initial, 0.05 to 0.1 mg/kg IV over 2 to 3 minutes; may titrate to desired level of sedation (allowing 2 to 3 additional minutes to evaluate full effect after each increment); a total dose up to 0.6 mg/kg may be necessary (MAX total dose: 6 mg) [2]
  • (6 to 12 years of age) initial, 0.025 to 0.05 mg/kg IV over 2 to 3 minutes, may titrate to desired level of sedation (allowing 2 to 3 additional minutes to evaluate full effect after each increment); a total dose up to 0.4 mg/kg may be necessary (MAX total dose: 10 mg) [2]
  • (12 years or older) initial, 1 to 2.5 mg IV over at least 2 minutes, may titrate using small increments to desired level of sedation (allowing 2 additional minutes to evaluate full effect after each increment) (MAX total dose: 10 mg) [2]
Premedication for anesthetic procedure
  • 0.2 mg/kg intranasally 30 to 60 minutes before induction of anesthesia or 60 minutes before surgery (study dosage) [8]
  • 0.5 mg/kg orally 30 to 60 minutes before induction of anesthesia or 30 minutes before surgery (study dosage) [8]
  • (1 to 12 years) 0.25 mg/kg sublingually 20 minutes before induction of anesthesia (study dosage) [9]
Procedural sedation
  • (6 months or older) 0.25 to 0.5 mg/kg ORALLY as a single dose; up to 1 mg/kg for younger (6 months to less than 6 years) or uncooperative patients (MAX dose: 20 mg) [1]
  • 0.1 to 0.15 mg/kg IM as a single dose; 0.5 mg/kg for more anxious patients (MAX total dose: 10 mg) [2]
  • (6 months to 5 years of age) initial, 0.05 to 0.1 mg/kg IV over 2 to 3 minutes; may titrate to desired level of sedation (allowing 2 to 3 additional minutes to evaluate full effect after each increment); a total dose up to 0.6 mg/kg may be necessary (MAX total dose: 6 mg) [2]
  • (6 to 12 years of age) initial, 0.025 to 0.05 mg/kg IV over 2 to 3 minutes, may titrate to desired level of sedation (allowing 2 to 3 additional minutes to evaluate full effect after each increment); a total dose up to 0.4 mg/kg may be necessary (MAX total dose 10 mg) [2]
  • (12 years or older) initial, 1 to 2.5 mg IV over at least 2 minutes, may titrate using small increments to desired level of sedation (allowing 2 additional minutes to evaluate full effect after each increment) (MAX total dose: 10 mg) [2]
  • 0.2 to 0.6 mg/kg INTRANASALLY [10][11]
  • 0.25 to 0.5 mg/kg RECTALLY [10][11
Sedation for a mechanically ventilated patient
  • (non-neonatal) loading dose, 0.05 to 0.2 mg/kg IV over at least 2 to 3 minutes [2]
  • (non-neonatal), maintenance, continuous IV infusion initiated at a rate of 0.06 to 0.12 mg/kg/hr (1 to 2 mcg/kg/min), may adjust rate up or down by 25% of initial or subsequent rate to achieve adequate sedation [2]
  • (neonatal younger than 32 weeks) continuous IV infusion initiated at a rate of 0.03 mg/kg/hr (0.5 mcg/kg/min) [2].
  • (neonatal older than 32 weeks) continuous IV infusion initiated at a rate of 0.06 mg/kg/hr (1 mcg/kg/min) [2]
Seizure
  • Refractory status epilepticus, 0.2 mg/kg IV bolus followed by a continuous IV infusion starting at 2 mcg/kg/min and increasing at 5-minute intervals until seizure control (MAX, 10 mcg/kg/min); continue infusion for at least 6 hours after seizure control, then gradually taper over 12 to 24 hours; increase infusion rate for seizure recurrence; thiopental was administered if seizures were not controlled (study dose) [12]
  • 0.3 mg/kg via the BUCCAL route by placing nozzle of a 26-gauge cannula between the cheek and teeth, with a second dose 5 minutes later for continued seizure activity; other anticonvulsive therapy administered if seizure activity continued after 10 minutes (study dose) [13]
  • 0.2 mg/kg INTRANASALLY (study dose) [14][15][16][17] by dripping midazolam solution (5 mg/mL) into both nostrils in equal doses [14] or using Mucosal Atomization Device (MAX, 10 mg) [15]; IV diazepam administered if seizures did not cease within 10 minutes [14]

Dose Adjustments:

  • debilitated and high-risk patients: require lower dosages whether or not concomitant sedating medications have been administered [2]
  • (pediatric) debilitated and high-risk patients: 0.25 mg/kg ORALLY as a single dose is recommended for sedation and anxiolysis [1], IV doses must be reduced [2]
  • geriatrics: require lower dosages whether or not concomitant sedating medications have been administered [2]
  • narcotic premedication or other CNS depressants: decrease dose by 30% to 50% for sedation/anxiolysis/amnesia [2]
  • (pediatrics) narcotic premedication or other CNS depressants: 0.25 mg/kg ORALLY as a single dose is recommended for sedation and anxiolysis [1], IV doses must be reduced [2]
  • (pediatrics) obese patients: dose calculated based on ideal body weight [1]
  • renal failure (CrCl less than 10 mL/min): decrease dose by 50% [18]

Administration:

Intramuscular
  • administer as a deep injection into a large muscle mass [2]
  • may be administered concomitantly with atropine sulfate, scopolamine, meperidine, or morphine in the same syringe [2]
Intravenous
  • may be administered concomitantly with atropine sulfate, scopolamine, meperidine, or morphine in the same syringe [2]
  • when diluted to 0.5 mg/mL, stable in D5W or NS for up to 24 hours and in LR for up to 4 hours [2]
  • (induction of anesthesia) administer by IV bolus over 20 to 30 seconds; wait at least 2 minutes between doses to evaluate full effect [2]
  • (sedation/anxiolysis/amnesia for procedures) administer by IV injection over at least 2 minutes; 1 mg/mL formulation is recommended to facilitate slower injection; wait at least 2 minutes between doses to evaluate full effect [2]
  • (continuous infusion) 5 mg/mL formulation should be diluted to a concentration of 0.5 mg/mL with NS or D5W [2]
  • (neonatal) should not be administered by rapid IV injection in the neonatal population; severe hypotension and seizures have been reported, particularly with concomitant use of fentanyl [2]

Contraindications:

  • concomitant use with HIV protease inhibitors, efavirenz, or elvitegravir/cobicistat (oral) [19]
  • hypersensitivity to cherries or any other component of the product (oral) [1]
  • hypersensitivity to midazolam [1][20]
  • narrow-angle glaucoma, acute [1][20]
  • open-angle glaucoma, untreated [1][20]

Precautions:

  • cardiorespiratory adverse events, serious and sometimes fatal, have been reported; increased risk in noncritical care settings and when used with other CNS depressants; monitoring recommended [1][20]
  • elderly (over 60 years of age) or debilitated; dose reduction required (injection) [20]
  • neonates; risk of severe hypotension and seizure with rapid injection, especially with concomitant administration of fentanyl [20]
  • alcohol intoxication with depression of vital signs, acute; use is not recommended (injection) [20]
  • compromised cardiac or respiratory function; increased risk of respiratory depression in pediatric patients (oral) [1]
  • congestive heart failure; risk of drug toxicity [1][20]
  • COPD; increased risk of respiratory depression [1][20]
  • procedures involving upper airway (eg, upper endoscopy, dental care); increased risk of desaturation and hypoventilation from partial airway obstruction [1][20]
  • shock or coma; use is not recommended (injection) [20]
  • renal failure, chronic; risk of drug toxicity [1][20]
  • surgical patients, higher-risk; dose reduction recommended [1][20]
  • uncompensated acute illness (eg, severe fluid or electrolyte disturbance); use is not recommended (injection) [20]

Adverse Effects:

Common
  • Neurologic: Excessive somnolence (1.6%), Headache (1.3% to 1.5%), Somnolence (1.2%)
  • Respiratory: Hiccoughs (3.6% )
Serious
  • Cardiovascular: Cardiac arrest, Usually in combinations with CNS depressant drug
  • Neurologic: Involuntary movement
  • Psychiatric: Agitation (less than 1% )
  • Respiratory: Apnea (adult, 15.4%; pediatric, 2.8% ), Desaturation of blood, Pediatric patients (4.6% ), Respiratory arrest, Usually in combinations with CNS depressant drug (rare), Respiratory depression

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