Drug Guide

Generic Name

Midazolam

Brand Names Nayzilam, Midazolam in 0.9% Sodium Chloride, Midazolam in 0.8% Sodium Chloride

Classification

Therapeutic: Sedative, Anxiolytic, Amnesic, Hypnotic, Sedative-Hypnotic

Pharmacological: Benzodiazepine

FDA Approved Indications

  • Acute treatment of intermittent, stereotypic episodes of partial seizures with or without generalization in patients aged 12 years and older.

Mechanism of Action

Midazolam enhances the effect of gamma-aminobutyric acid (GABA) at the GABA-A receptor, resulting in sedative, anxiolytic, amnesic, anticonvulsant, and muscle-relaxant properties.

Dosage and Administration

Adult: For seizures, the typical dose is 2.5 mg administered intranasally. Doses may be repeated after 10 minutes if seizures persist. Maximum dose per episode is 5 mg.

Pediatric: Dosing varies by weight and age; typically 0.2 mg/kg (up to 5 mg) intranasally or buccally, repeated after 10 minutes if needed.

Geriatric: Lower initial doses due to increased sensitivity; close monitoring recommended.

Renal Impairment: Use with caution; dose adjustments not well established.

Hepatic Impairment: Use with caution; may prolong sedation.

Pharmacokinetics

Absorption: Rapid via intranasal or buccal routes.

Distribution: Widely distributed, crosses blood-brain barrier.

Metabolism: Hepatic CYP3A4 metabolism.

Excretion: Metabolites excreted primarily in urine.

Half Life: Approximately 2 hours in healthy adults, may be prolonged in certain populations.

Contraindications

  • Hypersensitivity to midazolam or benzodiazepines.
  • Severe respiratory insufficiency.
  • Sleep apnea syndrome.
  • Acute narrow-angle glaucoma.

Precautions

  • Use with caution in elderly, debilitated, or patients with compromised respiratory or hepatic function.
  • Risk of respiratory depression, especially when combined with other CNS depressants.

Adverse Reactions - Common

  • Drowsiness (Common)
  • Dizziness (Common)
  • Respiratory depression (Uncommon)

Adverse Reactions - Serious

  • Respiratory arrest (Rare)
  • Hypotension (Uncommon)
  • Prolonged sedation (Uncommon)

Drug-Drug Interactions

  • CNS depressants (opioids, alcohol)
  • Other benzodiazepines
  • Cimetidine (may increase plasma levels)

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Assessment: Monitor respiratory status (rate, depth), sedation level, and blood pressure.

Diagnoses:

  • Risk for respiratory depression
  • Impaired spontaneous ventilation

Implementation: Administer in healthcare setting with resuscitation equipment available. Adjust dosing based on patient response.

Evaluation: Ensure patient remains stable with adequate airway and breathing; assess for adverse reactions.

Patient/Family Teaching

  • Do not operate heavy machinery or drive after administration.
  • Report excessive sedation, difficulty breathing, or other concerning symptoms.
  • Inform about the potential for drowsiness and impairment.

Special Considerations

Black Box Warnings:

  • Respiratory depression and respiratory arrest

Genetic Factors: CYP3A4 polymorphisms may affect metabolism.

Lab Test Interference: None.

Overdose Management

Signs/Symptoms: Extreme drowsiness, respiratory depression, hypotension, coma.

Treatment: Supportive care, maintain airway, oxygen, IV fluids, and ventilatory support if needed. Flumazenil as an antagonist may be considered, with caution.

Storage and Handling

Storage: Store at room temperature, protected from light and moisture.

Stability: Stable under recommended storage conditions.

This guide is for educational purposes only and is not intended for clinical use.