Classes
DEA Class; Rx
Common Brand Names; Seizalam, Versed (DSC), Nayzilam
- Antianxiety Agents;
- Anxiolytics, Benzodiazepines;
- Anticonvulsants, Benzodiazepine
Description
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
Indications
Indicated for procedural sedation and amnesia induction and to control preoperative anxiety.
Contraindications
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
Adverse Effects
- 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
Warnings
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
Pregnancy and Lactation
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
Maximum Dosage
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.
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.
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.
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.
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.
Specific maximum dosage information is not available; the dose required is dependent on route of administration, indication, and clinical response.
How supplied
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
