Midazolam Hcl Injection Generic Name & Formulations
Legal Class
CIV
General Description
Midazolam HCl 1mg/mL or 5mg/mL; soln for IV or IM inj; contains benzyl alcohol.
Pharmacological Class
Benzodiazepine.
How Supplied
Contact supplier.
Manufacturer
Midazolam Hcl Injection Indications
Indications
Preoperative sedation/anxiolysis/amnesia (IV or IM). Sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic or endoscopic procedures either alone or in combination with other CNS depressants (IV). Induction of general anesthesia before administration of other anesthetics, or as a component of IV supplementation of nitrous oxide and oxygen (balanced anesthesia). Continuous IV infusion for sedation of intubated and mechanically ventilated patients as a component of anesthesia or during treatment in a critical care setting.
Midazolam Hcl Injection Dosage and Administration
Adult
Individualize, titrate slowly. Preoperative sedation/anxiolysis/amnesia: <60yrs: 0.07-0.08mg/kg deep IM inj dosed up to 1 hour before surgery. Sedation/anxiolysis/amnesia for procedures: <60yrs: initially 1–2.5mg IV; administer over 2 minutes, allow additional 2 minutes to evaluate sedation, may increase dose in small increments (max 2.5mg) to total max 5mg in ≥2 minute increments. ≥60yrs or other risk factors: reduce dose and slow inj or infusion rate, see literature. Induction of anesthesia: Administer IV over 20–30 seconds; allow 2 minutes for effect. Unpremedicated: <55yrs: initially 0.3–0.35mg/kg; if needed to complete induction, increments of approx. 25% of initial dose may be used; resistant cases: up to 0.6mg/kg total dose may be used; >55yrs: initially 0.3mg/kg; severe systemic disease, debilitated: initially 0.15–0.25mg/kg. Premedicated: usual range: 0.15–0.35mg/kg: see literature. Continuous IV infusion: loading dose: 0.01–0.05mg/kg; may repeat dose at 10–15 minute intervals until adequate sedation achieved. Maintenance of sedation: initially 0.02–0.1mg/kg/hr; adjust to find minimum effective infusion rate.
Children
Individualize, titrate slowly, see literature. Sedation/anxiolysis/amnesia (IM): 0.1–0.15mg/kg; more anxious may use up to 0.5mg/kg; max total dose 10mg. Sedation/anxiolysis/amnesia (IV); administer initial dose over 2–3 minutes: 6months–5yrs: initially 0.05–0.1mg/kg; max total dose 6mg. 6–12yrs: initially 0.025–0.05mg/kg; max total dose 10mg. 12–16yrs: use adult dose. Continuous IV infusion (non-neonatal): loading dose: 0.05–0.2mg/kg administered over 2–3 minutes; adjust to minimum effective infusion rate; Neonatal: <32weeks: 0.03mg/kg/hr; >32weeks: 0.06mg/kg/hr.
Midazolam Hcl Injection Contraindications
Contraindications
Acute narrow-angle glaucoma. Intrathecal or epidural use.
Midazolam Hcl Injection Boxed Warnings
Not Applicable
Midazolam Hcl Injection Warnings/Precautions
Warnings/Precautions
Risk of respiratory depression/arrest: only use in hospital or ambulatory care settings that provide continuous monitoring of respiratory and cardiac function. To be administered under the supervision of experienced clinicians. Have intubation, artificial respiration, oxygen therapy and reversal agents available. Shock, coma, acute alcohol intoxication: not recommended. Uncompensated acute illness (eg, severe fluid or electrolyte disturbances). COPD. Procedures involving the upper airway (eg, endoscopy, dental care). Chronic renal failure. CHF. Avoid extravasation. Neonates: avoid rapid inj. Pre-term infants. Debilitated. Elderly. Labor & delivery: not recommended. Pregnancy (Cat.D). Nursing mothers.
Midazolam Hcl Injection Pharmacokinetics
See Literature
Midazolam Hcl Injection Interactions
Interactions
Severe hypotension in neonates with concomitant fentanyl. Potentiated by CNS depressants, CYP3A4 inhibitors (eg, cimetidine, erythromycin, diltiazem, verapamil, ketoconazole, itraconazole). Potentiates thiopental, halothane.
Midazolam Hcl Injection Adverse Reactions
Adverse Reactions
Inj site reactions, headache, hiccoughs, GI upset, cough, oversedation, drowsiness; cardiorespiratory events (eg, respiratory depression, apnea, respiratory arrest and/or cardiac arrest, airway obstruction, oxygen desaturation; may be fatal). Also children: hypotension, paradoxical reactions, seizure-like activity, nystagmus.
Midazolam Hcl Injection Clinical Trials
See Literature
Midazolam Hcl Injection Note
Notes
Formerly known under the brand name Versed.
Midazolam Hcl Injection Patient Counseling
See Literature