Dormicum Injection

Midazolam
F. Hoffmann-La Roche Ltd
Pack size
Dispensing mode
Source
Agent
Retail Price 12.41 NPR

Indications

Dormicum Injection is used for: Insomnia, Sedation, Induction of anesthesia

Adult Dose

Adult Oral Short-term management of insomnia Adult: 7.5-15 mg at bedtime. Elderly: 7.5 mg at bedtime. Hepatic impairment: Mild to moderate: Dosage reduction needed. Severe: Contraindicated. Parenteral Preoperative Sedation IM 70-80 mcg/kg (dose range ~5 mg) 30-60 minutes before surgery (reduce 50% for chronically ill or geriatric patients) IV Initial: Usually 0.5-1 mg given over 2 minutes (not to exceed 2.5 mg/dose); wait 2-3 minutes to evaluate sedative effect after each dose adjustment; total dose >5 mg usually not necessary to reach desired sedation; use 30% less midazolam if patient premedicated with narcotics or other CNS depressants Debilitated or chronically ill patients: 1.5 mg IV initially; may repeat with 1 mg/dose IV q2-3 min PRN; not to exceed cumulative dose of 3.5 mg; peak effect may be delayed in elderly, so increments should be smaller and rate of injection slower Maintenance: 25% of initial effective dose PRN by slow titration; reduce 30% if premedicated with opiate (50% in elderly/chronically ill) Anesthesia Induction <55 years without premedication: 300-350 mcg/kg IV injection over 20-30 seconds; wait 2-3 minutes to evaluate sedative effect after each dose adjustment; may use increments of 25% of initial dose PRN to complete induction; may use up to 0.6 mg/kg total dose in resistant cases, but such dosing may prolong recovery >55 years without premedication and with no systemic disease, in a patient who is not weak: 300 mcg/kg over 20-30 seconds initially; wait 2-3 minutes to evaluate sedative effect after each dose adjustment >55 years without premedication but presence of systemic disease or weak patient: 200-250 mcg/kg over 20-30 seconds usually enough; 0.15 mg/kg enough in some cases; wait 2-3 minutes to evaluate sedative effect after each dose adjustment >55 years with premedication: 150-350 mcg/kg IV injection over 20-30 seconds; wait 2-3 minutes to evaluate sedative effect after each dose adjustment; a dose of 250 mcg/kg usually enough to achieve desired effect Maintenance May administer increments of 25% of induction dose PRN when there are signs that anesthetic effects are lightening Sedation of Intubated/Ventilated Patients Load: 10-50 mcg/kg (dose range 0.5-4 mg) slow IV injection or infusion over several minutes; repeat q5-15min PRN Maintenance: Initial, 20-100 mcg/kg/hr infusion; titrate up or down 25-50% PRN Elderly Preoperative sedation IM: 2-3 mg (~20-50 mcg/kg) 30-60 minutes before surgery; some elderly patients may respond to as little as 1 mg; onset is 15 minutes (peaking at 30-60 min) IV (>60 years): 1-1.5 mg initially; not to exceed >1.5 mg in 2 min period; may repeat with 1 mg/dose q2-3min PRN; not to exceed cumulative dose of 3.5 mg; peak effect may be delayed in elderly, so increments should be smaller and rate of injection slower IV maintenance: 25% of initial effective dose PRN by slow titration Anesthesia: Typical adult induction and maintenance doses may need to be decreased in some elderly patients by 20-50%, because the elderly overall are more susceptible to CNS depressants than is the general population Hepatic impairment: Dosage reduction needed.

Child Dose

Oral Seizures Child: 3-6 mth Hospital setting: 2.5 mg; >6 mth to <1 yr 2.5 mg; 1-<5 yr 5 mg; 5-<10 yr 7.5 mg; 10-<18 yr 10 mg. Doses are given as single dose. Sedation 500-750 mcg/kg PO once diluted by juice 20-30 minutes prior to procedure; not to exceed 20 mg Parenteral Sedation IM 100-150 mcg/kg IM; up to 500 mcg/kg used; not to exceed 10 mg IV <6 months: Initial, 50 mcg/kg IV over 2-3 minutes; titrate with small increments to clinical effect; monitor closely 6 months-6 years: Initial, 50-100 mcg/kg IV over 2-3 minutes; repeat q2-3min PRN; may require up to 600 mcg/kg total dose; not to exceed 6 mg total dose 6-12 years: Initial, 25-50 mcg/kg IV over 2-3 minutes; repeat q2-3min PRN; may require up to 400 mcg/kg; not to exceed 10 mg total dose Anesthesia (Non-neonatal) Loading dose: 50-150 mcg/kg IV over 2-3 minutes PRN to achieve desired effect Continuous infusion: 1-2 mcg/kg/min IV infusion Anesthesia (Neonatal) IV loading dose should not be used in neonates Continuous infusion: 0.5 mcg/kg/min IV infusion

Renal Dose

Administration

May be taken with or without food.

Contra Indications

Severe resp failure or acute resp depression, acute narrow-angle glaucoma, myasthenia gravis, sleep apnoea syndrome; severe hepatic impairment (oral). Concomitant use w/ potent CYP3A4 inhibitors.

Precautions

Patients w/ heart failure, impaired gag reflex, resp disease, history of alcohol or drug abuse. Patient at risk of falls. Hepatic and renal impairment. Childn, elderly and debilitated patient. Pregnancy and lactation. Avoid abrupt withdrawal after prolonged use. Avoid rapid inj in neonates. Patient Counselling May impair ability to drive or operate machinery. Monitoring Parameters Monitor resp and CV status, BP. Lactation: Distributed in breast milk, use caution

Pregnancy-Lactation

Interactions

Increased CNS depression with alcohol, opioids, barbiturates, other sedatives and anaesthetics. Increased respiratory depression with opiates, phenobarbital, other benzodiazepines. Plasma concentrations increased by CYP3A4 inhibitors such as cimetidine, erythromycin, clarithromycin, diltiazem, verapamil, ketoconazole and itraconazole, antiretroviral agents, quinupristin with dalfopristin. Midazolam concentration decreased by phenytoin, carbamazepine, phenobarbital, rifampicin. Halothane, thiopental requirements may be reduced during concurrent use.

Adverse Effects

Side effects of Midazolam : >10% Decreased respiratory rate (23%),Apnea (15%) 1-10% Drowsiness (1-5%),Seizure-like activity (1%),Nausea/vomiting (3%),Cough (1%),Pain at injection site (4-5%) Frequency Not Defined Headache,Sedation,Hiccoughs,Delirium,Euphoria Pediatric Desaturation,Hypotension,Seizurelike activity,Nystagmus,Paradoxical reactions,Hiccoughs,Apnea

Mechanism of Action

Midazolam is a short-acting benzodiazepine. It exerts sedative and hypnotic, muscle relaxant, anxiolytic and anticonvulsant actions. While the probable anxiolytic action might be as a result of the drug's ability to increase glycine inhibitory neurotransmitter level, the hypnotic/anaesthetic action may be due to the occupation of the benzodiazepine and GABA receptors leading to membrane hyperpolarisation and neuronal inhibition, and further interfering with the re-uptake of GABA at the synapses.

Note

Dormicum Injection manufactured by F. Hoffmann-La Roche Ltd. Its generic name is Midazolam. Dormicum is availble in Nepal. Farmaco Nepal drug index information on Dormicum Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.

Some other brands of Midazolam :