Benzosed Injection
Midazolam
5mg/ml
Troikaa Pharmaceuticals Ltd.
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Retail Price | 88.00 NPR |
Indications
Benzosed 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
Benzosed 5mg/ml Injection manufactured by Troikaa Pharmaceuticals Ltd.. Its generic name is Midazolam. Benzosed is availble in Nepal.
Farmaco Nepal drug index information on Benzosed Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.