Delex Pharma
Full Prescribing Info
Each mL contains: Midazolam 1 mg or 5 mg.
It is used for sedation in minor surgical or investigative procedures and in intensive care, for premedication, and for induction of general anaesthesia. It is also used as hypnotic in the short-term management of insomnia.
Dosage/Direction for Use
Dosage and administration should be individualized.
Low dose is required in elderly and debilitated patients.
Intramuscular administration: For preoperative sedation/amnesia (induction of sleepiness or drowsiness and relief of apprehension and to impair memory of perioperative events).
The recommended premedication dose of Midazolam is 0.07 to 0.08 mg/kg IM (approximately 5 mg IM) administered up to 1 hour before surgery. Onset is within 15 minutes, peaking at 30 to 60 minutes. It can be administered concomitantly with atropine sulfate or scopolamine hydrochloride and reduced doses of narcotics.
Intravenous administration: Endoscopic or cardiovascular procedures.
This drug may be diluted with 0.9% Sodium chloride or 5% Dextrose in Water. For conscious sedation, Midazolam should not be administered rapidly or by single bolus IV, and it should immediately before the procedure. For peroral procedures, the use of an appropriate topical anaesthetic is recommended. For bronchoscopic procedures, the use of an opioid predicament is recommended.
Healthy Adults below the age of 60: Titrate slowly to the desired effect (of slurred speech). Some patients may respond to as little as 1 mg, 2 or 2.5 mg (0.0035 mg/kg) should be given over a period of 2 to 3 minutes. Wait an additional 2 or more minutes to fully evaluate the sedative effect. If further titration is necessary, continue to titrate, using small increments, to the appropriate level of sedation. A total dose greater than 5 mg is not usually necessary to reach the desired endpoint. If narcotic premedication or other CNS depressants are used, patients will require approximately 30% less Midazolam than unpremedicated patients.
Patients Age 60 or older, and Debilitated: Because the danger of hypoventilation, airway obstruction, or apnea is greater than in those patients, and because the peak effect may take longer in these patients, increments should be smaller and the rate of injection slower. Titrate slowly to the desired effect (eg, the initiation of slurred speech). Some patients may respond to as little as 1 mg, 1 or 1.5 mg should be given over a period of 2 or 3 minutes. Wait an additional 2 or more minutes to fully evaluate the sedative effect. If additional titration is necessary, it should be given at a rate of no more than 1 mg over a period of 2 minutes, waiting an additional 2 or more minutes each time to fully evaluate the sedative effect. Total doses greater than 3.5 mg are not usually necessary. If concomitant CNS depressant remedications are used in these patients, they will require at least 55-60% less Midazolam than healthy young unpremedicated patients.
Maintenance Dose: Additional doses to maintain the desired level of sedation may be given in increments of 25% of the dose used to first reach the sedative endpoint.
Induction of Anesthesia: (For induction of general anesthesia, before administration of other anesthetic agents).
Individual response to the drug is variable, particularly when a narcotic premedication is not used. The dosage should be titrated to the desired effect according to the patient's age and clinical status.
Unpremedicated Patients: In the absence of premedication, an average adult under the age of 55 years will usually require an initial dose of 0.3 to 0.35 mg/kg for induction, administered over 20 to 30 seconds and allowing 2 minutes for effect. If needed to complete induction, increments of approximately 25% of the patient's initial dose may be used; induction may instead be completed with inhalational anesthetics. In resistant cases, up to 0.6 mg/kg total dose may be used for induction, but such longer doses may prolong recovery.
Unpremedicated Patients over the age of 55 years usually require less Midazolam for induction; an initial dose of 0.3 mg/kg is recommended.
Unpremedicated patients with severe systematic disease or other debilitation usually require less Midazolam for induction. An initial dose of 0.2 to 0.25 mg/kg will usually suffice; in some cases, as little as 0.15 mg/kg may suffice.
Premedicated Patients: When the patient has received sedative or narcotic premedication, particularly narcotic premedication, the range of recommended doses is 0.15 to 0.35 mg/kg.
In average adults below the age of 55 years, a dose of 0.25 mg/kg, administered over 20 to 30 seconds and allowing 2 minutes for effect, will usually suffice.
The initial dose of 0.2 mg/kg is recommended for good risk surgical patients over the age of 55 years.
In some patients with severe systemic disease or debilitation, as little as 0.15 mg/kg may suffice.
Narcotic premedication frequently used during clinical trials included Fentanyl (1.5 to 2 mcg/kg IV, administered 5 minutes before induction), Morphine (dosage individualized, up to 0.15 mg/kg IM), and Meperidine (dosage individualized, up to 1 mg/kg IM). Sedative premedications were Hydroxyzine pamoate (100 mg orally) and Sodium secobarbital (200 mg orally). Except for intravenous Fentanyl, administered 5 minutes before induction, all other premedications should be administered approximately 1 hour prior to the time anticipated for Midazolam induction. Incremental injections of approximately 25% of the induction dose should be given in response to signs of lightening of anesthesia and repeated as necessary.
Sedation in Intensive Care Units: Safe use for Midazolam for periods of over 14 days in duration has not been established in clinical trials. Dosage should be titrated according to an individual's response, clinical requirement, physical condition, age and concurrent drug. A loading dose of 0.03-0.3 mg/kg and a maintenance dose of 0.03-0.2 mg/kg/hour are recommended by bolus IV or continuous infusion. The loading dose should be reduced or omitted in hypovolaemic, vasoconstricted or hypothermic patient, renal or hepatic impairment. Dosage is adjusted according to age and severity.
Cautions on application: For sedation under conscious condition, Midazolam should not be administered by rapid or single bolus intravenous administration.
Extravasation should be avoided. The hazards of intra-arterial injection of Midazolam into humans are unknown. Precautions against unintended intra-arterial injection should be taken.
Before administration, foreign matter and color change should be tested by unaided eyes.
Known hypersensitivity to benzodiazepines or any other ingredients.
Patients with acute narrow angle glaucoma.
Patients in shock, coma.
Acute alcoholic intoxication with depression of vital signs.
Patients with sleep apnea syndrome.
Patients with alcohol or drug dependence.
Severe or acute respiratory insufficiency/depression.
When ampoule is cut, glass particles can be mixed in drug solution and cause adverse reactions. Therefore, the ampoule containing drug is carefully broken to minimize mixing of glass particles. When children or elderly use this preparation, special caution should be taken.
Special Precautions
This drug should be used with caution in the following patient: In general rule, this drug should not be administered to the following patients, however this drug should be carefully administered if inevitable: hypoventilation in cases of pulmonary heart disease, chronic obstructive pulmonary disease, bronchial asthma, acute; cardiac disease (for example, congestive hepatic insufficiency); Heart disease (Congestive heart failure); Myasthenia gravis; Elderly patient; Debilitated patients; Patients with organic brain syndrome; Chronic renal failure; Patients with uncompensated acute illnesses, such as severe fluid or electrolyte disturbances; Acute toxicity due to hypnotics, analgesics, antipsychotic drug, anti depressant or lithium; Spinal or cerebellar kinetic apraxia; Patient with chronic disease; Pediatrics who have unstable cardiovascular system (rapid IV administration should be avoided because haemodynamic disorder can occur).
General caution: Dose of this drug should be individualized. Prior to intravenous administration of Midazolam in any dose, the immediate availability of oxygen, resuscitative drugs, age- and size-appropriate equipment for bag/valve/mask ventilation and intubation, and skilled personnel for the maintenance of a patent airway and support of ventilation should be ensured. Patients should be continuously monitored with some means of detection for early signs of hypoventilation, airway obstruction, or apnea, ie, pulse oximetry. Hypoventilation, airway obstruction, and apnea can lead to hypoxia and/or cardiac arrest unless effective countermeasures are taken immediately. Because intravenous Midazolam depresses respiration and because opioid agonists and other sedatives can add to this depression, Midazolam should be administered as an induction agent only by a person trained in general anesthesia and should be used for sedation/anxiolysis/amnesia only in the presence of personnel skilled in early detection of hypoventilation, maintaining a patent airway and supporting ventilation.
Higher risk adult and pediatric surgical patients, elderly patients and debilitated adult and pediatric patients require lower dosages, whether or not concomitant sedating medications have been administered.
ATC Classification
N05CD08 - midazolam ; Belongs to the class of benzodiazepine derivatives. Used as hypnotics and sedatives.
Soln for inj (amp) 1 mg/mL x 5 mL x 10's. 5 mg/mL x 3 mL x 5's.
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