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MIDAZOLAM is a brand name for Midazolam, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: MIDAZOLAM INJECTION (midazolam) is indicated as: • an intramuscular premedication prior to surgical or diagnostic procedures. • an intravenous agent for patients requiring sedation/anxiolysis/amnesia prior to and during short endoscopic or short diagnostic procedures and direct-current cardioversion. • an alternative…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations General • MIDAZOLAM INJECTION should always be prescribed at the lowest effective dose for the shortest duration possible. Long-term use of MIDAZOLAM INJECTION should be avoided. • The dosage of midazolam must be carefully individualized.
• As with other sedative medications, there is wide interpatient variability in midazolam dosage requirements, and these requirements may change with time. • Doses used for intravenous sedation should be always restricted to the special low levels recommended and careful attention should be given in the selection and exclusion of patients that might be especially susceptible to adverse cardiac and respiratory reactions.
• The dosage of midazolam should further be adjusted according to the type and amount of premedication used. • Outside the ICU setting, midazolam should not be administered to patients in shock, coma, acute alcoholic intoxication, renal failure, or with severe depression of vital signs.
• Reactions such as agitation, involuntary movements, hyperactivity and combativeness have been reported. Should such reactions occur, the response to each dose of midazolam and all other drugs, including local anesthetics, should be evaluated before proceeding with the administration of the drug (see 7 WARNINGS AND PRECAUTIONS, Peri-Operative Considerations).
Geriatrics: • Geriatric patients in particular may be more sensitive to benzodiazepines (see 7 WARNINGS AND PRECAUTIONS, Falls and Fractures) • In elderly patients, enhanced monitoring is recommended. 1 Serious Drug Interactions). Pediatrics: • As a group, pediatric patients generally require higher doses of midazolam than do adults and younger children may require higher doses than older children.
2 Recommended Dose and Dosage Adjustment) • In obese pediatric patients, the dose should be calculated based on ideal body weight. 1 Serious Drug Interactions). • Midazolam should not be administered by rapid injection in the neonatal population.
2 Recommended Dose and Dosage Adjustment). Intramuscular Premedication • For intramuscular use, MIDAZOLAM INJECTION should be injected deep in a large muscle mass. Intravenous 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, maintenance of a patent airway and support of ventilation.
) MIDAZOLAM INJECTION (midazolam) Page 17 of 55 Unclassified / Non classifié Dependence/Tolerance Use of benzodiazepines, such as MIDAZOLAM INJECTION, can lead to abuse, misuse, addiction, physical dependence (including tolerance) and withdrawal reactions.
Abuse and misuse can result in overdose or death, especially when benzodiazepines are combined with other medicines, such as opioids, alcohol, or illicit drugs. The risk of dependence increases with higher doses and longer term use but can occur with short-term use at recommended therapeutic doses.
The risk of dependence is greater in patients with a history of psychiatric disorders and/or substance (including alcohol) use disorder. • Discuss the risks of treatment with MIDAZOLAM INJECTION with the patient, considering alternative (including non-drug) treatment options.
• Carefully evaluate each patient’s risk of abuse, misuse and addiction, considering their medical condition and concomitant drug use, prior to prescribing MIDAZOLAM INJECTION. In individuals prone to substance use disorder, MIDAZOLAM INJECTION should only be administered if deemed medically necessary, employing extreme caution and close supervision.
• MIDAZOLAM INJECTION should always be prescribed at the lowest effective dose for the shortest duration possible. • All patients receiving opioids should be routinely monitored for signs and symptoms of misuse and abuse. If a substance use disorder is suspected, evaluate the patient and refer them for substance abuse treatment, as appropriate.
Withdrawal:
Benzodiazepines, such as MIDAZOLAM INJECTION, can produce withdrawal signs and symptoms, ranging from mild to severe and even life threatening, following abrupt discontinuation or rapid dose reduction. Other factors that may precipitate withdrawal are switching from a long-acting to a short-acting benzodiazepine, decreasing blood levels of the drug or administration of an antagonist.
, Falls and Fractures). 2 CONTRAINDICATIONS MIDAZOLAM INJECTION is contraindicated in patients with: • a known hypersensitivity to this drug or to benzodiazepines, or any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • acute pulmonary insufficiency • severe chronic obstructive pulmonary disease (see 7 WARNINGS AND PRECAUTIONS, Respiratory). 4 Administration) Intravenous sedation with MIDAZOLAM INJECTION is contraindicated in: • elderly or debilitated patients outside the ICU setting • patients not sufficiently alert to respond appropriately to verbal requests 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Serious Cardiorespiratory Events Serious cardiorespiratory events have occurred.
These have included respiratory depression, apnea, respiratory arrest and/or cardiac arrest, sometimes resulting in death. MIDAZOLAM INJECTION must never be used without individualization of dose. The immediate availability of oxygen and other appropriate medication, and the equipment necessary for resuscitation, the maintenance of a patent airway, support of ventilation and cardiac function, should be ensured prior to the use of intravenous midazolam in any dose.
Patients should be continuously monitored for early signs of hypoventilation or apnea which can lead to hypoxia/cardiac arrest unless effective countermeasures are taken. Vital signs should continue to be monitored during the recovery period.
Opioid agonists and other sedatives add to the respiratory depression produced by midazolam. Addiction, Abuse and Misuse The use of benzodiazepines, including MIDAZOLAM INJECTION, can lead to abuse, misuse, addiction, physical dependence and withdrawal reactions.
Abuse and misuse can result in overdose or death, especially when benzodiazepines are combined with other medicines, such as opioids, alcohol or illicit drugs. • Assess each patient’s risk prior to prescribing MIDAZOLAM INJECTION • Monitor all patients regularly for the development of these behaviours or conditions.
1 Dosing Considerations; 7 WARNINGS AND PRECAUTIONS, Falls and Fractures). 2 CONTRAINDICATIONS MIDAZOLAM INJECTION is contraindicated in patients with: • a known hypersensitivity to this drug or to benzodiazepines, or any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • acute pulmonary insufficiency • severe chronic obstructive pulmonary disease (see 7 WARNINGS AND PRECAUTIONS, Respiratory). 4 Administration) Intravenous sedation with MIDAZOLAM INJECTION is contraindicated in: • elderly or debilitated patients outside the ICU setting • patients not sufficiently alert to respond appropriately to verbal requests
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Midazolam in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
The necessary equipment and the appropriate medications must be immediately available to ensure the safety of the procedures involved and the maintenance of respiratory and cardiovascular functions (see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX).
Geriatrics: • Midazolam can be administered concomitantly with atropine sulfate or scopolamine hydrobromide. When administered concomitantly with an opioid, the dose of midazolam should be reduced. 2 Recommended Dose and Dosage Adjustment) Pediatrics: • Midazolam and an opioid should not be mixed as a premedication, however if required then constant monitoring is recommended.
Should both be required the initial dose of each must be reduced and the second agent of the two should be administered intravenously on arrival at the procedure area. 4 MIDAZOLAM INJECTION (midazolam) Page 8 of 55 Unclassified / Non classifié Administration).
Rapid intravenous injection may cause respiratory depression or apnea requiring respiratory assistance or controlled ventilation. • The initial dose and all subsequent doses should always be titrated slowly; administered over 2-3 minutes and allow about 2 minutes to fully evaluate the sedative effect.
The use of the 1 mg/mL formulation or dilution of the 1 mg/mL or 5 mg/mL formulation is recommended to facilitate slower injection. • Midazolam can be used either alone or combined with an opioid immediately before the procedure, with supplemental doses to maintain the desired level of sedation throughout the procedure.
For peroral procedures, the use of an appropriate topical anesthetic is recommended. During routine diagnostic bronchoscopies, with no compromise of respiratory function, the use of opioid premedication is recommended. • When used intravenously as an agent for sedation/anxiolysis/amnesia for short endoscopic or other short diagnostic procedures, the desired psychosedation can usually be attained within 3 to 6 minutes, depending on the dose administered and whether or not opioid premedication is used concomitantly.
• The dose of MIDAZOLAM INJECTION must be reduced in patients premedicated with opioids or other sedative agents including midazolam. 1 Serious Drug Interactions Pediatrics: • Doses of […]
The risk of withdrawal is higher with higher dosages and/or prolonged use but can occur with short-term use at recommended therapeutic doses. The onset of withdrawal signs and symptoms can range from hours to weeks following drug cessation and occur even with tapered dosage.
Some symptoms can persist for months. Since symptoms are often similar to those for which the patient is being treated, it may be difficult to distinguish from a relapse of the patient’s condition. g. hallucinations), mania, psychosis, seizures (including status epilepticus) and suicidal ideation and behavior.
Other withdrawal signs and symptoms include abdominal cramps, cognitive impairment, diarrhea, dysphoria, extreme anxiety or panic attacks, headache, hypersensitivity to light, noise MIDAZOLAM INJECTION (midazolam) Page 18 of 55 Unclassified / Non classifié and physical contact, insomnia, irritability, muscle pain or stiffness, paresthesia, restlessness, sweating, tension, tremors and vomiting.
There is also a possibility of rebound anxiety or rebound insomnia. • Abrupt discontinuation should be avoided and treatment - even if only of short duration - should be terminated by gradually tapering the dosage schedule under close monitoring.
• Tapering should be tailored to the specific patient. Special attention should be given to patients with a history of seizure. • If a patient experiences withdrawal signs and symptoms, consider postponing the taper or raising the benzodiazepine to the previous dosage prior to proceeding with a gradual taper.
• Inform patients of risk of discontinuing abruptly, reducing dosage rapidly or switching medications. • Stress the importance of consulting with their health care professional in order to discontinue safely. • Patients experiencing withdrawal signs and symptoms should seek immediate medical attention.
e. operating machinery or driving a motor vehicle) until the effects of the drug, such as drowsiness, have subsided, or until one full day after anesthesia and surgery, whichever is longer. Patients should also be cautioned about the ingestion of alcohol or other CNS depressant drugs until the effects of midazolam have subsided.
Falls and Fractures There have been reports of falls and fractures among benzodiazepine users due to adverse reactions such as sedation, dizziness and ataxia. The risk is increased in those taking concomitant sedatives (including alcoholic beverages), the elderly or debilitated patients.
3 Pharmacokinetics, Special Populations and Conditions). Caution should therefore be exercised in administering midazolam to these patients Musculoskeletal Myasthenia: Myasthenic patients have the potential for respiratory decompensation if a substance with CNS-depressant and/or muscle-relaxant properties is administered.
However, those myasthenic patients with established respiratory failure will need mechanical ventilation MIDAZOLAM INJECTION (midazolam) Page 19 of 55 Unclassified / Non classifié and for this sedation will be necessary. Careful monitoring of the patients is recommended should midazolam be used for sedation.
Neurologic MIDAZOLAM INJECTION has been shown to cause dose-related anterograde amnesia, an impairment or a lack of recall of events following administration of the drug. Ophthalmologic Benzodiazepines such as MIDAZOLAM INJECTION are contraindicated in patients with acute narrow angle glaucoma (see 2 CONTRAINDICATIONS).
Midazolam lowered the intraocular pressure in subjects […]
• MIDAZOLAM INJECTION should be stored securely to avoid theft or misuse. Withdrawal Benzodiazepines, like MIDAZOLAM INJECTION, can produce severe or life-threatening withdrawal symptoms with repeated or continuous administration: • Avoid abrupt discontinuation or rapid dose reduction of MIDAZOLAM INJECTION.
• Terminate treatment with MIDAZOLAM INJECTION by gradually tapering the dosage schedule under close monitoring. (see 7 WARNINGS AND PRECAUTIONS, Dependence/Tolerance) MIDAZOLAM INJECTION (midazolam) Page 6 of 55 Unclassified / Non classifié Risks from Concomitant use with Opioids Concomitant use of MIDAZOLAM INJECTION and opioids may result in profound sedation, respiratory depression, coma and death (see 7 WARNINGS AND PRECAUTIONS, General, Concomitant use with opioids).
• Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are not possible. • Limit dosages and durations to the minimum required. • Follow patients for signs and symptoms of respiratory depression and sedation.
1 Dosing Considerations General • MIDAZOLAM INJECTION should always be prescribed at the lowest effective dose for the shortest duration possible. Long-term use of MIDAZOLAM INJECTION should be avoided. • The dosage of midazolam must be carefully individualized.
• As with other sedative medications, there is wide interpatient variability in midazolam dosage requirements, and these requirements may change with time. • Doses used for intravenous sedation should be always restricted to the special low levels recommended and careful attention should be given in the selection and exclusion of patients that might be especially susceptible to adverse cardiac and respiratory reactions.
• The dosage of midazolam should further be adjusted according to the type and amount of premedication used. • Outside the ICU setting, midazolam should not be administered to patients in shock, coma, acute alcoholic intoxication, renal failure, or with severe depression of vital signs.
• Reactions such as agitation, involuntary movements, hyperactivity and combativeness have been reported. Should such reactions occur, the response to each dose of midazolam and all other drugs, including local anesthetics, should be evaluated before proceeding with the administration of the drug (see 7 WARNINGS AND PRECAUTIONS, Peri-Operative Considerations).
Geriatrics: • Geriatric patients in particular may be more sensitive to benzodiazepines (see 7 WARNINGS AND PRECAUTIONS, Falls and Fractures) • In elderly patients, enhanced monitoring is recommended. 1 Serious Drug Interactions). Pediatrics: • As a group, pediatric patients generally require higher doses of midazolam than do adults and younger children may require higher doses than older children.
2 Recommended Dose and Dosage Adjustment) • In obese pediatric patients, the dose should be calculated based on ideal body weight. • Pediatric patients are more susceptible to respiratory depression/airway obstruction when MIDAZOLAM INJECTION is given in conjunction with opioids or other sedativesEnhanced monitoring is required (see 3 […]