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MIDAZOLAM is a brand name for Midazolam. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: As intravenous sedative cover before and during minor medical, dental and surgical procedures such as gastroscopy, endoscopy, cystoscopy, bronchoscopy and cardiac catheterisation. For sedation by continuous infusion in patients in intensive care. As an intramuscular premedication for patients with physical status ASA…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Intravenous sedation :
One or more intravenous administrations over a single operating session. In most circumstances, the 2mg/ml formulation is more convenient for titration purposes.
Adults:
An assessment should be made of the degree of sedation necessary for the planned procedure. The dose should be titrated against the response of the patient. The desired titration end point will depend upon the procedure. Full sedation will be evident by drowsiness, slurred speech but response to commands will be maintained.
4ml of Midazolam 5mg/ml solution (equivalent to 2mg midazolam) be administered intravenously over 30 seconds. 5 to 1mg midazolam) should be given. 07mg/kg body weight). 0mg are not usually necessary.
Elderly people:
OLDER PATIENTS ARE MORE SENSITIVE TO THE EFFECTS OF BENZODIAZEPINES. 4ML) MAY BE ADEQUATE. 3ML).
Paediatric population:
Midazolam Injection has not been evaluated for use as an intravenous sedative in children.
Sedation by continuous infusion in intensive care :
For sedation in the intensive care unit, dosages vary considerably and the dosage of Midazolam Injection should be individualised and titrated to the desired state of sedation according to the clinical need, physical status, age and concomitant medication.
Patients receiving Midazolam Injection for sedation by continuous infusion in the intensive care situation should receive ventilatory support. Safety of continuous infusion of midazolam injection for periods of over fourteen days in duration has not been established in clinical trials.
Adults and children :
Loading dose : For patients already sedated, a loading dose of midazolam is not required. 3mg/kg is recommended, depending on the level of sedation required. This should be administered over a five minute period.
Maintenance dose :
The dosage varies considerably. 2mg/kg per hour is recommended, commencing at the lower end of the range. The dosage should be reduced or the loading dose should even be omitted in hypovolaemic, vasoconstricted and hypothermic patients.
4). 4). *** The risk of falls and fractures is increased in those taking concomitant sedatives (including alcoholic beverages) and in the elderly. ****particularly after parenteral administration.
Dependence:
Use of midazolam even in therapeutic doses may lead to the development of physical dependence. 4). Cases of abuse have been reported. Severe cardio-respiratory adverse events have occurred. 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
4 Method of administration Intravenous injection or by intravenous infusion For the administration of Midazolam Injection, the patient should be placed in a supine position and remain there throughout the procedure. Resuscitation facilities should always be available and a second person fully trained in the use of such equipment should always be present.
It is recommended that patients should remain under medical supervision until at least 1 hour has elapsed from the time of injection. They should always be accompanied home by a responsible adult. Patients who have received Midazolam Injection alone for IV sedation prior to minor procedures should be warned not to drive or operate machinery for 12 hours.
g. potent analgesics) recovery may be prolonged. Patients should therefore be assessed carefully before being allowed to go home or resume normal activities. 1. 4 Special warnings and precautions for use Midazolam should be administered only by experienced physicians in a setting fully equipped for the monitoring and support of respiratory and cardiovascular function and by persons specifically trained in the recognition and management of expected adverse events including respiratory and cardiac resuscitation.
Severe cardiorespiratory adverse events have been reported. These have included respiratory depression, apnoea, respiratory arrest and/or cardiac arrest. 8). Special caution is required for the indication of conscious sedation in patients with impaired respiratory function.
Paediatric population less than 6 months In this population, midazolam is indicated for sedation in ICU only. Paediatric patients less than 6 months of age are particularly vulnerable to airway obstruction and hypoventilation, therefore titration with small increments to clinical effect and careful respiratory rate and oxygen saturation monitoring are essential (see also section 'Preterm infants' below).
1. • Use of this drug for conscious sedation in patients with severe respiratory failure, or acute respiratory depression
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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4ml) may be adequate. 2ml) may be adequate.
Sedation by continuous infusion in intensive care :
Where analgesia is provided by narcotic analgesics, the rate of infusion of Midazolam Injection should be titrated carefully to the sedative needs of the patient.
Intravenous induction of anaesthesia :
One or more bolus intravenous injections over a single anaesthetic session.
Adults :
The dose should be titrated against the individual response of the patient. Midazolam Injection should be given by slow intravenous injection until there is a loss of eyelid reflex, response to commands and voluntary movements. In anticipating the required dose of midazolam, both the premedication already given and the age of the patient are important.
2mg/kg body-weight.
Older people :
OLDER PATIENTS ARE MORE SENSITIVE TO THE EFFECTS OF BENZODIAZEPINES. 2MG/KG BODY-WEIGHT IN UNPREMEDICATED PATIENTS. 15mg/kg body-weight. 1mg/kg body-weight, administered 30 - 60 minutes pre-operatively, has been shown to be adequate in most cases.
The usual dose is about 5mg. Atropine or hyoscine hydrobromide may be given concomitantly, bearing in mind that hyoscine hydrobromide will enhance and prolong the sedative and amnesic effects of midazolam. Midazolam Injection can be combined with atropine or hyoscine hydrobromide in the same syringe to be given as a single intramuscular injection.
5MG MAY BE ADEQUATE.
Paediatric population:
Midazolam Injection has not been evaluated for use as an intramuscular premedicant in children.
Use in Special Populations:
Renal Impairment: In patients with renal impairment (creatinine clearance <10ml/min) the pharmacokinetics of unbound midazolam following a single IV dose is similar to that reported in healthy volunteers. However, after prolonged infusion in intensive care unit (ICU) patients, the mean duration of the sedative effect in the renal failure population was considerably increased most likely due to accumulation of α-hydroxymidazolam glucuronide.
There is no specific data in patients with severe renal impairment (creatinine clearance below 30 ml/min) receiving midazolam for induction of anaesthesia. v. midazolam with a subsequent increase in terminal half-life. Therefore, the clinical effects may be stronger and prolonged.
The required dose of midazolam may be reduced and proper monitoring of vital signs should be established. 4). Paediatric population See above and section
When midazolam is used for premedication, adequate observation of the patient after administration is mandatory as inter-individual sensitivity varies and symptoms of overdose may occur. g. − patients with chronic respiratory insufficiency − patients with chronic renal failure, impaired hepatic function or with impaired cardiac function − pediatric patients specially those with cardiovascular instability.
2) and should be continuously monitored for early signs of alterations of vital functions. As with any substance with CNS depressant and/or muscle-relaxant properties, particular care should be taken when administering midazolam to a patient with myasthenia gravis.
Tolerance Some loss of efficacy has been reported when midazolam was used as long- term sedation in intensive care units (ICU). Dependence When midazolam is used in long-term sedation in ICU, it should be borne in mind that physical dependence on midazolam may develop.
8). Withdrawal symptoms During prolonged treatment with midazolam in ICU, physical dependence may develop. Therefore, abrupt termination of the treatment will be accompanied by withdrawal symptoms. The following symptoms may occur: headaches, muscle pain, anxiety, tension, restlessness, confusion, irritability, rebound insomnia, mood changes, hallucinations and convulsions.
Since the risk of withdrawal symptoms is greater after abrupt discontinuation of treatment, it is recommended to decrease doses gradually. Amnesia Midazolam causes anterograde amnesia (frequently this effect is very desirable in situations such as before and during surgical and diagnostic procedures), the duration of which is directly related to the administered dose.
Prolonged amnesia can present problems in outpatients, who are scheduled for discharge following intervention. After receiving midazolam parenterally, patients should be discharged from hospital or consulting room only if accompanied by an attendant.
Paradoxical reactions Paradoxical reactions such as agitation, involuntary movements (including tonic/clonic convulsions and muscle tremor), hyperactivity, hostility, rage reaction, aggressiveness, paroxysmal excitement and assault, have been reported to occur with midazolam.
These reactions may occur with high doses and/or when the injection is given rapidly. The highest incidence to such reactions has been reported among children and the elderly. 5). 2). Preterm infants and neonates Due to an increased risk of apnoea, extreme caution is advised when sedating preterm and former preterm non intubated patients.
Careful monitoring of respiratory rate and oxygen saturation is required. Rapid injection should be avoided in the neonatal population. Neonates have reduced and/or immature organ function and are also vulnerable to profound and/or prolonged respiratory effects of midazolam.
Adverse haemodynamic events have been […]