MIDAZOLAM is a brand name for Midazolam. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Midazolam is a short-acting sleep-inducing drug that is indicated: In adults • Conscious sedation before and during diagnostic or therapeutic procedures with or without local anaesthesia. • Anaesthesia − Premedication before induction of anaesthesia. − Induction of anaesthesia. − As an induction agent or as a sedative…
Verbatim from this product's MHRA label. Tap a section to expand.
Standard Dosage Midazolam is a potent sedative agent that requires titration and slow administration. Titration is strongly recommended to safely obtain the desired level of sedation according to the clinical need, physical status, age and concomitant medication.
In adults over 60 years, debilitated or chronically ill patients and paediatric patients, dose should be determined with caution and risk factors related to each patient should be taken into account. Standard dosages are provided in in Table 1 and additional details are provided in the text following the table.
v. v. v. m. v. m. v. m. m. v. v. v. v. v. v. v. v. The dose must be individualised and titrated and should not be administered by rapid or single bolus injection. g. speed of administration, amount of dose). If necessary, subsequent doses may be administered according to the individual need.
The onset of action is about 2 minutes after the injection. Maximum effect is obtained in about 5 to 10 minutes. v. injection of midazolam should be given slowly at a rate of approximately 1mg in 30 seconds. 5mg given 5 to 10 minutes before the beginning of the procedure.
Further doses of 1mg may be given as necessary. 5mg. A total dose greater than 5mg is usually not necessary. 0 mg and given 5-10 minutes before the beginning of the procedure. 5 to 1mg may be given as necessary. Since in these patients the peak effect may be reached less rapidly, additional midazolam should be titrated very slowly and carefully.
5mg is usually not necessary. V. administration: midazolam should be titrated slowly to the desired clinical effect. The initial dose of midazolam should be administered over 2 to 3 minutes. One must wait an additional 2 to 5 minutes to fully evaluate the sedative effect before initiating a procedure or repeating a dose.
If further sedation is necessary, continue to titrate with small increments until the appropriate level of sedation is achieved. Infants and young children less than 5 years of age may require substantially higher doses (mg/kg) than older children and adolescents.
• Paediatric patients less than 6 months of age: paediatric patients less than 6 months of age are particularly vulnerable to airway obstruction and hypoventilation. For this reason, the use in conscious sedation in children less than 6 months of age is not recommended.
4). ***There have been reports of falls and fractures in benzodiazepine users. The risk of falls and fractures is increased in those taking concomitant sedatives (including alcoholic beverages) and in the elderly. 2).
Dependence:
Use of midazolam - even in therapeutic doses - may lead to the development of physical dependence. v. 4). Cases of abuse have been reported. Severe cardiorespiratory 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. m. and rectal administration. 1. Conscious sedation in patients with severe respiratory failure or acute respiratory depression. 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 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.
When midazolam is used for premedication, adequate observation of the patient after administration is mandatory as interindividual sensitivity varies and symptoms of overdose may occur. Benzodiazepines are not recommended for the primary treatment of psychotic illness.
g. - patients with chronic respiratory insufficiency - patients with chronic renal failure, − patients with impaired hepatic function (benzodiazepines may precipitate or exacerbate encephalopathy in patients with severe hepatic impairment) − patients with impaired cardiac function - paediatric patients especially 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.
1. 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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1mg/kg. 6mg/kg may be necessary to reach the desired endpoint, but the total dose should not exceed 6mg. Prolonged sedation and risk of hypoventilation may be associated with the higher doses. 05mg/kg. 4mg/kg to a maximum of 10mg may be necessary.
Prolonged sedation and risk of hypoventilation may be associated with the higher doses. • Paediatric patients 12 to 16 years of age: should be dosed as adults. 5mg/kg. Rectal administration of the solution is performed by means of a plastic applicator fixed on the end of the syringe.
If the volume to be administered is too small, water may be added up to a total volume of 10ml. Total dose should be administered at once and repeated rectal administration avoided. The use in children less than 6 months of age is not recommended, as available data in this population are limited.
M. 15mg/kg. 0mg is usually not necessary. This route should only be used in exceptional cases. m. injection is painful. In children less than 15kg of body weight, midazolam solutions with concentrations higher than 1mg/ml are not recommended.
Higher concentrations should be diluted to 1mg/ml. Anaesthesia Dosage Premedication Premedication with midazolam given shortly before a procedure produces sedation (induction of sleepiness or drowsiness and relief of apprehension) and pre-operative impairment of memory.
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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, diarrhoea, muscle pain, extreme anxiety, tension, restlessness, confusion, irritability, sleep disturbances, mood changes, hallucinations and convulsions.
In severe cases, the following symptoms may occur: depersonalisation, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact. Since the risk of withdrawal symptoms is greater after abrupt discontinuation of treatment, it is recommended to decrease doses gradually.
Amnesia Anterograde amnesia may occur with therapeutic doses (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 , with the risk increasing at higher dosages.
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 restlessness, agitation, irritability, involuntary movements (including tonic/clonic convulsions and muscle tremor), hyperactivity, hostility, delusion, ange, aggressiveness, anxiety, nightmares, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects, 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. In the event of these reactions discontinuation of the drug should be considered.
5). 2). Sleep Apnoea Midazolam ampoules should be used with extreme caution in patients with sleep apnoea syndrome and patients should be regularly monitored. Paediatric population 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 reported in paediatric patients with cardiovascular instability; rapid intravenous administration should be avoided in this population. Paediatric patients less than 6 months In this population, […]