MIDAZOLAM

Posology STANDARD DOSAGES Midazolam is a potent sedative agent that requires slow administration and titration. Titration is strongly recommended to safely obtain the desired level of sedation according to clinical needs, physical status, age, and concomitant medication.

For patients over 60 years of age, debilitated patients or chronically ill patients and children the medicine should be administered with care and the risk factors related to each patient should be evaluated on an individual basis.

Standard dosages are provided in the table below. Additional information is provided in the text following the table. 12 mg/kg/h CONSCIOUS SEDATION DOSAGE For sedation required for diagnostic and surgical procedures midazolam is administered intravenously.

The suitable dose is determined on an individual basis. The medicine should not be administered rapidly or as a bolus injection, but by titrating the dose. g. rate of administration, dose level). If necessary, additional doses may be administered according to individual needs.

The onset of action is approximately 2 minutes after the injection. The maximum effect is obtained in approximately 5 to 10 minutes. Adults Midazolam should be administered slowly as an intravenous injection at a rate of approximately 1 mg/30 seconds.

5 mg is administered 5 to 10 minutes before the beginning of the procedure as an initial dose. The initial dose may be followed by additional 1 mg doses as necessary. 5 mg. Administration of a total dosage higher than 5 mg is usually not necessary.

5 to 1 mg, administered 5 to 10 minutes before the beginning of the procedure. 5 to 1 mg of midazolam may be administered as necessary. In these patients it may take more time to reach the peak effect; therefore additional doses of midazolam should be titrated very slowly and carefully.

5 mg is usually not necessary. Paediatric population Intravenous administration: doses of midazolam are titrated slowly until the desired clinical effect is reached. The initial dose is administered in 2 to 3 minutes. To fully evaluate the sedative effect, one should wait another 2 to 5 minutes before beginning with the procedure or repeating the dose.

If it is necessary to increase the sedative effect, continue to administer additional low doses until the appropriate sedation level is reached. For infants and children under 5 years of age, significantly higher doses may be required (mg/kg) compared to older children and adolescents.

• Children under 6 months of age: children under 6 months of age are especially predisposed to develop airway obstruction and hypoventilation. Therefore, conscious sedation is not recommended in children under 6 months of age. 1 mg/kg.

6 mg/kg. However, the total dosage should not exceed 6 mg. Higher doses may cause prolonged sedation and risk of hypoventilation. 05 mg/kg. 4 mg/kg (10 mg as the maximum dosage). Higher doses may cause prolonged sedation and risk of hypoventilation.

• Children 12 to 16 years of age: use the recommended dosages for adults. 5 mg/kg. The solution contained in the ampoule is administered rectally by means of a plastic applicator attached to a syringe. If the volume to be administered is too small, water may be added for a total volume of 10 ml.

The whole dose should be administered at once. Avoid repeated rectal administration. Rectal administration is not recommended in children under 6 months, due to limited data concerning this age group. 15 mg/kg. 0 mg is not required. The intramuscular route should only be used in exceptional cases.

Rectal administration should be preferred, as intramuscular injection is painful. In children weighing less than 15 kg midazolam solutions with a concentration higher than 1 mg/ml are not recommended. Higher concentrations should be diluted […]

Frequency categories according to the MedDRA convention are as follows: very common: ≥1/10; common: ≥1/100 to <1/10; uncommon: ≥1/1,000 to <1/100; rare: ≥1/10,000 to <1/1,000; very rare: <1/10,000; not known: cannot be estimated from the available data.

4). 4). *** Particularly after parenteral administration. **** There have been reports of falls and fractures in benzodiazepine users. The risk of falls and fractures is higher for those taking concomitant sedatives (including alcoholic beverages) and in elderly patients.

2). Dependence: midazolam may cause development of physical dependence, even if used in therapeutic doses. 4). Cases of drug abuse have been reported. Severe cardiorespiratory adverse reactions 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 For intravenous, intramuscular and rectal use. 6. 1. Use of this drug for 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, or by persons specifically trained in the recognition and management of adverse reactions, including respiratory and cardiac resuscitation.

Severe cardiorespiratory adverse reactions have been reported, including respiratory depression, apnoea, respiratory arrest and/or cardiac arrest. 8). Benzodiazepines are not recommended for the primary treatment of psychotic illness.

Special caution is required for conscious sedation in patients with impaired respiratory function. Paediatric patients under 6 months of age are especially predisposed to develop airway obstruction and hypoventilation. Therefore it is essential to titrate the dosage with small increments to clinical effect and to carefully monitor respiratory rate and oxygen saturation.

After midazolam is administered as premedication, the patient should be kept under careful observation as individual sensitivity varies and symptoms of overdose may occur. : - 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 they should be continuously monitored for early signs of alterations of vital functions. As with any medicine that has CNS depressant and/or muscle-relaxant properties, special caution is required when administering midazolam to patients with myasthenia gravis.

Tolerance Some loss of efficacy has been reported when using midazolam as long-term sedation in intensive care unit. Dependence When midazolam is used in long-term sedation in intensive care, possible development of physical dependence should be taken into account.

8). Withdrawal symptoms Physical dependence may develop during prolonged treatment with midazolam in intensive care. Therefore, abrupt termination of treatment leads to withdrawal symptoms. The following symptoms may occur: headaches, diarrhoea, muscle pain, 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 higher after abrupt termination of treatment, it is recommended to decrease doses gradually.

Amnesia Anterograde amnesia may occur with therapeutic doses, with the risk increasing at higher dosages (in some situations this effect is very desirable, primarily prior and during surgical and diagnostic procedures), the duration of which is directly related to the administered dose.

Prolonged amnesia may cause problems in outpatients who are discharged after the procedure. After receiving midazolam parenterally, patients should be discharged from the hospital or sent to a 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, anger, aggressiveness, anxiety, nightmares, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects, paroxysmal excitement and assault have been reported with midazolam use.

Such reactions may occur when high doses are used and/or the medicine is administered rapidly. Such reactions are more prevalent in children and elderly patients. 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. Preterm infants and neonates Due to an increased risk of apnoea, extreme caution is required when sedating preterm and former preterm non-intubated children.

Careful monitoring of breathing rate and oxygen saturation is required. Rapid injection should be avoided in neonates. Neonates have immature organs and/or reduced organ function and are therefore more sensitive to profound and/or prolonged respiratory effects of midazolam.

Adverse haemodynamic reactions have been reported in children with cardiovascular instability; rapid intravenous administration should be avoided in these patients. Paediatric […]

1. Use of this drug for conscious sedation in patients with severe respiratory failure or acute respiratory depression.