MIDAZOLAM injectable

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    Last updated: October 2024

     

    Prescription under medical supervision

     

     
    • During and after administration, have ventilation equipment (Ambu and mask) and solutions for fluid replacement ready for use.
    • For seizures, preferably use the buccal or intranasal route, especially in children.

     

    Therapeutic action

    • Short-acting antiseizure (anticonvulsant), muscle relaxant, sedative-hypnotic, anxiolytic

    Indications

    • First-line treatment of convulsive status epilepticus

    Forms and strengths, route of administration

    • 5 mg in 5 ml ampoule (1 mg/ml) and 50 mg in 10 ml ampoule (5 mg/ml), for administration by buccal or intranasal route or IM injection
    • For buccal or intranasal administration, preferably use the 50 mg in 10 ml ampoule (5 mg/ml).
    • For IM injection, use only the 5 mg in 5 ml ampoule (1 mg/ml).

    Dosage and duration

    • Child 1 month to 11 years:
      • Buccal or intranasal route: one dose of 0.2 to 0.3 mg/kg (0.04 to 0.06 ml/kg of the 5 mg/ml solution or 0.2 to 0.3 ml/kg of the 1 mg/ml solution); max. 10 mg
      • IM injection: one dose of 0.15 to 0.2 mg/kg (0.15 to 0.2 ml/kg of the 1 mg/ml solution); max. 10 mg

     

    Age Weight 5 mg/ml solution 1 mg/ml solution

    Buccal/

    intranasal route

    Buccal/

    intranasal route 

     IM  injection

    1 to < 4 months 3 to < 6 kg 0.25 ml 1 ml 0.6 ml

    4 to < 12 months

    6 to < 10 kg

    0.4 ml 

    1.8 ml

    (max. 2 ml)

    1.2 ml

    1 to < 3 years

    10 to < 15 kg

    0.6 ml 2 ml

    3 to < 5 years

    15 to < 20 kg

    1 ml 3 ml

    5 to < 9 years 

    20 to < 30 kg

    1.2 ml 4 ml
    9 to < 12 years 30 to < 40 kg

    2 ml

    6 ml

     

    • Child 12 years and over and adult:
      • Buccal or intranasal route: one dose of 10 mg (2 ml of the 5 mg/ml solution)
      • IM injectionone dose of 10 mg (10 ml of the 1 mg/ml solution) 

     

    In children and adults, if seizures do not stop 5 minutes after the first dose, readminister the same dose, regardless of the route of administration. Do not administer more than 2 doses in total.

    Buccal/intranasal administration technique 

    Buccal route:

    Lay the patient on their side. Withdraw the required dose using a 1 ml or 2 ml syringe. Remove the needle. Insert the tip of the syringe into the space between the gum and cheek. Administer the dose by slowly pushing the syringe plunger.

     

    Intranasal route:

    Lay the patient on their back or side. Withdraw the required dose using a 1 ml or 2 ml syringe (add an additional 0.1 ml to the calculated dose to account for the remaining liquid in the atomising device). Remove the needle. Attach the intranasal atomisation device to the syringe. Briskly push the syringe plunger to spray the dose into the nostril. The dose can be split in both nostrils to reduce irritation. 

    Contra-indications, adverse effects, precautions

    • Do not administer to patients with severe respiratory insufficiency or severe hepatic impairment.
    • Administer with caution to older patients and patients with renal or hepatic impairment.
    • May cause:
      • pain at injection site; nasal irritation (if used intranasally);
      • hypotension, muscle weakness, ataxia, hypotonia, drowsiness, lethargy, confusional state;
      • respiratory depression and coma in the event of overdose.
    • Avoid or monitor in combination with:
      • opioid analgesics, antipsychotics, first-generation antihistamines (hydroxyzine, promethazine), antidepressants, other antiseizure medications, etc. (increased sedation);
      • enzyme inducers such as rifampicin, rifabutin, nevirapine, phenobarbital, phenytoin, carbamazepine, etc. (reduced effect of midazolam);
      • omeprazole, macrolides, ritonavir, isoniazid, fluconazole, itraconazole, etc. (increased midazolam toxicity);
      • phenytoin (increased phenytoin toxicity).
    • Pregnancy and breast-feeding: avoid, except if vital (passage through the placenta and breast milk)

    Remarks

    • Midazolam is subject to international controls: follow national regulations.
    • Midazolam is also used as premedication prior to surgical procedures, for sedation in medical procedures and intensive care, for induction of general anaesthesia, etc.
    • Do not mix with other drugs in the same syringe.

    Storage

     
    –  Below 25 °C