Therapeutic Action
Short-acting antiseizure (anticonvulsant), muscle relaxant, sedative-hypnotic, anxiolytic
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Individual generic drug information
Extracted information for MIDAZOLAM only.
Short-acting antiseizure (anticonvulsant), muscle relaxant, sedative-hypnotic, anxiolytic
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First-line treatment of convulsive status epilepticus
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Extracted information for MIDAZOLAM only.
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)
Source pages 457, 458
Extracted information for MIDAZOLAM only.
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).
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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 5 mg/ml solution 1 mg/ml solution Age Weight Buccal/ Buccal/ IM intranasal route intranasal route injection 1 to < 4 months 3 to < 6 kg 0.25 ml 1 ml 0.6 ml 1.8 ml 4 to < 12 months 6 to < 10 kg 0.4 ml 1.2 ml (max. 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 injection: one 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.
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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.
Source page 457
Extracted information for MIDAZOLAM only.
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.
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– Below 25 °C
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