DIAZEPAM 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 rectal route in children.

    Therapeutic action

    • Antiseizure (anticonvulsant), muscle relaxant, sedative, anxiolytic

    Indications

    • First-line treatment of convulsive status epilepticus
    • Muscle spasms due to tetanus
    • Severe agitation in adults

    Forms and strengths, route of administration

    • 10 mg in 2 ml ampoule (5 mg/ml) for IM injection, slow IV injection (3 to 5 minutes) or IV infusion in 0.9% sodium chloride or 5% glucose
    • The injectable solution may be used rectally.

    Dosage and duration 

    Convulsive status epilepticus

    • Child 1 month to 11 years:
      • Rectal route: one dose of 0.5 mg/kg (0.1 ml/kg); max. 10 mg (2 ml)
      • Slow IV injection: one dose of 0.2 to 0.3 mg/kg (0.04 to 0.06 ml/kg); max. 10 mg (2 ml)

     

    Age

    Weight

    10 mg/2 ml solution

    Rectal route IV injection
    1 to < 4 months 3 to < 6 kg 0.4 ml 0.25 ml

    4 to < 12 months

    6 to < 10 kg

    0.7 ml

    0.4 ml

    1 to < 3 years

    10 to < 15 kg

    1.2 ml

    0.6 ml

    3 to < 5 years

    15 to < 20 kg

    1.5 ml

    1 ml

    5  to < 9 years

    20 to < 30 kg

    2 ml 

    1.2 ml

    9  to < 12 years 30 to < 40 kg 2 ml 2 ml 
    • Child 12 years and over and adult:
      • Rectal route:  one dose of 10 to 20 mg (2 to 4 ml); one dose of 10 mg (2 ml) in older patients
      • Slow IV injection: one dose of 10 mg (2 ml); one dose of 5 mg (1 ml) in older patients

     

    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.

     

    Muscle spasms due to tetanus
    The dosage range is variable, depending on the severity of symptoms and clinical response. For information:

    • Child 1 month and over and adult: 0.1 to 0.3 mg/kg by slow IV injection every 1 to 4 hours or 0.1 to 0.5 mg/kg/hour by IV infusion over 24 hours

     

    Severe agitation

    • Adult: 10 mg (2 ml) by IM injection, to be repeated once after 30 to 60 minutes if necessary

    Rectal administration technique 

    • Lay the patient on their side.
    • For volumes up to 1 ml, use a 1 ml syringe. Withdraw the required dose. Remove the needle. Insert the syringe into the rectum for a length of 1 to 3 cm (depending on age) to administer the dose. For volumes greater than 1 ml, use a 2 ml syringe and attach to the tip of the syringe a nasogastric tube n°8 cut to a length of 2 to 3 cm to administer the dose.
    • After administration, hold the buttocks together for at least one minute.

    Contra-indications, adverse effects, precautions

    • Do not administer to neonates (contains benzyl alcohol) and to patients with severe respiratory insufficiency or severe hepatic impairment.
    • Administer with caution: 
      • to older patients and patients with renal or hepatic impairment (reduce the dose by half);
      • to patients with history of substance abuse or mental disorders.
    • May cause:
      • pain at injection site;
      • hypotension, muscle weakness, ataxia, hypotonia, drowsiness, lethargy, confusional state;
      • respiratory depression, especially if injected rapidly by IV route and if large doses are administered;
      • 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 diazepam);
      • omeprazole, macrolides, ritonavir, isoniazid, fluconazole, itraconazole, etc. (increased diazepam toxicity);
      • phenytoin (increased phenytoin toxicity).
    • Pregnancy and breast-feeding: avoid, except if vital (passage through the placenta and breast milk)

    Remarks

    • Diazepam is subject to international controls: follow national regulations.
    • For administration by IV infusion, the concentration of diazepam in the solution should not exceed 0.25 mg/ml (e.g. 1 mg in at least 4 ml). 
    • Diazepam slow IV is also used in delirium tremens (alcohol withdrawal) in adults: 10 to 20 mg every 4 to 6 hours under close supervision in intensive care unit.
    • Do not mix with other drugs in the same syringe or infusion. 

    Storage

     
    – Below 25 °C