DIAZEPAM emulsion

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    Prescription under medical supervision

     

     
    For administration, equipment for ventilation must be available and ready for use.

     

    Therapeutic action

    • Anxiolytic, sedative, anticonvulsant, muscle relaxant

    Indications

    • Muscle spasms due to tetanus in neonates

    Forms and strengths, route of administration

    • 10 mg ampoule (5 mg/ml, 2 ml) emulsion for slow IV injection (3 to 5 minutes) or infusion in 10% glucose (if not available, 5%).
      DO NOT ADMINISTER BY IM OR RECTAL ROUTE.

    Dosage and duration

    The dosage range is variable, depending on the severity of symptoms and clinical response. For information:

    • 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 continuous perfusion, preferably via an electric syringe

     

    Dilute one ampoule of diazepam emulsion (10 mg) in a syringe of 50 ml of 10% glucose to obtain a solution containing 0.2 mg of diazepam per ml.
    Every 6 hours, discharge the content remaining in the electric syringe and prepare a new syringe for 6 hours.

     

     

    Weight

    Dose

    Diluted solution 0.2 mg/ml

    2.5 kg

    0.1 mg/kg/hour

    1.3 ml/hour

    0.3 mg/kg/hour

    3.8 ml/hour

    0.5 mg/kg/hour

    6.2 ml/hour

    3 kg

    0.1 mg/kg/hour

    1.5 ml/hour

    0.3 mg/kg/hour

    4.5 ml/hour

    0.5 mg/kg/hour

    7.5 ml/hour

    3.5 kg

    0.1 mg/kg/hour

    1.8 ml/hour

    0.3 mg/kg/hour

    5.2 ml/hour

    0.5 mg/kg/hour

    8.8 ml/hour

     

    Contra-indications, adverse effects, precautions

    • Do not administer to patients with severe respiratory insufficiency or severe hepatic impairment.
    • Reduce the dose by one half in patients with renal or hepatic impairment.
    • May cause:
      • hypotension, respiratory depression, if injected too rapidly by IV route and if large doses are administered;
      • drowsiness, muscle weakness;
      • in the event of overdose: hypotonia, lethargy, respiratory distress, coma.
    • Avoid and monitor in combination with:
      • drugs containing alcohol, opioid analgesics, other anticonvulsants, etc. (increased sedation);
      • enzyme inducers such as nevirapine, ritonavir, phenobarbital, phenytoin, etc. (efficacy of diazepam reduced);
      • omeprazole, macrolides, ritonavir, fluconazole, etc. (effects of diazepam increased);
      • phenytoin (phenytoin plasmatic concentrations modified).

    Remarks

    • Diazepam is subject to international controls: follow national regulations.
    • Do not mix with other drugs in the same syringe or infusion.

    Storage

     
    – Below 25 °C 
    Emulsion diluted in glucose can be kept 6 hours maximum.