NALOXONE injectable

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    Prescription under medical supervision

     

    Therapeutic action

    • Specific opioid antagonist

    Indications

    • Respiratory depression induced by opioids (analgesia, anaesthesia, intoxication)

    Forms and strengths, route of administration

    • 0.4 mg in 1 ml ampoule (0.4 mg/ml) for IV, IM injection or infusion in sodium chloride 0.9% or glucose 5%

    Dosage

    IV route is preferred, use IM route if IV route is not feasible:

    • Child: 5 to 10 micrograms/kg by IV injection, repeated if necessary after 2 to 3 minutes, until adequate spontaneous ventilation is restored, followed by a continuous infusion of 1 to 5 micrograms/kg/hour, or by 5 to 10 micrograms/kg by IM injection every 90 minutes
    • Adult: 1 to 3 micrograms/kg by IV injection, repeated if necessary after 2 to 3 minutes, until adequate spontaneous ventilation is restored, followed by a continuous infusion of 1 to 5 micrograms/kg/hour, or by 5 to 10 micrograms/kg by IM injection every 90 minutes

    Duration

    • The duration of action of naloxone (20 to 30 minutes by IV route) is shorter than that of opioids: administration must be maintained several hours even if breathing improves.

    Contra-indications, adverse effects, precautions

    • May cause:
      • tachycardia, fibrillation, hypertension, pulmonary oedema when given postoperatively, due to a sudden reversal of analgesia;
      • nausea, vomiting;
      • acute withdrawal syndrome in opioid-dependent patients.
    • Administer with caution and reduce dosage in case of heart failure or coronary artery disease.
    • Naloxone is used in addition to assisted ventilation and must be administered under close medical supervision.
    • Pregnancy: risks linked to respiratory depression appear greater than risks linked to naloxone.
    • Breast-feeding: no contra-indication

    Remarks

    • Naloxone is a specific opioid antidote. It cannot be used to antagonise the effects of other drugs producing CNS or respiratory depression.
    • Efficacy in antagonising opioid effects depends not only on the dose of naloxone but also on the dose and potency of the specific opioid involved.

    Storage

     
     Below 25 °C