NALOXONE HYDROCHLORIDE INJECTION USP 0.4 MG/ML [SIN05964P]

Product Info

NALOXONE HYDROCHLORIDE INJECTION USP 0.4 MG/ML

[SIN05964P]

4.1 Therapeutic indications
Naloxone may be used for the complete or partial reversal of opioid depression, including mild to severe respiratory depression induced by natural and synthetic opioids, the agonist/antagonists nalbuphine and pentazocine, or dextropropoxyphene. It may also be used for the diagnosis of suspected acute opioid overdosage. Naloxone may be used to counteract respiratory and other CNS depression in the newborn resulting from the administration of analgesics to the mother during childbirth.

4.2 Posology and method of administration
NALOXONE HYDROCHLORIDE INJECTION USP is for intravenous (IV), intramuscular (IM) or subcutaneous (SC) injection. It may also be administered by intravenous infusion.

Intravenous infusion:
Addition of 2 mg of naloxone hydrochloride to 500 mL of normal saline (0.9%) or to 500 mL of 5% dextrose in water or in saline will provide a concentration of 4 micrograms/mL (0.004 mg/mL). After 24 hours, any unused solution should be discarded. The rate of infusion should be titrated according to the patient's response to the infused naloxone hydrochloride and to any previously administered bolus doses.
Naloxone hydrochloride should not be mixed with preparations containing bisulphite, metabisulphite, long-chain or high molecular weight anions or any solution having an alkaline pH. No drug or chemical agent should be added to naloxone hydrochloride unless its effect on the chemical and physical stability of the solution has first been established. Before administration, parenteral drugs should be inspected visually for particulate matter and discolouration whenever the solution and container permit.

Adults:
Opioid overdosage (known or suspected):
An initial dose of 400 to 2,000 micrograms (0.4 mg to 2 mg) of naloxone hydrochloride may be given intravenously and may, if required, be repeated at 2 to 3 minute intervals. The diagnosis of opioid-related toxicity should be reconsidered if there is still failure to respond after a total of 10 mg of naloxone has been administered. If intravenous administration is impracticable, naloxone may be administered by the intramuscular or subcutaneous route. The duration of action of some opioids (including dextropropoxyphene, dihydrocodeine and methadone) may exceed that of naloxone hydrochloride. In these circumstances an intravenous infusion of naloxone hydrochloride will provide sustained antagonism of the opioid and obviate the need for repeated injections.

Post-operative use:
When Naloxone Hydrochloride Injection is used postoperatively, the dose should be titrated for each patient in order to obtain optimum respiratory response while maintaining adequate analgesia.

Intravenous doses of 100 to 200 micrograms (0.1 to 0.2 mg), corresponding to 1.5 to 3 micrograms (0.0015 to 0.003 mg) per kg body weight, may be used. The dose should be titrated according to the individual patient's response and a full 2 minutes should be allowed between each 100 micrograms (0.1 mg) increment of naloxone hydrochloride administered. Depending on the type of opioid, the dose and the time interval from its last administration, repeat doses of naloxone hydrochloride may be required within one to two hours and may be administered by intramuscular injection or by intravenous infusion in order to produce a more sustained effect.

Children:
The usual initial dose is 10 micrograms (0.01 mg) per kg body weight, intravenously. A subsequent dose of 100 micrograms (0.1 mg) per kg body weight may be used if required.
Naloxone hydrochloride may be administered by intravenous infusion, if appropriate. Alternatively, it may be given IM or SC in divided doses.

Neonatal use:
For opioid-related depression, the usual initial dose is 10 micrograms (0.01 mg) per kg body weight, IV, IM or SC, and this may be repeated, if required, at 2 to 3 minute intervals. Alternatively, a single dose of 200 micrograms (0.2 mg), approximately 60 micrograms (0.06 mg) per kg body weight, may be administered intramuscularly at birth. An adequate airway should be established prior to administering naloxone hydrochloride to the apnoeic infant.

4.3 Contraindications
Naloxone hydrochloride should not be given to patients who are known to be hypersensitive to the drug or any of the excipients (see section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).