l INDICATIONS AND DOSE

Overdosage with opioids

BY INTRAVENOUS INJECTION

Child 1 month–11 years: Initially 100 micrograms/kg (max. per dose 2 mg), if no response, repeat at intervals of 1 minute to a max. of 2 mg, then review diagnosis; further doses may be required if respiratory function deteriorates, doses can be given by subcutaneous or intramuscular routes but only if intravenous route is not feasible; intravenous administration has more rapid onset of action  Child 12–17 years: Initially 400 micrograms, then 800 micrograms for up to 2 doses at 1 minute intervals if no response to preceding dose, then increased to 2 mg for 1 dose if still no response (4 mg dose may be required in seriously poisoned patients), then review diagnosis; further doses may be required if respiratory function deteriorates, doses can be given by subcutaneous or intramuscular routes but only if intravenous route is not feasible; intravenous administration has more rapid onset of action  Adult: Initially 400 micrograms, then 800 micrograms for up to 2 doses at 1 minute intervals if no response to preceding dose, then increased to 2 mg for 1 dose if still no response (4 mg dose may be required in seriously poisoned patients), then review diagnosis; further doses may be required if respiratory function deteriorates, doses can be given by subcutaneous or intramuscular routes but only if intravenous route is not feasible; intravenous administration has more rapid onset of action

BY CONTINUOUS INTRAVENOUS INFUSION

 Child: Using an infusion pump, adjust rate according to response (initially, rate may be set at 60% of the initial resuscitative intravenous injection dose per hour). The initial resuscitative intravenous injection dose is that which maintained satisfactory ventilation for at least 15 minutes  Adult: Using an infusion pump, adjust rate according to response (initially, rate may be set at 60% of the initial resuscitative intravenous injection dose per hour). The initial resuscitative intravenous injection dose is that which maintained satisfactory ventilation for at least 15 minutes 

BY INTRANASAL ADMINISTRATION

 Child 14–17 years: 1.8 mg, administered into one nostril, if no response, give a second dose after 2–3 minutes. If the patient responds to the first dose then relapses into respiratory depression, give the second dose immediately. Further doses should be administered into alternate nostrils ? Adult: 1.8 mg, administered into one nostril, if no response, give a second dose after 2–3 minutes. If the patient responds to the first dose then relapses into respiratory depression, give the second dose immediately. Further doses should be administered into alternate nostrils Overdosage with opioids in a non-medical setting 

 BY INTRAMUSCULAR INJECTION

Adult: 400 micrograms every 2–3 minutes, each dose given in subsequent resuscitation cycles if patient not breathing normally, continue until consciousness regained, breathing normally, medical assistance available, or contents of syringe used up; to be injected into deltoid region or anterolateral thigh 

BY INTRANASAL ADMINISTRATION 

Child 14–17 years: 1.8 mg, administered into one nostril, if no response, give a second dose after 2–3 minutes. If the patient responds to the first dose then relapses into respiratory depression, give the second dose immediately. Further doses should be administered into alternate nostrils  Adult: 1.8 mg, administered into one nostril, if no response, give a second dose after 2–3 minutes. If the patient responds to the first dose then relapses into respiratory depression, give the second dose immediately. Further doses should be administered into alternate nostrils Reversal of postoperative respiratory depression 

INITIALLY BY INTRAVENOUS INJECTION

Child 1 month–11 years: 1 microgram/kg, repeated every 2–3 minutes if required  Child 12–17 years: Initially 100–200 micrograms, alternatively (by intravenous injection) initially 1.5–3 micrograms/kg, if response inadequate, give subsequent doses, (by intravenous injection) 100 micrograms every 2 minutes, alternatively (by intramuscular injection) 100 micrograms every 1–2 hours  Adult: Initially 100–200 micrograms, alternatively (by intravenous injection) initially 1.5–3 micrograms/kg, if response inadequate, give subsequent doses, (by intravenous injection) 100 micrograms every 2 minutes, alternatively (by intramuscular injection) 100 micrograms every 1–2 hours

DOSE EQUIVALENCE AND CONVERSION

 With intranasal use  1 spray equivalent to 1.8 mg.

PHARMACOKINETICS

 Naloxone has a short duration of action; repeated doses or infusion may be necessary to reverse effects of opioids with longer duration of action

 l UNLICENSED USE

Naloxone doses in BNF may differ from those in product literature.

IMPORTANT SAFETY INFORMATION SAFE PRACTICE

Doses used in acute opioid overdosage may not be appropriate for the management of opioid-induced respiratory depression and sedation in those receiving palliative care and in chronic opioid use.

l CAUTIONS

Cardiovascular disease or those receiving cardiotoxic drugs (serious adverse cardiovascular effects reported). maternal physical dependence on opioids (may precipitate withdrawal in newborn). pain . physical dependence on opioids (precipitates withdrawal)

CAUTIONS, FURTHER INFORMATION 

Titration of dose In postoperative use, the dose should be titrated for each patient in order to obtain sufficient respiratory response; however, naloxone antagonises analgesia.

l SIDE-EFFECTS GENERAL SIDE-EFFECTS 

Common or very common Arrhythmias . dizziness . headache . hypertension . hypotension . nausea . vomiting  Uncommon Diarrhoea . dry mouth . hyperhidrosis . hyperventilation .tremor  Rare or very rare Cardiac arrest. erythema multiforme . pulmonary oedema

SPECIFIC SIDE-EFFECTS

Uncommon  With parenteral use Inflammation localised . pain . vascular irritation  Rare or very rare  With parenteral use Anxiety . seizure  Frequency not known  With parenteral use Analgesia reversed . asthenia . chills . death . dyspnoea . fever. irritability . nasal complaints . piloerection . yawning

l PREGNANCY Use only if potential benefit outweighs risk.

l BREAST FEEDING Not

orally bioavailable.

l DIRECTIONS FOR ADMINISTRATION

 With intravenous use in children For continuous intravenous infusion, dilute to a concentration of up to 200 micrograms/mL with Glucose 5% or Sodium Chloride 0.9%.  With intravenous use in adults For intravenous infusion (Minijet ® Naloxone Hydrochloride), give continuously in Glucose 5% or Sodium Chloide 0.9%. Dilute to a concentration of up to 200 micrograms/mL and administer via an infusion pump.

l PRESCRIBING AND DISPENSING INFORMATION  With intranasal use The manufacturer has provided a Healthcare Professional Guidance Document.

 l PATIENT AND CARER ADVICE

Patients and carers should be given advice on how to administer naloxone nasal spray. ? With intranasal use Patient training and information cards should be provided.