Formulary
Naloxone hydrochloride: Indications, Dosing, Side Effects and Interactions
Naloxone hydrochloride clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 9 min read
Naloxone hydrochloride: Indications, Dosing, Side Effects and Interactions
Naloxone hydrochloride clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Acute opioid overdose-high-dose regimen [when rapid titration with naloxone is necessary to reverse potentially life-threatening effects]**
- **Neonate** (By Intravenous Injection): Initially 100 micrograms/kg, if no response, repeat at intervals of 1 minute to a total max. of 2 mg, then review diagnosis; further doses may be required if respiratory function deteriorates following initial response, intravenous administration has more rapid onset of action, doses may be given by intramuscular route but only if intravenous route is not feasible.
- **Child** (By Intravenous Injection): 12-17 years Initially 400 micrograms for 1 dose, 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 following initial response, intravenous administration has more rapid onset of action, doses may be given by intramuscular route but only if intravenous route is not feasible.
- **Adult** (By Intravenous Injection): Initially 400 micrograms for 1 dose, 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 following initial response, intravenous administration has more rapid onset of action, doses may be given by intramuscular route but only if intravenous route is not feasible. By continuous intravenous infusion
- **Child** (Using An Infusion Pump, Adjust Rate According To Response): intravenous injection dose is that which maintained satisfactory respiratory effort for at least 15 minutes.
- **Adult** (Using An Infusion Pump, Adjust Rate According To Response): intravenous injection dose is that which maintained satisfactory respiratory effort for at least 15 minutes.
**Opioid overdose-low-dose regimen [when there is risk of acute withdrawal, or when a continued therapeutic effect is required (e.g. postoperative use, palliative care)]**
- **Neonate** (By Intravenous Injection): Initially 1-10 micrograms/kg, if no response, repeat at intervals of 1 minute up to 5 times, if no response then give a single dose of 100 micrograms/kg then review diagnosis if still no response, further doses may be required if respiratory function deteriorates following initial response, intravenous administration has a more rapid onset of action, doses may be given by intramuscular route but only if intravenous route is not feasible.
- **Child** (By Intravenous Injection): 12-17 years Initially 100-200 micrograms for 1 dose, then 100 micrograms for up to 2 doses at 1 minute intervals if no response to preceding dose, continue titrating up to a max. of 2 mg until adequate response achieved. If still no response, give a further 2 mg dose (4 mg dose may be required in seriously poisoned patients), then review diagnosis; further doses may be required if respiratory function deteriorates following initial response, intravenous administration has a more rapid onset of action, doses may be given by intramuscular route but only if intravenous route is not feasible.
- **Adult** (By Intravenous Injection): Initially 100-200 micrograms for 1 dose, then 100 micrograms for up to 2 doses at 1 minute intervals if no response to preceding dose, continue titrating up to a max. of 2 mg until adequate response achieved. If still no response, give a further 2 mg dose (4 mg dose may be required in seriously poisoned patients), then review diagnosis; further doses may be required if respiratory function deteriorates following initial response, intravenous administration has a more rapid onset of action, doses may be given by intramuscular route but only if intravenous route is not feasible.
**Opioid overdose in a non-medical setting**
- **Adult** (By Intramuscular Injection): 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.
**Acute opioid overdose-high-dose regimen [when rapid titration with naloxone is necessary to reverse potentially life-threatening effects] for naloxone hydrochloride**
- **Neonate** (By intravenous injection): Initially 100 micrograms/kg, if no response, repeat at intervals of 1 minute to a total max. of 2 mg, then review diagnosis; further doses may be required if respiratory function deteriorates following initial response, intravenous administration has more rapid onset of action, doses may be given by intramuscular route but only if intravenous route is not feasible.
- **Child 1 month-11 years** (By intravenous injection): Initially 100 micrograms/kg (max. per dose 2 mg), if no response, repeat at intervals of 1 minute to a total max. of 2 mg, then review diagnosis; further doses may be required if respiratory function deteriorates following initial response, intravenous administration has more rapid onset of action, doses may be given by intramuscular route but only if intravenous route is not feasible.
- **Child 12-17 years** (By intravenous injection): Initially 400 micrograms for 1 dose, 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 following initial response, intravenous administration has more rapid onset of action, doses may be given by intramuscular route but only if intravenous route is not feasible.
- **Neonate** (By continuous intravenous infusion): 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 respiratory effort for at least 15 minutes.
- **Child** (By continuous intravenous infusion): 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 respiratory effort for at least 15 minutes.
**Opioid overdose-low-dose regimen [when there is risk of acute withdrawal, or when a continued therapeutic effect is required (e.g. postoperative use, palliative care)] for naloxone hydrochloride**
- **Neonate** (By intravenous injection): Initially 1-10 micrograms/kg, if no response, repeat at intervals of 1 minute up to 5 times, if no response then give a single dose of 100 micrograms/kg then review diagnosis if still no response, further doses may be required if respiratory function deteriorates following initial response, intravenous administration has a more rapid onset of action, doses may be given by intramuscular route but only if intravenous route is not feasible.
- **Child 1 month-11 years** (By intravenous injection): Initially 1-10 micrograms/kg (max. per dose 200 micrograms), if no response, repeat at intervals of 1 minute up to 5 times, if no response then give a single dose of 100 micrograms/kg (max. dose 2 mg) then review diagnosis if still no response, further doses may be required if respiratory function deteriorates following initial response, intravenous administration has a more rapid onset of action, doses may be given by intramuscular route but only if intravenous route is not feasible.
- **Child 12-17 years** (By intravenous injection): Initially 100-200 micrograms for 1 dose, then 100 micrograms for up to 2 doses at 1 minute intervals if no response to preceding dose, continue titrating up to a max. of 2 mg until adequate response achieved. If still no response, give a further 2 mg dose (4 mg dose may be required in seriously poisoned patients), then review diagnosis; further doses may be required if respiratory function deteriorates following initial response, intravenous administration has a more rapid onset of action, doses may be given by intramuscular route but only if intravenous route is not feasible.
**Opioid overdose in non-medical and medical settings for naloxone hydrochloride**
- **Child 14-17 years** (By intranasal administration): 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 respiratory and CNS depression resulting from opioid administration to mother during labour for naloxone hydrochloride**
- **Neonate** (By intramuscular injection): 200 micrograms for 1 dose, to be given at birth, alternatively 60 micrograms/kg for 1 dose, to be given at birth.
- **Neonate** (By intravenous injection, or by subcutaneous injection): 10 micrograms/kg, repeated every 2-3 minutes if required, further doses may be required if respiratory function deteriorates following initial response, intravenous administration has a more rapid onset of action.
Cautions
Cardiovascular disease or those receiving cardiotoxic drugs (serious adverse cardiovascular effects reported); chronic opioid use (risk of acute withdrawal); maternal chronic opioid use (risk of acute withdrawal in newborn); palliative care (risk of returning pain and acute withdrawal); postoperative use (risk of returning pain) 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. M
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
Interactions
**Other interactions (7):**
- The effect of naloxone hydrochloride is due to the interaction with opioids and opioid agonists.
- When administered to subjects dependent on opioids, in some subjects the administration of naloxone hydrochloride can cause pronounced withdrawal symptoms.
- Data on interaction with alcohol are not unanimous.
- In patients with multi-intoxication as a result of opioids and sedatives or alcohol, depending on the cause of the intoxication, one may possibly observe a less rapid result after administration of...
- When administering naloxone hydrochloride to patients who have received buprenorphine as an analgesic complete analgesia may be restored.
- It is thought that this effect is a result of the arch-shaped dose-response curve of buprenorphine with decreasing analgesia in the event of high doses.
Pregnancy
Use only if potential benefit outweighs risk.
Breast feeding
Not orally bioavailable.
Medicinal forms
Solution,Spray
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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