Applies to the following strength(s): 0.4 mg/mL ; 0.02 mg/mL ; 1 mg/mL ; 0.4 mg/0.4 mL
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Usual Adult Dose for:
Usual Pediatric Dose for:
Additional dosage information:
Usual Adult Dose for Opioid Overdose
0.4 to 2 mg/dose IV/IM/subcutaneously. May repeat every 2 to 3 minutes as needed. Therapy may need to be reassessed if no response is seen after a cumulative dose of 10 mg.
Continuous infusion: 0.005 mg/kg loading dose followed by an infusion of 0.0025 mg/kg/hr.
Usual Pediatric Dose for Opioid Overdose
Infants, Children, and Adolescents:
Opioid intoxication (full reversal):
IV (preferred) or Intraosseous (IO): Note: May be administered IM, Subcutaneous, or endotracheal tube (ET), but onset of action may be delayed, especially if patient has poor perfusion; ET preferred if IV or IO route not available; doses may need to be repeated.
Infants and Children less than or equal to 5 years or less than or equal to 20 kg: 0.1 mg/kg/dose; repeat every 2 to 3 minutes if needed; may need to repeat doses every 20 to 60 minutes.
Children greater than 5 years or greater than 20 kg and Adolescents: 2 mg/dose; if no response, repeat every 2 to 3 minutes; may need to repeat doses every 20 to 60 minutes.
ET: Optimal endotracheal dose unknown; current expert recommendations are 2 to 3 times the IV dose.
Manufacturer recommendations: IV (preferred), IM, Subcutaneous:
Initial: 0.01 mg/kg/dose; if no response, a subsequent dose of 0.1 mg/kg may be given
Note: If using IM or Subcutaneous route, dose should be given in divided doses.
Continuous IV infusion:
Children: If continuous infusion is required, calculate the initial dosage/hour based on the effective intermittent dose used and duration of adequate response seen; titrate dose; a range of 2.5 to 160 mcg/kg/hour has been reported; taper continuous infusion gradually to avoid relapse.
Respiratory depression [therapeutic opioid use (e.g., postanesthesia)]:
PALS Guidelines, 2010: IV: 0.001 to 0.005 mg/kg/dose; titrate to effect
Manufacturer recommendations: Initial: 0.005 to 0.01 mg/kg; repeat every 2 to 3 minutes as needed based on response.
Children and Adolescents: Limited data available
Renal Dose Adjustments
Naloxone and metabolites are excreted in the urine. However, there are no data to indicate that a dosage reduction is necessary during the typically short duration of therapy. Clinical monitoring of patient response and tolerance is recommended in patients with renal dysfunction.
Liver Dose Adjustments
Naloxone is metabolized by the liver. However, there are no data to indicate that a dosage reduction is necessary during the typically short duration of therapy. Clinical monitoring of patient response and tolerance is recommended in patients with hepatic dysfunction.
Naloxone may precipitate withdrawal in opioid-dependent patients. Naloxone should be used cautiously in newborns of mothers who are known or suspected to be physically dependent on opioids. In such cases, an abrupt and complete reversal may precipitate an acute abstinence syndrome. Withdrawal is characterized by nausea, vomiting, diarrhea, fever, body aches, sneezing, sweating, lacrimation, rhinorrhea, cramping, insomnia, chills/hot flashes, piloerection, tachycardia, anxiety, nervousness, restlessness, irritability, tremulousness, shivering, weakness, and increased blood pressure. In the neonate, opioid withdrawal may also include convulsions, excessive crying, and hyperactive reflexes.
Patients successfully treated with naloxone should be kept under continued surveillance and repeated doses should be administered, as necessary, since the duration of action of some narcotics may exceed that of naloxone.
Naloxone is not effective against respiratory depression due to non-opioid drugs and in the management of acute toxicity caused by levopropoxyphene. Reversal of respiratory depression by partial agonists or mixed agonist/antagonists, such as buprenorphine and pentazocine, may be incomplete or require higher doses of naloxone therapy. If an incomplete response is observed, respirations should be mechanically assisted as clinically indicated.
In addition to naloxone, other resuscitative measures such as maintenance of a free airway, artificial ventilation, cardiac massage, and vasopressor agents should be readily available and utilized when necessary to counteract acute opioid poisoning.
Naloxone may precipitate withdrawal in opioid-dependent patients. Withdrawal is characterized by nausea, vomiting, diarrhea, fever, body aches, sneezing, sweating, lacrimation, rhinorrhea, cramping, insomnia, chills/hot flashes, piloerection, tachycardia, anxiety, nervousness, restlessness, irritability, tremulousness, shivering, weakness, and increased blood pressure.
Additionally, some postoperative patients have experienced tachycardia, seizures, hypotension, hypertension, ventricular tachycardia and fibrillation, pulmonary edema, and cardiac arrest resulting in encephalopathy, coma, and/or death. Most of these patients had preexisting cardiovascular disease or had received other drugs with similar cardiovascular adverse effects. Although a direct cause and effect relationship has not been determined, naloxone should be used with caution in patients with preexisting cardiac disease or patients who have received medications with potential adverse cardiovascular effects such as hypotension, ventricular tachycardia or fibrillation and pulmonary edema. The etiology of pulmonary edema may be similar to neurogenic pulmonary edema, i.e., a centrally mediated massive catecholamine response leading to a dramatic shift of blood volume into the pulmonary vascular bed resulting in increased hydrostatic pressures.
The safety and effectiveness of naloxone in patients with renal insufficiency/failure have not been established. Caution should be exercised when naloxone is given to patients with renal insufficiency.
The safety and efficacy of naloxone in patients with liver disease have not been established. Caution should be exercised when naloxone is given to patients with liver disease.
Naloxone may be given intravenously, intramuscularly, or subcutaneously in children and neonates to reverse the effects of opiates. The American Academy of Pediatrics, however, does not endorse subcutaneous or intramuscular use in opiate intoxication since absorption may be erratic or delayed. Although the opiate-intoxicated child responds dramatically to naloxone, he/she must be carefully observed for at least 24 hours as a relapse may occur as naloxone is metabolized.
When naloxone therapy is given to the mother shortly before delivery, the duration of its effects lasts only for the first two hours of neonatal life. It is preferable to administer naloxone directly to the neonate if needed after delivery. Naloxone has no apparent benefit as an additional method of resuscitation in the newly born infant with intrauterine asphyxia, which is not related to opioid administration.
The safety and efficacy of naloxone in the treatment of hypotension in pediatric patients and neonates with septic shock have not been determined. A single study of two neonates in septic shock reported a positive pressor response; however, one patient subsequently died after intractable seizures.
Data not available