Evzio injection

Avoid leaving a person alone after giving him or her a naloxone injection. An overdose can impair a person's thinking or reactions.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

In someone who has been using an opioid regularly, withdrawal symptoms can happen suddenly after receiving this medication. Withdrawal symptoms may include body aches, fever, sweating, watering eyes, runny nose, sneezing, goose bumps, yawning, weakness, shivering/trembling, nervousness, restlessness, diarrhea, nausea/vomiting, stomach cramps, increased blood pressure, fast heartbeat. In babies younger than 4 weeks who have been receiving an opioid regularly, sudden opioid withdrawal may be life-threatening if not treated the right way. Symptoms in babies may include seizures, crying more than usual, and muscle twitching/spasms.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Initial dose: 0.4 mg to 2 mg IV; alternatively, may give IM or subcutaneously
-If desired response is not obtained, doses should be repeated at 2 to 3 minute intervals
-If no response is observed with a total dose of 10 mg, the diagnosis of opioid-induced or partial opioid-induced toxicity should be questioned

Auto-injector: For emergency use in the home or other non-medical setting
-Administer 0.4 mg (1 actuation) IM or subcutaneously into the anterolateral aspect of the thigh (through clothing if necessary)
-If desired response is not achieved, a second dose may be administered after 2 or 3 minutes; additional doses may be administered every 2 to 3 minutes until emergency medical assistance arrives

Nasal Spray:
-Administer 1 spray intranasally into 1 nostril
-If desired response is not achieved after 2 or 3 minutes, give a second dose intranasally into alternate nostril; additional doses may be administered every 2 to 3 minutes in alternating nostrils until emergency medical assistance arrives

Comments:
-IV route is recommended in emergency situations since it has the most rapid onset of action.
-The duration of action of some opioids exceed that of this drug, therefore, repeat doses may be needed; the need for repeat doses will depend on the amount, type, and route of administration of the opioid being antagonized.
-Patients should remain under continued surveillance; if a patients responds and relapses back into respiratory depression, additional doses should be given.
-Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance.

Use: For the emergency treatment of known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression.

Initial dose: 0.1 to 0.2 mg IV at 2 to 3 minute intervals to the desired degree of reversal
-Supplemental doses administered IM have been shown to produce a longer lasting effect

Intravenous Infusion:
-A concentration of 0.004 mg/mL may be administered by IV infusion; titrate in accordance with patient's response

Comments:
-For the partial reversal of opioid depression following the use of opioids during surgery, smaller doses of naloxone are usually sufficient; larger than necessary doses may result in significant reversal of analgesia and increases in blood pressure.

Use: For the complete or partial reversal of opioid depression including respiratory depression, induced by natural and synthetic opioids and certain mixed agonist-antagonist analgesics.

Neonates:
Initial dose: 0.01 mg/kg IV, IM or subcutaneously at 2 to 3 minute intervals to the desired degree of reversal

Children: 0.005 mg to 0.01 mg IV at 2 to 3 minute intervals to the desired degree of reversal

Intravenous Infusion:
-A concentration of 0.004 mg/mL may be administered by IV infusion; titrate in accordance with patient's response

Comments:
-For the partial reversal of opioid depression following the use of opioids during surgery, smaller doses of naloxone are usually sufficient; larger than necessary doses may result in significant reversal of analgesia and increases in blood pressure.

Use: For the complete or partial reversal of opioid depression including respiratory depression, induced by natural and synthetic opioids and certain mixed agonist-antagonist analgesics.

Consult WARNINGS section for additional precautions.

Data not available

Administration during organogenesis to mice and rats at subcutaneous dose up to 6 and 12 times, respectively, the expected human exposure showed no evidence of embryotoxicity or teratogenicity. This drug does cross the placenta and therefore may precipitate withdrawal in the fetus. There are no adequate and well controlled studies in pregnant women. AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

Use is recommended only if clearly needed and benefit outweighs risk. AU TGA pregnancy category: B1 US FDA pregnancy category (IV/IM/subcutaneously): B/C US FDA pregnancy category (nasal): Not assigned Comments: -This drug can cause withdrawal symptoms in fetus as well as mother; both mother and fetus should be monitored for signs of distress until stable. -During labor, blood pressure should be monitored closely in mothers with moderate hypertension as severe hypertension may occur.

Substance Name

Naloxone

CAS Registry Number

465-65-6

Drug Class

Narcotic Antagonists