INDICATION
EVZIO is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression in adults and pediatric patients. EVZIO is intended for immediate administration as emergency therapy in settings where opioids may be present. EVZIO is not a substitute for emergency medical care.
IMPORTANT SAFETY INFORMATION
EVZIO is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the ingredients in EVZIO.
Seek emergency medical assistance immediately after use. Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance.
The following warnings and precautions should be taken when administering EVZIO:
- Risk of Recurrent Respiratory and CNS Depression: Due to the duration of action of naloxone relative to the opioid, keep the patient under continued surveillance and administer repeated doses of naloxone using a new EVZIO, as necessary, while awaiting emergency medical assistance.
- Risk of Limited Efficacy With Partial Agonists or Mixed Agonists/ Antagonists: Reversal of respiratory depression caused by partial agonists or mixed agonists/ antagonists, such as buprenorphine and pentazocine, may be incomplete. Larger or repeat doses may be required.
- Precipitation of Severe Opioid Withdrawal: Use in patients who are opioid dependent may precipitate opioid withdrawal. In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated. Monitor for the development of opioid withdrawal.
- Risk of Cardiovascular (CV) Effects: Abrupt postoperative reversal of opioid depression may result in adverse CV effects. These events have primarily occurred in patients who had pre-existing CV disorders or received other drugs that may have similar CV effects. Monitor these patients closely in an appropriate healthcare setting after use of naloxone hydrochloride.
The following adverse reactions were most commonly observed in EVZIO clinical studies: dizziness and injection site erythema.
Abrupt reversal of opioid effects in persons who were physically dependent on opioids has precipitated signs and symptoms of opioid withdrawal including: body aches, fever, sweating, runny nose, sneezing, piloerection, yawning, weakness, shivering or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, abdominal cramps, increased blood pressure, and tachycardia. In the neonate, opioid withdrawal signs and symptoms also included: convulsions, excessive crying, and hyperactive reflexes.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
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