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The following adverse events have been associated with the use of NARCAN (naloxone) in postoperative patients: hypotension, hypertension, ventricular tachycardia and fibrillation, dyspnea, pulmonary edema, and cardiac arrest. Death, coma, and encephalopathy have been reported as sequelae of these events. Excessive doses of NARCAN (naloxone) in postoperative patients may result in significant reversal of analgesia and may cause agitation (see PRECAUTIONS and DOSAGE AND ADMINISTRATION; Usage in Adults-Postoperative Opioid Depression) Opioid Depression
Abrupt reversal of opioid depression may result in nausea, vomiting, sweating, tachycardia, increased blood pressure, tremulousness, seizures, ventricular tachycardia and fibrillation, pulmonary edema, and cardiac arrest which may result in death (see PRECAUTIONS).
Abrupt reversal of opioid effects in persons who are physically dependent on opioids may precipitate an acute withdrawal syndrome which may include, but is not limited to, the following signs and symptoms: 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, tachycardia. In the neonate, opioid withdrawal may also include: convulsions; excessive crying; hyperactive reflexes (see WARNINGS).
Adverse events associated with the postoperative use of NARCAN (naloxone) are listed by organ system and in decreasing order of frequency as follows:
Cardiac Disorders: pulmonary edema, cardiac arrest or failure, tachycardia, ventricular fibrillation, and ventricular tachycardia. Death, coma, and encephalopathy have been reported as sequelae of these events.
Gastrointestinal Disorders: vomiting, nausea
Psychiatric Disorders: agitation, hallucination, tremulousness
Respiratory Thoracic and Mediastinal Disorders: dyspnea, respiratory depression, hypoxia
Skin and Subcutaneous Tissue Disorders: nonspecific injection site reactions, sweating
Vascular Disorders: hypertension, hypotension, hot flushes or flushing.
Drug Abuse And Dependence
NARCAN (naloxone) is an opioid antagonist. Physical dependence associated with the use of NARCAN (naloxone) has not been reported. Tolerance to the opioid antagonist effect of NARCAN (naloxone) is not known to occur.
Read the Narcan (naloxone hydrochloride injection) Side Effects Center for a complete guide to possible side effects
Large doses of naloxone are required to antagonize buprenorphine since the latter has a long duration of action due to its slow rate of binding and subsequent slow dissociation from the opioid receptor. Buprenorphine antagonism is characterized by a gradual onset of the reversal effects and a decreased duration of action of the normally prolonged respiratory depression. The barbiturate methohexital appears to block the acute onset of withdrawal symptoms induced by naloxone in opiate addicts.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/20/2009
Additional Narcan Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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