"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
The following serious adverse reactions are discussed elsewhere in the labeling:
- Duration of effect [see WARNINGS AND PRECAUTIONS]
- Precipitation of Severe Opioid Withdrawal [see WARNINGS AND PRECAUTIONS]
The following adverse reactions have been identified during post-approval use of naloxone hydrochloride in the post-operative setting. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: 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 naloxone hydrochloride in post-operative patients have resulted in significant reversal of analgesia and have caused agitation [see WARNINGS AND PRECAUTIONS].
Abrupt reversal of opioid effects in persons who were physically dependent on opioids has precipitated an acute withdrawal syndrome. Signs and symptoms have included: 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 signs and symptoms also included: convulsions, excessive crying, hyperactive reflexes [see WARNINGS AND PRECAUTIONS].
Read the Evzio (naloxone hydrochloride auto-injector for injection) Side Effects Center for a complete guide to possible side effects
No information provided.
Last reviewed on RxList: 4/14/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Evzio Information
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