ZIMHI
Generic: NALOXONE HYDROCHLORIDE
Basic Information
Manufacturer
ZMI Pharma Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAMUSCULAR
FDA Set ID
523c0909-bff6-4010-988a-53de18b7cb3f
Indications & Usage
1.
INDICATIONS AND USAGE ZIMHI is indicated in adults and pediatric patients for: the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.
ZIMHI is intended for immediate administration as emergency therapy in settings where opioids may be present.
ZIMHI is not a substitute for emergency medical care.
ZIMHI 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.
( 1 ) ZIMHI is intended for immediate administration as emergency therapy in settings where opioids may be present.
( 1 ) ZIMHI is not a substitute for emergency medical care.
( 1 )
INDICATIONS AND USAGE ZIMHI is indicated in adults and pediatric patients for: the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.
ZIMHI is intended for immediate administration as emergency therapy in settings where opioids may be present.
ZIMHI is not a substitute for emergency medical care.
ZIMHI 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.
( 1 ) ZIMHI is intended for immediate administration as emergency therapy in settings where opioids may be present.
( 1 ) ZIMHI is not a substitute for emergency medical care.
( 1 )
Adverse Reactions
6.
ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: Precipitation of Severe Opioid Withdrawal [ see Warnings and Precautions ( 5.3 )] Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to the rates in the clinical studies of another drug and may not reflect the rates observed in practice.
The following adverse reactions were observed in ZIMHI clinical studies in healthy volunteers without opioid dependence: nausea, dizziness, lightheadedness, and elevated bilirubin.
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 ( 5.3 ) ].
Other events that have been reported in post-marketing use of naloxone hydrochloride include agitation, disorientation, confusion, and anger.
Abrupt reversal of opioid effects in persons who were opioid dependent resulted in opioid withdrawal characterized by rapid onset of severe body aches, vomiting, diarrhea, tachycardia, fever, runny nose, sneezing, piloerection, sweating, yawning, nausea, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure.
In some patients, aggressive behavior has occurred in the context of abrupt reversal of an opioid overdose.
In the neonate, opioid withdrawal signs and symptoms also included: convulsions, excessive crying, and hyperactive reflexes [ see Warnings and Precautions ( 5.3 ) ].
The following adverse reactions were most commonly observed in ZIMHI clinical studies: dizziness and injection site erythema.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact ZMI Pharma Corporation at 1-800-230-3935 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: Precipitation of Severe Opioid Withdrawal [ see Warnings and Precautions ( 5.3 )] Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to the rates in the clinical studies of another drug and may not reflect the rates observed in practice.
The following adverse reactions were observed in ZIMHI clinical studies in healthy volunteers without opioid dependence: nausea, dizziness, lightheadedness, and elevated bilirubin.
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 ( 5.3 ) ].
Other events that have been reported in post-marketing use of naloxone hydrochloride include agitation, disorientation, confusion, and anger.
Abrupt reversal of opioid effects in persons who were opioid dependent resulted in opioid withdrawal characterized by rapid onset of severe body aches, vomiting, diarrhea, tachycardia, fever, runny nose, sneezing, piloerection, sweating, yawning, nausea, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure.
In some patients, aggressive behavior has occurred in the context of abrupt reversal of an opioid overdose.
In the neonate, opioid withdrawal signs and symptoms also included: convulsions, excessive crying, and hyperactive reflexes [ see Warnings and Precautions ( 5.3 ) ].
The following adverse reactions were most commonly observed in ZIMHI clinical studies: dizziness and injection site erythema.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact ZMI Pharma Corporation at 1-800-230-3935 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.