Zimhi

(Naloxone Hydrochloride)

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Zimhi Prescribing Information

ZIMHI is for intramuscular or subcutaneous use only. (
2.1
Important Administration Instructions
ZIMHI is for intramuscular and subcutaneous use only.
Because treatment of known or suspected opioid overdose must be performed by someone other than the patient, instruct the prescription recipient to inform those around them about the presence of ZIMHI and the Instructions for Use.
ZIMHI is intended to be administered by individuals 12 years of age or older.
Younger individuals or those with limited hand strength may find the device difficult to use.
ZIMHI is light sensitive. Store ZIMHI in the outer case provided to protect it from light.
Prior to a medical emergency (during storage), periodically visually inspect ZIMHI through the viewing window on the device. If the solution is discolored yellow or brown color, cloudy, or contains particles, replace ZIMHI with a new one [
see How Supplied/Storage and Handling (
16.2
)
].
Do not attempt to reuse ZIMHI. Each ZIMHI contains a single-dose of naloxone hydrochloride for single-dose injection.
Instruct the patient or caregiver to read the Instructions for Use at the time they receive a prescription for ZIMHI^®. Emphasize the following instructions to the patient or caregiver:
- Seek emergency medical care immediately after use
  . Because the duration of action of most opioids exceeds that of naloxone hydrochloride and the suspected opioid overdose may occur outside of supervised medical settings, seek immediate emergency medical assistance, keep the patient under continued surveillance until emergency personnel arrive, and administer repeated doses of ZIMHI as necessary. Always seek emergency medical assistance in the event of a suspected potentially life-threatening opioid emergency after administration of the first dose of ZIMHI.
- Additional doses of ZIMHI may be required until emergency medical assistance becomes available [
  see Dosage and Administration (
  2.2
  )
  ].
- Administer ZIMHI according to the Instructions for Use and the printed instructions on the device label:
  
  - Place the patient in the supine position.
  
  - Inject ZIMHI intramuscularly or subcutaneously into the anterolateral aspect of the thigh with the needle facing downwards. Inject through clothing if necessary [
  see
  Instructions for Use
  ].
  
  - Embed the needle completely before transferring the thumb to the syringe plunger.
- Immediately after injection, using one hand with fingers behind the needle, slide the safety guard over the needle. Do not use two hands to activate the safety guard.
-
Never put thumb, fingers
,
or hand over the exposed needle. Failure to follow these instructions may result in a needlestick injury
. If an accidental needlestick occurs, get medical help immediately [
see Warnings and Precautions (
5.4
)
].

- Do NOT attempt to re-cap the needle with the needle cap once it has been removed [
see Warnings and Precautions (
5.4
)]
.

- Place the patient in the lateral recumbent position (recovery position).

- ZIMHI must be used and/or properly disposed of as described below once the protective cap covering the needle is removed.

- Put the used syringe into the blue case, close the case, and give your used ZIMHI syringe to the healthcare provider for inspection and proper disposal.

- Tell the healthcare provider that you have received or administered an injection of naloxone HCl. Show the healthcare provider where the injection was administered.
Do not attempt to reuse ZIMHI. Each ZIMHI contains a single-dose of naloxone hydrochloride for single-dose injection.
Embed the needle completely before transferring the thumb to the syringe plunger.
Immediately after injection, using one hand with fingers behind the needle, slide the safety guard over the needle. Do not use two hands to activate the safety guard.
)
Seek emergency medical care immediately after use. (
2.1
Important Administration Instructions
ZIMHI is for intramuscular and subcutaneous use only.
Because treatment of known or suspected opioid overdose must be performed by someone other than the patient, instruct the prescription recipient to inform those around them about the presence of ZIMHI and the Instructions for Use.
ZIMHI is intended to be administered by individuals 12 years of age or older.
Younger individuals or those with limited hand strength may find the device difficult to use.
ZIMHI is light sensitive. Store ZIMHI in the outer case provided to protect it from light.
Prior to a medical emergency (during storage), periodically visually inspect ZIMHI through the viewing window on the device. If the solution is discolored yellow or brown color, cloudy, or contains particles, replace ZIMHI with a new one [
see How Supplied/Storage and Handling (
16.2
)
].
Do not attempt to reuse ZIMHI. Each ZIMHI contains a single-dose of naloxone hydrochloride for single-dose injection.
Instruct the patient or caregiver to read the Instructions for Use at the time they receive a prescription for ZIMHI^®. Emphasize the following instructions to the patient or caregiver:
- Seek emergency medical care immediately after use
  . Because the duration of action of most opioids exceeds that of naloxone hydrochloride and the suspected opioid overdose may occur outside of supervised medical settings, seek immediate emergency medical assistance, keep the patient under continued surveillance until emergency personnel arrive, and administer repeated doses of ZIMHI as necessary. Always seek emergency medical assistance in the event of a suspected potentially life-threatening opioid emergency after administration of the first dose of ZIMHI.
- Additional doses of ZIMHI may be required until emergency medical assistance becomes available [
  see Dosage and Administration (
  2.2
  )
  ].
- Administer ZIMHI according to the Instructions for Use and the printed instructions on the device label:
  
  - Place the patient in the supine position.
  
  - Inject ZIMHI intramuscularly or subcutaneously into the anterolateral aspect of the thigh with the needle facing downwards. Inject through clothing if necessary [
  see
  Instructions for Use
  ].
  
  - Embed the needle completely before transferring the thumb to the syringe plunger.
- Immediately after injection, using one hand with fingers behind the needle, slide the safety guard over the needle. Do not use two hands to activate the safety guard.
-
Never put thumb, fingers
,
or hand over the exposed needle. Failure to follow these instructions may result in a needlestick injury
. If an accidental needlestick occurs, get medical help immediately [
see Warnings and Precautions (
5.4
)
].

- Do NOT attempt to re-cap the needle with the needle cap once it has been removed [
see Warnings and Precautions (
5.4
)]
.

- Place the patient in the lateral recumbent position (recovery position).

- ZIMHI must be used and/or properly disposed of as described below once the protective cap covering the needle is removed.

- Put the used syringe into the blue case, close the case, and give your used ZIMHI syringe to the healthcare provider for inspection and proper disposal.

- Tell the healthcare provider that you have received or administered an injection of naloxone HCl. Show the healthcare provider where the injection was administered.
Do not attempt to reuse ZIMHI. Each ZIMHI contains a single-dose of naloxone hydrochloride for single-dose injection.
Embed the needle completely before transferring the thumb to the syringe plunger.
Immediately after injection, using one hand with fingers behind the needle, slide the safety guard over the needle. Do not use two hands to activate the safety guard.
)
ZIMHI is intended to be administered by individuals 12 years of age or older. (
2.1
Important Administration Instructions
ZIMHI is for intramuscular and subcutaneous use only.
Because treatment of known or suspected opioid overdose must be performed by someone other than the patient, instruct the prescription recipient to inform those around them about the presence of ZIMHI and the Instructions for Use.
ZIMHI is intended to be administered by individuals 12 years of age or older.
Younger individuals or those with limited hand strength may find the device difficult to use.
ZIMHI is light sensitive. Store ZIMHI in the outer case provided to protect it from light.
Prior to a medical emergency (during storage), periodically visually inspect ZIMHI through the viewing window on the device. If the solution is discolored yellow or brown color, cloudy, or contains particles, replace ZIMHI with a new one [
see How Supplied/Storage and Handling (
16.2
)
].
Do not attempt to reuse ZIMHI. Each ZIMHI contains a single-dose of naloxone hydrochloride for single-dose injection.
Instruct the patient or caregiver to read the Instructions for Use at the time they receive a prescription for ZIMHI^®. Emphasize the following instructions to the patient or caregiver:
- Seek emergency medical care immediately after use
  . Because the duration of action of most opioids exceeds that of naloxone hydrochloride and the suspected opioid overdose may occur outside of supervised medical settings, seek immediate emergency medical assistance, keep the patient under continued surveillance until emergency personnel arrive, and administer repeated doses of ZIMHI as necessary. Always seek emergency medical assistance in the event of a suspected potentially life-threatening opioid emergency after administration of the first dose of ZIMHI.
- Additional doses of ZIMHI may be required until emergency medical assistance becomes available [
  see Dosage and Administration (
  2.2
  )
  ].
- Administer ZIMHI according to the Instructions for Use and the printed instructions on the device label:
  
  - Place the patient in the supine position.
  
  - Inject ZIMHI intramuscularly or subcutaneously into the anterolateral aspect of the thigh with the needle facing downwards. Inject through clothing if necessary [
  see
  Instructions for Use
  ].
  
  - Embed the needle completely before transferring the thumb to the syringe plunger.
- Immediately after injection, using one hand with fingers behind the needle, slide the safety guard over the needle. Do not use two hands to activate the safety guard.
-
Never put thumb, fingers
,
or hand over the exposed needle. Failure to follow these instructions may result in a needlestick injury
. If an accidental needlestick occurs, get medical help immediately [
see Warnings and Precautions (
5.4
)
].

- Do NOT attempt to re-cap the needle with the needle cap once it has been removed [
see Warnings and Precautions (
5.4
)]
.

- Place the patient in the lateral recumbent position (recovery position).

- ZIMHI must be used and/or properly disposed of as described below once the protective cap covering the needle is removed.

- Put the used syringe into the blue case, close the case, and give your used ZIMHI syringe to the healthcare provider for inspection and proper disposal.

- Tell the healthcare provider that you have received or administered an injection of naloxone HCl. Show the healthcare provider where the injection was administered.
Do not attempt to reuse ZIMHI. Each ZIMHI contains a single-dose of naloxone hydrochloride for single-dose injection.
Embed the needle completely before transferring the thumb to the syringe plunger.
Immediately after injection, using one hand with fingers behind the needle, slide the safety guard over the needle. Do not use two hands to activate the safety guard.
)
Administer ZIMHI to adult or pediatric patients into the anterolateral aspect of the thigh, through clothing if necessary. (

2.2
Dosing Information
Initial Dosing
Administer the initial dose of ZIMHI^®to adult or pediatric patients intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary, and seek emergency medical assistance. Administer ZIMHI^®as quickly as possible because prolonged respiratory depression may result in damage to the central nervous system or death.
Repeat Dosing
The requirement for repeat doses of ZIMHI depends upon the amount, type, and route of administration of the opioid being antagonized.
If the desired response is not obtained after 2 or 3 minutes, an additional dose of ZIMHI may be administered. If there is still no response and additional doses are available, additional doses of ZIMHI may be administered every 2 to 3 minutes until emergency medical assistance arrives.
Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance.
If the patient responds to ZIMHI and relapses back into respiratory depression before emergency assistance arrives, administer an additional dose of ZIMHI and continue surveillance of the patient after administering an additional dose.
Reversal of respiratory depression by partial agonists or mixed agonist/antagonists, such as buprenorphine and pentazocine, may be incomplete and may require higher doses of naloxone hydrochloride or repeated administration of ZIMHI.
Dosing in Adults and Pediatric Patients
Instruct patients or their caregivers to administer ZIMHI according to the Instructions for Use, intramuscularly or subcutaneously.
Dosing in Pediatric Patients under Age One Year
In pediatric patients under the age of one year, the caregiver should pinch the thigh muscle while administering ZIMHI. Carefully observe the administration site for signs of infection following resolution of the opioid emergency.
)
See the Full Prescribing Information and Instructions for Use for important information on how to safely administer ZIMHI. (
2.1
Important Administration Instructions
ZIMHI is for intramuscular and subcutaneous use only.
Because treatment of known or suspected opioid overdose must be performed by someone other than the patient, instruct the prescription recipient to inform those around them about the presence of ZIMHI and the Instructions for Use.
ZIMHI is intended to be administered by individuals 12 years of age or older.
Younger individuals or those with limited hand strength may find the device difficult to use.
ZIMHI is light sensitive. Store ZIMHI in the outer case provided to protect it from light.
Prior to a medical emergency (during storage), periodically visually inspect ZIMHI through the viewing window on the device. If the solution is discolored yellow or brown color, cloudy, or contains particles, replace ZIMHI with a new one [
see How Supplied/Storage and Handling (
16.2
)
].
Do not attempt to reuse ZIMHI. Each ZIMHI contains a single-dose of naloxone hydrochloride for single-dose injection.
Instruct the patient or caregiver to read the Instructions for Use at the time they receive a prescription for ZIMHI^®. Emphasize the following instructions to the patient or caregiver:
- Seek emergency medical care immediately after use
  . Because the duration of action of most opioids exceeds that of naloxone hydrochloride and the suspected opioid overdose may occur outside of supervised medical settings, seek immediate emergency medical assistance, keep the patient under continued surveillance until emergency personnel arrive, and administer repeated doses of ZIMHI as necessary. Always seek emergency medical assistance in the event of a suspected potentially life-threatening opioid emergency after administration of the first dose of ZIMHI.
- Additional doses of ZIMHI may be required until emergency medical assistance becomes available [
  see Dosage and Administration (
  2.2
  )
  ].
- Administer ZIMHI according to the Instructions for Use and the printed instructions on the device label:
  
  - Place the patient in the supine position.
  
  - Inject ZIMHI intramuscularly or subcutaneously into the anterolateral aspect of the thigh with the needle facing downwards. Inject through clothing if necessary [
  see
  Instructions for Use
  ].
  
  - Embed the needle completely before transferring the thumb to the syringe plunger.
- Immediately after injection, using one hand with fingers behind the needle, slide the safety guard over the needle. Do not use two hands to activate the safety guard.
-
Never put thumb, fingers
,
or hand over the exposed needle. Failure to follow these instructions may result in a needlestick injury
. If an accidental needlestick occurs, get medical help immediately [
see Warnings and Precautions (
5.4
)
].

- Do NOT attempt to re-cap the needle with the needle cap once it has been removed [
see Warnings and Precautions (
5.4
)]
.

- Place the patient in the lateral recumbent position (recovery position).

- ZIMHI must be used and/or properly disposed of as described below once the protective cap covering the needle is removed.

- Put the used syringe into the blue case, close the case, and give your used ZIMHI syringe to the healthcare provider for inspection and proper disposal.

- Tell the healthcare provider that you have received or administered an injection of naloxone HCl. Show the healthcare provider where the injection was administered.
Do not attempt to reuse ZIMHI. Each ZIMHI contains a single-dose of naloxone hydrochloride for single-dose injection.
Embed the needle completely before transferring the thumb to the syringe plunger.
Immediately after injection, using one hand with fingers behind the needle, slide the safety guard over the needle. Do not use two hands to activate the safety guard.
)
Keep the patient under continued surveillance until emergency personnel arrive and administer repeated doses of ZIMHI as necessary. (
2.1
Important Administration Instructions
ZIMHI is for intramuscular and subcutaneous use only.
Because treatment of known or suspected opioid overdose must be performed by someone other than the patient, instruct the prescription recipient to inform those around them about the presence of ZIMHI and the Instructions for Use.
ZIMHI is intended to be administered by individuals 12 years of age or older.
Younger individuals or those with limited hand strength may find the device difficult to use.
ZIMHI is light sensitive. Store ZIMHI in the outer case provided to protect it from light.
Prior to a medical emergency (during storage), periodically visually inspect ZIMHI through the viewing window on the device. If the solution is discolored yellow or brown color, cloudy, or contains particles, replace ZIMHI with a new one [
see How Supplied/Storage and Handling (
16.2
)
].
Do not attempt to reuse ZIMHI. Each ZIMHI contains a single-dose of naloxone hydrochloride for single-dose injection.
Instruct the patient or caregiver to read the Instructions for Use at the time they receive a prescription for ZIMHI^®. Emphasize the following instructions to the patient or caregiver:
- Seek emergency medical care immediately after use
  . Because the duration of action of most opioids exceeds that of naloxone hydrochloride and the suspected opioid overdose may occur outside of supervised medical settings, seek immediate emergency medical assistance, keep the patient under continued surveillance until emergency personnel arrive, and administer repeated doses of ZIMHI as necessary. Always seek emergency medical assistance in the event of a suspected potentially life-threatening opioid emergency after administration of the first dose of ZIMHI.
- Additional doses of ZIMHI may be required until emergency medical assistance becomes available [
  see Dosage and Administration (
  2.2
  )
  ].
- Administer ZIMHI according to the Instructions for Use and the printed instructions on the device label:
  
  - Place the patient in the supine position.
  
  - Inject ZIMHI intramuscularly or subcutaneously into the anterolateral aspect of the thigh with the needle facing downwards. Inject through clothing if necessary [
  see
  Instructions for Use
  ].
  
  - Embed the needle completely before transferring the thumb to the syringe plunger.
- Immediately after injection, using one hand with fingers behind the needle, slide the safety guard over the needle. Do not use two hands to activate the safety guard.
-
Never put thumb, fingers
,
or hand over the exposed needle. Failure to follow these instructions may result in a needlestick injury
. If an accidental needlestick occurs, get medical help immediately [
see Warnings and Precautions (
5.4
)
].

- Do NOT attempt to re-cap the needle with the needle cap once it has been removed [
see Warnings and Precautions (
5.4
)]
.

- Place the patient in the lateral recumbent position (recovery position).

- ZIMHI must be used and/or properly disposed of as described below once the protective cap covering the needle is removed.

- Put the used syringe into the blue case, close the case, and give your used ZIMHI syringe to the healthcare provider for inspection and proper disposal.

- Tell the healthcare provider that you have received or administered an injection of naloxone HCl. Show the healthcare provider where the injection was administered.
Do not attempt to reuse ZIMHI. Each ZIMHI contains a single-dose of naloxone hydrochloride for single-dose injection.
Embed the needle completely before transferring the thumb to the syringe plunger.
Immediately after injection, using one hand with fingers behind the needle, slide the safety guard over the needle. Do not use two hands to activate the safety guard.
)
Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance. (

2.2
Dosing Information
Initial Dosing
Administer the initial dose of ZIMHI^®to adult or pediatric patients intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary, and seek emergency medical assistance. Administer ZIMHI^®as quickly as possible because prolonged respiratory depression may result in damage to the central nervous system or death.
Repeat Dosing
The requirement for repeat doses of ZIMHI depends upon the amount, type, and route of administration of the opioid being antagonized.
If the desired response is not obtained after 2 or 3 minutes, an additional dose of ZIMHI may be administered. If there is still no response and additional doses are available, additional doses of ZIMHI may be administered every 2 to 3 minutes until emergency medical assistance arrives.
Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance.
If the patient responds to ZIMHI and relapses back into respiratory depression before emergency assistance arrives, administer an additional dose of ZIMHI and continue surveillance of the patient after administering an additional dose.
Reversal of respiratory depression by partial agonists or mixed agonist/antagonists, such as buprenorphine and pentazocine, may be incomplete and may require higher doses of naloxone hydrochloride or repeated administration of ZIMHI.
Dosing in Adults and Pediatric Patients
Instruct patients or their caregivers to administer ZIMHI according to the Instructions for Use, intramuscularly or subcutaneously.
Dosing in Pediatric Patients under Age One Year
In pediatric patients under the age of one year, the caregiver should pinch the thigh muscle while administering ZIMHI. Carefully observe the administration site for signs of infection following resolution of the opioid emergency.
)
In pediatric patients under the age of one, the caregiver should pinch the thigh muscle while administering the dose. (

2.2
Dosing Information
Initial Dosing
Administer the initial dose of ZIMHI^®to adult or pediatric patients intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary, and seek emergency medical assistance. Administer ZIMHI^®as quickly as possible because prolonged respiratory depression may result in damage to the central nervous system or death.
Repeat Dosing
The requirement for repeat doses of ZIMHI depends upon the amount, type, and route of administration of the opioid being antagonized.
If the desired response is not obtained after 2 or 3 minutes, an additional dose of ZIMHI may be administered. If there is still no response and additional doses are available, additional doses of ZIMHI may be administered every 2 to 3 minutes until emergency medical assistance arrives.
Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance.
If the patient responds to ZIMHI and relapses back into respiratory depression before emergency assistance arrives, administer an additional dose of ZIMHI and continue surveillance of the patient after administering an additional dose.
Reversal of respiratory depression by partial agonists or mixed agonist/antagonists, such as buprenorphine and pentazocine, may be incomplete and may require higher doses of naloxone hydrochloride or repeated administration of ZIMHI.
Dosing in Adults and Pediatric Patients
Instruct patients or their caregivers to administer ZIMHI according to the Instructions for Use, intramuscularly or subcutaneously.
Dosing in Pediatric Patients under Age One Year
In pediatric patients under the age of one year, the caregiver should pinch the thigh muscle while administering ZIMHI. Carefully observe the administration site for signs of infection following resolution of the opioid emergency.
)

Risk Summary

Life-sustaining therapy for opioid overdose should not be withheld (

see

Clinical Considerations

)

Available data from retrospective cohort studies on naloxone use in pregnant women have not identified a drug-associated risk of major birth defects or miscarriage. In animal reproduction studies, no embryotoxic or teratogenic effects were observed in mice and rats treated with naloxone hydrochloride during the period of organogenesis at doses equivalent to 4-times and 8-times, respectively, a human dose of 10 mg/day.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations

Disease-associated maternal and/or embryo/fetal risk

An opioid overdose is a medical emergency and can be fatal for the pregnant woman and fetus if left untreated. Treatment with ZIMHI for opioid overdose should not be withheld because of potential concerns regarding the effects of ZIMHI on the fetus.

Data

Animal Data

Naloxone hydrochloride was administered during organogenesis to mice and rats at doses 4-times and 8-times, respectively, the dose of 10 mg/day given to a 50 kg human (when based on body surface area or mg/m
²). These studies demonstrated no embryotoxic or teratogenic effects due to naloxone hydrochloride.

Risk of Recurrent Respiratory and CNS Depression
: Due to the duration of action of naloxone relative to the opioid, respiratory and CNS depression may recur after the first dose of naloxone. Seek emergency medical assistance immediately after the first dose, keep the patient under continued surveillance, and administer repeated doses of naloxone using a new ZIMHI, as necessary, while awaiting emergency medical assistance. (

5.1
Risk of Recurrent Respiratory and Central Nervous System Depression
The duration of action of most opioids may exceed that of ZIMHI resulting in a return of respiratory and/or central nervous system depression after an initial improvement in symptoms. Therefore, it is necessary to seek emergency medical assistance immediately after delivering the first dose of ZIMHI. Keep the patient under continued surveillance and administer additional doses of ZIMHI if the patient is not adequately responding or responds and then relapses back into respiratory depression, as necessary [
see Dosage and Administration (
2.2
)
]. Additional supportive and/or resuscitative measures may be helpful 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. (

5.2
Risk of Limited Efficacy with Partial Agonists or Mixed Agonist/Antagonists
Reversal of respiratory depression by partial agonists or mixed agonist/antagonists such as buprenorphine and pentazocine, may be incomplete. Larger or repeat doses of naloxone hydrochloride may be required to antagonize buprenorphine because the latter has a long duration of action due to its slow rate of binding and subsequent slow dissociation from the opioid receptor [
see Dosage and Administration (
2
)
]. Buprenorphine antagonism is characterized by a gradual onset of the reversal effects and a decreased duration of action of the normally prolonged respiratory depression.
)
Precipitation of Severe Opioid Withdrawal
: Use in patients who are opioid dependent results in rapid onset of opioid withdrawal. In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated. Monitor for the development of opioid withdrawal. (

5.3
Precipitation of Severe Opioid Withdrawal
The use of ZIMHI in patients who are opioid dependent results 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 neonates, opioid withdrawal may be life-threatening if not recognized and properly treated and may include the following signs and symptoms: convulsions, excessive crying, and hyperactive reflexes. Monitor patients for the development of the signs and symptoms of opioid withdrawal.
Abrupt postoperative reversal of opioid depression after using naloxone hydrochloride may result in nausea, vomiting, sweating, tremulousness, tachycardia, hypotension, hypertension, seizures, ventricular tachycardia and fibrillation, pulmonary edema, and cardiac arrest. Death, coma, and encephalopathy have been reported as sequelae of these events. These events have primarily occurred in patients who had pre-existing cardiovascular disorders or received other drugs that may have similar adverse cardiovascular effects. Although a direct cause and effect relationship has not been established, after use of naloxone hydrochloride, monitor patients with pre-existing cardiac disease or patients who have received medications with potential adverse cardiovascular effects for hypotension, ventricular tachycardia or fibrillation, and pulmonary edema in an appropriate healthcare setting. It has been suggested that the pathogenesis of pulmonary edema associated with the use of naloxone hydrochloride is similar to neurogenic pulmonary edema, i.e., a centrally mediated massive catecholamine response leading to a dramatic shift of blood volume into the pulmonary vascular bed resulting in increased hydrostatic pressures.
There may be clinical settings, particularly the postpartum period in neonates with known or suspected exposure to maternal opioid use, where it is preferable to avoid the abrupt precipitation of opioid withdrawal symptoms. In these settings, consider use of an alternative naloxone product which can be titrated to effect and, where applicable, dosed according to weight [
see Use in Specific Populations (
8.4
)
].
)
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. (

5.3
Precipitation of Severe Opioid Withdrawal
The use of ZIMHI in patients who are opioid dependent results 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 neonates, opioid withdrawal may be life-threatening if not recognized and properly treated and may include the following signs and symptoms: convulsions, excessive crying, and hyperactive reflexes. Monitor patients for the development of the signs and symptoms of opioid withdrawal.
Abrupt postoperative reversal of opioid depression after using naloxone hydrochloride may result in nausea, vomiting, sweating, tremulousness, tachycardia, hypotension, hypertension, seizures, ventricular tachycardia and fibrillation, pulmonary edema, and cardiac arrest. Death, coma, and encephalopathy have been reported as sequelae of these events. These events have primarily occurred in patients who had pre-existing cardiovascular disorders or received other drugs that may have similar adverse cardiovascular effects. Although a direct cause and effect relationship has not been established, after use of naloxone hydrochloride, monitor patients with pre-existing cardiac disease or patients who have received medications with potential adverse cardiovascular effects for hypotension, ventricular tachycardia or fibrillation, and pulmonary edema in an appropriate healthcare setting. It has been suggested that the pathogenesis of pulmonary edema associated with the use of naloxone hydrochloride is similar to neurogenic pulmonary edema, i.e., a centrally mediated massive catecholamine response leading to a dramatic shift of blood volume into the pulmonary vascular bed resulting in increased hydrostatic pressures.
There may be clinical settings, particularly the postpartum period in neonates with known or suspected exposure to maternal opioid use, where it is preferable to avoid the abrupt precipitation of opioid withdrawal symptoms. In these settings, consider use of an alternative naloxone product which can be titrated to effect and, where applicable, dosed according to weight [
see Use in Specific Populations (
8.4
)
].
)
Risk of Accidental Needlestick Injury
: After use, the ZIMHI needle is exposed until the safety guard is deployed. Stress to patients the importance of familiarizing themselves with the device and its operation prior to experiencing an emergency situation, and to immediately seek medical attention should a needlestick occur. (

5.4
Risk of
A
ccidental
N
eedlestick
I
njury
After use, the ZIMHI needle is exposed until the safety guard is deployed. A needlestick injury could occur during use in emergency situations. In the event that an accidental needlestick occurs, medical attention should be sought. Potential exposure to blood borne pathogens including HIV, HBV, and HCV requires immediate evaluation by a medical professional. Stress to patients the importance of familiarizing themselves with the device and its operation prior to experiencing an emergency situation, so they are familiar with the safety guard and its deployment.
)

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