Naloxonedosage

Naloxone HCl Nasal Spray is for intranasal use only.

Seek emergency medical care immediately after use.

Administration of a single spray of Naloxone HCl Nasal Spray intranasally into one nostril.

Administer additional doses of Naloxone HCl Nasal Spray, using a new nasal spray with each dose, if the patient does not respond or responds and then relapses into respiratory depression, additional doses of Naloxone HCl Nasal Spray may be given every 2 to 3 minutes until emergency medical assistance arrives.

Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance.

2.1 Important

Administration Instructions Naloxone HCl Nasal Spray is for intranasal use only. No additional device assembly is required. Because treatment of 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 Naloxone HCl Nasal Spray and the Instructions for Use. Instruct the patient or caregiver to read the Instructions for Use at the time they receive a prescription for Naloxone HCl Nasal Spray. Emphasize the following instructions to the patient or caregiver:

Administer Naloxone HCl Nasal Spray as quickly as possible because prolonged respiratory depression may result in damage to the central nervous system or death. Since 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 Naloxone HCl Nasal Spray, 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 Naloxone HCl Nasal Spray.

Additional doses of Naloxone HCl Nasal Spray may be required until emergency medical assistance becomes available.

Do not attempt to reuse Naloxone HCl Nasal Spray. Each Naloxone HCl Nasal Spray contains a single dose of naloxone and cannot be reused.

Re-administer Naloxone HCl Nasal Spray, using a new nasal spray, every 2 to 3 minutes if the patient does not respond or responds and then relapses into respiratory depression.

Administer Naloxone HCl Nasal Spray in alternate nostrils with each dose.

Administer Naloxone HCl Nasal Spray according to the printed instructions on the device label and the Instructions for Use.

Place the patient in the supine position. Prior to administration, be sure the device nozzle is inserted in either nostril of the patient, and provide support to the back of the neck to allow the head to tilt back. Do not prime or test the device prior to administration.

To administer the dose, press firmly on the device plunger.

Remove the device nozzle from the nostril after use.

Turn patient on their side as shown in the Instructions for Use and call for emergency medical assistance immediately after administration of the first dose of Naloxone HCl Nasal Spray.

2.2 Dosing in

Adults and Pediatric Patients Initial Dosing The recommended initial dose of Naloxone HCl Nasal Spray in adults and pediatric patients is one spray delivered by intranasal administration into one nostril. Repeat Dosing Seek emergency medical assistance as soon as possible after administering the first dose of Naloxone HCl Nasal Spray. The requirement for repeat doses of Naloxone HCl Nasal Spray depends upon the amount, type, and route of administration of the opioid being antagonized. Administer Naloxone HCl Nasal Spray in alternate nostrils with each dose. If the patient responds to Naloxone HCl Nasal Spray and relapses back into respiratory depression before emergency assistance arrives, administer an additional dose of Naloxone HCl Nasal Spray using a new Naloxone HCl Nasal Spray and continue surveillance of the patient. If the desired response is not obtained after 2 or 3 minutes, administer an additional dose of Naloxone HCl Nasal Spray using a new Naloxone HCl Nasal Spray. If there is still no response and additional doses are available, administer additional doses of Naloxone HCl Nasal Spray every 2 to 3 minutes using a new Naloxone HCl Nasal Spray with each dose until emergency medical assistance arrives. Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance.

2.3 Dosing Modifications due to

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 and require higher doses of naloxone hydrochloride or repeated administration of Naloxone HCl Nasal Spray using a new nasal spray.