Naloxonedosage

KLOXXADO is for intranasal use only.

Seek emergency medical care immediately after use.

All approved naloxone hydrochloride products achieve plasma concen- trations effective at reversing the effects of opioid overdose. Comparing products on a nominal mg-for-mg basis may be misleading.

Administer a single spray of KLOXXADO to adult or pediatric patients intranasally into one nostril.

Administer additional doses of KLOXXADO, 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 KLOXXADO 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

Dosage and Administration Instructions

KLOXXADO is for intranasal use only.

One spray delivers the entire contents of the drug product.

All approved naloxone hydrochloride products achieve plasma concentrations that have been shown to be efficacious in reversing the effects of opioid overdose. Comparing different products on a nominal mg-for-mg basis may be misleading.

The device is ready to use. Do not prime or test prior to administration.

Do not attempt to reuse KLOXXADO. Each KLOXXADO contains a single dose of naloxone and cannot be reused.

Because suspected opioid overdose is usually managed by someone other than the patient, instruct the prescription recipient to inform those around them about the presence of KLOXXADO and the Instructions for Use. Instruct the patient or caregiver to read the Instructions for Use at the time they receive a prescription for KLOXXADO. Emphasize the following instructions to the patient or caregiver.

Administer KLOXXADO as quickly as possible because prolonged respiratory depression may result in damage to the central nervous system or death.

Always seek immediate emergency medical assistance after the first dose of KLOXXADO has been administered in the event of a suspected, potentially life-threatening opioid emergency because the duration of action of most opioids exceeds that of naloxone hydrochloride. Keep the patient under continued surveillance and administer repeated doses of KLOXXADO, as necessary, until emergency personnel arrive.

Administer KLOXXADO according to the printed instructions on the carton 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 and remove the device nozzle from the nostril after use. Place the patient in recovery position by turning him/her onto their side as shown in the Instructions for Use and call for emergency medical assistance immediately after the first dose of KLOXXADO.

Administer additional doses of KLOXXADO, using a new nasal spray, every 2 to 3 minutes as needed if the patient does not respond or responds and then relapses into respiratory depression. Administer KLOXXADO in alternate nostrils with each dose.

2.2 Dosing in

Adult and Pediatric Patients Initial Dosing KLOXXADO nasal spray, 8 mg The recommended initial dose of KLOXXADO in adult and pediatric patients is one spray delivered by intranasal administration into one nostril, which delivers 8 mg of naloxone hydrochloride to adult or pediatric patients. Repeat Dosing Seek emergency medical assistance as soon as possible, after administering the first dose of KLOXXADO. If the desired response is not obtained after 2 or 3 minutes, administer an additional dose using a new KLOXXADO in alternate nostril. If there is still no response and additional doses are available, administer additional doses of KLOXXADO every 2 to 3 minutes, alternating nostrils and using a new KLOXXADO, until emergency medical assistance arrives. The requirement for repeat doses of KLOXXADO depends upon the amount, type, and route of administration of the opioid being antagonized. If the patient responds to KLOXXADO and subsequently relapses back into respiratory depression before emergency assistance arrives, administer an additional dose using a new KLOXXADO, in the opposite nostril, and continue surveillance of the patient. Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance. Reversal of respiratory depression by partial agonists or mixed agonist/antagonists, such as buprenorphine and pentazocine, may be incomplete and require repeated administration of KLOXXADO using a new nasal spray.