Tilidin 100 8mg Overview

DOSAGE AND ADMINISTRATION

• Tilidin Comp. Nasal Spray is for intranasal use only. (2.1)
• Seek emergency medical care immediately after use. (2.1)
• Administration of a single spray of Tilidin Comp. (Naloxone) Nasal Spray intranasally into one nostril. (2.2)
• Administer additional doses of Tilidin Comp. (Naloxone) 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 Tilidin Comp. (Naloxone) Nasal Spray may be given every 2 to 3 minutes until emergency medical assistance arrives. (2.2)
• Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance. (2.2)

Important Administration Instructions

Tilidin 100 8mg Comp. (Naloxone) 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 Tilidin Comp. (Naloxone) 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 Tilidin Comp. (Naloxone) Nasal Spray. Emphasize the following instructions to the patient or caregiver:

• Administer Tilidin 100 8mg. (Naloxone) 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 Tilidin Comp. (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 Tilidin Comp. (Naloxone) 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 Tilidin Comp. (Naloxone) Nasal Spray.
• Additional doses of Tilidin Comp. (Naloxone) Nasal Spray may be required until emergency medical assistance becomes available.
• Do not attempt to reuse Tilidin 100 8mg. (Naloxone) Nasal Spray. Each Tilidin Comp. (Naloxone) Nasal Spray contains a single dose of Tilidin Comp. (Naloxone) and cannot be reused.
• Re-administer Tilidin 100 8mg (Naloxone) 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 Tilidin Comp. (Naloxone) Nasal Spray in alternate nostrils with each dose.
• Administer Tilidin Comp. (Naloxone) 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.