NARCAN NALOXONE HCI

FDA Drug Profile — NARCAN NALOXONE HCI

Drug Details

Generic Name
NARCAN NALOXONE HCI
Brand Names
NARCAN NALOXONE HCI
Application Number
NDA208411
Sponsor
HF Acquisition Co LLC, DBA HealthFirst
NDC Codes
1
Dosage Forms
SPRAY
Routes
NASAL
Active Ingredients
NALOXONE HYDROCHLORIDE

Indications and Usage

1 INDICATIONS & USAGE NARCAN Nasal Spray is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. NARCAN Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present. NARCAN Nasal Spray is not a substitute for emergency medical care. Limitations of Use: Restrict prescription of NARCAN Nasal Spray 2 mg to opioid-dependent patients expected to be at risk for severe opioid withdrawal in situations where there is a low risk for accidental or intentional opioid exposure by household contacts.