naloxone HCl

FDA Drug Profile — REZENOPY

Drug Details

Generic Name
naloxone HCl
Brand Names
REZENOPY
Application Number
NDA215487
Sponsor
Scienture LLC
NDC Codes
1
Dosage Forms
SPRAY
Routes
NASAL
Active Ingredients
NALOXONE HYDROCHLORIDE

Indications and Usage

1 INDICATIONS & USAGE Naloxone HCl Nasal Spray is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. Naloxone HCl Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present. Naloxone HCl Nasal Spray is not a substitute for emergency medical care. Limitations of Use: Restrict prescription of naloxone hydrochloride 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.