naloxone hydrochloride

FDA Drug Profile — NALOXONE HYDROCHLORIDE, naloxone hydrochloride, Naloxone Hydrochloride, RiVive

Drug Details

Generic Name
naloxone hydrochloride
Brand Names
NALOXONE HYDROCHLORIDE, naloxone hydrochloride, Naloxone Hydrochloride, RiVive
Application Number
ANDA211951
Sponsor
BluePoint Laboratories
NDC Codes
23
Dosage Forms
SPRAY, INJECTION, SOLUTION, INJECTION
Routes
NASAL, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, PARENTERAL
Active Ingredients
NALOXONE HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND 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. NARCAN Nasal Spray is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. ( 1 ) NARCAN Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present. ( 1 ) NARCAN Nasal Spray is not a substitute for emergency medical care. ( 1 ) 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.