Label: NALOXONE HYDROCHLORIDE spray, metered

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 7, 2025

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use NALOXONE HYDROCHLORIDE NASAL SPRAY safely and effectively. See full prescribing information for NALOXONE HYDROCHLORIDE NASAL ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    Naloxone hydrochloride 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 ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Important Administration Instructions - Naloxone hydrochloride nasal spray is for intranasal use only. No additional device assembly is required. Because treatment of suspected opioid ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Naloxone hydrochloride nasal spray is supplied as a single-dose intranasal spray containing 4 mg of naloxone hydrochloride in 0.1 mL.
  • 4 CONTRAINDICATIONS
    Naloxone hydrochloride nasal spray is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients.
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Risk of Recurrent Respiratory and Central Nervous System Depression - The duration of action of most opioids may exceed that of naloxone hydrochloride nasal spray resulting in a return of ...
  • 6 ADVERSE REACTIONS
    The following serious adverse reactions are discussed elsewhere in the labeling: Precipitation of Severe Opioid Withdrawal - [see Warnings and Precautions ( 5.3)] Because ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - The limited available data on naloxone use in pregnant women are not sufficient to inform a drug-associated risk. However, there are clinical considerations ...
  • 11 DESCRIPTION
    Naloxone hydrochloride nasal spray is a pre-filled, single dose intranasal spray. Chemically, naloxone hydrochloride dihydrate is the hydrochloride salt of ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Naloxone hydrochloride is an opioid antagonist that antagonizes opioid effects by competing for the same receptor sites. Naloxone hydrochloride reverses the effects of ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis - Long-term animal studies to evaluate the carcinogenic potential of naloxone have not been ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    16.1 How Supplied - Naloxone hydrochloride nasal spray 4 mg is supplied as a carton containing two blister packages (NDC 0093-2165-68) each with a single spray device. Naloxone hydrochloride ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient and family members or caregivers to read the FDA-approved patient labeling ( Patient Informationand - Instructions for Use). Recognition of Opioid Overdose - Inform ...
  • PATIENT PACKAGE INSERT
    PATIENT INFORMATION - Naloxone Hydrochloride (nal ox’ one hye” droe klor’ ide) Nasal Spray - You and your family members or caregivers should read this Patient Information leaflet ...
  • PRINCIPAL DISPLAY PANEL
    NDC 0093-2165-68 - 0.1 mL intranasal spray per unit - For use in the nose only - Rx only - Naloxone Hydrochloride Nasal Spray - 4 mg - Use Naloxone Hydrochloride Nasal Spray for ...
  • INGREDIENTS AND APPEARANCE
    Product Information