Label: NALOXONE HYDROCHLORIDE spray

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

Drug Label Information

Updated July 24, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use - NALOXONE HYDROCHLORIDE NASAL SPRAYsafely and effectively. See full prescribing information for - NALOXONE HYDROCHLORIDE NASAL ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND 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 ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Important Administration Instructions - Naloxone HCl Nasal Spray is for intranasal use only. No additional device assembly is required. Because treatment of suspected opioid overdose must be ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Naloxone HCl Nasal Spray is supplied as a single-dose intranasal spray containing 4 mg of naloxone hydrochloride in 0.1 mL.
  • 4 CONTRAINDICATIONS
    Naloxone HCl 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 HCl Nasal Spray resulting in a return of respiratory ...
  • 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 HCl Nasal Spray is a pre-filled, single dose intranasal spray. Chemically, naloxone hydrochloride is the hydrochloride salt of 17-Allyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one ...
  • 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 HCl Nasal Spray 4 mg is supplied as Carton containing two (2) blister packages - (NDC 45802-811-84) each with a single spray device. Naloxone HCl Nasal Spray is not ...
  • 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 INFORMATION
    PATIENT INFORMATION - Naloxone (nal-OKS-one) Hydrochloride Nasal Spray - You and your family members or caregivers should read this Patient Information leaflet before an opioid emergency ...
  • Instructions for Use
    Instructions for Use - Naloxone (nal-OKS-one) Hydrochloride Nasal Spray - You and your family members or caregivers should read the Instructions for Use that comes with Naloxone HCl Nasal Spray ...
  • QUICK START GUIDE
    QUICK START GUIDE - Opioid Overdose Response Instructions - Naloxone HCl Nasal Spray 4 mg - Use Naloxone Hydrochloride Nasal Spray for known or suspected opioid overdose in adults and ...
  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
    Rx Only - NDC 45802-811-84 - Naloxone HCl Nasal Spray - 4 mg - Important: FOR USE IN THE NOSE ONLY. Use Naloxone HCl Nasal Spray for known or suspected opioid overdose in adults and children. Do not ...
  • INGREDIENTS AND APPEARANCE
    Product Information