Naloxone Hydrochloride Injection, USP, Auto-Injector

Naloxone Hydrochloride Injection, USP, Auto-Injector is an FDA-registered drug product whose active ingredient is NALOXONE HYDROCHLORIDE. It is labelled by Kaleo, Inc. taken by intramuscular and marketed as a human prescription drug product. Identifiers on file: NDC 60842-002, application NDA215457, label effective 20220311. It is one of 27 FDA drug label records sharing the active ingredient NALOXONE HYDROCHLORIDE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing NALOXONE HYDROCHLORIDE are most often described in connection with: military personnel, chemical incident, high-potency opioids, fentanyl analogues, naloxone hydrochloride, emergency treatment, patients years, weapon suspected. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE NALOXONE HYDROCHLORIDE injection is indicated for use by military personnel and chemical incident responders for: Emergency treatment of patients 12 years of age and older where use of high-potency opioids such as fentanyl analogues as a chemical weapon is suspected. Temporary prophylaxis of respiratory and/or central nervous system depression in military personnel and chemical incident responders entering an area contaminated with high-potency opioids such as fentanyl analogues. NALOXONE HYDROCHLORIDE injection is an opioid antagonist indicated for use by military personnel and chemical incident responders for: Emergency treatment of patients 12 years of age and older where use of high-potency opioids such as fentanyl analogues as a chemical weapon is suspected. ( 1 ) Temporary prophylaxis of respiratory and/or central nervous system depression in military personnel and chemical incident responders entering an area contaminated with high-potency opioids such as fentanyl analogues. ( 1 )

2 DOSAGE AND ADMINISTRATION Administer NALOXONE HYDROCHLORIDE injection according to the INSTRUCTIONS FOR USE. ( 2.1 ) Administer as soon as possible after known or suspected opioid exposure and seek emergency medical assistance immediately after the first dose. ( 2.1 ) Administer into the anterolateral aspect of the thigh, through clothing if necessary. ( 2.2 ) If the patient relapses into respiratory or central nervous system depression after the first dose, administer additional naloxone HCl, as necessary, until emergency medical assistance becomes available. ( 2.2 ) Keep the patient under continued surveillance until medical care is available. ( 2.2 ) 2.1 Important Administration Instructions Read the Instructions for Use at the time of receiving a single-dose, pre-filled NALOXONE HYDROCHLORIDE injection auto-injector. Administer NALOXONE HYDROCHLORIDE injection as soon as possible after known or suspected opioid exposure because prolonged respiratory depression may result in damage to the central nervous system or death. NALOXONE HYDROCHLORIDE injection contains 10 mg/0.4 mL naloxone HCl in a single-dose, pre-filled auto-injector for intramuscular or subcutaneous use only. Do not attempt to reuse the NALOXONE HYDROCHLORIDE injection auto-injector. Periodically visually inspect NALOXONE HYDROCHLORIDE injection through the viewing window for particulate matter. Request a replacement if the solution is cloudy or contains particles, or if the glass container is damaged. Once the red safety guard is removed, NALOXONE HYDROCHLORIDE injection auto-injector must be used immediately or disposed of properly. Do not attempt to replace the red safety guard once it is removed. 2.2 Dosing in Adults and Pediatric Patients at Least 12 Years Old Inject NALOXONE HYDROCHLORIDE injection into the anterolateral aspect of the thigh according to the Instructions for Use and the printed instructions on the device label. In summary, Ensure that the injection site is free of other materials (e.g., equipment or other obstructions), except for clothing. Pull the auto-injector from the outer case. When ready to use, firmly pull off the red safety guard. Do not touch the black base of the auto-injector, which is where the needle comes out. Place the black end of the auto-injector against the anterolateral aspect of the thigh, through clothing, if needed. Press firmly until you hear a click and hiss sound and then hold in place for 5 seconds. Upon actuation, the auto-injector automatically inserts the needle intramuscularly or subcutaneously, delivers the naloxone HCl injection, and retracts the needle into the device. The needle will not be visible before, during, or after the injection. Post-injection, the black base locks in place and a red indicator appears in the drug viewing window. NALOXONE HYDROCHLORIDE injection can be injected through clothing or MOPP4 PPE. NALOXONE HYDROCHLORIDE injection can be self- or buddy-administered. Emergency treatment of patients 12 years of age and older where use of high-potency opioids such as fentanyl analogues as a chemical weapon is suspected. Seek immediate emergency medical assistance immediately after administration of the first dose of NALOXONE HYDROCHLORIDE injection. Keep the patient under continued surveillance until medical care is available. If the patient relapses into respiratory and/or central nervous system depression after the first dose of NALOXONE HYDROCHLORIDE injection, administer additional naloxone HCl, as necessary, until emergency medical assistance becomes available. If the patient does not show some improvement after administering the dose of NALOXONE HYDROCHLORIDE injection, consider if the respiratory depression is due to a non-opioid etiology. Temporary prophylaxis of respiratory and/or central nervous system depression in military personnel and chemical incident responders entering an area contaminated with high-potency opioids such as fentanyl analogues. Administer immediately prior to entering an area believed to be contaminated with high-potency opioids. Each pre-filled NALOXONE HYDROCHLORIDE injection can only be used one time. NALOXONE HYDROCHLORIDE injection provides temporary protection. If exposure to high potency opioids is prolonged, additional doses may be necessary.

4 CONTRAINDICATIONS NALOXONE HYDROCHLORIDE injection is contraindicated in individuals known to be hypersensitive to naloxone HCl or to any of the other ingredients. Hypersensitivity to naloxone hydrochloride or to any of the other ingredients in NALOXONE HYDROCHLORIDE injection. ( 4 )

6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: Precipitation of Severe Opioid Withdrawal [see Warnings and Precautions (5.1) ] Recurrent Respiratory and Central Nervous System Depression [see Warnings and Precautions (5.2) ] The following adverse reactions were observed in more than one subject in clinical studies evaluating NALOXONE HYDROCHLORIDE injection: dizziness, feeling hot, headache, and injection site erythema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact kaleo, Inc. at 1-877-341-5330 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to the rates in the clinical studies of another drug and may not reflect the rates observed in practice. In three pharmacokinetic studies with a total of 78 healthy adult subjects exposed to NALOXONE HYDROCHLORIDE injection 0.4 mg auto-injector, two NALOXONE HYDROCHLORIDE injection 0.4 mg (0.8 mg naloxone HCl total) auto-injectors, NALOXONE HYDROCHLORIDE injection 2 mg auto-injector, or NALOXONE HYDROCHLORIDE injection 10 mg auto-injector, adverse reactions occurring in more than one subject were dizziness, feeling hot, headache, and injection site erythema. 6.2 Postmarketing Experience The following adverse reactions have been identified during the use of naloxone HCl to reverse the effects of opioids. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: aggression, anger, anxiety, back pain, bradycardia, cardiac arrest, confusion, depression, disorientation, dyspnea, hypertension, hypotension, loss of consciousness, malaise, miosis, pain, pulmonary edema, somnolence, unresponsiveness to stimuli, and ventricular tachycardia and fibrillation. Death, coma, and encephalopathy have been reported as sequelae of these events. Excessive doses of naloxone HCl have resulted in significant reversal of analgesia and have caused agitation [see Warnings and Precautions (5.1) ] .

FDA lists 27 drug label records with NALOXONE HYDROCHLORIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Naloxone Hydrochloride Injection, USP, Auto-Injector used for?
1 INDICATIONS AND USAGE NALOXONE HYDROCHLORIDE injection is indicated for use by military personnel and chemical incident responders for: Emergency treatment of patients 12 years of age and older where use of high-potency opioids such as fentanyl analogues as a chemical weapon is suspected. Temporary prophylaxis of respiratory and/or central nervous system depression in military personnel and …

Who makes Naloxone Hydrochloride Injection, USP, Auto-Injector?
Kaleo, Inc. is the labeler of record for Naloxone Hydrochloride Injection, USP, Auto-Injector. 27 FDA label records share the active ingredient NALOXONE HYDROCHLORIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Naloxone Hydrochloride Injection, USP, Auto-Injector come in?
administered by intramuscular. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Naloxone Hydrochloride Injection, USP, Auto-Injector prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing NALOXONE HYDROCHLORIDE?
Yes. 27 FDA drug label records list NALOXONE HYDROCHLORIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Naloxone Hydrochloride Injection, USP, Auto-Injector been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.