Naloxone Hydrochloride Injection, USP, Auto-Injector 10 mg/.4mL

Naloxone Hydrochloride · INJECTION, SOLUTION · Kaleo, Inc.

No Recall History

Plain English

Naloxone Hydrochloride Injection, USP, Auto-Injector is a injection, solution containing naloxone hydrochloride at 10 mg/.4mL, taken intramuscular. Manufactured by Kaleo, Inc..

Key Facts

Brand Name: Naloxone Hydrochloride Injection, USP, Auto-Injector
Generic Name: Naloxone Hydrochloride
NDC Code (Product): 60842-002
Manufacturer: Kaleo, Inc.
Strength: 10 mg/.4mL
Dosage Form: INJECTION, SOLUTION
Route: INTRAMUSCULAR, SUBCUTANEOUS
Marketing Status
Application #: NDA215457
Marketing Start: 02/28/2022

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective93 reports

toxicity to various agents76 reports

vomiting59 reports

fatigue49 reports

off label use48 reports

drug withdrawal syndrome45 reports

nausea45 reports

overdose41 reports

diarrhoea40 reports

pain40 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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 )

Dosage & Administration

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 …

Contraindications

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 )

Adverse Reactions

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 …

Frequently Asked Questions

What is Naloxone Hydrochloride Injection, USP, Auto-Injector used for?

Naloxone Hydrochloride Injection, USP, Auto-Injector contains Naloxone Hydrochloride. It is a injection, solution taken intramuscular. Consult your doctor for specific uses.

Is Naloxone Hydrochloride Injection, USP, Auto-Injector a controlled substance?

Naloxone Hydrochloride Injection, USP, Auto-Injector is not classified as a controlled substance by the DEA.

What is the generic name for Naloxone Hydrochloride Injection, USP, Auto-Injector?

The generic name for Naloxone Hydrochloride Injection, USP, Auto-Injector is Naloxone Hydrochloride. There are 12 other brand versions of Naloxone Hydrochloride.

What is the NDC code for Naloxone Hydrochloride Injection, USP, Auto-Injector 10 mg/.4mL?

The NDC (National Drug Code) for Naloxone Hydrochloride Injection, USP, Auto-Injector 10 mg/.4mL is 60842-002, listed by Kaleo, Inc..

Product NDC

60842-002

Package NDC

60842-002-02

Other Naloxone Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)