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Naloxone Injection (Narcan): Uses, Side Effects and Dosage

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Facts
Status:
Prescription (Rx)
Strength:
10 mg/0.4 mL
Brand names:
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Active ingredient:
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Naloxone Injection

How to use the auto-injector:

Step 1.

Firmly pull the auto-injector from the outer case. See Figure B .

Do not go to Step 2 (Do not remove the Red safety guard) until you are ready to use the auto-injector. If you are not ready to use the auto-injector, put it back in the outer case for later use.

If NALOXONE HYDROCHLORIDE injection auto-injector is frozen, do not wait for it to thaw. Use another auto-injector if available. If another auto-injector is not available, get emergency medical help right away.

NALOXONE HYDROCHLORIDE injection auto-injector may still be used if it has been thawed after being previously frozen.

Step 2.

Pull off the Red safety guard. See Figure C .

To reduce the chance of an accidental injection, do not touch the Black base of the auto-injector, which is where the needle comes out

Note: The Red safety guard is made to fit tightly. Pull firmly to remove.

Do not replace the Red safety guard after it is removed.

Step 3.

Place the Black end of the auto-injector against the outer thigh, through clothing or personal protective equipment (including MOPP4 PPE), if needed. Make sure that the injection site is free of other materials such as equipment or other obstructions, except for clothing. NALOXONE HYDROCHLORIDE injection auto-injector may be self-administered or administered by a buddy.

Press firmly until you hear a click and hiss sound and then hold in place for 5 seconds. See Figure D .

Note: The auto-injector makes a distinct sound (click and hiss) when it is pressed against the thigh. The click and hiss indicates the start of the injection. This is normal and means that the auto-injector is working correctly. Keep the auto-injector firmly pressed against the thigh for 5 seconds after you hear the click and hiss sound. After the medicine is injected, the needle will retract back up into the auto-injector and is not visible after use.

Step 4.

After administering the first dose of NALOXONE HYDROCHLORIDE injection, get emergency medical help right away.

Rescue breathing or CPR (cardiopulmonary resuscitation) may be given while waiting for emergency medical help. If there is no response to NALOXONE HYDROCHLORIDE injection consider if respiratory depression is caused by something other than opioid exposure. Watch the person closely. If symptoms return, additional naloxone may be administered.

You may need additional doses of NALOXONE HYDROCHLORIDE injection if you are being exposed to high-potency opioids for an extended period of time. NALOXONE HYDROCHLORIDE injection auto-injector provides temporary protection against opioid exposure.

How to know that the auto-injector has been used.. See Figure E .

  • The viewing window will no longer be clear. You will see a Red indicator.
  • The Black base will lock into place.

Figure E - NALOXONE HYDROCHLORIDE injection auto-injector – After Use

What to do after the auto-injector has been used:

  • Get emergency medical help right away.
  • The auto-injector cannot be reused. Put the auto-injector back in the outer case after it has been used.
  • Do not throw away the auto-injector in the trash. Do not recycle the auto-injector.
  • The auto-injector must be properly disposed of in a sharps container.

There may be local or state laws about how to throw away used auto-injectors.

How should I store NALOXONE HYDROCHLORIDE injection?

  • Store NALOXONE HYDROCHLORIDE injection auto-injector at room temperature between 59°F to 77°F (15°C to 25°C). Storage temperature excursions permitted between 39°F to 104°F (4°C to 40°C).
  • Protect from heat and do not freeze.
  • Keep the NALOXONE HYDROCHLORIDE injection auto-injector in its outer case until ready to use.
  • Occasionally check the viewing window of the NALOXONE HYDROCHLORIDE injection auto-injector. If the medicine is cloudy, contains particles, or if the glass container is damaged, replace the auto-injector with a new one.
  • NALOXONE HYDROCHLORIDE injection auto-injector has an expiration date. See Figure F . Replace it before the expiration date.

Figure F – Expiration Date Located on Back of the NALOXONE HYDROCHLORIDE injection auto-injector

Keep NALOXONE HYDROCHLORIDE injection and all medicines out of the reach of children.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Manufactured for: Kaleo, Inc., Richmond, VA 23219

Issued: 02/2022

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 215457 · View the label on DailyMed

Revision date stated in the text: February 2022

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Naloxone Injection

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Opioid Antagonist
Active ingredient Naloxone hydrochloride 10 mg/0.4 mL
Dosage form Injection, solution
Route Intramuscular, Subcutaneous
Marketing status listed in the FDA NDC Directory
Company (applicant) KALEO INC
FDA approval NDA 215457New Drug Application (NDA) Approved February 28, 2022
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Manufacturers 16 labelers list this drug on DailyMed
Packages (NDC)
Package
10 mg/0.4 mL – 0.4 ml in 1 dose pack / 10 in 1 carton NDC 60842-002-02

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.