Narcan

Name: Narcan

Uses of Narcan

Narcan is a prescription medication used to treat manage opioid overdose.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Inform MD

Before taking Narcan, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

  • are allergic to Narcan or to any of its ingredients
  • have or have had a heart condition
  • have heart problems
  • have an addiction or dependance on any substance
  • are pregnant or breastfeeding

Narcan and Pregnancy

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Narcan falls into category C. There are no well-controlled studies that have been done in pregnant women. Narcan should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Narcan Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known
  • Abdominal or stomach cramps
  • body aches
  • convulsions
  • diarrhea
  • difficult or troubled breathing
  • excessive crying
  • fast, pounding, or irregular heartbeat or pulse
  • fever
  • goosebumps
  • increased or excessive unconscious or jerking movements
  • irregular, fast or slow, or shallow breathing
  • irritability
  • nausea or vomiting
  • nervousness
  • pale or blue lips, fingernails, or skin
  • restlessness
  • runny nose
  • shivering
  • sneezing
  • sweating
  • trembling
  • weakness
  • yawning

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Uses of Narcan

  • It is used to avoid side effects from some drugs.
  • It is used to treat some overdoses.
  • It may be given to you for other reasons. Talk with the doctor.

What are some things I need to know or do while I take Narcan?

  • Tell all of your health care providers that you take Narcan. This includes your doctors, nurses, pharmacists, and dentists.
  • If you are addicted to pain drugs and are given this medicine, you may have signs of withdrawal. Talk with your doctor.
  • In infants younger than 4 weeks old who have been getting opioid drugs on a regular basis, sudden withdrawal may be life-threatening if not treated right away. Get medical help right away if your child has a seizure, is crying more than normal, or has increased reflexes.
  • After using Narcan, overdose symptoms may go away and come back. It is important to get medical help right away after using this medicine.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Narcan while you are pregnant.
  • If this medicine is used during pregnancy, it may cause withdrawal in the unborn baby. A doctor will need to check on the unborn baby after Narcan is used.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Narcan Dosage and Administration

Important Administration Instructions

Narcan Nasal Spray is for intranasal use only.

No additional device assembly is required.

Because treatment of suspected opioid overdose must be performed by someone other than the patient, instruct the prescription recipient to inform those around them about the presence of Narcan Nasal Spray and the Instructions for Use.

Instruct the patient or caregiver to read the Instructions for Use at the time they receive a prescription for Narcan Nasal Spray. Emphasize the following instructions to the patient or caregiver:

  • Administer Narcan Nasal Spray as quickly as possible because prolonged respiratory depression may result in damage to the central nervous system or death. Since the duration of action of most opioids exceeds that of naloxone hydrochloride and the suspected opioid overdose may occur outside of supervised medical settings, seek immediate emergency medical assistance, keep the patient under continued surveillance until emergency personnel arrive, and administer repeated doses of Narcan Nasal Spray, as necessary. Always seek emergency medical assistance in the event of a suspected, potentially life-threatening opioid emergency after administration of the first dose of Narcan Nasal Spray.
  • Additional doses of Narcan Nasal Spray may be required until emergency medical assistance becomes available.
  • Do not attempt to reuse Narcan Nasal Spray. Each Narcan Nasal Spray contains a single dose of naloxone and cannot be reused.
  • Re-administer Narcan Nasal Spray, using a new nasal spray, every 2 to 3 minutes if the patient does not respond or responds and then relapses into respiratory depression.
  • Administer Narcan Nasal Spray in alternate nostrils with each dose.
  • Administer Narcan Nasal Spray according to the printed instructions on the device label and the Instructions for Use.
  • Place the patient in the supine position. Prior to administration, be sure the device nozzle is inserted in either nostril of the patient, and provide support to the back of the neck to allow the head to tilt back. Do not prime or test the device prior to administration.
  • To administer the dose press firmly on the device plunger.
  • Remove the device nozzle from the nostril after use.
  • Turn patient on their side as shown in the InstructionsforUse and call for emergency medical assistance immediately after administration of the first dose of Narcan Nasal Spray.

Dosing in Adults and Pediatric Patients

Initial Dosing

The recommended initial dose of Narcan Nasal Spray in adults and pediatric patients is one spray delivered by intranasal administration into one nostril.

Repeat Dosing

Seek emergency medical assistance as soon as possible after administering the first dose of Narcan Nasal Spray.

The requirement for repeat doses of Narcan Nasal Spray depends upon the amount, type, and route of administration of the opioid being antagonized.

Administer Narcan Nasal Spray in alternate nostrils with each dose.

If the patient responds to Narcan Nasal Spray and relapses back into respiratory depression before emergency assistance arrives, administer an additional dose of Narcan Nasal Spray using a new Narcan Nasal Spray and continue surveillance of the patient.

If the desired response is not obtained after 2 or 3 minutes, administer an additional dose of Narcan Nasal Spray using a new Narcan Nasal Spray. If there is still no response and additional doses are available, administer additional doses of Narcan Nasal Spray every 2 to 3 minutes using a new Narcan Nasal Spray with each dose until emergency medical assistance arrives.

Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance.

Dosing Modifications due to Partial Agonists or Mixed Agonist/Antagonists

Reversal of respiratory depression by partial agonists or mixed agonist/antagonists, such as buprenorphine and pentazocine, may be incomplete and require higher doses of naloxone hydrochloride or repeated administration of Narcan Nasal Spray using a new nasal spray [see Warnings and Precautions (5.2)]

Instructions for Use

Instructions for Use

Narcan (nar´ kan)

(naloxonehydrochloride)

Nasal Spray

You and your family members or caregivers should read the Instructions for Use that comes with Narcan Nasal Spray before using it. Talk to your healthcare provider if you and your family members or caregivers have any questions about the use of Narcan Nasal Spray.

Use Narcan Nasal Spray for known or suspected opioid overdose in adults and children.

Important: For use in the nose only.

  • Do not remove or test the Narcan Nasal Spray until ready to use.
  • Each Narcan Nasal Spray has 1 dose and cannot be reused.
  • You do not need to prime Narcan Nasal Spray.

Howto use Narcan Nasal Spray:

Step 1.     Lay the person on their back to receive a dose of Narcan Nasal Spray.

Step 2.     Remove Narcan Nasal Spray from the box. Peel back the tab with the circle to open the Narcan Nasal Spray.

Step 3.     Hold the Narcan Nasal Spray with your thumb on the bottom of the plunger and your first and middle fingers on either side of the nozzle.

Step 4.     Tilt the person’s head back and provide support under the neck with your hand. Gently insert the tip of the nozzle into one nostril until your fingers on either side of the nozzle are against the bottom of the person’s nose.

Step 5.     Press the plunger firmly to give the dose of Narcan Nasal Spray.

Step 6.     Remove the Narcan Nasal Spray from the nostril after giving the dose.

What to do after Narcan Nasal Spray has been used:

Step 7.    Get emergency medical help right away.

  • Move the person on their side (recovery position) after giving Narcan Nasal Spray.
  • Watch the person closely.
  • If the person does not respond by waking up, to voice or touch, or breathing normally another dose may be given.  Narcan Nasal Spray may be dosed every 2 to 3 minutes, if available.
  • Repeat Steps 2 through 6 using a new Narcan Nasal Spray to give another dose in the other nostril.  If additional Narcan Nasal Sprays are available, Steps 2 through 6 may be repeated every 2 to 3 minutes until the person responds or emergency medical help is received.

Step 8.   Put the used Narcan Nasal Spray back into its box.

Step 9.   Throw away (dispose of) the used Narcan Nasal Spray in a place that is away from children.

HowshouldI store Narcan Nasal Spray?

  • Store Narcan Nasal Spray at room temperature between 59°F to 77°F (15°C to 25°C). Narcan Nasal Spray may be stored for short periods up to 104°F (40°C).
  • Do not freeze Narcan Nasal Spray.
  • Keep Narcan Nasal Spray in the box until ready to use. Protect from light.
  • Replace Narcan Nasal Spray before the expiration date on the box.

KeepNarcan Nasal Sprayand all medicines out of the reach of children.

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

Distributed by Adapt Pharma, Inc. Radnor, PA 19087 USA.

For more information, go to www.Narcannasalspray.com or call 1-844-4Narcan (1-844-462-7226).

Issued: 02/2017

2 mg - 4 pack

NDC 69547-212-04

Blister

Carton Four Pack

2 mg - 24 pack

NDC 69547-212-24

Carton 24 Pack

4 mg - 2 pack

NDC 69547-353-02

Blister

Carton Two Pack

Narcan 
naloxone hydrochloride spray
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:69547-353
Route of Administration NASAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NALOXONE HYDROCHLORIDE (NALOXONE) NALOXONE HYDROCHLORIDE 4 mg  in 0.1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE  
EDETATE DISODIUM  
SODIUM CHLORIDE  
WATER  
HYDROCHLORIC ACID  
Packaging
# Item Code Package Description
1 NDC:69547-353-02 2 VIAL, SINGLE-DOSE in 1 PACKAGE
1 0.1 mL in 1 VIAL, SINGLE-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208411 11/18/2015
Narcan 
naloxone hydrochloride spray
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:69547-212
Route of Administration NASAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NALOXONE HYDROCHLORIDE (NALOXONE) NALOXONE HYDROCHLORIDE 2 mg  in 0.1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE  
EDETATE DISODIUM  
SODIUM CHLORIDE  
WATER  
HYDROCHLORIC ACID  
Packaging
# Item Code Package Description
1 NDC:69547-212-04 4 VIAL, SINGLE-DOSE in 1 PACKAGE
1 0.1 mL in 1 VIAL, SINGLE-DOSE
2 NDC:69547-212-24 24 VIAL, SINGLE-DOSE in 1 PACKAGE
2 0.1 mL in 1 VIAL, SINGLE-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208411 01/24/2017
Labeler - Adapt Pharma, Inc. (079673287)
Revised: 06/2017   Adapt Pharma, Inc.
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