Narcan

Dosage Forms & Strengths

injectable solution

• 0.4mg/mL
• 1mg/mL

IM/SC auto-injector

• 0.4mg/0.4mL (2 auto-injectors/package)

Opioid Overdose

Indicated for the complete or partial reversal of opioid depression (including respiratory depression) induced by natural and synthetic opioids

0.4-2 mg IV/IM/SC; repeat q2-3min PRN; not to exceed 10 mg (0.01 mg/kg) 

Consider other causes of respiratory depression if desired response not achieved after administering 10 mg cumulative total

Endotracheal (this is the least desirable route of administration and supported only by anecdotal evidence): 2-2.5 times (0.8-5 mg) initial IV dose

For chronic opioid abuse, use smallest doses (0.1-0.2 mg) to avoid acute withdrawal; titrate to reversal of respiratory depression

Following reversal, additional dose(s) may need to be administered at later interval (ie, 20 to 60 min) depending on type and duration of opioid

Continuous IV infusion (Off-label)

• For use in patients exposed to long acting opioids (eg, methadone), sustained release products
• Calculate dose/hr based on effective intermittent dose used and duration of adequate response seen
• Alternatively, use two-thirds of initial effective naloxone bolus on an hourly basis (0.25-6.25 mg/hr); administer one-half of initial bolus dose 15 min after initiating continuous IV infusion to prevent drop in naloxone levels

Inhalation via Nebulization (Off-label)

• 2 mg as inhalation via nebulization; may repeat
• Switch to IV or IM administration when possible
• Nebulization method is not included in the AHA recommendations for initial management of opioid-associated life-threatening emergency

Evzio Auto-Injector

• Indicated for immediate administration as emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression
• 0.4 mg or 2 mg IM/SC into anterolateral aspect of the thigh (through clothing if necessary)
• Seek emergency medical care immediately after use
• Additional doses may be administered q2-3min until EMS arrives

Dosing considerations (Evzio)

• Take-home, single-use auto-injector with visual and voice instruction for guidance
• May be prescribed to a family member or caregiver
• Compact size for portability with retractable needle system
• Intended for immediate administration as emergency therapy in settings where opioids may be present
• Not a substitute for emergency medical care
• Also see Administration

Reversal of Respiratory Depression with Therapeutic Opioid Doses

0.04-0.4 mg IV/IM/SC initially; may repeat until desired response achieved; if desired response not observed after 0.8 mg total, consider other causes of respiratory depression

Postoperative Opioid Depression

0.1-0.2 mg IV q2-3min to desired degree of reversal (eg, adequate ventilation and alertness without significant pain)

May repeat within 1-2hr intervals depending on amount, type (eg, short or long acting) and timing of last dose administered; supplemental IM doses have produced longer lasting effects

Dosage Forms & Strengths

injectable solution

• 0.4mg/mL
• 1mg/mL

IM/SC auto-injector

• 0.4mg/0.4mL (2 auto-injectors/package)

Opioid Reversal

Postanesthesia (acute) opioid reversal

• Neonates: 0.01 mg/kg IV into umbilical vein/IM/SC; give subsequent dose of 0.1 mg/kg if needed 
• Children: 0.01 mg/kg IV once; may repeat with 0.1 mg/kg

Reversal of respiratory depression with therapeutic opioid dosing

• Manufacturer dosing: 0.005-0.01 mg; repeat q2-3min PRN based on response
• AAP dosing: 0.001-0.015 mg/kg/dose IV; titrate to effect 

Acute opioid overdose

• ≤20 kg or <5 years: 0.1 mg/kg/dose IV/IM/SC/ET; if needed, repeat q2-3min PRN; not to exceed 2 mg/dose 
• >20 kg or ≥5 years: 2 mg IV/IM/SC/ET; if needed, repeat q2-3min PRN
• Consider endotracheal administration when IV/intraosseous route not available; optimal endotracheal dose unknown; 2-3 times the IV dose recommended

Opioid Overdose (Evzio Auto-Injector)

Indicated for immediate administration as emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression

0.4 mg or 2 mg IM/SC into anterolateral aspect of the thigh (through clothing if necessary); if child is <1 yr, pinch the thigh muscle while administering the dose

Seek emergency medical care immediately after use

Additional doses may be administered q2-3min until EMS arrives

Dosing considerations (Evzio)

• Take-home, single-use auto-injector with visual and voice instruction for guidance
• May be prescribed to a family member or caregiver
• Compact size for portability with retractable needle system
• Intended for immediate administration as emergency therapy in settings where opioids may be present
• Not a substitute for emergency medical care
• Also see Administration

Pregnancy category: C

Lactation: Not known if distributed in milk; use caution

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

No Narcan drug interactions have been studied by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Essentially a pure opiate antagonist.113 119 127

• Essentially a pure opiate antagonist.113 119 127

• In usual doses in patients who have not recently received opiates, naloxone exerts little or no pharmacologic effect.113

• In patients who have received large doses of morphine or other analgesic drugs with morphine-like effects, naloxone antagonizes most of the effects of the opiate.113

• Increase in respiratory rate and minute volume, decrease toward normal in arterial PCO2, and return to normal in blood pressure if depressed.b

• Because the duration of action of naloxone is generally shorter than that of the opiate, the effects of the opiate may return as the effects of naloxone dissipate.113 119

• Antagonizes opiate-induced sedation or sleep.b

• Does not produce tolerance or physical or psychological dependence.113

• It is thought to act as a competitive antagonist at µ, κ, and σ opiate receptors in the CNS; it is thought that the drug has the highest affinity for the μ receptor.113 127

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of naloxone injection in children.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of naloxone injection in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving naloxone injection.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Morphine
• Morphine Sulfate Liposome
• Naldemedine
• Naloxegol
• Oxycodone
• Oxymorphone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Clonidine
• Yohimbine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart disease or
• Kidney disease or
• Liver disease—Use with caution. May make these conditions worse.

• If you have an allergy to naloxone or any other part of Narcan (naloxone nasal spray).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• For the nose only.
• Your doctor will teach you how to take Narcan.
• Follow how to use as you have been told by the doctor or read the package insert.
• Read how to use before an emergency happens.
• Someone else may have to give this medicine. Be sure others know where Narcan is stored and how to give it if needed.
• Get medical help right away after using this medicine.
• Each nasal spray has only 1 dose and cannot be reused. If another dose is needed, you will need to use new nasal spray.
• If using more than 1 dose, switch nostrils with each dose.
• Do not use if Narcan (naloxone nasal spray) is out of date. Get a new one.

What do I do if I miss a dose?

• Get medical help right away.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Muscle pain.
• Muscle spasm.
• Headache.
• Dry nose.
• Stuffy nose.
• Runny nose.
• Swelling in the nose.
• Hard stools (constipation).
• Tooth pain.
• Dry skin.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Narcan Nasal Spray is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.

Narcan Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present.

Narcan Nasal Spray is not a substitute for emergency medical care.

Limitations of Use:

Restrict prescription of Narcan Nasal Spray 2 mg to opioid-dependent patients expected to be at risk for severe opioid withdrawal in situations where there is a low risk for accidental or intentional opioid exposure by household contacts.

Narcan (naloxone hydrochloride) 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 hydrochloride with the following structure:

C19H21NO4• HCl

M.W. 363.84

Naloxone hydrochloride, an opioid antagonist, occurs as a white to slightly off-white powder, and is soluble in water, in dilute acids, and in strong alkali; slightly soluble in alcohol; practically insoluble in ether and in chloroform.

Each Narcan Nasal Spray contains a 2 mg or 4 mg single dose of naloxone hydrochloride in a 0.1 mL (100 microliter) aqueous solution.  

Inactive ingredients include benzalkonium chloride (preservative), disodium ethylenediaminetetraacetate (stabilizer), sodium chloride, hydrochloric acid to adjust pH, and purified water. The pH range is 3.5 to 5.5.