Why NARCAN®Nasal Spray?

NARCAN® (naloxone HCl) Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present.

Dispense with confidence

NARCAN® (naloxone HCI) Nasal Spray is an opioid antagonist 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.

Not a substitute for emergency medical care. Repeat doses may be necessary.

FACT: NARCAN® can help reverse the effects of an opioid-induced, life-threatening emergency while emergency services are on the way.5,6

WITH NARCAN®, HELP REVERSE AN OPIOID OVERDOSE

  • Concentrated 4 mg dose
  • Needle-free
  • Designed for ease-of-use in the community setting
  • Inhalation not required
  • Requires no specialized training*

*Administer in accordance with the Instructions for Use.


NARCAN® NASAL SPRAY PHARMACOKINETIC STUDY

IM: intramuscular injection.
SD: standard deviation.

  • 4 mg concentrated dosing designed for effective intranasal delivery
  • Delivers approximately the same amount of naloxone as a 2 mg dose of IM naloxone

Study results

Compared to a 0.4 mg dose of IM naloxone—the historical standard of care in opioid overdose rescue—NARCAN® Nasal Spray 4 mg shows:

  • Greater Cmax compared to 0.4 mg IM dose5
  • Comparable time to maximal plasma concentration (Cmax)
  • A longer half-life (t1/2)5
The clinical significance of these results has not been measured and is not known.

Study design

Open-label, randomized crossover study, conducted in the United States, in 30 healthy adult volunteers (18-55 years of age).
Mean ± SD Plasma Concentration of Naloxone.
Based on a pharmacokinetic study comparing a 4 mg single nasal spray versus 0.4 mg intramuscular injection in healthy volunteers.5


Key steps to administering NARCAN® NASAL SPRAY*

PEEL

Peel back the package to remove the device. Hold the device with your thumb on the bottom of the red plunger and 2 fingers on the nozzle.

PLACE

Place and hold the tip of the nozzle in either nostril until your fingers touch the bottom of the patient's nose.

PRESS

Press the red plunger firmly to release the dose into the patient's nose.

NARCAN® Nasal Spray does not need to be inhaled.

*Administer in accordance with the Instructions for Use. Please refer to the Instructions for Use.

In a nonrandomized intervention study of naloxone (n=1985), compared with patients who did not receive naloxone, patients who received a naloxone prescription had7:

  • 47% fewer opioid-related emergency department visits per month 6 months after the receipt of the prescription
  • 63% fewer visits after 1 year

Design: 2-year nonrandomized intervention study.

Setting: 6 safety-net primary care clinics in San Francisco, California.

Intervention: Providers and clinic staff were trained and supported in naloxone prescribing.

Measurements: Outcomes were proportion of patients prescribed naloxone, opioid-related emergency department (ED) visits, and prescribed opioid dose based on chart review.

Limitation: Results are observational and may not be generalizable beyond safety-net (closed network) settings.

INDICATION AND USAGE

NARCAN® (naloxone hydrochloride) Nasal Spray is an opioid antagonist 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.

IMPORTANT SAFETY INFORMATION

NARCAN® Nasal Spray is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients.

Seek emergency medical assistance immediately after initial use, keeping the patient under continued surveillance.

Risk of Recurrent Respiratory and CNS Depression: Due to the duration of action of naloxone relative to the opioid, keep the patient under continued surveillance and administer repeat doses of naloxone using a new nasal spray with each dose, as necessary, while awaiting emergency medical assistance.

Risk of Limited Efficacy with Partial Agonists or Mixed Agonists/Antagonists: Reversal of respiratory depression caused by partial agonists or mixed agonists/antagonists, such as buprenorphine and pentazocine, may be incomplete. Larger or repeat doses may be required.

Precipitation of Severe Opioid Withdrawal: Use in patients who are opioid dependent may precipitate opioid withdrawal characterized by body aches, fever, sweating, runny nose, sneezing, piloerection, yawning, weakness, shivering or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, abdominal cramps, increased blood pressure, and tachycardia. In some patients, there may be aggressive behavior upon abrupt reversal of an opioid overdose. Monitor for the development of opioid withdrawal.

In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated and may also include convulsions, excessive crying, and hyperactive reflexes.

Abrupt Postoperative Reversal of Opioid Depression: Abrupt postoperative reversal of opioid depression may result in nausea, vomiting, sweating, tremulousness, tachycardia, hypotension, hypertension, seizures, ventricular tachycardia and fibrillation, pulmonary edema, and cardiac arrest. Serious sequelae of these events, including coma and death, have been reported. These events have primarily occurred in patients who had pre-existing cardiovascular (CV) disorders or received other drugs that may have similar adverse CV effects. Monitor these patients closely in an appropriate healthcare setting after use of naloxone HCl.

Adverse Reactions: The following adverse reactions were observed in a NARCAN® Nasal Spray clinical study: increased blood pressure, constipation, toothache, muscle spasms, musculoskeletal pain, headache, nasal dryness, nasal edema, nasal congestion, nasal inflammation, rhinalgia, and xeroderma.

To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

NNS HCP ISI 08/2020

Please see full Prescribing Information.

References: 1. Vital signs—Prescription painkiller overdoses in the US. Centers for Disease Control and Prevention website. https://www.cdc.gov/vitalsigns/painkilleroverdoses/index.html. Accessed April 13, 2020. 2. Opioid overdose. Centers for Disease Control and Prevention website. https://www.cdc.gov/drugoverdose/index.html. Accessed April 13, 2020. 3. Wide-ranging online data for epidemiologic research (WONDER). Atlanta, GA: CDC, National Center for Health Statistics; 2020. 4. Bratberg JP. Opioids, naloxone, and beyond: The intersection of medication safety, public health, and pharmacy. J Am Pharm Assoc. 2017;57:S5-S7. 5. NARCAN® Nasal Spray [prescribing information]. Plymouth Meeting, PA: ADAPT Pharma, Inc.; 2020. 6. Mell HK, Mumma SN, Hiestand B. Emergency medical services response times in rural, suburban, and urban areas. JAMA Surg. 2017;152(10):983-984. 7. Coffin PO, Behar E, Rowe C, et al. Nonrandomized intervention study of naloxone coprescription for primary care patients receiving long-term opioid therapy for pain. Ann Intern Med. 2016;165(4):245-252. 8. San Francisco Department of Public Health. Naloxone for opioid safety: a provider’s guide to prescribing naloxone to patients who use opioids. January 2015. https://prescribetoprevent.org/wp2015/wp-content/uploads/CA.Detailing_Provider_final.pdf. Accessed April 13, 2020. 9. Management of substance abuse: information sheet on opioid overdose. World Health Organization website. http://www.who.int/substance_abuse/information-sheet/en. Updated August 2018. Accessed April 13, 2020. 10. Calculating total daily dose of opioids for safer dosage. Centers for Disease Control and Prevention website. https://www.cdc.gov/drugoverdose/pdf/calculating_total_daily_dose-a.pdf. Accessed April 13, 2020.

INDICATION AND USAGE

NARCAN® (naloxone hydrochloride) Nasal Spray is an opioid antagonist 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.

IMPORTANT SAFETY INFORMATION

NARCAN® Nasal Spray is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients.

Seek emergency medical assistance immediately after initial use, keeping the patient under continued surveillance.

Risk of Recurrent Respiratory and CNS Depression: Due to the duration of action of naloxone relative to the opioid, keep the patient under continued surveillance and administer repeat doses of naloxone using a new nasal spray with each dose, as necessary, while awaiting emergency medical assistance.

Risk of Limited Efficacy with Partial Agonists or Mixed Agonists/Antagonists: Reversal of respiratory depression caused by partial agonists or mixed agonists/antagonists, such as buprenorphine and pentazocine, may be incomplete. Larger or repeat doses may be required.

Precipitation of Severe Opioid Withdrawal: Use in patients who are opioid dependent may precipitate opioid withdrawal characterized by body aches, fever, sweating, runny nose, sneezing, piloerection, yawning, weakness, shivering or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, abdominal cramps, increased blood pressure, and tachycardia. In some patients, there may be aggressive behavior upon abrupt reversal of an opioid overdose. Monitor for the development of opioid withdrawal.

In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated and may also include convulsions, excessive crying, and hyperactive reflexes.

Abrupt Postoperative Reversal of Opioid Depression: Abrupt postoperative reversal of opioid depression may result in nausea, vomiting, sweating, tremulousness, tachycardia, hypotension, hypertension, seizures, ventricular tachycardia and fibrillation, pulmonary edema, and cardiac arrest. Serious sequelae of these events, including coma and death, have been reported. These events have primarily occurred in patients who had pre-existing cardiovascular (CV) disorders or received other drugs that may have similar adverse CV effects. Monitor these patients closely in an appropriate healthcare setting after use of naloxone HCl.

Adverse Reactions: The following adverse reactions were observed in a NARCAN® Nasal Spray clinical study: increased blood pressure, constipation, toothache, muscle spasms, musculoskeletal pain, headache, nasal dryness, nasal edema, nasal congestion, nasal inflammation, rhinalgia, and xeroderma.

To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

NNS HCP ISI 08/2020

Please see full Prescribing Information.

References: 1. Vital signs—Prescription painkiller overdoses in the US. Centers for Disease Control and Prevention website. https://www.cdc.gov/vitalsigns/painkilleroverdoses/index.html. Accessed April 13, 2020. 2. Opioid overdose. Centers for Disease Control and Prevention website. https://www.cdc.gov/drugoverdose/index.html. Accessed April 13, 2020. 3. Wide-ranging online data for epidemiologic research (WONDER). Atlanta, GA: CDC, National Center for Health Statistics; 2020. 4. Bratberg JP. Opioids, naloxone, and beyond: The intersection of medication safety, public health, and pharmacy. J Am Pharm Assoc. 2017;57:S5-S7. 5. NARCAN® Nasal Spray [prescribing information]. Plymouth Meeting, PA: ADAPT Pharma, Inc.; 2020. 6. Mell HK, Mumma SN, Hiestand B. Emergency medical services response times in rural, suburban, and urban areas. JAMA Surg. 2017;152(10):983-984. 7. Coffin PO, Behar E, Rowe C, et al. Nonrandomized intervention study of naloxone coprescription for primary care patients receiving long-term opioid therapy for pain. Ann Intern Med. 2016;165(4):245-252. 8. San Francisco Department of Public Health. Naloxone for opioid safety: a provider’s guide to prescribing naloxone to patients who use opioids. January 2015. https://prescribetoprevent.org/wp2015/wp-content/uploads/CA.Detailing_Provider_final.pdf. Accessed April 13, 2020. 9. Management of substance abuse: information sheet on opioid overdose. World Health Organization website. http://www.who.int/substance_abuse/information-sheet/en. Updated August 2018. Accessed April 13, 2020. 10. Calculating total daily dose of opioids for safer dosage. Centers for Disease Control and Prevention website. https://www.cdc.gov/drugoverdose/pdf/calculating_total_daily_dose-a.pdf. Accessed April 13, 2020.