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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.