For: Opioid Overdose
Narcan Nasal Spray (naloxone) is an intranasal opioid antagonist formulation indicated for the emergency treatment of known or suspected opioid overdose. These highlights do not include all the information needed to use NARCAN® NASAL SPRAY safely and effectively. See full prescribing information for NARCAN® NASAL SPRAY.
NARCAN® (naloxone hydrochloride) nasal spray
Initial U.S. Approval: 1971
INDICATIONS AND USAGE
NARCAN 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. (1)
NARCAN Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present. (1)
NARCAN Nasal Spray is not a substitute for emergency medical care. (1)
DOSAGE AND ADMINISTRATION
NARCAN Nasal Spray is for intranasal use only. (2.1)
Seek emergency medical care immediately after use. (2.1)
Administration of a single spray of NARCAN Nasal Spray intranasally into one nostril. (2.2)
Administer additional doses of NARCAN Nasal Spray, using a new nasal spray with each dose, if the patient does not respond or responds and then relapses into respiratory depression, additional doses of NARCAN Nasal Spray may be given every 2 to 3 minutes until emergency medical assistance arrives. (2.2)
Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance. (2.2)
DOSAGE FORMS AND STRENGTHS
Nasal spray: 2 mg and 4 mg of naloxone hydrochloride in 0.1 mL. (3)
CONTRAINDICATIONS
Hypersensitivity to naloxone hydrochloride. (4)
WARNINGS AND PRECAUTIONS
Risk of Recurrent Respiratory and CNS Depression: Due to the duration of action of naloxone relative to the opioid, keep 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. (5.1)
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. (5.2)
Precipitation of Severe Opioid Withdrawal: Use in patients who are opioid dependent may precipitate opioid withdrawal. In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated. Monitor for the development of opioid withdrawal. (5.3)
Risk of Cardiovascular (CV) Effects: Abrupt postoperative reversal of opioid depression may result in adverse CV effects. These events have primarily occurred in patients who had pre-existing 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 hydrochloride. (5.3)
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. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Adapt Pharma, Inc. at 1-844-4NARCAN (1-844-462-7226) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 9/2019
