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FDA Approves Narcan Nasal Spray for Opioid Overdose

Nasal spray form of naloxone for emergency usage

The FDA approved Narcan nasal spray, the first FDA-approved nasal spray version of naloxone hydrochloride, a life-saving medication that can stop or reverse the effects of an opioid overdose.

Indications: Narcan (naloxone hydrochloride) nasal spray in an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. It is intended for immediate administration as emergency therapy in settings where opioids may be present.

Dosage/Administration: Narcan is for intranasal use only and should be administered as a single spray to adults or pediatric patients intranasally into one nostril. Administer additional doses using a new nasal spray with each dose, it the patient does not respond or responds and then relapses into respiratory depression. Additional does may be given every 2 to 3 minutes until emergency medical assistance arrives. Nasal spray strength is 4 mg of naloxone hydrochloride in 0.1 mL.

Adverse Reactions: Adverse reactions observed in a Narcan nasal spray clinical study included increased blood pressure, musculoskeletal pain, headache, nasal dryness, nasal edema, nasal congestion, and nasal inflammation.

Citation: U.S. Food and Drug Administration. FDA moves quickly to approve easy-to-use nasal spray to treat opioid overdose. FDA Web site. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm473505.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed November 23, 2015.