NARCAN® (naloxone HCl) nasal spray 2mg approved by U.S. Food and Drug Administration (FDA).
The U.S. FDA approved NARCAN® Nasal Spray as a 2mg formulation for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. The 2mg dose is approved for use in 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.
This approval comes just over one year after the FDA approved the first-of-its-kind, ready-to-use, needle-free version of naloxone, NARCAN® Nasal Spray 4mg, which has been commercially available since February 2016 following expedited FDA review and approval.
NARCAN® Nasal Spray 2mg and 4mg are concentrated naloxone nasal sprays providing ready-to-use emergency treatments of opioid overdose, including prescription opioid painkiller-, fentanyl-, carfentanil- and heroin-related overdose. NARCAN® Nasal Spray is not a substitute for emergency medical care.
ABOUT NARCAN® (naloxone HCl) NASAL SPRAY
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. Always seek emergency medical assistance in the event of a suspected, potentially life-threatening opioid emergency after administration of the first dose of NARCAN® nasal spray.
If the desired response is not obtained after 2 or 3 minutes, administer an additional dose of NARCAN® Nasal Spray in an alternate nostril using a new NARCAN® Nasal Spray. If the patient responds to NARCAN® Nasal Spray and relapses back into respiratory depression before emergency assistance arrives, administer an additional dose and continue surveillance of the patient. If there is still no response and additional doses are available, administer additional doses of NARCAN® Nasal Spray every 2 to 3 minutes using a new NARCAN® Nasal Spray in alternate nostrils with each dose until emergency medical assistance arrives. Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance.
(Source: PR Newswire)