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FDA Approves NARCAN® (naloxone HCl) Nasal Spray 4mg

On November 18, 2015, after Fast Track Designation and Priority Review, the US Food and Drug Administration (FDA) approved NARCAN® (naloxone HCl) Nasal Spray 4mg for commercial use in the United States. NARCAN® Nasal Spray became commercially available in early 2016.

Visit www.NarcanNasalSpray.com to learn more. Find the official press release, including Indications and Important Safety Information here.

Group purchasers, such as law enforcement, firefighters, first responders, departments of health, educational facilities and community-based organizations can learn more about pre-ordering and purchasing NARCAN® Nasal Spray at (844) 4-NARCAN (844-462-7226) or customerservice@adaptpharma.com

Indications

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.

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, diarrhea, increased heart rate (tachycardia), fever, runny nose, sneezing, goose bumps (piloerection), sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure. In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated and may be characterized by convulsions, excessive crying, and hyperactive reflexes. Monitor for the development of opioid withdrawal.

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.

The following adverse reactions were observed in a NARCAN Nasal Spray clinical study: increased blood pressure, musculoskeletal pain, headache, nasal dryness, nasal edema, nasal congestion, and nasal inflammation.

See Instructions for Use and full prescribing information in the use of this product.

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.