KLOXXADO® contains 8 mg of naloxone HCl, a medicine that can reverse the effects of opioids including fentanyl and fentanyl analogs.*† Synthetic fentanyl can impact us all. Help your [...]
If a patient obtains opioids from anywhere other than a pharmacy, they are at risk of acquiring counterfeit medications that contain illicitly manufactured synthetic opioids.* In these situations, your [...]
In two pharmacokinetic (PK) studies of 47 healthy adult volunteers, the following adverse reactions were reported in two subjects each: abdominal pain, asthenia, dizziness, headache, nasal discomfort, and presyncope. [...]
KLOXXADO® (naloxone HCl) Nasal Spray 8 mg is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous [...]
Yes.* * FDA 2021, “FDA Approves Higher Dosage of Naloxone Nasal Spray to Treat Opioid Overdose,” https://www.fda.gov/news-events/press-announcements/fda-approves-higher-dosage-naloxone-nasal-spray-treat-opioid-overdose, Accessed May 3, 2021.
You are encouraged to report negative side effects to the FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch. You can also contact Hikma Specialty USA Inc. at: [email protected] or call 1-877-845-0689 or 1-800-962-8364. [...]
KLOXXADO® is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients in KLOXXADO®.* * KLOXXADO® (naloxone HCl) Nasal Spray [prescribing [...]
Co-prescribing naloxone is recommended for your patients who are taking opioids, and:* Have a history of overdose or a substance use disorder (SUD) Have sleep apnea or other sleep-disordered [...]
What is KLOXXADO® Nasal Spray?
What is the most important information I should know about KLOXXADO® Nasal Spray?
Get emergency medical help right away after giving the first dose of KLOXXADO® Nasal Spray. The signs and symptoms of an opioid emergency can return after KLOXXADO® Nasal Spray is given. If this happens, give another dose after 2 to 3 minutes using a new KLOXXADO® Nasal Spray and watch the person closely until emergency help is received.
The medicine in KLOXXADO® Nasal Spray is safe to use in people who are not taking opioids. KLOXXADO® Nasal Spray is not intended for self-administration.
What should I tell my healthcare provider (pharmacist or prescriber) before using?
Before using KLOXXADO® Nasal Spray, tell your healthcare provider about all of your medical conditions, including if you:
What are the possible serious side effects of KLOXXADO® Nasal Spray?
KLOXXADO® Nasal Spray may cause sudden opioid withdrawal symptoms including body aches, diarrhea, increased heart rate, fever, runny nose, sneezing, goose bumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, stomach cramping, weakness, and increased blood pressure.
In infants under 4 weeks old who have been receiving opioids regularly, sudden opioid withdrawal may be life-threatening if not treated the right way. Signs and symptoms include seizures, crying more than usual, and increased reflexes.
Who should not use KLOXXADO® Nasal Spray?
Do not use KLOXXADO® Nasal Spray if you are allergic to naloxone hydrochloride or any of the ingredients in KLOXXADO® Nasal Spray.
What are the most common side effects of KLOXXADO® nasal spray?
The most common side effects of KLOXXADO® Nasal Spray in adults include stomach-area (abdomen) pain, weakness, dizziness, headache, nose (nasal) discomfort, and a feeling like you are going to faint.
These are not all of the possible side effects of KLOXXADO® Nasal Spray. Please click here for the accompanying full Prescribing Information, including Patient Information, which includes a more complete discussion of the risks associated with KLOXXADO® Nasal Spray. Always contact your healthcare provider (pharmacist or prescriber) if you have questions or experience any side effects.
You are encouraged to report negative side effects to the FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch. You can also contact Hikma Specialty USA Inc. at: [email protected] or call 1-877-845-0689 or 1-800-962-8364.
Tell Us About a Side Effect
1-877-845-0689 or 1-800-962-8364 | Email
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KLOXXADO®️ is a registered trademark of Hikma Pharmaceuticals USA Inc.
Better Health. Within Reach. Every Day.®️ is a registered trademark of Hikma Pharmaceuticals PLC.
Emergent Devices Inc. is wholly owned subsidiary of Emergent BioSolutions Inc.
KLOXXADO® is manufactured by Hikma Pharmaceuticals USA Inc. Columbus, OH 43228, and distributed by Emergent Devices Inc. Plymouth Meeting, PA 19462.
PP-KLOX-US-00040
July 2025