Pharmacists2025-04-22T15:55:25-04:00

Pharmacists

Your pharmacy patients may be at increased risk for opioid overdose. Help them be ready with KLOXXADO® (naloxone HCl) Nasal Spray 8 mg.

Kloxxado Inhaler

Naloxone is a critical tool in opioid overdose response1

Any patient prescribed an opioid may be at risk of opioid overdose2—consider co-dispensing naloxone. KLOXXADO® provides an option for 8 mg per spray in a single dose.3

  • A high dose option.3
  • Stocked at all major wholesalers

Is your pharmacy prepared to dispense KLOXXADO®? It’s simple and easy to keep in stock.

Overdose doesn’t wait for your wholesaler

Extremely potent, illegally-made synthetic opioids like fentanyl are the most common drugs involved in overdose deaths in the United States.5

KLOXXADO® Nasal Spray provides another tool for responding to synthetic fentanyl overdoses. A higher dose option for those who may need more.*3

Synthetic fentanyl can impact us all6, consider stocking KLOXXADO® in your pharmacy.

* The clinical significance of a higher dose is currently unknown.

Get the facts about fentanyl ›

More than 150 people die from synthetic opioid overdose each day5

Adding KLOXXADO® is another step forward to help people stay safe if an opioid overdose happens1,2

Minutes Matter

During an opioid overdose, 4 minutes without breathing can cause permanent brain damage.7 With EMS response times for an opioid emergency averaging 13 minutes8, KLOXXADO® can provide an additional step to help prevent accidental death by opioid overdose.4

Find out more

How do I stock and dispense KLOXXADO®?

KLOXXADO® is available from your regular wholesalers. Here’s the item number to find it. Need help? Contact us.

Product Image Strength Unit Size/Quantity NDC Number WAC Wholesaler Item #
8mg / 0.1mL Carton: 2-unit dose nasal spray devices 59467-679-01 $125.00 AmeriSource Bergen 10260066
Cardinal 5735550
McKesson 2342855
Morris & Dickson 104455

Product Description: Clear, colorless-to-yellow solution supplied in a single-dose spray device that consists of a stoppered glass vial encased in a container holder fitted with a spray actuator, cannula, and spray pin.

The Opioid Epidemic

With the spread of illegally-made, synthetic opioids like fentanyl, overdose deaths have grown across ages, races, ethnicities and communities.*†

*Drug Overdose Deaths Among Persons Aged 10-19 Years – United States, July 2019-December 2021. †Drug Overdose Deaths Rise, Disparities Widen. Centers for Disease Control and Prevention website. Available at: https://www.cdc.gov/vitalsigns/overdose-death-disparities/index.html. Accessed June 25, 2023.

Facts About Fentanyl

Facts About Fentanyl

Extremely potent, illegally-made synthetic opioids such as fentanyl and carfentanil are the most common drugs involved in overdose deaths in the United States.*

* Fentanyl Facts. Centers for Disease Control and Prevention website. Available at: https://www.cdc.gov/stop-overdose/caring/fentanyl-facts.html. Accessed March 17, 2025.

Understanding Overdose

Understanding Overdose

More than a million Americans will die this decade of an opioid overdose.* You could save someone.

* Humphreys et. Al. 2022, “Responding to the opioid crisis in North America and beyond: recommendations of the Stanford–Lancet Commission,” The Lancet, 399:10324, p555-604

Healthcare Resources

Access helpful online tools, videos, research studies, educational materials and more.

Get more resources

Healthcare FAQs

Find answers to questions about KLOXXADO® for healthcare professionals.

See frequently asked questions

KLOXXADO® Quick Use Instructions

Easy-to-follow instructions for administering KLOXXADO®.

See More Resources ›

References

  1. Access to Naloxone Can Save a Life During an Opioid Overdose. US Food & Drug Administration website. Available at: https://www.fda.gov/consumers/consumer-updates/access-naloxone-can-save-life-during-opioid-overdose#:~:text=Naloxone%20is%20a%20life%2Dsaving,including%20nasal%20sprays%20and%20injections. Accessed March 5, 2025.
  2. About Prescription Opioids. US Centers for Disease Control and Prevention website. Available at: https://www.cdc.gov/overdose-prevention/about/prescription-opioids.html. Accessed March 14, 2025.
  3. KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021.
  4. Preventing an Opioid Overdose Tip Card. US Centers for Disease Control and Prevention website. Available at: https://www.cdc.gov/overdose-resources/pdf/Preventing-an-Opioid-Overdose-Tip-Card-a_508.pdf. Accessed March 5, 2025.
  5. Fentanyl Facts. Centers for Disease Control and Prevention website. Available at: https://www.cdc.gov/stopoverdose/fentanyl/index.html. Accessed June 27, 2023.
  6. Opioid Crisis Affects All Americans, Rural and Urban. US Department of Agriculture website. Available at: https://www.usda.gov/about-usda/news/blog/opioid-crisis-affects-all-americans-rural-and-urban#:~:text=The%20effects%20of%20the%20opioid,olds%20and%20tripled%20for%20females. Accessed March 5, 2025.
  7. CPR – Adult and Child After Onset of Puberty. Mediline Plus website. Available at: https://medlineplus.gov/ency/article/000013.htm. Accessed April 22, 2025.
  8. Drug Overdose Surveillance Dashboard. National EMS Information System (NEMSIS). Available at: https://nemsis.org/drug-overdose-surveillance-dashboard. Accessed March 5, 2025.

Important Safety Information About KLOXXADO® (naloxone HCl) Nasal Spray 8 mg

Contraindications

Hypersensitivity to naloxone hydrochloride or to any of the other ingredients

Warnings and Precautions

  • Use KLOXXADO® right away if you suspect an opioid overdose emergency, even if you are not sure, because an opioid overdose emergency can cause severe injury or death. Signs and symptoms of an opioid overdose emergency may include:
    • Unusual sleepiness; you are not able to awaken the person with a loud voice or by rubbing firmly on the middle of their chest (sternum).
    • Breathing problems, including slow or shallow breathing in someone difficult to awaken or who looks like they are not breathing.
    • The black circle in the center of the colored part of the eye (pupil) is very small (sometimes called “pinpoint pupils”) in someone difficult to awaken.
  • Family members, caregivers or other people who may have to use KLOXXADO® in an opioid overdose emergency should know where KLOXXADO® is stored and how to give KLOXXADO® before an opioid overdose emergency happens.
  • Get emergency medical help right away after using the first dose of KLOXXADO®. Rescue breathing or CPR (cardiopulmonary resuscitation) may be needed while waiting for emergency medical help.
  • The signs and symptoms of an opioid overdose emergency can return after KLOXXADO® is given. If this happens, give another dose after 2 to 3 minutes, using a new KLOXXADO® device, alternating nostrils, and watch the person closely until emergency medical help arrives.
  • Do not use KLOXXADO® if you are allergic to naloxone hydrochloride or any of the ingredients in KLOXXADO®.
  • KLOXXADO® can cause sudden and severe opioid withdrawal, the symptoms of which may include body aches, diarrhea, increased heart rate, fever, runny nose, sneezing, goosebumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, stomach cramps, 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.
  • Tell your doctor about all of your medical conditions before using KLOXXADO®, including if you have heart problems, are pregnant or plan to become pregnant, are breastfeeding or plan to breastfeed.
  • Tell your doctor about all of the medicines you take, including prescription drugs and over-the-counter medicines, drugs, vitamins and herbal supplements.

Side Effects

The following serious side effect is discussed in the full Prescribing Information for KLOXXADO®:

  • Sudden and Severe Opioid Withdrawal

Symptoms of sudden and severe opioid withdrawal resulting from the use of KLOXXADO® in someone regularly using opioids include: body aches, diarrhea, increased heart rate, fever, runny nose, sneezing, goosebumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, stomach cramps, weakness and increased blood pressure.

Infants may have seizures, cry more than normal and have increased reflexes.

Some people may become aggressive after abrupt reversal of opioid overdose.

In two clinical studies, a total of 47 healthy adult volunteers were exposed to a single dose of KLOXXADO®, one spray in one nostril. Side effects were reported in two subjects for each of the following: abdominal pain, asthenia, dizziness, headache, nasal discomfort, and presyncope.

These are not all of the possible side effects of KLOXXADO®. Contact your doctor for medical advice about side effects.

Pregnancy, Infancy and Breastfeeding, Children

Tell your doctor if you are pregnant or plan to become pregnant. If you are pregnant and opioid dependent, use of KLOXXADO® may cause withdrawal symptoms in you and your unborn baby. A healthcare provider should monitor you and your unborn baby right away after you use KLOXXADO®.

There is no information regarding the presence of naloxone in human milk, the effects of naloxone on the breastfed infant or on milk production.

If the primary concern is an infant at risk of an overdose, consider whether other naloxone-containing products may be more appropriate.

KLOXXADO® nasal spray is safe and effective in children for known or suspected opioid overdose.

Dosage and Administration

Do not attempt to prime or test-fire the device. Each KLOXXADO® Nasal Spray contains only 1 dose of medicine and cannot be reused. Read the “instructions for use” at the end of the Prescribing Information and Medication Guide for detailed information about the right way to use KLOXXADO® Nasal Spray.

Storage and Handling

Store KLOXXADO® at room temperature between 68°F to 77°F (20°C to 25°C). Do not expose to temperatures below 41°F (5°C) or above 104°F (40°C). Do not freeze KLOXXADO®. Keep KLOXXADO® in its box until ready to use. Protect from light. Replace KLOXXADO® before the expiration date on the box. Keep KLOXXADO® and all medicines out of the reach of children.

For more information, please see the full Prescribing Information and Medication Guide.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/medwatch or call 1-800-FDA-1088.

This website is intended for U.S. audiences
Customer Service: Phone 1-800-631-2174 | Email

© Hikma Pharmaceuticals USA Inc. All rights reserved.

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-00025

March 2025

This website uses cookies and third party services. Please see our cookie policy and privacy policy for more information. OK
Go to Top
Read More...

Important Safety Information About KLOXXADO® (naloxone HCl) Nasal Spray 8 mg

Contraindications