Patient FAQs
KLOXXADO® provides an option for 8 mg of naloxone HCl per spray in a single dose.* KLOXXADO® can be used by anyone to reverse the effects of an opioid overdose until medical help arrives.* Each box of KLOXXADO® contains two individually packaged single-spray devices.*
Always carry KLOXXADO® with you in case of an opioid emergency.
* KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021
Use KLOXXADO® Nasal Spray right away if you think there are signs of an opioid overdose emergency.* Get emergency medical help right away after giving the first dose of KLOXXADO® Nasal Spray, even if the person wakes up.*
Some signs of an opioid overdose include:*
-
- unusual sleepiness and 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
Get emergency medical help right away in any case of known or suspected overdose.
KLOXXADO® is not a substitute for emergency medical care.* Administer in accordance with the Instructions for Use.
* KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021
Read the KLOXXADO® Quick Instructions resource or visit the How to Use page for detailed information about how to administer KLOXXADO®.
Remember:
- Use KLOXXADO® Nasal Spray exactly as prescribed by your healthcare provider.*
- KLOXXADO® Nasal Spray is for use in the nose only.*
- Do not remove or test the KLOXXADO® Nasal Spray device until ready to use.*
- Each KLOXXADO® Nasal Spray device contains only one dose of medicine and cannot be reused.*
- KLOXXADO® Nasal Spray should be given into one nostril.*
- If additional doses are needed, give KLOXXADO® Nasal Spray in the other nostril.*
- KLOXXADO® is not a substitute for emergency medical care.*
* KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021
Yes, KLOXXADO® Nasal Spray is for intranasal (in the nose/nostril) use only.*
* KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021
No, treatment of suspected opioid overdose is usually performed by someone other than the affected person. Make sure your family and friends know where KLOXXADO® is stored and how to use it.*
* KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021
Opioids work by attaching to specific receptors found in the brain and in the nervous system.‡ This includes the nerves that sense pain, as well as the nerves that control breathing.† Taking too many opioids can lead to an overdose and that can stop someone from breathing.‡
Naloxone, the active ingredient in KLOXXADO®, stops the opioids from attaching to the receptors on the nerves.* This reverses the effects and symptoms of the overdose.*†
KLOXXADO® Nasal Spray is administered in the nostril and does not require evidence of breathing through the nose during administration.*
Get emergency medical help right away in any case of known or suspected overdose emergency. KLOXXADO® Nasal Spray is not a substitute for emergency medical care.* Administer in accordance with the instructions provided in the KLOXXADO® Quick Instructions resource.
Each device is a single dose.* If an additional dose is needed, you must use another device.*
* KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021.
† NIDA 2021. “Naloxone DrugFacts,” National Institute on Drug Abuse, https://www.drugabuse.gov/publications/drugfacts/naloxone, Accessed May 3, 2021.
‡ White JM & Irvine RJ. 1999, “New Horizons/Mechanisms of fatal opioid overdose,” Addiction, 94(7):961–972.
No, you cannot reuse KLOXXADO® Nasal Spray.* Each device is single-use, single-dose only.* It is intended to be sprayed once, in a nostril, and then discarded.*
* KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021
A second dose of KLOXXADO® Nasal Spray may be necessary. One dose of naloxone may not be enough to reverse the effects of an opioid overdose. Or, sometimes, the naloxone dose can wear off before the opioids—necessitating another dose.*
Emergency medical services (EMS) should be called immediately after administering the first dose and will hopefully arrive before a second dose is needed. But if help hasn’t arrived, bystanders can administer additional doses of KLOXXADO® Nasal Spray every 2 to 3 minutes in alternating nostrils if the patient doesn’t respond, responds insufficiently or relapses back into respiratory depression.*
Get emergency medical help right away in any cases of known or suspected overdose emergency. KLOXXADO® Nasal Spray is not a substitute for emergency medical care.* Administer in accordance with the Instructions for Use. See KLOXXADO® Quick Instructions document.
* KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021
Naloxone HCl has no potential for abuse or overdose. Naloxone is safe to use even if opioids are not present.*†
* Stop Overdose/Frequently Asked Questions about Naloxone. Centers for Disease Control and Prevention website. Available at: https://www.cdc.gov/stopoverdose/naloxone/faq.html. Accessed June 25, 2023.
† Naloxone DrugFacts. National Institute on Drug Abuse website. Available at: https://nida.nih.gov/publications/drugfacts/naloxone. Accessed June 25, 2023.
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.
The most common side effects in adults include: stomach-area (abdomen) pain, weakness, dizziness, headache, nose (nasal) discomfort, and a feeling like you are going to faint.*
Serious side effects include sudden opioid withdrawal symptoms. In someone who has been using opioids regularly, opioid withdrawal symptoms can happen suddenly after receiving KLOXXADO® Nasal Spray and may include 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, or increased blood pressure.*
For more information, please see the full Prescribing Information and Important Safety Information.
To report an adverse event or product complaint, please contact us at [email protected] or call 1-877- 845-0689 or 1-800-962-8364. Adverse events may also be reported to the FDA directly at 1-800-FDA-1088 or www.fda.gov/medwatch.
* KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021
KLOXXADO® is a prescription medicine. KLOXXADO® Nasal Spray is available at your local pharmacy with a prescription from your doctor. Ask your doctor if a prescription for naloxone is right for you. Depending on your state, KLOXXADO® may also be available through a standing order. Check with your state to see if this applies.
Organizations wishing to order KLOXXADO® Nasal Spray:
Qualified public entities such as government entities, first responders, community organizations, schools and universities can purchase at a discounted price through KLOXXADODirect™.
KLOXXADO® is covered by many health insurance plans, including most Medicaid programs. Contact your insurance provider to learn more.
Active ingredient: naloxone hydrochloride*
Inactive ingredients: benzalkonium chloride, disodium ethylenediaminetetraacetate, sodium chloride, hydrochloric acid and purified water.*
KLOXXADO® is not made with natural rubber latex.*
* KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021
- Store at room temperature 68°F to 77°F (20°C to 25°C).*
- Do not freeze. Do not expose to temperatures below 41°F (5°C) or above 104°F (40°C).*
- Keep KLOXXADO® Nasal Spray in its box until ready to use. Protect from light.*
- Replace KLOXXADO® Nasal Spray before the expiration date on the box.*
Keep KLOXXADO® Nasal Spray and all medicines out of the reach of children.*
* KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021
Please see full Prescribing Information.
If you or someone you love is at risk for misusing opioids, resources and help are available. Find information about substance use disorder treatment options on findtreatment.gov, a product of the Substance Abuse and Mental Health Services Administration. Connect with harm reduction resources near you at harmreduction.org, the official website of the National Harm Reduction Coalition.
Naloxone, the medicine in KLOXXADO®, works only if a person has opioids in their system.*† It is safe to use even if opioids aren’t present.† Administering naloxone is unlikely to harm someone, but it could save their life if they are experiencing an opioid overdose.†
* KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021
† Access to Naloxone Can Save a Life During an Opioid Overdose. US Food and Drug Administration website. Available at: https://www.fda.gov/consumers/consumer-updates/access-naloxone-can-save-life-during-opioid-overdose. Accessed March 5, 2023.
KLOXXADO® is a prescription medication available at retail pharmacies across the U.S. Talk to your doctor to find out if KLOXXADO® is right for you. Depending on your state, KLOXXADO® may also be available through a standing order. Check with your state to see if this applies.
The idea of discussing the risks of opioid overdose may be uncomfortable, but your doctor is ready for it. If you think there is a risk for you or your family, talk to your doctor about a KLOXXADO® prescription.
Anyone taking opioids could be at risk for accidental opioid overdose. You may be at a higher risk of accidental overdose if you take opioids and:
- Have a history of overdose or a substance use disorder (SUD)
- Have sleep apnea or other sleep-disordered breathing
- Are taking higher dosages of opioids (e.g., ≥50 MME/day)
- Are returning to a high dose after losing tolerance (e.g., patients undergoing tapering or recently released from prison)
- Take benzodiazepines with opioids
- Have kidney or liver failure
- Are 65 years and older
* Opioids/Risks and How to Reduce Them. Centers for Disease Control and Prevention website. Available at: https://www.cdc.gov/opioids/patients/reduce-risks.html. Accessed June 23, 2023
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. Keeping KLOXXADO® on hand is one more way to be prepared for an opioid overdose emergency.‡¶
* KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021.
† Stop Overdose – Naloxone. CDC, https://www.cdc.gov/stopoverdose/naloxone/index.html, Accessed June 22, 2023.
‡ 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.
¶ The clinical significance of a higher dose is currently unknown.
Opioid & Fentanyl FAQs
KLOXXADO® provides an option for 8 mg of naloxone HCl per spray in a single dose.* KLOXXADO® can be used by anyone to reverse the effects of an opioid overdose until medical help arrives.* Each box of KLOXXADO® contains two individually packaged single-spray devices.*
Always carry KLOXXADO® with you in case of an opioid emergency.
* KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021
Opioids work by attaching to specific receptors found in the brain and in the nervous system.‡ This includes the nerves that sense pain, as well as the nerves that control breathing.† Taking too many opioids can lead to an overdose and that can stop someone from breathing.‡
Naloxone, the active ingredient in KLOXXADO®, stops the opioids from attaching to the receptors on the nerves.* This reverses the effects and symptoms of the overdose.*†
KLOXXADO® Nasal Spray is administered in the nostril and does not require evidence of breathing through the nose during administration.*
Get emergency medical help right away in any case of known or suspected overdose emergency. KLOXXADO® Nasal Spray is not a substitute for emergency medical care.* Administer in accordance with the instructions provided in the KLOXXADO® Quick Instructions resource.
Each device is a single dose.* If an additional dose is needed, you must use another device.*
* KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021.
† NIDA 2021. “Naloxone DrugFacts,” National Institute on Drug Abuse, https://www.drugabuse.gov/publications/drugfacts/naloxone, Accessed May 3, 2021.
‡ White JM & Irvine RJ. 1999, “New Horizons/Mechanisms of fatal opioid overdose,” Addiction, 94(7):961–972.
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.
The most common side effects in adults include: stomach-area (abdomen) pain, weakness, dizziness, headache, nose (nasal) discomfort, and a feeling like you are going to faint.*
Serious side effects include sudden opioid withdrawal symptoms. In someone who has been using opioids regularly, opioid withdrawal symptoms can happen suddenly after receiving KLOXXADO® Nasal Spray and may include 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, or increased blood pressure.*
For more information, please see the full Prescribing Information and Important Safety Information.
To report an adverse event or product complaint, please contact us at [email protected] or call 1-877- 845-0689 or 1-800-962-8364. Adverse events may also be reported to the FDA directly at 1-800-FDA-1088 or www.fda.gov/medwatch.
* KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021
If you or someone you love is at risk for misusing opioids, resources and help are available. Find information about substance use disorder treatment options on findtreatment.gov, a product of the Substance Abuse and Mental Health Services Administration. Connect with harm reduction resources near you at harmreduction.org, the official website of the National Harm Reduction Coalition.
Naloxone, the medicine in KLOXXADO®, works only if a person has opioids in their system.*† It is safe to use even if opioids aren’t present.† Administering naloxone is unlikely to harm someone, but it could save their life if they are experiencing an opioid overdose.†
* KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021
† Access to Naloxone Can Save a Life During an Opioid Overdose. US Food and Drug Administration website. Available at: https://www.fda.gov/consumers/consumer-updates/access-naloxone-can-save-life-during-opioid-overdose. Accessed March 5, 2023.
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