Patient & Caregiver FAQs

Frequently Asked Questions2025-04-23T11:44:41-04:00

Patient FAQs

What is Kloxxado® (naloxone HCl) nasal spray 8 mg?2023-07-15T10:36:33-04:00

Kloxxado® is a nasal spray that contains a single spray with 8 mg of naloxone HCl.* 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

When should Kloxxado® be used?2023-07-15T10:54:47-04:00

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.*

Signs of an opioid overdose may 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

How do I use Kloxxado® nasal spray 8 mg?2023-07-15T10:49:57-04:00

Read the Kloxxado® Quick Instructions for Use 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

Does Kloxxado® only work in the nose?2023-07-15T10:53:03-04:00

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

Can I give myself Kloxxado® nasal spray?2023-07-15T10:59:08-04:00

No, treatment of suspected opioid overdose is usually performed by someone other than the affected person. This is why you should tell the people around you where you keep Kloxxado®.*

* KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021

How does Kloxxado® nasal spray work?2023-07-15T10:57:12-04:00

Kloxxado® nasal spray is administered in the nostril and does not require evidence of breathing through the nose during administration.*

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.*‡

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 for Use.

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.
† White JM & Irvine RJ. 1999, “New Horizons/Mechanisms of fatal opioid overdose,” Addiction, 94(7):961–972.
‡ NIDA 2021. “Naloxone DrugFacts,” National Institute on Drug Abuse, https://www.drugabuse.gov/publications/drugfacts/naloxone, Accessed May 3, 2021.

Can I reuse Kloxxado® nasal spray?2023-07-15T11:00:53-04:00

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

Will one dose of Kloxxado® work to reverse an overdose or will a second dose be needed?2023-05-26T16:16:07-04:00

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 that involves strong opioids. 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 for Use.

* KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021

Is Kloxxado® nasal spray addictive?2023-07-15T11:08:13-04:00

Naloxone HCl has no potential for abuse or overdose. It does not work in the absence of opioids.*†

* 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.

What are the possible side effects from using Kloxxado® nasal spray?2023-09-15T14:08:25-04:00

Across Kloxxado® nasal spray’s two pharmacokinetics (PK) studies, adverse reactions were reported in two subjects for each of the following: abdominal pain, asthenia, dizziness, headache, nasal discomfort, and presyncope.*

Risks include: Risk of Recurrent Respiratory & CNS Depression; Risk of limited efficacy with partial agonists or mixed agonist/antagonists; Precipitation of severe opioid withdrawal; Risk of CV effects.*

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

Where can I get KLOXXADO® Nasal Spray?2025-03-13T23:39:00-04:00

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™.

Is KLOXXADO® Nasal Spray covered by insurance?2025-04-21T17:40:22-04:00

KLOXXADO® is covered by many health insurance plans, including most Medicaid programs. Contact your insurance provider to learn more.

What are the ingredients in Kloxxado® nasal spray?2023-07-15T11:16:46-04:00

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

How should I store Kloxxado® nasal spray?2023-07-15T11:20:26-04:00

  • 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

Where can I get additional information on Kloxxado®?2023-05-26T16:15:37-04:00

Please see full Prescribing Information.

Someone I know may be misusing opioids. Where can I learn more?2023-07-15T11:21:38-04:00

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.

What happens if you give Kloxxado® to someone who is not on opioids?2023-07-15T11:23:14-04:00

Naloxone, the medicine in Kloxxado®, works only if a person has opioids in their system.*† It has no effect if opioids are not 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.

Do I need a prescription to get KLOXXADO®?2025-03-13T23:33:45-04:00

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.

How do I talk to my doctor about KLOXXADO®?2025-04-21T17:39:26-04:00

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

Can KLOXXADO® reverse an overdose on illicitly manufactured fentanyl or fentanyl analogs?2025-03-17T17:57:21-04:00

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 patients be prepared with KLOXXADO® – a higher dose option for opioid overdose response.‡

* 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

What is Kloxxado® (naloxone HCl) nasal spray 8 mg?2023-07-15T10:36:33-04:00

Kloxxado® is a nasal spray that contains a single spray with 8 mg of naloxone HCl.* 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

How does Kloxxado® nasal spray work?2023-07-15T10:57:12-04:00

Kloxxado® nasal spray is administered in the nostril and does not require evidence of breathing through the nose during administration.*

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.*‡

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 for Use.

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.
† White JM & Irvine RJ. 1999, “New Horizons/Mechanisms of fatal opioid overdose,” Addiction, 94(7):961–972.
‡ NIDA 2021. “Naloxone DrugFacts,” National Institute on Drug Abuse, https://www.drugabuse.gov/publications/drugfacts/naloxone, Accessed May 3, 2021.

What are the possible side effects from using Kloxxado® nasal spray?2023-09-15T14:08:25-04:00

Across Kloxxado® nasal spray’s two pharmacokinetics (PK) studies, adverse reactions were reported in two subjects for each of the following: abdominal pain, asthenia, dizziness, headache, nasal discomfort, and presyncope.*

Risks include: Risk of Recurrent Respiratory & CNS Depression; Risk of limited efficacy with partial agonists or mixed agonist/antagonists; Precipitation of severe opioid withdrawal; Risk of CV effects.*

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

Someone I know may be misusing opioids. Where can I learn more?2023-07-15T11:21:38-04:00

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.

What happens if you give Kloxxado® to someone who is not on opioids?2023-07-15T11:23:14-04:00

Naloxone, the medicine in Kloxxado®, works only if a person has opioids in their system.*† It has no effect if opioids are not 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.

Don’t see an answer to your question? Contact us

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-00024

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