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Product Information

Kloxxado® Quick Use Instructions

Easy-to-follow instructions for administering Kloxxado®.

En Español ›

Kloxxado® Patient Information

View Kloxxado® Patient Information online.

Who Should Carry Kloxxado®

Wondering if naloxone should be part of your first aid kit? This checklist will help you decide.

Kloxxado® Quick Use Instructions – Spanish

En español: instrucciones fáciles de seguir para administrar Kloxxado®.

Kloxxado® Community One-Pager

Find out why your community may need more naloxone.

Be Ready Postcard

Use this postcard to help spread the word about Kloxxado®.

The MORE Study

Life Saving Confidence

Listen to the voices of real people who participated in The MORE Study as they recount their experience using naloxone HCI nasal spray 4 mg.1

Real-world study of multiple naloxone administration for opioid overdose reversal among bystanders

Known as The MORE Study, this recent study published in the Harm Reduction Journal found that 78% of opioid overdose reversals required multiple doses of Narcan® Nasal Spray 4 mg, which suggests  the need for a naloxone nasal spray that contains 8 mg of naloxone in a single dose.1

Read the Study

Guidance & Recommendations

AT Forum Explains Kloxxado®

The Addiction Treatment Forum describes how the opioid epidemic has evolved and why patients need Kloxxado®.

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FDA on Kloxxado® Approval

The FDA describes the approval of Kloxxado® as meeting “another critical need in combatting opioid overdose.”

Read More

FDA Recommendations

The FDA urges healthcare professionals to discuss naloxone with their patients.6
Read More

FDA Statement on Naloxone

Learn why the FDA is expanding access to naloxone.

Read More

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 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.

Distributed by: Hikma Specialty USA Inc., Columbus, OH 43228.

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

© Hikma Specialty USA Inc. All rights reserved.
NARCAN® is a registered trademark of Emergent Operations Ireland Limited.

KLOXXADO®️ is a registered trademark of Hikma Pharmaceuticals USA Inc.
The brand statement “Better Health. Within Reach. Every Day.” is a registered trademark of Hikma Pharmaceuticals PLC.

HK-1266-v3

June 2023

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

Contraindications