Naloxone Hydrochloride (nal-OX-one hye-droe-KLOR-ide)

Treats opioid overdose in an emergency situation. Must be given as soon as possible.

Brand Name(s):

Kloxxado, Narcan, Rextovy, Rivive

When This Medicine Should Not Be Used:

How to Use This Medicine:

Spray

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Your doctor or a pharmacist can tell you where to buy this medicine. It is available without a doctor's order at most major pharmacies. Follow the instructions on the medicine label if you are using this medicine without a prescription.
• This medicine must be given to you (the patient) by someone else. Talk with people close to you so they know what to do in case of an emergency.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• This medicine is for use only in the nose. Do not get any of it in your eyes or on your skin. If it does get on these areas, rinse it off right away.
• To use:
  • Each nasal spray contains only one dose of naloxone. Do not prime or test the nasal spray.
  • Hold the nasal spray with your thumb on the bottom of the plunger and your first and middle fingers on either side of the nozzle.
  • Lay the patient on his or her back. Support the patient's neck with your hand and let the head tilt back.
  • Gently insert the tip of the nozzle into one nostril, until your fingers on either side of the nozzle are against the bottom of the patient's nose.
  • Press the plunger firmly to give the dose. Remove the nasal spray from the patient's nose.
  • Move the patient on his or her side (recovery position). Get emergency medical help right away.
  • Watch the patient closely. If needed, you may give more doses every 2 to 3 minutes until the patient responds. Use a new nasal spray for each dose and spray the medicine into the other nostril each time.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Do not freeze or expose to excessive heat. If the spray is frozen and is needed in an emergency, do not wait for the spray to thaw. Get medical help right away. However, the spray may be thawed for 15 minutes in room temperature, and it can still be used if it has been thawed after being frozen before.
• Ask your pharmacist about the best way to dispose of medicine that you do not use.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have heart or blood vessel disease.
• This medicine should be given right away after a suspected or known overdose of an opioid medicine. This will help prevent serious breathing problems and severe sleepiness that can lead to death.
• The effects of the opioid medicine may last longer than the effects of the naloxone. This means the breathing problems and sleepiness could come back. Always call for emergency help after the first dose of naloxone.
• This medicine could cause withdrawal symptoms from the opioid medicine.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Crying more than usual (in babies)
• Diarrhea, nausea, vomiting, stomach cramps or pain
• Fast, pounding, or uneven heartbeat
• Fever, runny nose, sneezing, sweating, yawning, discomfort in the nose
• Lightheadedness, dizziness, fainting
• Ongoing trouble breathing
• Seizure, shaking, or feeling restless, nervous, or irritable
• Unusual tiredness or weakness

If you notice these less serious side effects, talk with your doctor:

• Headache
• Joint or muscle pain

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088