Naloxone

Naloxone is a prescription medication used to treat opioid overdose. Naloxone is not a substitute for emergency medical care.

Naloxone Overview

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Naloxone is a prescription medication used to treat the side effects of opioids (narcotics), opioid overdose, and opioid effects in babies delivered by mothers with opioid addiction. Naloxone belongs to a group of drugs called opioid antagonists, they work by by blocking the effects of opioids to relieve dangerous symptoms caused by high levels of opioids in the blood.

Naloxone is the active ingredient of a variety of medications found in many different forms including injectable solution to be given directly into a vein (IV), the muscle (IM), or directly under the skin (SQ). This medication is also available as a nasal spray and a prefilled syringe for intranasal use. 

Common side effects of naloxone include opioid withdrawal (if patient is dependent), low or high blood pressure, and injection site reactions.

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Naloxone Cautionary Labels

precautions

Uses of Naloxone

Naloxone is a prescription medication used to treat the side effects of opioids (narcotics), opioid overdose, and opioid effects in babies delivered by mothers with opioid addiction. Signs and symptoms of an opioid overdose may include the following:

  • extreme sleepiness - inability to awaken a patient verbally or with a firm sternal rub
  • respiratory depression - this can range from slow or shallow breathing to no breathing
  • miosis (constriction of eye pupil) - very small pupils
  • slow heart beat and/or low blood pressure

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Naloxone Brand Names

Naloxone may be found in some form under the following brand names:

Naloxone Drug Class

Naloxone is part of the drug class:

Side Effects of Naloxone

Serious side effects have been reported with naloxone. See the “Naloxone Precautions” section.

Common side effects of naloxone include the following:

  • changes in heart rhythm
  • shortness of breath
  • nausea 
  • vomiting
  • sweating
  • fast heart rate
  • trembling
  • seizures
  • pulmonary edema (fluid accumulation in lungs)
  • cardiac arrest (sudden loss of heart function)
  • paraesthesia (tingling or pricking)
  • agitation
  • respiratory depression (breathing problems)
  • hypoxia (oxygen deficiency)
  • injection site reactions (swelling and redness)
  • low blood pressure
  • increased blood pressure
  • hot flushes
  • flushing

This is not a complete list of naloxone side effects. Ask your doctor or pharmacist for more information. Tell your doctor if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

 

Naloxone Interactions

No naloxone drug interactions have been studied by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

 

Naloxone Precautions

Serious side effects have been reported with naloxone including the following: 

 

  • Risk of recurrent respiratory and central nervous system (CNS) depression (problems with breathing and nervous system function) . Naloxone effects do not last long; threfore, it is necessary to seek medical help right after the administration of the first dose of naloxone. Also, additional doses might be necessary to sustain its effects.
  • Risk of limited efficacy with partial agonists or mixed agonist/antagonists. Naloxone may not be effective  for managing overdose from drugs like buprenorphine and pentazocine. Larger or repeat doses of naloxone may be required. 
  • Precipitation of severe opioid withdrawal (causing narcotic withdrawal symptoms). Naloxone may cause opioid withdrawal in patients with opioid dependance. Opioid withdrawal is characterized by the following signs and symptoms: body aches, diarrhea, fast heart beat, fever, runny nose, sneezing, sweating, yawning, nausea or vomiting, nervousness, irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure. The doctor will monitor the patient for the development of the signs and symptoms of opioid withdrawal. In babies, opioid withdrawal may be life-threatening and may include the following signs and symptoms: convulsions, excessive crying, and jerking movements.
  • Risk of cardiovascular (heart) event. Patients with heart problems should be closely observed by the doctor when treated with naloxone due to an increased risk of convulsions, heart arrhythmias, lung edema (fluid build up in the lungs), and sudden loss of heart function.
  • Respiratory depression (serious breathing problems) due to other drugs. Naloxone is not effective against respiratory depression caused by non-opioid drugs. 

Do not use naloxone if you:

  • are allergic to naloxone or to any of its ingredients

Naloxone Food Interactions

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of naloxone, there are no specific foods that you must exclude from your diet when receiving this medication.

Inform MD

Before taking naloxone, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

  • are allergic to naloxone or to any of its ingredients
  • have or have had a heart condition
  • have an addiction or dependance on any substance
  • are pregnant or breastfeeding

Naloxone and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Naloxone and Lactation

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if naloxone crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using naloxone.

Naloxone Usage

Take naloxone exactly as prescribed.

Naloxone is the active ingredient of a variety of medications found in many different forms including injectable solution to be given directly into a vein (IV), the muscle (IM), or directly under the skin (SQ). This medication is also available as a nasal spray and a prefilled syringe for intranasal use. 

Naloxone Dosage

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

  • the condition being treated
  • other medical conditions you have
  • other medications you are taking
  • how you respond to this medication
  • naloxone formulation
  • your weight
  • your age

The recommended dose range of naloxone in adults for IV (into a vein), IM (into a muscle), and SQ (under the skin) is 0.4 mg to 2 mg. If the desired effect is not observed, it may be repeated at 2 to 3 minute intervals. If no response is observed after 10 mg of naloxone have been administered, the narcotic overdose is unlikely.

The recommended dose of naloxone in children for IV use (into a vein) is 0.01 mg/kg body weight. If desired effect is not observed, a subsequent dose of 0.1 mg/kg body weight may be administered.

The recommended dose of naloxone nasal spray in adults and children is one spray (4 mg) into one nostril. Additional doses of naloxone may be required (if the patient does not respond or responds and then relapses into respiratory depression). Additional doses may be given every 2 to 3 minutes until emergency medical assistance arrives.

The recommended dose of naloxone for intranasal prefilled syringe is 2mg into each nostril. Additional doses of naloxone may be required (if the patient does not respond or responds and then relapses into respiratory depression). Additional doses may be given every 2 to 3 minutes until emergency medical assistance arrives.

 

 

 

Naloxone Overdose

If you take too much naloxone, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If naloxone is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Other Requirements

  • Store naloxone at room temperature between 59°F to 77°F (15°C to 25°C).
  • Keep naloxone in its outer case until ready to use.
  • Occasionally check naloxone solution for contamination. The solution should be clear. If the naloxone solution is discolored, cloudy, or contains solid particles, replace it with a new naloxone.
  • Your naloxone has an expiration date. Replace it before the expiration date.