Uses

This medication is used for the emergency treatment of known or suspected opioid overdose. Serious opioid overdose symptoms may include unusual sleepiness, unusual difficulty waking up, or breathing problems (ranging from slow/shallow breathing to no breathing). Other symptoms of overdose may include very small "pinpoint" pupils, slow heartbeat, or low blood pressure. If someone has serious overdose symptoms but you are not sure if the symptoms are due to overdose, give this medication right away anyway, since lasting slow/shallow breathing may cause permanent damage to the brain or death.

This medication belongs to a class of drugs known as opioid antagonists. It works by blocking the effects of the opioid in the brain. This medication may not work as well to block the effects of certain types of opioids (mixed agonist/antagonists such as buprenorphine, pentazocine). With these types of opioids, blocking may be incomplete or you may need a higher dose of naloxone.

The effects of naloxone will not last as long as the effects of the opioid. Since treatment with this medication is not long lasting, be sure to get medical help right away after giving the first dose of naloxone. Treatment of opioid overdose should also include breathing treatment (such as oxygen given through tubes in the nose, mechanical ventilation, artificial respiration).

How To Use

See also Uses section.

Read the Patient Information Leaflet and Instructions for Use provided by your pharmacist when you get this medication and each time you get a refill. Be sure to keep this medication handy in case it is needed. Learn ahead of time how to properly give this medication so you will be ready to use naloxone if needed. If you have any questions, ask your doctor or pharmacist.

Remove the naloxone spray from the package only when you are ready to use it. Lay the person on their back. Tilt the person's head back and support their neck with your hand. Use your other hand to gently insert the tip of the spray nozzle into one nostril, then firmly press the plunger to give the dose. Remove the spray nozzle from the nostril and move the person onto their side as directed by the manufacturer.

The effects of this medication are rapid but not long lasting. After giving naloxone, get medical help right away, even if the person wakes up. If symptoms return after giving the spray, give another dose in the other nostril every 2 to 3 minutes, changing sides of the nose with each dose. Each spray contains only one dose and cannot be reused. Continue to closely watch the person until emergency help comes. Tell the health care professional that you have given naloxone spray.

Side Effects

Nasal dryness, swelling, or stuffy nose may occur. Muscle/joint pain or headache may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

In someone who has been using an opioid regularly, withdrawal symptoms can happen suddenly after receiving this medication. Withdrawal symptoms may include body aches, fever, sweating, watering eyes, runny nose, sneezing, goose bumps, yawning, weakness, shivering/trembling, nervousness, restlessness, diarrhea, nausea/vomiting, stomach cramps, increased blood pressure, fast heartbeat. In babies younger than 4 weeks who have been receiving an opioid regularly, sudden opioid withdrawal may be life threatening if not treated the right way. Symptoms in babies may include seizures, crying more than usual, and muscle twitching/spasms.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using naloxone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• heart problems (such as irregular heartbeat, previous heart attack)

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. It may cause opioid withdrawal in an unborn baby whose mother has been regularly taking an opioid. The doctor will carefully monitor both the pregnant woman and the unborn baby after this medication is given. Ask your doctor for details.

It is unknown if this medication passes into breast milk. However, it is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Overdose

Naloxone overdose in somebody not regularly taking an opioid is highly unlikely. However, if someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 9-1-1. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Ask your doctor or pharmacist about ways to prevent opioid overdose. Teach your close family or household members the signs and symptoms of an opioid overdose and tell them where you keep this medication.

Missed Dose

Not applicable.

Storage

Store this product in the original package at room temperature away from light and moisture. Do not freeze. Do not store in the bathroom. Keep all medications away from children and pets.

From time to time, check the expiration date. Replace the spray before it expires.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this medication when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.