Naloxone 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 opioid overdose, give naloxone right away anyway, since lasting slow/shallow breathing may cause permanent damage to the brain or death. Since symptoms of opioid overdose may return after treatment, be sure to get medical help right away after giving the first dose of naloxone.

Naloxone belongs to a class of drugs known as opioid antagonists. It works by blocking the effects of the opioid in the brain.

Read the Instructions for Use if available from your pharmacist before you start using naloxone and each time you get a refill. Ask your health care professional how to prepare and use this medication. If you have any questions, ask your doctor or pharmacist.

Inject this medication into a muscle or under the skin as directed by your doctor. It may also be given by injection into a vein by a health care professional. The dosage is based on your medical condition and response to treatment. Children's dosage is also based on weight.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the product package. Before using, check this product for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely. Close family and household members should know the symptoms of an opioid overdose and be instructed on how to give naloxone if needed. Opioid overdose should be treated right away to prevent serious effects (such as brain damage). See also Uses section.

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 an injection, give another naloxone injection every 2 to 3 minutes. Continue to closely watch the person until emergency help is received. Tell the healthcare professional that you have given an injection of naloxone.

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.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

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.

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).

Since untreated opioid overdose can harm both a pregnant woman and her unborn baby, this medication may be used during pregnancy. However, naloxone may cause opioid withdrawal in your unborn baby. Tell your doctor right away that you used this medication, so you and your unborn baby can be monitored. 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 breastfeeding.

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 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 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

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.

Not applicable.

Store at room temperature. Keep the medication in the original carton to protect from light. Keep all medications away from children and pets.

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