Naloxone is used in an emergency situation to treat a known or suspected opioid overdose in an adult or child.

This medicine should not be used in place of emergency medical care for an overdose.

Naloxone may also be used for purposes not listed in this medication guide.

Naloxone is used to reverse the effects of opioid medicine and treat an opioid overdose. An opioid overdose can be fatal. Symptoms may include severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

A person caring for you can give the naloxone if you stop breathing or don't wake up. Make sure any person caring for you knows where you keep naloxone and how to use it.

Your caregiver must get emergency help after giving a naloxone injection and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive. You may need another injection every 2 to 3 minutes until emergency help arrives.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Naloxone is injected into a muscle or under the skin, or into a vein. The injection may be given by a healthcare provider, emergency medical provider, or a family member or caregiver who is trained to properly give a naloxone injection.

Naloxone is injected into a vein by a healthcare provider.

If you are a caregiver or family member read all instructions when you first get this medicine. If provided, use the "trainer" device to practice giving an injection so you will know how to do it in an emergency. Ask your doctor or pharmacist if you have any questions. Seek medical help right away if an accidental needlestick injury occurs.

Be sure you know how to recognize the signs of an opioid overdose in the person you are caring for. Overdose symptoms may include:

• slowed breathing, or no breathing;

• very small or pinpoint pupils in the eyes;

• slow heartbeats; or

• extreme drowsiness, especially if you are unable to wake the person from sleep.

Even if you are not sure an opioid overdose has occurred, if the person is not breathing or is unresponsive, give the naloxone injection right away and then seek emergency medical care.

Do not assume that an overdose episode has ended if symptoms improve. You caregiver must still get emergency help after giving a naloxone injection, even if the person wakes up. You may need to perform CPR (cardiopulmonary resuscitation) on the person while you are waiting for emergency help to arrive.

Naloxone injection is given in the outer thigh. In an emergency, you may give an injection through the person's clothing.

After injecting naloxone, stay with the person and watch for continued signs of overdose. You may need to give another injection every 2 to 3 minutes until emergency help arrives. Read and carefully follow the instructions provided with this medicine.

Throw away a prefilled syringe after one use, even if there is still medicine left inside.

Store at room temperature away from moisture, heat, and light. Keep the auto-injector in its outer case until you are ready to use it.

You should not be treated with naloxone if you are allergic to it.

If possible before you receive a naloxone injection, tell your doctor if:

• you have heart problems.

If you use opioid medicine during pregnancy, your baby could be born with life-threatening withdrawal symptoms, and may need medical treatment for several weeks.

Using naloxone injection while you are pregnant may also cause opioid withdrawal symptoms in your unborn baby. However, having an opioid overdose can be fatal to both mother and baby. It is much more important to treat an overdose in the mother. You must get emergency medical help after using naloxone injection. Be sure all emergency medical caregivers know that you are pregnant and any follow-up doctor knows you received this medicine.

Ask a doctor if it is safe to breastfeed while using this medicine.

Naloxone is used when needed and does not have a daily dose.

Since naloxone is supplied as the correct dose in a single-dose auto-injector, an overdose is unlikely to occur.

Avoid leaving a person alone after giving him or her a naloxone injection. An opioid overdose can impair a person's thinking or reactions.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Because naloxone reverses opioid effects, this medicine may cause sudden withdrawal symptoms such as:

• nausea, vomiting, diarrhea, stomach cramps;

• fever, sneezing, sweating, body aches, weakness;

• tremors or shivering, fast heart rate, pounding heartbeats, increased blood pressure;

• goose bumps;

• runny nose, yawning; or

• feeling nervous, restless, or irritable.

Sudden withdrawal symptoms in a baby younger than 4 weeks old may be life-threatening if not treated the right way. Symptoms include unusual crying, stiffness, overactive reflexes, and seizures. Call your doctor or get emergency medical help if you are not sure how to properly give this medicine to a baby.

Common side effects of Zimhi may include:

• nausea, dizziness;

• skin redness where an injection was given;

• feeling lightheaded; or

• yellowing of the skin or eyes.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect naloxone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.