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

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

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

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

Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive. You may need to give another spray 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.

This medicine may be given by a healthcare provider, emergency medical provider, or a family member or caregiver who is trained to properly give naloxone nasal.

Naloxone nasal should be sprayed into the nose while the person is lying on his or her back.

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;

• pinpoint pupils;

• 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 naloxone nasal right away and then seek emergency medical care.

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

Stay with the person and watch for continued signs of overdose. You may need to give another dose every 2 to 3 minutes until emergency help arrives. Follow all medication instructions carefully.

Each nasal spray pump is for one use only. Throw away after one use, even if there is still medicine left inside.

Store at room temperature away from moisture, heat and light. Do not freeze. Keep each spray pump in the box until you are ready to give a dose. Do not use this medicine if the expiration date on the label has passed.

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

If possible before you use naloxone nasal, 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 nasal while you are pregnant may also cause opioid withdrawal effects 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 nasal. Be sure all emergency medical caregivers know that you are pregnant and any follow-up doctor knows you received naloxone.

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

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

Since naloxone nasal is supplied as the correct dose in a single-use spray pump, an overdose is unlikely to occur.

Avoid leaving a person alone after giving a dose of naloxone nasal. 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 nasal reverses opioid effects, this medicine may cause sudden withdrawal symptoms such as:

• nausea, vomiting, diarrhea, stomach pain;

• fever, sweating, body aches, weakness;

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

• goose bumps, sneezing;

• 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 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 naloxone may include:

• stomach pain, constipation;

• increased blood pressure;

• dry skin, tooth pain, muscle pain;

• weakness, dizziness, headache, feeling light-headed; or

• stuffy nose, nasal discomfort and dryness.

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 nasal, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.