Naloxone Hydrochloride Nasal spray, solution

What is this medicine?

NALOXONE (nal OX one) is a narcotic blocker. It is used to treat narcotic drug overdose.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• drug abuse or addiction

• heart disease

• an unusual or allergic reaction to naloxone, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for use in the nose. Lay the person on their back. Support their neck with your hand and allow the head to tilt back before giving the medicine. The nasal spray should be given into 1 nostril. After giving the medicine, move the person onto their side. Do not remove or test the nasal spray until ready to use.

Get emergency medical help right away after giving the first dose of this medicine, even if the person wakes up. You should be familiar with how to recognize the signs and symptoms of a narcotic overdose. If more doses are needed, give the additional dose in the other nostril.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as newborns for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply.

What may interact with this medicine?

This medicine is only used during an emergency. No interactions are expected during emergency use.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Keep this medicine ready for use in the case of a narcotic overdose. Make sure that you have the phone number of your doctor or health care professional and local hospital ready. You may need to have additional doses of this medicine. Each nasal spray contains a single dose. Some emergencies may require additional doses.

After use, bring the treated person to the nearest hospital or call 911. Make sure the treating health care professional knows that the person has received an injection of this medicine. You will receive additional instructions on what to do during and after use of this medicine before an emergency occurs.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• fast, irregular heartbeat

• high blood pressure

• pain that was controlled by narcotic pain medicine

• seizures

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• anxious

• chills

• diarrhea

• fever

• headache

• muscle pain

• nausea, vomiting

• nose irritation like dryness, congestion, and swelling

• sweating

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store between 4 and 40 degrees C (39 and 104 degrees F). Do not freeze. Throw away any unused medicine after the expiration date. Keep in original box until ready to use.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Naloxone Hydrochloride Solution for injection

What is this medicine?

NALOXONE (nal OX one) is a narcotic blocker. It is used to treat narcotic drug overdose.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• drug abuse or addiction

• heart disease

• an unusual or allergic reaction to naloxone, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnantbreast-feeding

How should I use this medicine?

This medicine is for injection into the outer thigh. It can be injected through clothing if needed. Get emergency medical help right away after giving the first dose of this medicine, even if the person wakes up. You should be familiar with how to recognize the signs and symptoms of a narcotic overdose. Administer according to the printed instructions on the device label or the electronic voice instructions. You should practice using the Trainer injector before this medicine is needed.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as newborn for selected conditions, precautions do apply. For infants less than 1 year of age, pinch the thigh muscle while administering.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply.

What may interact with this medicine?

This medicine is only used during an emergency. No interactions are expected during emergency use.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Keep this medicine ready for use in the case of a narcotic overdose. Make sure that you have the phone number of your doctor or health care professional and local hospital ready. You may need to have additional doses of this medicine. Each injector contains a single dose. Some emergencies may require additional doses.

After use, bring the treated person to the nearest hospital or call 911. Make sure the treating health care professional knows that the person has received an injection of this medicine. You will receive additional instructions on what to do during and after use of this medicine before an emergency occurs.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• fast, irregular heartbeat

• high blood pressure

• pain that was controlled by narcotic pain medicine

• seizures

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• anxious

• chills

• diarrhea

• fever

• nausea, vomiting

• sweating

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 25 degrees C (59 and 77 degrees F). Keep this medicine in its outer case until ready to use. Occasionally check the solution through the viewing window of the injector. The solution should be clear. If it is discolored, cloudy, or contains solid particles, replace it with a new injector. Remember to check the expiration date of this medicine regularly. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.