Narcan (Nasal)

Naloxone nasal spray is used for emergency treatment of an opioid overdose or a possible overdose. It will temporarily reverse the effects of an opioid medicine. Some signs and symptoms of an opioid emergency include breathing problems (which can range from slow or shallow breathing to no breathing), extreme sleepiness, slow heartbeat, or not being able to respond, and a very small (pinpoint) pupil in a person who is difficult to awaken.

This medicine is available both without a prescription (OTC) and with your doctor's prescription.

The effects of the opioid medicine may last longer than the effects of the naloxone. This means that breathing problems and sleepiness could return. Always call for emergency help after the first dose of naloxone.

Severe opioid withdrawal symptoms may happen suddenly after receiving this medicine. These include body aches, a fever, sweating, runny nose, sneezing, goose bumps, yawning, weakness, shivering or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, stomach cramps, fast heartbeat, and increased blood pressure.

Some types of opioid medications (for example, buprenorphine, pentazocine) may require larger or repeat doses of naloxone to reverse the opioid effects.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This decision should be made between you and your doctor. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, tell your healthcare professional if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies done so far have not shown any specific problems in children that would limit the usefulness of naloxone nasal spray.

Geriatric

Studies done so far have not shown any specific problems in elderly patients that would limit the usefulness of naloxone nasal spray. However, older patients are more likely to have kidney, liver, or heart problems related to age, which may require caution and a dose adjustment for those using naloxone nasal spray.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if interactions might happen. In these situations, your doctor may need to adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below while using this medicine. The following interactions are significant but may not be a complete list.

Using this medicine with any of the following medicines is usually not recommended, but may be needed in some cases. If both medicines are prescribed together, your doctor may adjust the dose or how often you use one or both medicines.

• Morphine
• Morphine Sulfate Liposome
• Naldemedine
• Naloxegol
• Oxycodone
• Oxymorphone

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both drugs may be the best option for you. If both medicines are prescribed together, your doctor may adjust the dose or how often you use one or both medicines.

• Clonidine
• Yohimbine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around mealtime or with certain types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Be sure to inform your doctor if you have any other medical conditions, especially:

• Heart or blood vessel disease—Use with caution. This may worsen these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, you may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Discomfort in the nose
• lack or loss of strength
• lightheadedness, dizziness, fainting
• stomach pain

Incidence not known

• Agitation
• body aches
• crying more than usual (in babies)
• diarrhea
• fast, pounding, or irregular heartbeat or pulse
• fever
• goosebumps
• irritability
• loss of consciousness
• nausea or vomiting
• nervousness
• ongoing trouble breathing
• restlessness
• runny or stuffy nose
• seizures (in babies)
• shivering or trembling
• sleepiness or unusual drowsiness
• sneezing
• stomach cramps
• sweating
• weakness
• yawning

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Headache
• joint or muscle pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Kloxxado
• Narcan

Available Dosage Forms:

• Spray

Therapeutic Class: Antidote

Pharmacologic Class: Naloxone

This medicine should be given immediately upon when a suspected or known overdose of an opioid has occurred. This will help prevent serious breathing problems and severe sleepiness that can lead to death.

Your doctor or a pharmacist can tell you where to buy this medicine. It is available without a doctor's order at most major pharmacies. Follow the instructions on the medicine label if you are using this medicine without a prescription.

This medicine is for use only in the nose. Do not get any of it in the eyes or on the skin. If it does get on these areas, rinse it off right away.

This medicine must be given to you (the patient) by someone else. Talk with people close to you so they know what to do in case of an emergency.

This medicine is not a substitute for emergency medical care. Call for emergency assistance after administering the first dose and keep the patient under continued surveillance.

This medicine comes with a patient information leaflet and patient instructions. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

To use the nasal spray:

• Remove the nasal spray from the box. Peel back the tab with the circle to open it.
• Do not prime or test the nasal spray. It contains a single dose of naloxone and cannot be reused.
• Hold the nasal spray with your thumb on the bottom of the plunger and your first and middle fingers on either side of the nozzle.
• Lay the patient on their back. Support the patient's neck by your hand and allow the head to tilt back before giving this medicine.
• Gently insert the tip of the nozzle into one nostril of the patient, until your fingers on either side of the nozzle are against the bottom of the patient's nose.
• Press the plunger firmly to give the dose. Remove the nasal spray from the patient's nostril after giving the dose.
• Move the patient on their side (recovery position) after giving the medicine and get emergency medical help right away.
• Watch the patient closely. You may also give additional doses to the patient every 2 to 3 minutes until the patient responds or emergency medical assistance becomes available.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For opioid overdose: For nasal dosage form (Kloxxado™ spray):Adults and children—At first, 8 milligrams (mg) (1 spray into one nostril). Another spray may be given into the other nostril every 2 to 3 minutes until the patient responds or until emergency medical assistance becomes available. For nasal dosage form (Narcan® spray):Adults and children—At first, 4 milligrams (mg) (1 spray into one nostril). Another spray may be given into the other nostril every 2 to 3 minutes until the patient responds or until emergency medical assistance becomes available.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not freeze or expose to heat. If the spray is frozen and is needed in an emergency, do not wait for the spray to thaw. Get medical help right away. However, the spray may be thawed for 15 minutes in room temperature, and it can still be used if it has been thawed after being frozen before.

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