Description
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 are breathing problems (which can range from slow or shallow breathing to no breathing), extreme sleepiness, slow heartbeat, or not being able to respond, a very small (pinpoint) pupil in a person who is difficult to awaken.
This medicine is available over-the-counter (OTC) in the United States and with your doctor's prescription.
This product is available in the following dosage forms:
- Spray
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of naloxone nasal spray in children.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of naloxone nasal spray in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Morphine
- Morphine Sulfate Liposome
- Naldemedine
- Naloxegol
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Clonidine
- Yohimbine
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Heart or blood vessel disease—Use with caution. May make these conditions worse.
Proper Use
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.
Call for emergency help right away after the first dose of this medicine. The reversal effects of naloxone are temporary. Patients who receive this medicine should be closely monitored.
Your doctor or a pharmacist can tell you where to buy this medicine. It is available over-the-counter in the United States 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 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:
- Adults and children—At first, 3 milligrams (mg) (1 spray into one nostril). If needed, you may give more doses every 2 to 3 minutes until the patient responds or until emergency medical assistance becomes available. Use a new nasal spray for each dose and alternate nostrils each time.
- 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.
- For nasal dosage form (Rezenopy® spray):
- Adults and children—At first, 10 milligrams (mg) (1 spray into one nostril). A second spray may be given into the other nostril after 2 to 3 minutes if the patient has not responded. This can be repeated every 2 to 3 minutes, alternating nostrils, until the patient responds or until emergency medical assistance becomes available.
- For nasal dosage form:
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.
Precautions
The effects of the opioid medicine may last longer than the effects of the naloxone. This means the breathing problems and sleepiness could come back. 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 (eg, 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.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they 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 the 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. Also, your health care professional may 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 or 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.
DRG-20165181
