Naloxone (Injection route)
Uses of This Medicine:
Naloxone injection is used to treat an opioid emergency such as an overdose or a possible overdose of a narcotic 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.
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
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:
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.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of naloxone injection in children.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of naloxone injection in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving naloxone injection.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
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.
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 Sulfate Liposome
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.
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 disease or
- Kidney disease or
- Liver disease—Use with caution. May make these conditions worse.
Proper Use of This Medicine:
A home health caregiver or a family member will give you or your child this medicine. It is given as a shot under your skin or into a muscle.
This medicine comes with patient instructions and a training device. Let your home health caregiver or family member read and follow the directions carefully. Ask your doctor if you have any questions.
- This medicine is available as an autoinjector and can only be used one time. It is available in 2 dosage strengths: 0.4 milligram (mg)/0.4 milliliter (mL) autoinjector or 2 mg/0.4mL autoinjector.
- It also contains printed instructions on the device label and a speaker that provides electronic instructions which guides the user through each step of the injection.
- Inject the medicine into the outer thighs, through clothing, if needed. If you are giving this medicine to a child younger than 1 year of age, you should pinch the thigh muscle while giving the medicine.
- Do not use the medicine if it is cloudy, discolored, or has large particles in it.
- Do not remove the red safety guard until you are ready to use it.
- After giving the first dose of Evzio® to the patient, get emergency medical help right away.
- Closely watch the patient for signs and symptoms of opioid emergency may return after several minutes.
- Give a new naloxone injection every 2 to 3 minutes if symptoms returned and monitor the patient until emergency help is received.
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 injection dosage form:
- For opioid emergency:
- Adults and children—0.4 or 2 milligrams (mg) injected under the skin or into a muscle.
- For opioid emergency:
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
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.
Precautions While Using This Medicine:
This medicine should be given immediately after a suspected or known overdose of an opioid or narcotic medicine. This is to prevent a serious condition called respiratory or central nervous system depression.
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.
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 of This Medicine:
- Incidence not known
- Abdominal or stomach cramps
- body aches
- difficult or troubled breathing
- excessive crying
- fast, pounding, or irregular heartbeat or pulse
- increased or excessive unconscious or jerking movements
- irregular, fast or slow, or shallow breathing
- nausea or vomiting
- pale or blue lips, fingernails, or skin
- runny nose
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:
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.
Last Updated: 9/4/2017