Description
Nalmefene injection 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, and low blood pressure.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Solution
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 have not been performed on the relationship of age to the effects of nalmefene injection in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of nalmefene 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 nalmefene injection.
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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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 or
- Kidney disease or
- Liver disease—Use with caution. May make these conditions worse.
Proper Use
A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. It can also be given as a shot under your skin or into a muscle.
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 that can lead to death.
Precautions
The effects of the opioid medicine may last longer than the effects of the nalmefene. This means the breathing problems could come back. Always call for emergency help after the first dose of nalmefene.
Severe opioid withdrawal symptoms may happen suddenly after receiving this medicine. These include fast heartbeat, death, and increased blood pressure.
This medicine may cause heart or blood vessel problems (eg, pulmonary edema, tachycardia, ventricular fibrillation, high or low blood pressure). Check with your doctor right away if you have blue lips and fingernails, chest pain, coughing that sometimes produces a pink frothy sputum, difficulty, fast, or noisy breathing, fast heartbeat, fainting, increased sweating, trouble breathing, swelling in the legs and ankles, or unusual tiredness or weakness.
Nalmefene injection may not be able to completely reverse the opioid effects (eg, respiratory depression) of buprenorphine.
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 or nurse immediately if any of the following side effects occur:
More common
- Burred vision
- dizziness
- fast, pounding, or irregular heartbeat or pulse
- headache
- nervousness
- pounding in the ears
- slow or fast heartbeat
Less common
- Confusion
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- feeling of warmth or heat
- flushing or redness of the skin, especially on the face and neck
- sweating
- unusual tiredness or weakness
Rare
- Anxiety
- chest pain or discomfort
- discouragement
- dry mouth
- feeling sad or empty
- hyperventilation
- irritability
- lack of appetite
- loss of interest or pleasure
- muscle twitching or jerking
- rhythmic movement of the muscles
- shaking
- trouble breathing
- trouble concentrating
- trouble sleeping
Incidence not known
- Blue lips or fingernails
- coughing that sometimes produces a pink frothy sputum
- difficulty, fast, or noisy breathing
- pale skin
- swelling in the legs and ankles
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
- Nausea
- vomiting
Less common
- Chills
Rare
- Body aches or pain
- cough
- decrease in frequency of urination
- decrease in urine volume
- difficulty in passing urine
- dryness or soreness of the throat
- fever
- itching skin
- painful urination
- stuffy or runny nose
- swollen glands in the neck
- trouble swallowing
- voice changes
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.
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