Description
Naltrexone injection is used to help patients with opioid use disorder who have stopped taking opioids to stay drug-free and maintain their recovery. It is also used to help patients with alcohol use disorder stay alcohol-free. The medicine is not a cure for addiction. It is used as part of an overall program that may include counseling, attending support group meetings, and other treatment recommended by your healthcare provider.
Naltrexone is not an opioid. It works by blocking the effects of opioids, especially the euphoric and rewarding feeling that makes you want to use them. It also may block the euphoric and rewarding feeling that may make you want to use alcohol. It will not produce any opioid-like effects or cause mental or physical dependence. It will not prevent you from becoming impaired while drinking alcohol or using opioids.
Naltrexone will cause withdrawal symptoms in people who are no longer taking opioids for a period of time. Therefore, naltrexone treatment is started after you are no longer taking opioids for a period of time. The length of time this takes may depend on which opioid you took, the amount you took, and how long you took it. Before you start using this medicine, be sure to tell your healthcare provider if you think you are still having withdrawal symptoms.
This medicine is to be given only by or under the direct supervision of your healthcare provider.
This product is available in the following dosage forms:
- Powder for Suspension, Extended Release
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 naltrexone 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 naltrexone injection 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 receiving 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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Alfentanil
- Alphaprodine
- Anileridine
- Benzhydrocodone
- Buprenorphine
- Butorphanol
- Codeine
- Diacetylmorphine
- Difenoxin
- Dihydrocodeine
- Diphenoxylate
- Ethylmorphine
- Fentanyl
- Hydrocodone
- Hydromorphone
- Ketobemidone
- Levorphanol
- Meperidine
- Methadone
- Morphine
- Morphine Sulfate Liposome
- Nalbuphine
- Nicomorphine
- Opium
- Opium Alkaloids
- Oxycodone
- Oxymorphone
- Papaveretum
- Paregoric
- Piritramide
- Propoxyphene
- Remifentanil
- Sufentanil
- Tapentadol
- Tilidine
- Tramadol
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.
- Naldemedine
- Naloxegol
- Venlafaxine
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.
- 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:
- Allergy to polylactide-co-glycolide (PLG) or carboxymethylcellulose, history of or
- Failed the naloxone challenge test (medical test to check your dependence to opioid medicine) or
- Opioid withdrawal, acute or
- Physical drug dependence to opioid medicines or
- Positive urine test for opioids or
- Receiving opioid analgesics (eg, morphine)—Should not be used in patients with these conditions.
- Bleeding problems (eg, hemophilia) or
- Depression, history of or
- Kidney disease, moderate to severe or
- Liver disease or
- Lung or breathing problems or
- Thrombocytopenia (low platelets in the blood)—Use with caution. May make these conditions worse.
Proper Use
A nurse or other trained health professional will give you this medicine. This medicine is given as a shot into the buttocks (gluteal) muscle. It is usually given every 4 weeks or once a month.
Naltrexone injection should only be given to patients with alcohol use disorder who can abstain from drinking alcohol and do not need an overnight stay in the hospital.
This medicine usually comes with a Medication Guide. Read the information carefully and make sure you understand it before receiving this medicine. If you have any questions, ask your healthcare provider.
If you miss your scheduled dose, call your healthcare provider to make another appointment as soon as possible.
Precautions
It is very important that your healthcare provider check your progress at regular visits. This will allow your healthcare provider to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.
This medicine may cause injection site reactions. Check with your healthcare provider right away if you have bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site.
Check with your healthcare provider right away if you have dark urine, general tiredness and weakness, light-colored stools, nausea and vomiting, upper right stomach pain, and yellow eyes and skin. These may be symptoms of serious liver problems.
Check with your healthcare provider right away if you have chest pain, dry cough, fever, general feeling of tiredness or weakness, rapid breathing, skin rash, or trouble breathing. These may be symptoms of a lung problem called eosinophilic pneumonia.
This medicine may cause a serious allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your healthcare provider right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.
You will need to stop using opioids for at least 7 to 10 days before you can start receiving naltrexone injection. Your healthcare provider may need to do the naloxone challenge test or a urine test for opioids to make sure you are opioid-free.
This medicine may increase thoughts of suicide. Tell your healthcare provider right away if you start to feel more depressed. Also tell your healthcare provider right away if you have thoughts about hurting yourself. Report any unusual thoughts or behaviors that trouble you, especially if they are new or get worse quickly. Make sure your caregiver knows if you feel tired all the time, sleep a lot more or a lot less than usual, feel hopeless or helpless, or if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell your healthcare provider if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared.
Remember that use of naltrexone is only part of your treatment. Be sure that you follow all of your healthcare provider's orders, including seeing your therapist and/or attending support group meetings on a regular basis.
Do not try to overcome the effects of naltrexone injection by taking opioids. You may be more sensitive to the effects of opioids than you were before beginning naltrexone treatment. You could overdose and develop serious problems, including coma or death. Symptoms of an opioid overdose include: drowsiness, extreme dizziness or weakness, irregular, fast or slow, or shallow breathing, pale or blue lips, fingernails, or skin, pinpoint pupils, relaxed and calm, slow heartbeat or breathing, seizures, sleepiness, trouble breathing, or cold, clammy skin. Tell your healthcare provider right away if you notice these symptoms. Your healthcare provider may also give naloxone to treat an overdose. Naloxone is a medicine that temporarily reverses the effects of an overdose. If you have been prescribed naloxone, make sure household members know how to use this on you in the event of an overdose or suspected overdose. Emergency medical attention is still needed after naloxone is used because the reversal effects are only temporary.
Naltrexone injection also blocks the useful effects of opioids. Always use a non-opioid medicine to treat pain, diarrhea, or a cough. If you have any questions about the proper medicine to use, check with your healthcare provider.
Naltrexone injection will not prevent you from becoming impaired when you drink alcohol. Do not take naltrexone in order to drive or perform other activities while under the influence of alcohol.
After naltrexone is injected into your body, it is impossible to remove it.
It is recommended that you carry an identification card stating that you are receiving naltrexone injection. You may also need to carry a letter to let others know you are receiving this medicine in case you have a medical emergency.
You may experience nausea after the first injection of this medicine that should be mild and subside a few days afterwards. You will be less likely to have nausea with your next injections.
This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. If any of these side effects occur, do not drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert while you are receiving naltrexone injection.
Tell healthcare providers you are receiving this medicine. Naltrexone blocks the effects of opioids. You may need different medicine for pain control. Also tell healthcare providers if you plan to have surgery. You may need to stop this medicine before surgery.
Before you have any medical tests, tell the healthcare provider in charge that you are receiving this medicine. The results of some tests may be affected by this medicine.
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
- Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- body aches or pain
- chills
- congestion
- cough
- discouragement
- dryness or soreness of the throat
- ear congestion
- fear
- feeling sad or empty
- fever
- headache
- hoarseness
- irritability
- lack of appetite
- loss of interest or pleasure
- loss of voice
- nervousness
- rash
- runny or stuffy nose
- sneezing
- sore throat
- tender, swollen glands in the neck
- trouble breathing
- trouble concentrating
- trouble sleeping
- trouble swallowing
- unusual tiredness or weakness
- voice changes
Incidence not known
- Arm, back, or jaw pain
- black, tarry stools
- bladder pain
- bloating
- bloody or cloudy urine
- bloody stools
- blurred vision
- chest pain, discomfort, tightness, or heaviness
- chills
- confusion
- constipation
- cough
- cough producing mucus
- decreased urination
- diarrhea
- difficult, burning, or painful urination
- dilated neck veins
- dizziness or lightheadedness
- dry mouth
- fainting
- false or unusual sense of well-being
- fast, irregular, pounding, or racing heartbeat or pulse
- frequent urge to urinate
- general feeling of discomfort or illness
- hallucinations or seeing, hearing, or feeling things that are not there
- headache, severe and throbbing
- holding false beliefs that cannot be changed by fact
- hyperventilation
- increase in heart rate
- increase in white blood cells
- indigestion
- irregular or rapid breathing
- irritability
- itching, pain, redness, swelling, tenderness, or warmth on the skin
- joint or muscle pain
- lower back or side pain
- nausea
- nervousness
- numbness or tingling of the face, hands, or feet
- pain or discomfort in the arms, jaw, back, or neck
- pain, redness, or swelling in the arm or leg
- pounding in the ears
- redness and soreness of the eyes
- restlessness
- seizures
- shaking
- shivering
- skin rash
- slow or fast heartbeat
- sores in the mouth
- stomach cramps or pain
- sunken eyes
- sweating
- swelling of the face, fingers, feet, or lower legs
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- thirst
- tooth or gum pain
- unusual excitement, nervousness, or restlessness
- vomiting
- vomiting of blood or material that looks like coffee grounds
- watery or bloody diarrhea
- weight gain
- wrinkled skin
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Sleepiness or unusual drowsiness
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
- Difficulty with moving
- muscle stiffness
- swelling or redness in the joints
Incidence not known
- Bleeding after defecation
- bloated or full feeling
- change in taste
- decreased interest in sexual intercourse
- drowsiness
- excess air or gas in the stomach or intestines
- feeling of warmth
- feeling unusually cold
- heartburn
- inability to have or keep an erection
- increased sweating
- loss in sexual ability, desire, drive, or performance
- loss of taste
- night sweats
- passing gas
- redness of the face, neck, arms, and occasionally, upper chest
- relaxed and calm
- sleepiness
- sudden sweating
- uncomfortable swelling around anus
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
- weight loss
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.
CON-XXXXXXXX
