Vivitrol Consumer (continued)
Pain/redness/swelling/itching/bruising at the injection site may also occur. If any of these effects steadily worsen, or if they persist longer than two weeks, tell your doctor or pharmacist immediately. Rarely, a severe injection site reaction can cause permanent injury if not treated.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Sudden opiate withdrawal symptoms can occur within minutes after using naltrexone if you are physically addicted to narcotics. Tell your doctor immediately if any of these withdrawal symptoms occur: vomiting, diarrhea, mental/mood changes (e.g., anxiety, confusion, extreme sleepiness, visual hallucinations).
Tell your doctor right away if you have any serious side effects, including: fast/irregular heartbeat, depression/rare thoughts of suicide, signs of a serious breathing problem/pneumonia (e.g., cough, shortness of breath, wheezing), blisters/sores at injection site.
Get medical help right away if this rare but very serious side effect occurs: chest pain.
Naltrexone has rarely caused serious liver disease. The risk is increased when larger doses are used. (See also Warning section.)
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Vivitrol (naltrexone xr inj) Side Effects Center for a complete guide to possible side effects »
PRECAUTIONS: Before using naltrexone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you: have taken any type of opioid drugs (e.g., codeine, oxycodone, morphine) in the last 7 to 10 days, are currently withdrawing from or dependent on any opioid (including methadone maintenance), currently have liver disease/liver failure.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems (e.g., hemophilia, low platelets), kidney disease, liver problems.
You should carry or wear medical identification stating that you are using this drug so that appropriate treatment can be given in a medical emergency. See also Medical Alert section.
This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.
After stopping naltrexone treatment, you may be more sensitive to lower doses of opioids, increasing your risk of serious, possibly fatal side effects from the narcotic (e.g., decreased breathing, loss of consciousness).
Before having surgery or any medical/dental treatment, tell your doctor or dentist that you are using this medication.
This medication blocks the effects of opiate drugs (including heroin) and similar drugs (opioids). However, large doses of heroin or narcotics can overcome this block. Trying to overcome this block is very dangerous and may cause serious injury, loss of consciousness, and death. Make sure you completely understand and accept the risks and benefits of using this medication. Follow your doctor's instructions closely.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
Additional Vivitrol Information
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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