"The U.S. Food and Drug Administration today approved a prescription treatment that can be used by family members or caregivers to treat a person known or suspected to have had an opioid overdose. Evzio (naloxone hydrochloride injection) rapidly d"...
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 may rarely cause serious liver disease. The risk is increased when larger doses are used. Stop using this medication and get medical help right away if you have any symptoms of liver damage, including: dark urine, persistent nausea/vomiting/loss of appetite, stomach/abdominal pain, yellowing eyes/skin.
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.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: current or recent use (in the last 7 to 14 days) of any type of opioid drug (such as morphine, methadone, buprenorphine), bleeding problems (such as 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 or missing a dose of naltrexone, you may be more sensitive to lower doses of opioids, increasing your risk of serious, possibly fatal side effects from the narcotic (such as decreased breathing, loss of consciousness). You may also be more sensitive to lower doses of opioids near the end of the month that you received naltrexone treatment.
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.
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