naltrexone (injection) (Vivitrol)

Brand Names: Vivitrol

Generic Name: naltrexone (injection)

• What is naltrexone (Vivitrol)?
• What are the possible side effects of naltrexone (Vivitrol)?
• What is the most important information I should know about naltrexone (Vivitrol)?
• What should I discuss with my health care provider before receiving naltrexone (Vivitrol)?
• How is naltrexone used (Vivitrol)?
• What happens if I miss a dose (Vivitrol)?
• What happens if I overdose (Vivitrol)?
• What should I avoid while using naltrexone (Vivitrol)?
• What other drugs will affect naltrexone (Vivitrol)?
• Where can I get more information (Vivitrol)?

Naltrexone blocks the effects of opioid medication, including pain relief or feelings of well-being that can lead to opioid abuse. An opioid is sometimes called a narcotic. Naltrexone is used as part of a treatment program for drug or alcohol dependence.

Naltrexone injection is used to prevent relapse in people who became dependent on opioid medicine and then stopped using it. Naltrexone can help keep you from feeling a "need" to use the opioid.

Naltrexone injection is also used to treat alcoholism by reducing your urge to drink alcohol. This may help you drink less or stop drinking altogether. Naltrexone will not decrease the effects of alcohol you recently consumed. You should not be drinking at the time you receive your first naltrexone injection.

Naltrexone is not a cure for drug addiction or alcoholism.

Naltrexone may also be used for purposes not listed in this medication guide.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Using opioid medicine while you are receiving naltrexone injections could stimulate opioid withdrawal symptoms. Common withdrawal symptoms are yawning, irritability, sweating, fever, chills, shaking, vomiting, diarrhea, watery eyes, runny nose, goose bumps, body aches, trouble sleeping, and feeling restless.

Call your doctor at once if you have:

• weak or shallow breathing;
• confusion, severe dizziness, feeling like you might pass out;
• depression, thoughts about suicide or hurting yourself;
• severe pain, swelling, blistering, skin changes, a dark scab, or a hard lump where the medicine was injected;
• new or worsening cough, wheezing, trouble breathing; or
• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

• nausea, vomiting, changes in appetite;
• muscle cramps;
• dizziness, drowsiness;
• abnormal liver function tests;
• sleep problems (insomnia);
• stuffy nose, tooth pain; or
• pain, swelling, or itching where the injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You should not receive naltrexone if you are having drug or alcohol withdrawal symptoms, if you have taken any opioid medicine within the past 2 weeks, or if you are still actively drinking alcohol.

You should not receive a naltrexone injection if you still use opioid medicine, or you could have sudden and severe withdrawal symptoms.

You should not receive naltrexone if you are allergic to it, or if:

• you are having withdrawal symptoms from drug or alcohol addiction;
• you have used any opioid medicine within the past 10 days (including fentanyl, Vicodin, OxyContin, and many others); or
• you have used methadone or buprenorphine (Subutex, Butrans, Suboxone, Zubsolv) in the past 14 days.

To make sure naltrexone is safe for you, tell your doctor if you have:

• liver disease;
• kidney disease; or
• a bleeding or blood-clotting disorder such as hemophilia.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Naltrexone can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Naltrexone is injected into a muscle. This injection is usually given once a month (every 4 weeks) and can be given only by a doctor or nurse in a clinic.

It is important to receive your naltrexone regularly to get the most benefit.

You may notice pain, redness, bruising, swelling, or a hard lump where the medicine was injected. Call your doctor if you have this type of reaction to the shot, especially if it does not clear up or gets worse within 2 weeks.

Naltrexone injections are only part of a complete treatment program that may also include additional forms of counseling and/or monitoring. Follow your doctor's instructions very closely.

Wear a medical alert tag or carry an ID card stating that you use naltrexone. Any medical care provider who treats you should know that you are receiving this medication. If you need surgery, tell the surgeon ahead of time that you are receiving naltrexone injections.

After receiving naltrexone, your body will be more sensitive to opioids. If you use an opioid medicine in the future, you will need to use less than before naltrexone treatment. Using the same amount you used before could lead to overdose or death.

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Call your doctor for instructions if you miss an appointment to receive your naltrexone injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not use narcotic medication, heroin, or other street drugs while you are receiving naltrexone. Never try to overcome the effects of naltrexone by taking large doses of opioids. Doing so could result in dangerous effects, including coma and death.

Do not drink alcohol during treatment with naltrexone.

Ask your doctor before using any medicine to treat a cold, cough, diarrhea, or pain. These medicines may contain narcotics or alcohol.

Naltrexone may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you.

Naltrexone will block the effects of any narcotic medicines you take (such as prescription medicine for pain, cough, or diarrhea). Harmful side effects could also occur.

Other drugs may interact with naltrexone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Your doctor can provide more information about naltrexone.

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