naltrexone (oral)

What is the most important information I should know about naltrexone?

What is naltrexone?

Naltrexone blocks the effects of opioid medication, including pain relief or feelings of well-being that can lead to opioid abuse.

Naltrexone is used to prevent relapse in adults 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 is also used to treat alcoholism by reducing your urge to drink alcohol. This may help you drink less or stop drinking completely. Naltrexone will not cause you to "sober up" and will not decrease the effects of alcohol you recently consumed.

Naltrexone is not a permanent cure for drug addiction or alcoholism.

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

What should I discuss with my healthcare provider before taking naltrexone?

• you are currently addicted to opioids;
• you are having withdrawal symptoms from opioid addiction;
• you have used any opioid pain medicine within the past 7 to 10 days (including fentanyl, Vicodin, OxyContin, and many others);
• you have used methadone or LAAM in the past 7 to 10 days; or
• you have liver failure or active hepatitis.

Tell your doctor if you have ever had:

• liver disease; or
• kidney disease.

Tell your doctor if you are pregnant or breastfeeding.

How should I take naltrexone?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Your doctor may recommend you have a family member or other caregiver make sure you take naltrexone on schedule, to make sure you are using the medicine correctly as part of your treatment.

Naltrexone is 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.

After taking 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.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

What should I avoid while taking naltrexone?

Ask your doctor before using any medicine to treat a cold, cough, diarrhea, or pain. These medicines may contain opioids and may not work as well while you are taking naltrexone.

What are the possible side effects of naltrexone?

Using opioid medicine while you are taking naltrexone could stimulate opioid withdrawal symptoms. Common withdrawal symptoms are craving for opioids, sweating, fever, stomach pain, vomiting, diarrhea, watery eyes, runny or stuffy nose, tingling, goose bumps, body aches, shaking, muscle twitching, trouble sleeping, and feeling anxious, depressed, fearful, restless or uneasy.

• severe nausea, vomiting, or diarrhea;
• confusion, mood changes, crying, hallucinations; or
• depression, thoughts about suicide or hurting yourself.

Common side effects may include:

• nausea, vomiting, stomach pain;
• headache, dizziness, drowsiness;
• feeling anxious or nervous;
• sleep problems (insomnia); or
• muscle or joint pain.

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.

What other drugs will affect naltrexone?

Other drugs may affect naltrexone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about naltrexone.