ReVia

ReVia is used in adults to treat alcohol dependence and to block the effects of opioids.

ReVia may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

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

Wear a medical alert tag or carry an ID card to inform others that you use ReVia.

ReVia 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 carefully.

Store tightly closed at room temperature, away from moisture and heat. Protect from light.

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

You should not be treated with ReVia if you are currently using an opioid pain reliever, are addicted to opioids, or are experiencing opioid withdrawal symptoms. You also should not take ReVia if you have used any opioid medicine, such as methadone, buprenorphine, tramadol, or other opioids, within the last 7 to 14 days.

You should not use ReVia if you have failed the naloxone challenge test or if you have tested positive for opioids on a urine test.

You should not use ReVia if you are allergic to it, or if:

• you are currently addicted to opioids;
• you are having withdrawal symptoms from opioid addiction;
• you are using any opioid pain medicine (including fentanyl, Vicodin, OxyContin, and many others);
• you have failed the naloxone challenge test or have a positive urine screen for opioids; or
• you have used any opioid medicine such as methadone, buprenorphine, tramadol, and other opioids within 7 to 14 days.

Tell your doctor if you use thioridazine or disulfiram.

Also tell your doctor if you have or have ever had:

• liver or kidney disease.

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

Ask a doctor if it is safe to breastfeed while using ReVia.

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

Using opioid medicine while you are taking ReVia could trigger opioid withdrawal symptoms. Common withdrawal symptoms include 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 feelings of anxiety, depression, fear, restlessness, or unease.

ReVia may cause serious side effects. Call your doctor immediately if you have:

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

High doses of naltrexone oral may harm your liver. Stop taking ReVia and call your doctor at once if you have right-sided upper stomach pain, vomiting, loss of appetite, dark urine, clay-colored stools, or yellowing of your skin or eyes.

Common side effects of ReVia may include:

• nausea, vomiting, stomach pain;
• headache, dizziness, drowsiness;
• feelings of anxiety or nervousness;
• 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.

Take the medicine as soon as possible, but skip the missed dose if it is nearly time for your next dose. Do not take two doses at once.

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

Do not use opioid medication, heroin, or other street drugs while you are taking ReVia. Never try to overcome the effects of naltrexone by taking larger amounts of opioids. Doing so could result in dangerous effects, including coma or death.

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 ReVia.

ReVia may cause dizziness or drowsiness and may impair your reactions. Avoid driving or hazardous activity until you know how this medicine will affect you.

Other drugs may influence ReVia, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all other medicines you are using.