DRUG NAME

Revia ( Naltrexone/Revia )

WARNINGS/PRECAUTIONS

Do not use Revia if:

• you are allergic to any ingredient in Revia;
• you are taking narcotic medications for pain, are dependent on narcotics, are experiencing withdrawal symptoms from narcotics, have failed the challenge test with Revia , or have tested positive for narcotics;
• you have hepatitis, liver failure, or liver disease.

Contact your doctor or health care provider right away if any of these apply to you.

Important:

Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Carry identification to alert health care providers that you are taking Revia . You can get a medication card from your doctor to use for this purpose.

Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Revia.

Contact your health care provider at once if any of the following signs or symptoms of hepatitis occur while taking Revia: stomach pain lasting more than a few days; white bowel movements; dark urine; yellowing of the skin or eyes.

Do not use narcotics while taking Revia, including opioid-containing medicines (e.g., cough and cold products, pain relievers, heroin). Revia may increase your sensitivity to narcotics. Therefore, even very low doses may cause coma or be life-threatening.

Before you have any medical or dental surgery or emergency treatments, tell the doctor or dentist that you are taking Revia.

Lab tests, including liver function, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.

Use Revia with extreme caution in children younger than 18 years of age. Safety and effectiveness in this age group have not been confirmed.

Pregnancy and breast-feeding: If you become pregnant, discuss with your doctor the benefits and risks of using Revia during pregnancy. It is unknown if Revia is excreted in breast milk. If you are or will be breast-feeding while you are using Revia, check with your doctor or pharmacist to discuss the risks to your baby.

MISSED DOSE

If you miss a dose of Revia, skip the missed dose. Go back to your regular dosing schedule. Do not take 2 doses at once.

DRUG CLASS AND MECHANISM

Revia is a narcotic antagonist. It is thought to work by blocking the effects of injectable opioids (e.g., heroin, narcotic pain relievers). It has also been shown to decrease alcohol consumption.

POSSIBLE SIDE EFFECTS

Check with your doctor if any of these most common side effects persist or become bothersome:

• chills;
• constipation;
• increased energy;
• nausea;
• dizziness;
• feeling down;
• sleeplessness;
• drowsiness;
• increased thirst;
• irritability;
• anxiety;
• delayed ejaculation;
• stomach pain/cramps;
• low energy;
• appetite loss;
• nervousness;
• diarrhea;
• joint and muscle pain;
• headache;
• vomiting.

Seek medical attention right away if any of these severe side effects occur:

• vomiting;
• white bowel movements;
• yellowing of the skin or eyes.
• abdominal or stomach pain;
• severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue);
• cramping;
• dark urine;
• suicidal thoughts or behaviors;
• unusual tiredness or weakness;
• depression;

DRUG USES

Revia is used for treating alcoholism and narcotic (opioid) addiction in adults, as part of a complete treatment program. It may also be used to treat other conditions as determined by your doctor.

HOW TAKEN

Use Revia as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Revia by mouth with or without food.

Revia should not be taken until the naltrexone/Revia challenge test is negative.

Before taking Revia , you must be willing to take Revia to help with alcohol dependence, you must be free of substance abuse for 7 to 10 days, you must not have any severe or active liver or kidney problems, and you must not have any other medical problems or conditions that make taking Revia inadvisable.

MORE INFORMATION

Revia is to be used only by the patient for whom it is prescribed. Do not share it with other people.

STORAGE

Store Revia at 77 degrees F (25 degrees C). Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Revia out of the reach of children and away from pets.

What is the shelf life of the pills?

• The expiry date is mentioned on each blister. It is different for different batches. The shelf life is 2 years from the date of manufacture and would differ from batch to batch depending on when they were manufactured.