Description

10 tablets each 50 mg for alcohol and opioid use disorder.

Naltrexone hydrochloride (ReVia, Depade) is an opioid receptor antagonist used in the management of alcohol dependence and opioid dependence.

Naltrexone hydrochloride is supplied as blue, round, film-coated tablets containing 50 mg of naltrexone hydrochloride. The tablets are debossed with “50” on one side and are supplied as follows:

NDC 68382-0150-1 unit of use bottles of 100

NDC 68382-0150-5 unit of use bottles of 500

NDC 68382-0150-7 10 unit of use blister packages of 100

NDC 68382-0150-8 15 unit of use blister packages of 100

NDC 68382-0150-9 25 unit of use blister packages of 100

Storage

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) see USP Controlled Room Temperature.

Dispense in a well-closed, light-resistant container as defined in the USP.

Revia (naltrexone)

Generic Name: naltrexone (oral) (NAAL treks one)

Brand Names: Depade, ReVia

Medically reviewed by Sanjai Sinha, MD. Last updated on Dec 5, 2018.

What is naltrexone?

Naltrexone is an opioid receptor antagonist. It works in the brain to prevent cravings for alcohol and opioids, and reduces the amount of pleasure derived from drinking or using opioids.

Naltrexone is used as part of a complete treatment program for drug or alcohol dependence. This program may also include counseling, support groups, and other measures to help you quit drinking or using opioids.

Naltrexone is not a cure for alcoholism or dependence on opioids. You should still feel some effects from withdrawal when you first start taking naltrexone.

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

Important Information

You should not take naltrexone if you are having drug or alcohol withdrawal symptoms, or if you are addicted to drugs or alcohol.

Before taking this medicine

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

if you are having drug or alcohol withdrawal symptoms;

if you have recently stopped taking a narcotic (opioid) pain medicine and are still experiencing withdrawal symptoms;

if you are addicted to drugs or alcohol; or

if you have ever taken a medicine called naloxone (Narcan, Evzio).

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

liver disease (especially hepatitis);

kidney disease;

a history of mental illness or psychosis;

a history of brain damage or head injury; or

a history of opioid addiction.

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

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

alcoholism;

drug addiction;

liver disease;

kidney disease;

a history of mental illness or psychosis;

a head injury; or

a seizure.

How should I take naltrexone?

Take naltrexone exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose to make sure you get the best results.

Never take this medicine in larger amounts, or for longer than prescribed. An overdose of naltrexone can cause serious or life-threatening liver damage.

Do not take naltrexone if you have consumed alcohol within the past 12 hours.

Naltrexone is usually taken once every 24 hours. Follow your doctor’s instructions.

If you take this medicine every day, take your first dose at least 3 days after your last dose of an opioid drug.

If you take this medicine 3 times per week, take your first dose at least 2 days after your last dose of an opioid drug.

Call your doctor if you still have withdrawal symptoms after you start taking naltrexone.

If you stop taking naltrexone, you could experience uncomfortable withdrawal symptoms. To prevent withdrawal, your doctor may lower your dose of naltrexone slowly. Withdrawal is more likely if you have used opioids for a long time or in large doses. Tell your doctor or pharmacist if you have withdrawal symptoms such as restlessness, mental/mood changes (such as anxiety, trouble sleeping, thoughts of suicide), watering eyes, runny nose, nausea, diarrhea, sweating, muscle aches, or sudden changes in behavior.

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

Keep track of your medicine. Naltrexone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Since naltrexone is taken only once a day or every other day, you may not be on a dosing schedule. If you are taking the medicine 3 times per week, talk with your doctor if you miss a scheduled dose.

What happens if I overdose?

Seek emergency medical attention or call 115.

An overdose of naltrexone can damage your liver or cause death.

Overdose symptoms may include headache, drowsiness, confusion, weakness, vomiting, diarrhea, stomach pain, skin rash, decreased urination, irregular heartbeats, seizure, or fainting.

What should I avoid while taking naltrexone?

Avoid drinking alcohol. It may increase your risk of liver damage while you are taking naltrexone.

Some people who have taken naltrexone have developed liver damage and liver failure. Call your doctor immediately if you have yellowing of your skin or eyes, dark urine, nausea, vomiting, unusual tiredness, weakness, stomach or abdominal pain, and/or loss of appetite.

Grapefruit and grapefruit juice may interact with naltrexone and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

Naltrexone side effects

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

Call your doctor at once if you have:

a seizure (convulsions);

severe or ongoing vomiting;

stomach pain (that is new or worse);

a light-headed feeling, like you might pass out;

quick weight gain (especially in your face and midsection);

upper stomach pain, itching, dark urine, jaundice (yellowing of the skin or eyes);

any new or worsening mental or mood changes, such as depression, anxiety, aggression, agitation, confusion, unusual thoughts or behavior, hallucinations (seeing or hearing things that are not real);

new or worse addiction symptoms;

feeling confused, drowsy, or irritable; or

the sudden appearance of a skin rash.

Common naltrexone side effects may include:

nausea, vomiting;

headache;

dizziness;

tired feeling; or

weight loss.

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?

Taking naltrexone with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before taking a sleeping pill, narcotic medication, muscle relaxer, or medicine for anxiety or seizures.

Other drugs may interact with 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.