Pronunciation:

nal-TREX-one

Brand Names:

• Revia

Dosage Forms:

• Tablet
• Capsule

Classifications:

Therapeutic—

Antidote

Pharmacologic—

Opioid Antagonist

Uses of This Medicine:

Naltrexone is used to help patient with opioid use disorder who have stopped taking opioids to stay drug-free and maintain their recovery. It is also used to treat alcohol use disorder. The medicine is not a cure for addiction. It is used as part of an overall program that may include counseling, attending support group meetings, and other treatment recommended by your healthcare provider.

Naltrexone is not an opioid. It works by blocking the effects of opioids, especially the euphoric and rewarding feeling that makes you want to use them. It also may block the euphoric and rewarding feeling that may make you want to use alcohol. It will not produce any opioid-like effects or cause mental or physical dependence. It will not prevent you from becoming impaired while drinking alcohol or using opioids.

Naltrexone will cause withdrawal symptoms in people who are no longer taking opioids for a period of time. Naltrexone treatment is started after you are no longer taking opioids for a period of time. The length of time this takes may depend on which opioid you took, the amount you took, and how long you took it. Before you start taking this medicine, be sure to tell your healthcare provider if you think you are still having withdrawal symptoms.

This medicine is available only with your healthcare provider's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of naltrexone in the pediatric population. Safety and efficacy have not been established.

Older adults—

No information is available on the relationship of age to the effects of naltrexone in geriatric patients.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Alfentanil
• Alphaprodine
• Anileridine
• Benzhydrocodone
• Buprenorphine
• Butorphanol
• Codeine
• Diacetylmorphine
• Difenoxin
• Dihydrocodeine
• Diphenoxylate
• Ethylmorphine
• Fentanyl
• Hydrocodone
• Hydromorphone
• Ketobemidone
• Levorphanol
• Meperidine
• Methadone
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Nicomorphine
• Opium
• Opium Alkaloids
• Oxycodone
• Oxymorphone
• Papaveretum
• Paregoric
• Piritramide
• Propoxyphene
• Remifentanil
• Sufentanil
• Tapentadol
• Tilidine
• Tramadol

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Bremelanotide
• Naldemedine
• Naloxegol
• Venlafaxine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Lofexidine
• Yohimbine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Depression, or history of or
• Mental illness, or history of—Use with caution. May make these conditions worse.

• Failed the naloxone challenge test (medical test to check your dependence to opioid medicine) or
• Opioid withdrawal, acute or
• Positive urine test for opioids or
• Receiving opioid analgesics (eg, buprenorphine, methadone, morphine)—Should not be used in patients with these conditions.

• Kidney disease or
• Liver disease (including cirrhosis, hepatitis B or C)—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine only as directed by your healthcare provider. Do not take more of it, do not take it more often, and do not take it for a longer time than your healthcare provider ordered.

You will need to stop using opioids for at least 7 to 10 days before you can start taking naltrexone. Your healthcare provider may need to do the naloxone challenge test or a urine test for opioids to make sure you are opioid-free.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For alcohol use disorder:
    • Adults—50 milligrams (mg) once a day.
    • Children—Use and dose must be determined by your healthcare provider.
  • For opioid use disorder:
    • Adults—At first, 25 milligrams (mg) (one-half tablet) once a day. If no withdrawal side effects occur, you may take 50 mg (one tablet) once a day.
    • Children—Use and dose must be determined by your healthcare provider.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your healthcare provider check your progress at regular visits. This will allow your healthcare provider to see if the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

This medicine blocks the euphoric and rewarding feeling you get from opioid drugs, including heroin. Since naltrexone may make you more sensitive to lower doses of opioids than you have previously used, you should not use heroin or any other opioid drugs to overcome what the medicine is doing. You could overdose and develop serious problems.

Check with your healthcare provider right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Make sure your healthcare provider knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also, tell your healthcare provider if you have any sudden or strong feelings, including feeling nervous, angry, restless, violent, or scared. Let your healthcare provider know if you or anyone in your family has tried to commit suicide.

Remember that use of naltrexone is only part of your treatment. Be sure that you follow all of your healthcare provider's orders, including seeing your therapist and/or attending support group meetings on a regular basis.

Do not try to overcome the effects of naltrexone by taking opioids. To do so may cause coma or death. You may be more sensitive to the effects of opioids than you were before beginning naltrexone therapy.

Naltrexone also blocks the useful effects of opioids. Always use a non-opioid medicine to treat pain, diarrhea, or a cough. If you have any questions about the proper medicine to use, check with your healthcare provider.

Naltrexone will not prevent you from becoming impaired when you drink alcohol. Do not take naltrexone in order to drive or perform other activities while under the influence of alcohol.

This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Never share this medicine with anyone else, especially someone who is using opioids. Naltrexone causes withdrawal symptoms in people who are using opioids.

Tell all medical healthcare providers, dentists, and pharmacists you go to that you are taking naltrexone.

It is recommended that you carry identification stating that you are taking naltrexone. Identification cards may be available from your healthcare provider.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Skin rash

Rare

Blurred vision, aching, burning, or swollen eyes

chest pain

confusion

discomfort while urinating or frequent urination

fever

itching

mental depression or other mood or mental changes

ringing or buzzing in the ears

seeing, hearing, or feeling things that are not there

stomach pain

swelling of the face, feet, or lower legs

trouble breathing

weight gain

Incidence not known

Black, tarry stools

blood in the urine

bloody nose

fast, pounding, or irregular heartbeat or pulse

heavier menstrual periods

nervousness

pinpoint red spots on the skin

swelling

trouble sleeping

unusual bleeding or bruising

unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Headache

joint or muscle pain

nausea or vomiting

Less common

Chills

constipation

cough or hoarseness

diarrhea

dizziness

increased thirst

irritability

loss of appetite

sexual problems in males

sneezing

sore throat

stuffy or runny nose

Incidence not known

Bleeding after defecation

difficulty in moving

lack or loss of strength

muscle aches, cramps, pains, or stiffness

swollen joints

uncomfortable swelling around anus

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.