Pronunciation:

nal-TREX-one

Brand Names:

• Revia

Dosage Forms:

• Tablet

Warnings:

Naltrexone has the capacity to cause hepatocellular injury when given in excessive doses.

Naltrexone is contraindicated in acute hepatitis or liver failure, and its use in patients with active liver disease must be carefully considered in light of its hepatotoxic effects.

The margin of separation between the apparently safe dose of naltrexone and the dose causing hepatic injury appears to be only five-fold or less. Naltrexone does not appear to be a hepatotoxin at the recommended doses.

Patients should be warned of the risk of hepatic injury and advised to seek medical attention if they experience symptoms of acute hepatitis. Use of naltrexone should be discontinued in the event of symptoms and/or signs of acute hepatitis .

Naltrexone can cause hepatocellular injury when given in excessive doses, is contraindicated in acute hepatitis or liver failure, and its use in patients with active liver disease must be carefully considered in light of its hepatotoxic effects. Patients should be warned of the risk of hepatic injury and advised to stop the use of naltrexone and seek medical attention if they experience symptoms of acute hepatitis .

Naltrexone has the capacity to cause hepatocellular injury when given in excessive doses.

Naltrexone is contraindicated in acute hepatitis or liver failure, and its use in patients with active liver disease must be carefully considered in light of its hepatotoxic effects.

The margin of separation between the apparently safe dose of naltrexone and the dose causing hepatic injury appears to only five-fold or less. Naltrexone does not appear to be a hepatotoxin at the recommended doses.

Patients should be warned of the risk of hepatic injury and advised to stop the use of naltrexone and seek medical attention if they experience symptoms of acute hepatitis .

Can cause hepatocellular injury when given in excessive doses. Contraindicated in acute hepatitis or liver failure, and its use in patients with active liver disease must be carefully considered in light of its hepatotoxic effects. Patients should be warned of the risk of hepatic injury and advised to stop the use of naltrexone and seek medical attention if they experience symptoms of acute hepatitis .

Classifications:

Therapeutic—

Toxicology-Antidote Agent

Pharmacologic—

Opioid Antagonist

Uses of This Medicine:

Naltrexone is used to help narcotic addicts who have stopped taking narcotics to stay drug-free. It is also used to help alcoholics stay alcohol-free. 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 doctor.

Naltrexone is not a narcotic. It works by blocking the effects of narcotics, especially the "high'' feeling that makes you want to use them. It also may block the "high'' feeling that may make you want to use alcohol. It will not produce any narcotic-like effects or cause mental or physical dependence. It will not prevent you from becoming impaired while drinking alcohol.

Naltrexone will cause withdrawal symptoms in people who are physically dependent on narcotics. Therefore, naltrexone treatment is started after you are no longer dependent on narcotics. The length of time this takes may depend on which narcotic you took, the amount you took, and how long you took it. Before you start taking this medicine, be sure to tell your doctor if you think you are still having withdrawal symptoms.

Naltrexone is available only with your doctor'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—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of naltrexone in the elderly.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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—

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
• Codeine
• Dihydrocodeine
• Ethylmorphine
• Fentanyl
• Hydrocodone
• Hydromorphone
• Levorphanol
• Meperidine
• Methadone
• Morphine
• Morphine Sulfate Liposome
• Oxycodone
• Oxymorphone
• Propoxyphene
• Sufentanil

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:

• Hepatitis or other liver disease—The chance of side effects may be increased.

Proper Use of This Medicine:

Take naltrexone regularly as ordered by your doctor. It may be helpful to have someone else, such as a family member, doctor, or nurse, give you each dose as scheduled.

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 narcotic addiction:
    • Adults—25 milligrams (mg) (one-half tablet) for the first dose, then another 25 mg one hour later. After that, the dose is 350 mg a week. Your doctor will direct you to divide up this weekly dose and take naltrexone according to one of the following schedules:
      • 50 mg (one tablet) every day; or
      • 50 mg a day during the week and 100 mg (two tablets) on Saturday; or
      • 100 mg every other day; or
      • 100 mg on Mondays and Wednesdays, and 150 mg (three tablets) on Fridays; or
      • 150 mg every three days.
    • Children and teenagers up to 18 years of age—Use and dose must be determined by your doctor.
  • For alcoholism:
    • Adults—The first dose may be 25 milligrams (mg) (one-half tablet). After that, the dose is 50 mg (one tablet) every day.
    • Children and teenagers up to 18 years of age—Use and dose must be determined by your doctor.

Missed dose—

Call your doctor or pharmacist for instructions.

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 doctor check your progress at regular visits. Your doctor may want to do certain blood tests to see if the medicine is causing unwanted effects.

Remember that use of naltrexone is only part of your treatment. Be sure that you follow all of your doctor'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 narcotics. To do so may cause coma or death. You may be more sensitive to the effects of narcotics than you were before beginning naltrexone therapy.

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

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.

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

Tell all medical doctors, 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 doctor.

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

Abdominal or stomach pain (severe)

blurred vision, aching, burning, or swollen eyes

chest pain

confusion

discomfort while urinating and/or frequent urination

fever

hallucinations or seeing, hearing, or feeling things that are not there

itching

mental depression or other mood or mental changes

ringing or buzzing in the ears

shortness of breath

swelling of the face, feet, or lower legs

weight gain

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

Abdominal or stomach cramping or pain (mild or moderate)

anxiety, nervousness, restlessness and/or trouble in sleeping

headache

joint or muscle pain

nausea or vomiting

unusual tiredness

Less common

Chills

constipation

cough, hoarseness, runny or stuffy nose, sinus problems, sneezing, and/or sore throat

diarrhea

dizziness

fast or pounding heartbeat

increased thirst

irritability

loss of appetite

sexual problems in males

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