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NALTREXONE

(Also Known As: REVIA)

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 naltrexone 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 naltrexone. If your dose is different, do not change it unless your doctor tells you to do so.

• For oral dosage form (tablets):
  • For treating 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 treating 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

If you miss a dose of this medicine, and your regular dosing schedule is:

• One tablet every day:
  • Take the missed dose as soon as possible. However, if you do not remember until the next day, skip the missed dose and go back to your regular dosing schedule. Do not double the next day's dose.
• One tablet every weekday and two tablets on Saturday:
  • If you miss a weekday dose, follow the directions for one tablet every day.
  • If you miss the Saturday dose, take it as soon as possible. However, if you do not remember until Sunday, take one tablet on Sunday. Then go back to your regular dosing schedule on Monday.
• Two tablets every other day:
  • Take two tablets as soon as you remember, then skip a day, then go back to taking the medicine every other day; or
  • Take two tablets as soon as possible if you remember the same day. However, if you do not remember until the next day, take one tablet the next day. Then go back to your regular dosing schedule.
• Two tablets on Monday and Wednesday and three tablets on Friday:
  • If you miss one of the Monday or Wednesday doses, take it as soon as possible. However, if you do not remember until the next day, take one tablet the next day. Then go back to your regular dosing schedule.
  • If you miss the Friday dose, take it as soon as possible if you remember the same day. However, if you do not remember until Saturday, take two tablets on Saturday. If you do not remember until Sunday, take one tablet on Sunday. Then go back to your regular dosing schedule on Monday.
• Three tablets every three days:
  • Take three tablets as soon you remember, then skip two days, then go back to taking the medicine every three days; or
  • Take three tablets as soon as possible if you remember the same day. However, if you do not remember until the next day, take two tablets, then skip a day and go back to your regular dosing schedule. If you do not remember until the second day, take one tablet. Then go back to your regular dosing schedule.

Storage

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store this medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated 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 naltrexone, the following should be considered:

Allergies Tell your doctor if you have ever had any unusual or allergic reaction to naltrexone. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy Naltrexone has not been studied in pregnant women. However, studies in animals have shown that naltrexone causes unwanted effects when given in very large doses. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding It is not known whether naltrexone passes into the breast milk. However, this medicine has not been reported to cause problems in nursing babies.

Children Naltrexone has been tested only in adult patients and there is no specific information about its use in patients up to 18 years of age.

Older adults Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing the use of naltrexone in the elderly with use in other age groups.

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 naltrexone, it is especially important that your health care professional know if you are taking any of the following:

• Opioid (Narcotic) analgesics (e.g., butorphanol [e.g., Stadol], codeine, hydrocodone [e.g., Hycodan], hydromorphone [e.g., Dilaudid], levorphanol [e.g., Levo-Dromoran], meperidine [e.g., Demerol], methadone [e.g., Dolophine], morphine [e.g., MSIR], nalbuphine [e.g., Nubain], oxycodone [e.g., Roxicodone], propoxyphene [e.g., Darvon]) or
• Opioid-containing medications, other The effects of these medications may be blocked by naltrexone. Alternative medications for relief of pain should be used in patients receiving naltrexone. Naltrexone may cause withdrawal in patients dependent on narcotics.

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