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USP DI Vol. II - ACAMPROSATE (Systemic)

ACAMPROSATE (Systemic)?


Some commonly used brand names are:

In the U.S.?

  • Campral

? Not commercially available in Canada.


Category

  • Alcohol-abuse deterrent

Description

Acamprosate (a-kam-PROE-sate) is usedto help overcome your drinking problem. It is not a cure for alcoholism, butrather will help you maintain abstinence.

This medicine is available only with your doctor's prescription, in thefollowing dosage forms:

    Oral
  • Tablets (U.S.)


Before Using This Medicine

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

Allergies?Tell your doctor if you have ever had any unusualor allergic reaction to acamprosate. Also tell your doctor and pharmacistif you are allergic to any other substances, such as sulfites, foods, preservatives,or dyes.

Pregnancy?Acamprosate has not been studied inpregnant women. However, studies in animals have shown that acamprosate cancause birth defects or other problems. Before taking this medicine, make sureyour doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding?It is not known whether acamprosate passes intohuman breast milk. Because acamprosate is passed into the milk of rats acamprosateis not recommended during breast-feeding because it may cause unwanted effectsin nursing babies.

Children?Safety and efficacy in pediatric patients havenot been established.

Older adults?This medicine has been tested and has not beenshown to cause different side effects or problems in older people than itdoes in younger adults.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. Tell your health careprofessional if you are taking any other prescription or nonprescription (over-the-counter[OTC]) medicine.

Other medical problems?The presence of other medicalproblems may affect the use of acamprosate. Make sure you tell your doctorif you have any other medical problems, especially:

  • Kidney disease (severe)?Acamprosate is not recommended; seriousside effects could occur
  • Depression or
  • Suicidal thinking?Acamprosate may make the condition worse

Proper Use of This Medicine

Beginning treatment as soon as possible after the period of alcohol withdrawal,and after you have achieved abstinence.

Using acamprosate as part of a treatment program thatincludes counseling and support.

Continuing acamprosate therapy, even in the event ofa relapse.

In addition to beverages, alcohol is found in many other products. Readingthe list of ingredients on foods and other products before using them willhelp you to avoid alcohol. Do not use alcohol-containing foods such as saucesand vinegars.

Dosing?The dose of acamprosate will be differentfor different patients. Follow your doctor's orders orthe directions on the label. The following information includes onlythe average doses of acamprosate. If your dose is different,do not change it unless your doctor tells you to do so.

  • For oral dosage form (tablets):
    • To help overcome drinking problems:
      • Adults?Two tablets (666 mg per dose) taken three times daily.
      • Children?Use and dose must be determined by your doctor.

Missed dose?If you miss a dose of this medicine, take itas soon as possible. However, if it is almost time for your next dose, skipthe missed dose and go back to your regular dosing schedule. Do not doubledoses.

Storage?To store this medicine:

  • Keep out of the reach of children.
  • Store away from heat and direct light.
  • Do not store in the bathroom, near the kitchen sink, or in otherdamp places. heat or moisture may cause the medicine to break down.
  • Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Ifyou will be taking this medicine for a long time, itis very important that your doctor check you at regular visits

This medicine may cause some people to become drowsy, dizzy, or less alertthan they are normally. Make sure you know how you reactto this medicine before you drive, use machines, or do anything else thatcould be dangerous if you are dizzy or are not alert.


Side Effects of This Medicine

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

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

      More common

        Agitation; coma; confusion; decreased urine output; depression; dizziness; headache; hostility; irritability; lethargy; muscle twitching; nausea; rapid weight gain; seizures; stupor; swelling of face, ankles, or hands; unusual tiredness or weakness

      Symptoms of Overdose

      Get emergency help immediately if any of the followingsymptoms of overdose occur

        Abdominal pain; confusion; constipation; depression; diarrhea; dry mouth; headache; incoherent speech; increased urination; loss of appetite; metallic taste; muscle weakness; nausea; thirst; unusual tiredness; vomiting; weight loss

    Other side effects may occur that usually do not need medicalattention. These side effects may go away during treatment as your body adjuststo the medicine. However, check with your doctor if any of the following sideeffects continue or are bothersome.

      More Common

        Discouragement; feeling sad or empty; irritability; lack ofappetite; loss of interest or pleasure; tiredness; trouble concentrating; trouble sleeping; diarrhea; sleeplessness; trouble sleeping; unable to sleep

      Less common

        Accidental injury; pain; loss of appetite; weight loss; fear;nervousness; dry mouth; bloated full feeling; excess air or gas in stomach or intestines; passinggas; burning, crawling, itching, numbness, prickling,"pins and needles", or tingling feelings; itchingskin; sweating

Other side effects not listed above may also occur insome patients. If you notice any other effects, check with your doctor.


Developed: 09/15/2004