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USP DI Vol. II - BALSALAZIDE (Systemic)

BALSALAZIDE (Systemic)


Some commonly used brand names are:

In the U.S.?

  • Colazal

Category

  • Bowel disease, inflammatory,suppressant

Description

Balsalazide (bal-SAL-a-zide) helps to decrease inflammation in the colon by blockingthe production of certain chemicals that cause the bowel to become overactive.

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

    Oral
  • Capsules (U.S.)

Before Using This Medicine

In decidingto use a medicine, the risks of taking the medicine must be weighed againstthe good it will do. This is a decision you and your doctor will make. Forbalsalazide, the following should be considered:

Allergies?Tell your doctor if you have ever had any unusualor allergic reaction to salicylates or balsalazide or mesalamine. Also tellyour health care professional if you are allergic to any other substances,such as foods, preservatives, or dyes.

Pregnancy?Balsalazide has not been studied in pregnant women.However, balsalazide has not been shown to cause birth defects or other problemsin animal studies.

Breast-feeding?It is not known if balsalazide passes into breastmilk. Although most medicines pass into breast milk in small amounts, manyof them may be used safely while breast-feeding. Mothers who are taking thismedicine and who wish to breast-feed should discuss this with theirdoctor.

Children?Studies on this medicine have been done only inadult patients, and there is no specific information comparing the use ofbalsalazide in children with use in other age groups.

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

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 balsalazide. Make sure you tell your doctorif you have any other medical problems , especially:

  • Pyloric stenosis?Balsalazide capsules may take longer to reachthe colon.
  • Kidney problems?Balsalazide should be used with caution.
.

Proper Use of This Medicine

Dosing?The dose of balsalazide will be different for different patients. Follow your doctor's orders or the directions on thelabel. The following information includes only the average dose ofbalsalazide. If your dose is different, do not changeit unless your doctor tells you to do so.

  • For oral dosage form (capsules):
    • For treatment of ulcerative colitis
      • Adults?Three 750-milligram (mg) balsalazide capsules threetimes a day for a total daily dose of 6.75 grams for eight weeks. You mayneed to take the medicine for up to twelve weeks as ordered by your doctor.
      • Children?Use and dosage 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.
  • Keep the medicine from freezing. Do not refrigerate.
  • 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. Ask yourhealth care professional how you should dispose of any medicine you do notuse. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is important that your doctor check your progress at regularvisits. This will allow your doctor to check for any unwanted effects.

If your symptoms become worse, check with your doctor.


Side Effects of This Medicine

    Side effectsmay occur that usually do not need medical attention. These side effects maygo away during treatment as your body adjusts to the medicine. However, checkwith your doctor if any of the following side effects continue or are bothersome.

      More Common

        Diarrhea; stomach pain

      Less common

        Blood in urine; constipation; coughing; cramps; dry mouth; fever; flu-likesymptoms; passing of gas; heart burn or upset stomach; joint pain; loss of appetite; lower back pain; muscle pain; pain or burning while urinating; stuffy nose; trouble sleepingor getting to sleep; unusual tiredness or weakness; yellowish skin

Other side effects not listed abovemay also occur in some patients. If you notice any other effects, check withyour doctor.


Developed: 11/10/2000