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Balsalazide (Systemic)


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Balsalazide (Systemic)

US Brand Names

• Colazal

Description

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

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

    Oral

    • Capsules (U.S.)

Special Considerations

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 balsalazide, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to salicylates or balsalazide or mesalamine. Also tell your 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 problems in animal studies.

Breast-feeding

It is not known if balsalazide passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children

Studies on this medicine have been done only in adult patients, and there is no specific information comparing the use of balsalazide in children with use in other age groups.

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 balsalazide 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. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other medical problems

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

    • Pyloric stenosis-Balsalazide capsules may take longer to reach the colon.

    • Kidney problems-Balsalazide should be used with caution.

.

Administration

Dosing

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

    • For oral dosage form (capsules):

      o For treatment of ulcerative colitis

        § Adults-Three 750-milligram (mg) balsalazide capsules three times a day for a total daily dose of 6.75 grams for eight weeks. You may need 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 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

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 other damp places. Heat or moisture may cause the medicine to break down.

    • Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

Precautions

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

If your symptoms become worse, check with your doctor.

Side Effects

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. However, check with 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-like symptoms; 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 sleeping or getting to sleep; unusual tiredness or weakness; yellowish skin.

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

November 10, 2000

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Last updated: January 2004.

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