In the U.S.—

In Canada—

Other commonly used names are azodisal sodium; sodium azodisalicylate.

• Bowel disease (inflammatory) suppressant

Olsalazine (ole-SAL-a-zeen) is used in patients who have had ulcerative colitis to prevent the condition from occurring again. It works inside the bowel by helping to reduce inflammation and other symptoms of the disease.

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

Oral
• Capsules (U.S. and Canada)

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 olsalazine, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to olsalazine, mesalamine, sulfasalazine, or any salicylates (for example, aspirin). Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Olsalazine has not been studied in pregnant women. However, studies in rats have shown that olsalazine causes birth defects and other problems at doses 5 to 20 times the human dose. 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 olsalazine passes into human breast milk. However, olsalazine has been shown to cause unwanted effects, such as slowed growth, in the pups of rats given olsalazine while nursing. It may be necessary for you to take another medicine or to stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of olsalazine 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. Although there is no specific information comparing use of olsalazine in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

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 using any other prescription or nonprescription (over-the-counter [OTC]) medicine.

• Kidney disease—The use of olsalazine may cause further damage to the kidneys

Olsalazine is best taken with food, to lessen stomach upset. If stomach or intestinal problems continue or are bothersome, check with your doctor.

Keep taking this medicine for the full time of treatment , even if you begin to feel better after a few days. Do not miss any doses.

Dosing—

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

• For oral dosage form (capsules):
  • To prevent ulcerative colitis from occurring again:
    • Adults and teenagers—500 milligrams (mg) two times a day.
    • Children—Use and dose 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.
• 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 or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

It is very important that your doctor check your progress at regular visits, especially if you will be taking olsalazine for a long time.

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 as soon as possible if any of the following side effects occur:

• Rare
  • Back or stomach pain (severe);  bloody diarrhea;  fast heartbeat;  fever;  nausea or vomiting;  skin rash;  swelling of the stomach;  yellow eyes or skin 
  
  

Other 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
  • Abdominal or stomach pain or upset;  diarrhea;  loss of appetite 
  
  

• Less common
  • Aching joints and muscles;  acne;  anxiety or depression;  dizziness or drowsiness;  headache;  trouble in sleeping 
  
  

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

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, olsalazine may be used in certain patients to treat mild or moderate ulcerative colitis.

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for this use.