How does this medication work? What will it do for me?

Olsalazine belongs to the group of medications known as anti-inflammatories. This medication is used to treat ulcerative colitis, a disease involving inflammation of the bowel. It is used to prevent attacks of the disease, and for the long-term maintenance of remission for people with ulcerative colitis.

Olsalazine is also used to treat mild-to-moderate attacks of ulcerative colitis, sometimes in combination with a class of anti-inflammatory medications called corticosteroids. It works by decreasing inflammation in the bowel.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Each opaque, beige, hard gelatin capsule contains 250 mg olsalazine sodium. Nonmedicinal ingredients: magnesium stearate, black iron oxide, caramel, gelatin, and titanium dioxide.

How should I use this medication?

The recommended adult dose for treatment of attacks is usually increased slowly over a one-week period starting with 500 mg (2 capsules) daily and increasing to an average adult dose of 2 capsules 4 times daily. The recommended adult dose for prevention of attacks is 500 mg (2 capsules) 2 times daily. The dose for children is based on the age and weight of the child.

Take olsalazine at regular intervals together with meals. Do not take more than 1 g at any one time. This medication should be taken in evenly divided doses.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take olsalazine if you:

  • are allergic to olsalazine or to any of the ingredients of the medication
  • are allergic to salicylates (e.g., ASA)

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • abdominal or stomach pain or upset
  • aching joints and muscles
  • bloating
  • diarrhea
  • dizziness
  • drowsiness
  • headache
  • inflammation of the mouth
  • loss of appetite

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • anxiety or depression
  • back or stomach pain (severe)
  • bleeding
  • bloody diarrhea
  • bruising
  • fast heartbeat
  • fever
  • mouth ulcer
  • nausea or vomiting
  • skin rash
  • swelling of the stomach
  • yellow eyes or skin

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

General: 5-ASA (5-aminosalicylic acid) preparations have been reported to cause a worsening of colitis symptoms for less than 1% of patients with ulcerative colitis. This reaction may also occur with olsalazine treatment due to its similarities to 5-ASA medications. Ulcerative colitis rarely remits completely and the risk of relapse can be substantially reduced by continuous long-term use of olsalazine.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication may pass into breast milk. If you are breast-feeding and are taking olsalazine, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

What other drugs could interact with this medication?

There may be an interaction between olsalazine and any of the following:

  • aldesleukin
  • azathioprine
  • baricitinib
  • celecoxib
  • digoxin
  • low molecular weight heparins (LMWHs; e.g., dalteparin, enoxaparin, tinzaparin)
  • mercaptopurine
  • other cancer medications
  • nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., ibuprofen, naproxen)
  • romidepsin
  • sirolimus
  • tacrolimus
  • thioguanine
  • tofacitinib
  • upadacitinib
  • varicella vaccine
  • warfarin
  • zidovudine

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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