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Balsalazide Disodium

Balsalazide Disodium is an anti-inflammatory medication used to treat ulcerative colitis, a type of inflammatory bowel disease (IBD). It belongs to a class of drugs known as aminosalicylates, which work by reducing inflammation in the colon. Balsalazide is a prodrug, meaning it is inactive until it is metabolized in the colon, where it releases mesalamine (5-aminosalicylic acid or 5-ASA), the active compound that helps reduce inflammation and relieve symptoms such as diarrhea, rectal bleeding, and abdominal pain.


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Frequently Asked Questions

How long does it take for Balsalazide Disodium to start working?
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Improvement in symptoms such as diarrhea and abdominal pain may be seen within a few days to a few weeks of starting treatment. However, it is important to complete the full course of therapy to achieve the best results.

Can I stop taking Balsalazide Disodium if my symptoms improve?
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No, you should not stop taking Balsalazide Disodium without consulting your healthcare provider. Stopping the medication too early can lead to a recurrence of symptoms and may worsen the condition.

Is Balsalazide Disodium safe to use during pregnancy?
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Balsalazide Disodium should only be used during pregnancy if the potential benefits outweigh the risks. Pregnant women should discuss the risks and benefits with their healthcare provider before starting this medication.

What should I do if I miss a dose of Balsalazide Disodium?
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If you miss a dose, take it as soon as you remember unless it is close to the time of your next dose. Do not take two doses at once. Staying consistent with the medication schedule is important for controlling symptoms.

Can I use Balsalazide if I'm allergic to sulfa drugs?
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Balsalazide is not a sulfa drug and does not contain a sulfa moiety, so it is generally safe to take even if you have a sulfa allergy. However, individual reactions can vary, so always inform your healthcare provider of any drug allergies you have.

Comprehensive Drug Guide

How Does Balsalazide Disodium Work?

Balsalazide Disodium is converted by bacterial enzymes in the colon to its active form, mesalamine (5-ASA). Mesalamine works by inhibiting the production of inflammatory mediators such as prostaglandins and leukotrienes, which are involved in the inflammatory process in the colon. This action helps to reduce inflammation, decrease the frequency of bowel movements, and alleviate other symptoms of ulcerative colitis.

What is Balsalazide Disodium Used For?

Treatment of Mild to Moderate Ulcerative Colitis: Particularly in adults and children 5 years of age and older.

Common Dosages

Balsalazide Disodium is available by prescription only and is not classified as a controlled substance. It is typically available in capsule form, with each capsule containing 750 mg of Balsalazide Disodium.

Administration: Balsalazide Disodium capsules should be swallowed whole, with or without food. For patients who have difficulty swallowing capsules, the contents can be sprinkled on applesauce and consumed immediately. It is important to take the medication exactly as prescribed and to complete the full course of treatment, even if symptoms improve before the medication is finished.

Duration of Treatment: Treatment is typically continued for 8 weeks, but some patients may require longer treatment depending on their response and the severity of their condition.

Typical Dosing

FDA Approved Indications

The typical dosage of Balsalazide Disodium for the treatment of ulcerative colitis is:

  • Adults: 2.25 grams (three 750 mg capsules) taken orally three times a day for up to 8 weeks.


Pediatric Dosing

Children (5 years and older): The dosage may vary based on the child’s weight and the severity of the condition, but it is typically 1.5 to 2.25 grams (two to three 750 mg capsules) taken orally three times a day for up to 8 weeks.



Who Shouldn't Take Balsalazide Disodium?

Balsalazide Disodium is contraindicated in patients with:

  • Known hypersensitivity to Balsalazide, mesalamine, salicylates, or any component of the formulation.
  • Severe renal impairment, as mesalamine can potentially worsen kidney function.
  • Known or suspected bowel obstruction, due to the risk of exacerbation.


Advice From The Pharmacist

Patients using Balsalazide Disodium should be advised to:

  • Take the medication exactly as prescribed, and not skip doses even if they feel better. Consistency is key to controlling the symptoms of ulcerative colitis.
  • Stay hydrated, as diarrhea associated with ulcerative colitis can lead to dehydration.
  • Be aware of potential side effects, such as headaches or mild gastrointestinal upset, and report any severe or persistent symptoms to their healthcare provider.
  • Inform their healthcare provider of any other medications or supplements they are taking, as there may be potential interactions.
  • Store the medication at room temperature and keep it out of reach of children.


Side Effects of Balsalazide Disodium

Common Side Effects

Common side effects of Balsalazide Disodium may include:

  • Headache
  • Abdominal pain or discomfort
  • Diarrhea
  • Nausea
  • Vomiting
  • Respiratory symptoms (such as a cold or flu-like symptoms)


Uncommon/Severe Side Effects

Serious side effects can include:

  • Kidney Problems: Such as interstitial nephritis, particularly with long-term use. Regular monitoring of kidney function may be necessary.
  • Liver Problems: Elevated liver enzymes or liver injury, which may require discontinuation of the medication.
  • Severe Allergic Reactions: Such as rash, itching, swelling, or difficulty breathing.

Patients should seek immediate medical attention if they experience severe or persistent side effects, especially signs of kidney or liver problems or allergic reactions.



Risks and Warnings of Balsalazide Disodium

  • Kidney Function: Balsalazide Disodium can cause kidney problems, including interstitial nephritis. Patients with pre-existing kidney conditions or those taking nephrotoxic drugs should be closely monitored.
  • Liver Function: Although rare, Balsalazide can affect liver function. Patients should have their liver function monitored regularly, especially if they have a history of liver disease.

Blood Disorders: There is a potential risk of blood disorders, including decreased blood cell counts. Patients should report any signs of unusual bleeding, bruising, or infection to their healthcare provider.

Interactions with Balsalazide Disodium

Common Drug Interactions

Balsalazide Disodium may interact with other medications, including:

  • Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): Concurrent use can increase the risk of kidney damage.
  • Nephrotoxic Drugs: Such as certain antibiotics or chemotherapy agents, which can increase the risk of kidney problems.
  • Antacids: May alter the pH in the gastrointestinal tract and affect the release of mesalamine.

Patients should inform their healthcare provider of all medications and supplements they are taking to avoid potential interactions.



Alternatives to Balsalazide Disodium

Alternative treatments for ulcerative colitis include:

  • Other Aminosalicylates: Such as mesalamine (Asacol, Lialda) or sulfasalazine, which also target inflammation in the colon.
  • Corticosteroids: Such as prednisone, which can be used for short-term treatment during flare-ups.
  • Immunomodulators: Such as azathioprine or 6-mercaptopurine, which help reduce the immune response in more severe cases.
  • Biologics: Such as infliximab (Remicade) or adalimumab (Humira), which target specific components of the immune system.

The choice of treatment depends on the severity of the disease, the patient's response to previous treatments, and any underlying medical conditions.