Balsalazide is a prodrug that is metabolized in the colon into its active component, 5-aminosalicylic acid (5-ASA or mesalamine). The mechanism of action involves:

1. Local Anti-inflammatory Effects: 5-ASA works topically in the colon to reduce inflammation by inhibiting the production of pro-inflammatory mediators such as prostaglandins and leukotrienes.
2. Antioxidant Properties: It scavenges free radicals, which contribute to tissue damage in ulcerative colitis.
3. Immunomodulation: 5-ASA may also modulate the immune response by inhibiting the activation of nuclear factor-kappa B (NF-κB), a key regulator of inflammation.

Balsalazide is designed to deliver 5-ASA directly to the colon, minimizing systemic absorption and reducing the risk of side effects.

Balsalazide is primarily used for:

1. Ulcerative Colitis:
   • Treatment of mild to moderate active ulcerative colitis.
   • Maintenance of remission in ulcerative colitis.

It is particularly effective for patients who cannot tolerate other aminosalicylates like sulfasalazine due to side effects.

The dosage of balsalazide varies depending on the indication and patient response. Below are general guidelines:

1. Adults:
   • Active Ulcerative Colitis: 2.25 g (three 750 mg capsules) taken three times daily (total daily dose: 6.75 g) for up to 12 weeks.
   • Maintenance of Remission: 1.5 g (two 750 mg capsules) taken twice daily (total daily dose: 3 g).
2. Children (Aged 12–17 Years):
   • Active Ulcerative Colitis: 2.25 g taken three times daily (total daily dose: 6.75 g) for up to 8 weeks.
3. Administration:
   • Balsalazide should be taken with or without food.

Swallow the capsules whole; do not crush or chew

Balsalazide is generally well-tolerated, but some side effects may occur. These include:

1. Common Side Effects:
   • Headache
   • Abdominal pain
   • Diarrhea
   • Nausea
   • Flatulence (gas)
2. Less Common Side Effects:
   • Vomiting
   • Joint pain
   • Rash
3. Rare but Serious Side Effects:
   • Hypersensitivity Reactions: Allergic reactions such as rash, fever, and anaphylaxis.
   • Hepatotoxicity: Elevated liver enzymes or hepatitis.
   • Renal Impairment: Rare cases of interstitial nephritis or kidney dysfunction.

Blood Disorders: Leukopenia, thrombocytopenia, or agranulocytosis

1. Contraindications:
   • Hypersensitivity to balsalazide, salicylates, or any component of the formulation.
   • Severe renal or hepatic impairment.
2. Warnings:
   • Renal Function: Monitor renal function before and during treatment, especially in patients with pre-existing kidney disease.
   • Hepatic Function: Monitor liver function tests in patients with a history of liver disease.
   • Pregnancy and Lactation: Use with caution during pregnancy and breastfeeding. Consult a healthcare provider for risks and benefits.
3. Monitoring:
   • Regular monitoring of renal and hepatic function.
   • Watch for signs of hypersensitivity reactions or blood disorders.

Balsalazide has a low potential for drug interactions due to its localized action in the colon. However, the following should be considered:

1. Anticoagulants (e.g., warfarin): Balsalazide may increase the risk of bleeding due to its effect on platelet function.
2. Azathioprine or 6-Mercaptopurine: Concurrent use may increase the risk of blood disorders.
3. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): May increase the risk of nephrotoxicity.
4. Live Vaccines: Avoid administering live vaccines during balsalazide therapy due to potential immunosuppressive effects.

Balsalazide is available under its generic name as well as brand names. Some common formulations include:

• Generic Name: Balsalazide disodium

Brand Names: Colazide (UK), Giazo (US), and others depending on the region