Colozal (Balsalazide) – Targeted Anti-Inflammatory for Ulcerative Colitis

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What is Colozal used for
Colozal (balsalazide) is a prescription aminosalicylate used to treat mild-to-moderate active ulcerative colitis in adults and children aged 5+. It acts locally in the colon by releasing mesalamine to reduce inflammation and relieve symptoms like diarrhea, rectal bleeding, and stomach pain.
PubMed

Brand Name: Colozal®

Generic Name: Balsalazide Disodium

Drug Class: Aminosalicylate Prodrug (5‑ASA)

Formulation: 750 mg Sustained-release capsules

Prescription Status: Rx-only

Manufacturer: Salix Pharmaceuticals (and generics)

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Balsalazide Disodium, a prodrug enzymatically converted in the colon into mesalamine (5‑ASA) and inert carrier

Other names: Colazide, Giazo (brand for men), balsalazide sodium
Medscape Reference

Delivered intact to the colon, balsalazide is cleaved by colonic bacteria to release mesalamine, which inhibits local cyclooxygenase and lipoxygenase pathways, reducing inflammatory prostaglandins and leukotrienes.
Mayo Clinic

Treatment of mild-to-moderate active ulcerative colitis in adults and children aged 5+
Patent Images

Use in pediatric patients beyond 8 weeks or adults beyond 12 weeks not established

Adults:
2.25 g (three 750 mg capsules) three times daily for 8 weeks; some may require up to 12 weeks
FDA Access Data

Children (5–17 years):
Either same adult dose or 750 mg × 3/day for up to 8 weeks
Medscape Reference

Administration Tip:
Swallow capsules whole or sprinkle on applesauce immediately and swallow—do not store mixture

Safety & Prescribing Guidelines
Hypersensitivity to salicylates or balsalazide contraindicated
Mayo Clinic

Monitor renal, hepatic, and blood parameters, especially in elderly ≥65 yrs, due to risk of neutropenia/pancytopenia
FDA Access Data

Observe for worsening ulcerative colitis symptoms—stop if exacerbation occurs
FDA Access Data

Use caution in patients with pyloric stenosis (delayed gastric emptying)

Side Effects
Common (≥3%):

Headache, abdominal pain, diarrhea, nausea/vomiting, respiratory infections, arthralgia

Allergic reactions (anaphylaxis, bronchospasm)

Renal impairment, hepatic injury

Hematologic effects: neutropenia, anemia

Acute intolerance syndrome resembling colitis flare (<3%)

Monitor for renal/pulmonary injury, especially with NSAIDs or existing kidney disease

Beware potential acute intolerance syndrome — may mimic disease flare

Unlike many 5‑ASA drugs, balsalazide does not inhibit CYP450 enzymes, showing low interaction risk
FDA Access Data

Avoid with baricitinib (OAT3 substrate) due to decreased elimination
Medscape Reference

No significant interactions found with live vaccines in pediatric patients

Drug Classification
ATC Code: A07EC02

Therapeutic Class: Aminosalicylate, 5‑ASA prodrug

Prescription Only

Clinical Evidence
In adults, 6.75 g/day showed significant improvement in ulcerative colitis vs lower doses
DrugBank

In pediatrics, 85% on high-dose and 71% on low-dose achieved clinical improvement at 8 weeks

Long-term maintenance (1.5–6 g/day) is well tolerated with low relapse rates over three years
PubMed

Frequently Asked Questions (FAQs)
Q1. Can I use Colozal long-term?
In adults, up to 12 weeks; in children up to 8 weeks. Long-term maintenance dosing studies show tolerability, though not FDA-approved.
FDA Access Data
PubMed

Q2. How quickly does Colozal work?
Improvement typically observed within 8 weeks, though some may need up to 12 weeks.

Q3. Can children take Colozal?
Yes, from age 5, with pediatric dosing options. Safety beyond 8 weeks not established.
MedlinePlus

Q4. What if I miss a dose?
Take as soon as remembered, unless close to the next scheduled dose. Do not double-up.
Mayo Clinic
Drugs.com

Q5. Can I open the capsule?
Yes, sprinkle on applesauce and swallow immediately. Do not store mixture.
WebMD

Storage Instructions
Store at 20–25 °C (room temperature); permitted up to 30 °C

Keep sealed, away from moisture and heat

Out of reach of children

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