Colazal

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Colazal

Method of action: Antiulcer

Treatment option: Colitis, Colitis,Ulcerative

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Colazal

What is Colazal? (Balsalazide Disodium)

Property Description
Active Ingredient Balsalazide (as Balsalazide disodium)
Form Capsule
Pharmacological Class Aminosalicylate
General Purpose Provides localized anti-inflammatory action in the colon
Origin Synthetic

What Kind of Medicine is Colazal?

Colazal is an oral prescription medication whose active ingredient is Balsalazide, supplied as Balsalazide disodium. It is classified under the Aminosalicylate pharmacological group, a class of synthetic compounds used primarily for their anti-inflammatory action in the digestive tract. This drug is uniquely recognized as a pro-drug of 5-aminosalicylic acid (5-ASA), also known as Mesalamine, which functions as the final therapeutic agent. The specialized chemical structure of Balsalazide is clinically recognized for facilitating a targeted delivery approach when compared to older Aminosalicylates.

Composition and Form: The Pro-Drug Delivery System

Colazal is provided as a single-ingredient product in the capsule dosage form, intended for oral ingestion by adult patients. Its composition, unlike standard Mesalamine preparations, features the active component linked by an azo bond to an inert carrier molecule. This configuration is a key differentiating feature, chemically engineered to ensure delayed-release and minimal absorption in the upper gastrointestinal tract. The capsule form is designed to deliver the compound intact to the colon, ensuring maximum availability where the inflammation is present.

General Therapeutic Purpose of Aminosalicylates

The primary therapeutic purpose of Colazal is to provide highly localized anti-inflammatory action to the lining of the colon. This action is typical of Aminosalicylates and is central to mitigating the ongoing inflammatory processes in the bowel. The targeted delivery system ensures that a high concentration of the active anti-inflammatory agent is available precisely at the affected site. The overall benefit is focused on managing the inflammatory activity of the bowel, which is beneficial in scenarios where chronic inflammation affects the large intestine.

What side effects are possible with Colazal?

Possible Side Effects and Safety Information

Adverse reactions associated with balsalazide disodium are officially classified based on their frequency as observed in clinical trials and post-marketing reports, consistent with regulatory standards. The medicine's safety profile is defined by effects originating from its active component, mesalamine (5-aminosalicylic acid).

Official Adverse Reaction Classification

Classification Common Examples (Observed in 1/100 patients) SOC-Group Examples
Common Headache, Abdominal pain, Diarrhea, Nausea, Arthralgia (joint pain) Gastrointestinal Disorders, Nervous System Disorders
Rare Myocarditis, Pericarditis, Interstitial Nephritis, Pancreatitis, Hepatitis Cardiac Disorders, Renal and Urinary Disorders, Hepatobiliary Disorders

Serious Safety Considerations

The label documents serious, though infrequent, adverse reactions associated with mesalamine-releasing products. These include severe organ-system effects such as nephrotoxicity (damage to the kidneys) and hepatotoxicity (damage to the liver), as well as inflammation of the heart muscle or lining (myocarditis and pericarditis). The occurrence of a severe rash, such as Severe Cutaneous Adverse Reactions (SCARs), is also formally documented.

Safety Constraints and Monitoring

Use is contraindicated in individuals with known hypersensitivity to balsalazide, mesalamine, or other salicylates. Caution is mandated for patients with pre-existing renal dysfunction or hepatic impairment. Official regulatory documentation requires the evaluation of renal function prior to the start of treatment and periodic monitoring during ongoing therapy.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory information describes the overdose profile for Balsalazide (Colazal) based on its active metabolite, 5-aminosalicylic acid, which can cause signs of salicylate toxicity. To date, no cases of overdose have been reported with this specific product in official documentation.

Documented Overdose Manifestations

Symptoms of severe intoxication listed in prescribing information include nausea, vomiting, abdominal pain, tinnitus, headache, confusion, seizures, tachypnea, and hyperpnea. Overdose carries a risk of severe physiological derangements, including electrolyte and blood pH imbalance, and potential involvement of the renal and liver systems.

Required Emergency Actions

Proper medical care should be sought immediately if an acute overdosage is suspected or if any severe manifestations occur. There is no specific antidote known for Balsalazide overdose. Management is therefore symptomatic and supportive, and may involve measures to correct systemic imbalances, maintain adequate renal function, and perform gastrointestinal tract decontamination using methods such as activated charcoal, if clinically appropriate.

Therapeutic Uses of Colazal

Colazal (balsalazide) is an aminosalicylate drug applied in addressing conditions involving episodic or fluctuating manifestations, namely mildly to moderately active ulcerative colitis. Its use may assist with managing symptoms that interfere with daily comfort associated with this inflammatory bowel condition.

The medicine is commonly used to help with inflammatory or irritative processes that manifest in the colon. It supports patients by focusing on symptom clusters that may become intense or disruptive. This drug is relevant for easing symptoms related to physical discomfort, such as bloody diarrhea, rectal bleeding, and abdominal pain.

Relevant Context: Provides support that helps ease the overall symptom burden

This therapeutic approach contributes to improved comfort during periods of heightened symptoms and helps ease the overall symptom burden when the condition is active. It is applied when appropriate for supportive symptom management during phases of increased distress or discomfort.

“The medicine contributes to improved comfort during periods of heightened symptoms and may assist with maintaining functional stability.”

Regulatory References

  1. NIH MedlinePlus overview on Balsalazide

Eligibility and Restrictions for Use

Colazal (balsalazide) is indicated for the treatment of mildly to moderately active ulcerative colitis in adults and in pediatric patients 5 years of age and older. The active component of Colazal is converted in the colon to mesalamine (5-aminosalicylic acid), which provides the therapeutic effect.


Who Cannot Use Colazal?

Colazal is contraindicated in individuals with known hypersensitivity (severe allergic reaction) to balsalazide, its metabolites (including mesalamine), or any other component of the formulation. It is also contraindicated for patients who have had a hypersensitivity reaction to salicylates, such as aspirin.

Condition Recommendation
Allergy to Salicylates/Mesalamine Contraindicated
Pyloric Stenosis or GI Obstruction Avoid use, as this may delay drug release
Severe Renal Impairment Contraindicated

Use with Caution

Patients should discuss their medical history thoroughly with a healthcare provider, particularly if they have:

  • Kidney or Liver Disease: The risk and benefits should be evaluated, as these conditions may increase the risk of side effects.
  • Pyloric Stenosis: This condition, or any other organic or functional obstruction in the upper gastrointestinal tract, may prolong capsule retention and is generally avoided.
  • Pre-existing Skin Conditions: Patients with atopic dermatitis or atopic eczema may experience more severe photosensitivity (increased sensitivity to sunlight) and should take protective measures.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents define the interaction profile of Colazal (balsalazide) based on the known risks of its active metabolite, mesalamine (5-aminosalicylic acid). Formal drug-drug interaction studies with balsalazide itself are not documented in the regulatory label. The structure of the interactions is classified into two main areas of additive toxicity and metabolic/procedural interference.

Documented Interaction Patterns

Interacting Agent Class Officially Documented Outcome Interaction Type
Nephrotoxic Agents (including NSAIDs) Increased risk of renal reactions Pharmacodynamic (Additive Toxicity)
Azathioprine or 6-Mercaptopurine (6-MP) Increased risk for blood disorders Pharmacodynamic (Additive Toxicity)
Orally administered antibiotics Could theoretically interfere with mesalamine release Theoretical Metabolic Interference

Co-administration with Nephrotoxic Agents or myelotoxic agents, such as Azathioprine or 6-MP, carries an officially documented risk of increased adverse effects. Additionally, a procedural constraint exists, as the drug may cause spuriously elevated test results when measuring urinary normetanephrine through certain laboratory methods. No mandatory timing separation rules or contraindicated combinations are explicitly stated in the regulatory label.

Mechanism of Action

Pharmacodynamic Mechanism of Colazal

Colazal ( balsalazide) is a prodrug that undergoes targeted activation within the lower gastrointestinal tract. The molecule is composed of the active anti-inflammatory component, mesalamine (5-ASA), linked to an inert carrier via an azo bond.

This azo bond is specifically cleaved by azoreductase enzymes produced by the intestinal bacterial flora, resulting in the localized release of mesalamine into the colonic lumen. Once released, mesalamine acts as an enzyme inhibitor within the Arachidonic Acid Cascade, suppressing the activity of Cyclooxygenase (COX) and Lipoxygenase (LOX). This action limits the cellular synthesis and release of pro-inflammatory mediators, including prostaglandins and leukotrienes.

Additionally, mesalamine functions as a free radical scavenger to neutralize Reactive Oxygen Species (ROS), and it modulates intracellular signaling by inhibiting the activation of the NF-kappa B transcription factor complex. Inhibition of NF-kappa B suppresses the genetic instructions for inflammatory protein synthesis, thereby modulating cellular processes that contribute to tissue edema and immune cell recruitment.

Dosage and Administration Information

How to Use Colazal

The usage of Colazal (balsalazide disodium) capsules is governed by official instructions detailing the standardized administration method, dosing, and time-bound duration.


Official Administration Guidelines

Instruction Domain Official Guideline
Route of administration Oral
Adult Dosing schedule Three 750 mg capsules (2.25 g) per dose
Pediatric Dosing (5–17 years) EITHER three 750 mg capsules (2.25 g) OR one 750 mg capsule (750 mg) per dose
Frequency and duration Three times daily (TID) for a defined treatment course up to 8 weeks
Timing in relation to meals May be taken with or without food

Procedural Instructions and Constraints

The administration method is key to ensuring the drug's specialized delivery system functions correctly. The capsule must be swallowed whole. If swallowing the intact capsule is not possible, the contents may be carefully opened and sprinkled onto approximately 10 mL of applesauce; the entire mixture must be consumed immediately and should not be stored. The medicine is administered three times daily, and if a dose is missed, it should be taken as soon as possible, unless it is almost time for the next scheduled dose, in which case the missed dose should be skipped to prevent doubling the dose. Due to the systemic action of the drug, initial and periodic evaluation of renal function is a standard procedure in the use protocol, and caution is advised regarding use in patients with pre-existing liver disease. These instructions define the standardized approach to using the medicine.

Recent Clinical Evidence

Colazal is the brand name for balsalazide disodium, an aminosalicylate medication studied for the treatment of mildly to moderately active ulcerative colitis (UC).

Overview of Clinical Efficacy

Clinical trials have primarily focused on evaluating the proportion of patients achieving clinical improvement or remission (a substantial decrease in UC symptoms) after 8 to 12 weeks of treatment. These studies have involved both adult and pediatric patients (ages 5 to 17) diagnosed with mild-to-moderate active UC.

  • Adult Outcomes: In randomized, controlled trials evaluating induction of remission, a significantly larger proportion of adult participants receiving balsalazide disodium achieved clinical and symptomatic improvement compared to those receiving an inactive placebo.
  • Pediatric Outcomes: Dedicated studies confirmed similar findings in the pediatric population (5–17 years of age) over an 8-week treatment period, with clinical improvement being the primary outcome measured. Balsalazide is noted as one of the few non-sulfa aminosalicylate formulations with a specific pediatric indication for UC.

Safety and Long-Term Data

The safety profile of balsalazide disodium has been established through several clinical trials. Commonly reported adverse events include headache, abdominal pain, and diarrhea. Due to the design of the medication, which releases the active compound (mesalamine) primarily in the colon, systemic absorption is minimized.

Long-term data, including observational studies extending up to three years, have explored the use of balsalazide disodium for the maintenance of remission in patients with UC. These studies generally found the medication to be well-tolerated when used for extended periods.

Frequently Asked Questions (FAQ)

Common questions about Colazal (FAQ)

Q: How quickly can I expect Colazal to start working after I begin taking it?

Official documentation states that clinical trials evaluated the medicine for treatment periods of up to 12 weeks. The onset of effect for initial symptom relief is not specifically defined in the regulatory product information. Patients are generally advised to adhere to the prescribed treatment course duration.


Q: What is the difference between Colazal and mesalamine (or Lialda, Asacol)?

Colazal is officially described as a prodrug of mesalamine (5-ASA). This indicates that Colazal’s molecule is activated primarily when it reaches the colon. Its chemical structure uses a special azo bond that is cleaved by bacteria in the large intestine, ensuring the active mesalamine is released locally at the intended site.


Q: Why is the drug released only in the large intestine (colon)?

The medicine is chemically designed to be a prodrug with an azo bond. This bond is only broken by specific bacteria found in the large intestine (colon). This mechanism ensures that the active anti-inflammatory component is delivered directly and released primarily at the site of inflammation.


Q: What are the typical expectations for symptom improvement on Colazal?

Clinical trials focused on reducing the severity of symptoms associated with mildly to moderately active ulcerative colitis. These studies reported that a larger proportion of participants achieved improvement in symptoms compared to those receiving an inactive placebo. The expected outcomes observed in studies relate to common UC symptoms such as diarrhea, rectal bleeding, and abdominal pain.


Q: Are there reports of Colazal causing sensitivity to sunlight?

Official product information indicates that the drug may increase sensitivity to sunlight (photosensitivity). This effect is officially noted to be more likely in patients with pre-existing skin conditions, such as atopic dermatitis or atopic eczema.


Q: What information is available about long-term use of Colazal?

The safety and effectiveness of Colazal have been established in clinical trials for treatment periods of up to 12 weeks in adults. Information about use beyond this duration is often limited in product labels.


Q: How does Colazal differ from sulfasalazine, which is also a prodrug?

Colazal is classified as a non-sulfa aminosalicylate. This is a key distinction from sulfasalazine, which contains a sulfa component and is associated with certain sulfa-related side effects. Both are prodrugs, but they have different chemical structures for their carrier molecules.


Q: Can Colazal be used by people who have allergies to sulfa drugs?

The medicine is classified as a non-sulfa aminosalicylate, meaning it does not contain the sulfa component found in some other drugs in this class. The contraindications listed in official documents are specifically for hypersensitivity to salicylates, such as aspirin.


Q: Is there a generic version of Colazal available?

Yes, the U.S. Food and Drug Administration (FDA) has approved generic versions of balsalazide disodium capsules. Generic options provide the same active ingredient as the brand name product.


Q: What color is the Colazal capsule?

The capsules are intended to be swallowed whole. The powder contained inside the capsules is officially described as having a color that may range from orange to yellow.


Q: Will Colazal impact the effectiveness of oral birth control pills?

Drug interaction studies specifically for Colazal did not include hormonal contraceptives. The regulatory label does not list oral birth control pills as a documented interaction.


Q: Is it possible for Colazal to cause blood disorders?

Anemia (low red blood cell count) has been reported as a common side effect in some clinical trials for the drug. Official guidance encourages patients to discuss any concerns about blood health.


Q: Does using Colazal affect fertility in men or women?

Animal studies performed with the drug showed no evidence of impaired fertility. Specific information on the effects on human fertility is not fully detailed in the regulatory prescribing information.


Q: Is Colazal known to interact with stomach acid reducers or antacids?

The regulatory label does not list stomach acid reducers or antacids as documented drug interactions. This information is based on the available regulatory studies and information.


Q: Is Colazal used to prevent colon cancer in people with ulcerative colitis?

The drug is indicated only for the treatment of mildly to moderately active ulcerative colitis. It is not currently indicated or approved for the purpose of preventing colon cancer.


Q: Does Colazal have any known interactions with alcohol?

No specific drug interaction studies have been conducted with alcohol, and it is not listed as a documented interaction in the regulatory label.


Q: Is Colazal used for managing irritable bowel syndrome (IBS)?

The drug is indicated for the treatment of mildly to moderately active ulcerative colitis. It is not currently indicated or approved for the management of irritable bowel syndrome (IBS).


Q: Is the brand name Colazal still available, or has it been replaced?

The brand name Colazal is still listed in regulatory documents and remains available. However, generic versions of the active ingredient, balsalazide disodium, have also been approved by the FDA.


Q: What should I know about Colazal if I am taking a blood thinner?

The medication is metabolized into mesalamine, which is a salicylate. Though not specifically listed as an interaction with blood thinners, regulatory documents note the need for evaluation when using salicylates alongside other medications that affect blood coagulation.


Q: Are there any known interactions between Colazal and common supplements like iron or calcium?

The regulatory label does not list common supplements such as iron or calcium as documented drug interactions.

How should Colazal be stored and disposed of?

How to Store and Dispose of Colazal

Colazal (balsalazide disodium) capsules must be stored at Controlled Room Temperature, specifically between 20 C and 25 C (68 F and 77 F). The product must be protected from heat, moisture, and direct light, and it is required to be kept from freezing. Always store the capsules in a closed container and securely out of the reach and sight of children.

Stability and Handling

If the capsule contents are mixed with food, the mixture must be consumed immediately and not stored for future use.

Disposal

Unused or expired Colazal must not be thrown away in household waste or flushed down the toilet. Patients should consult a healthcare professional or pharmacist for instructions on proper disposal according to local environmental regulations.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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