• Colazal, an aminosalicylate, is used to treat ulcerative colitis and contains balsalazide disodium, a prodrug. When taken orally, it is delivered to the colon where it releases mesalamine (5-ASA), the active drug. The mechanism of 5-ASA is not fully understood, but may act locally by blocking production of arachidonic acid metabolites to lower inflammation.
• Colazal (generic name: balsalazide) is an oral prescription medicine approved by the FDA for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. It is made by Salix Pharmaceuticals.
• Ulcerative colitis is a long-term inflammatory bowel disease of the colon (the large intestine). Inflammation and ulcers form on the inner lining of the colon. Common symptoms include: diarrhea with blood or mucus, bleeding from the rectum, urgent need to have a bowel movement, stomach pain, fever, poor appetite, weight loss, and fatigue.

• Colazal capsules can be used in adults and children 5 years of age and older. You can take Colazal with or without food. If you cannot swallow intact capsules, you may open the capsule and sprinkle the contents on a tablespoonful of applesauce, then chew and swallow it immediately.
• Oral doses are taken for up to 8 weeks in children and for 8 to 12 weeks in adults. In studies, the number of adults who stopped therapy because of side effects was similar to those patients taking a placebo (an inactive treatment). It appears to be well-tolerated by most patients.
• The generic version of Colazal known as balsalazide may save you money at the pharmacy if you are paying out of pocket or have a high copay. Ask your doctor for the generic version, if you prefer, and talk to your pharmacist about the pricing for Colazal or balsalazide.
• Colazal capsules can be stored at room temperature, but keep away from moisture and heat.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Headache, stomach pain, fever, diarrhea, nausea, vomiting, lung infection, common cold symptoms, and arthralgia (joint pain), the most common side effects.
• It is not known if Colazal use is safe or effective in children (5 to 17 years of age) beyond 8 weeks of treatment, or beyond 12 weeks in adults.
• May cause kidney problems, especially in people taking drugs that are toxic to the kidney like NSAIDs (for example: ibuprofen or naproxen) or in people that already have kidney disease. May also cause kidney stone formation.
• May cause serious liver failure in patients with pre-existing liver disease.
• Can cause Acute Intolerance Syndrome to Colazal that may be difficult to distinguish from a worsening of ulcerative colitis. In some mesalamine studies, this side effect has occurred in up to 3% of patients.
• Patients 65 years and older and those taking certain medicines (azathioprine or 6-mercaptopurine) may develop blood disorders and need period monitoring of their blood cell counts and platelets. Colazal may cause serious allergies in people allergic to salicylates, like aspirin or other salicylates (including Kaopectate, Pamprin, Pepto-Bismol, Tricosal, Trilisate, and others).
• Severe, possibly fatal skin reactions may occur with the use of Colazal. Possible skin reactions include: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP).
• While taking Colazal, you may need to avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors. People that have eczema have reported more severe skin reactions when in the sun.
• If you are at risk of an upper gastrointestinal obstruction, such as pyloric stenosis, you may not be able to use Colazal. This may cause you to retain the medicine in your digestive tract and the active ingredient may not be released in your colon.
• If you take too much Colazal you may be at risk for salicylate toxicity, which may include: nausea, vomiting and abdominal pain, fast or deep breathing, ringing in your ears, and neurologic symptoms (headache, dizziness, confusion, seizures), electrolyte and blood pH imbalance and organ damage (such as the kidneys and liver).
• If you sprinkle Colazal on applesauce before taking it, instead of swallowing the capsule, it may cause your teeth or tongue to become stained.
• The Colazal brand name product is very expensive and your insurance may only pay for the generic version.

This is not a complete list of all of the possible side effects or warnings with Colazal. Call your doctor for medical advice about side effects.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

• Follow any medicine directions on your package. Tell your healthcare providers about all your medical conditions, allergies, and all medicines you use, including any over-the-counter (OTC), vitamin or herbal products.
• Tell your healthcare provider if you have ever had kidney disease, liver disease, or a stomach condition called pyloric stenosis. Tell your doctor if you have, or are at risk of, a gastric obstruction.
• Be sure to complete any laboratory tests ordered by your healthcare provider. Your doctor may need to monitor your kidneys, liver and blood cell counts to help prevent side effects. If your kidney function declines, your doctor may need to adjust your dose or stop treatment.
• Swallow Colazal capsules whole. Do not cut, break, crush or chew the capsules. If you open the capsule and mix it with applesauce, do not save the mixture for later use.
• If you miss a dose, take it as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
• Drink an adequate amount of fluids with Colazal to decrease your risk for kidney stone formation. Contact your healthcare provider if you have signs or symptoms of a kidney stone, such as severe side or back pain, blood in the urine.
• If you have signs or symptoms of liver disease, such as nausea, upper abdominal pain or swelling, yellow eyes / skin (jaundice), dark-colored urine, itchy skin, or pale-colored stools, contact your healthcare provider.
• Stop taking Colazal and contact your healthcare provider right away if you have new or worsening symptoms of cramping, abdominal pain, bloody diarrhea, fever, headache, rash. You may be experiencinga mesalamine Acute Intolerance Syndrome that may be difficult to distinguish from a worsening of ulcerative colitis. Your doctor may decide to stop your treatment with Colazal.
• Tell your doctor if you are pregnant or planning a pregnancy. It is not known whether Colazal will harm an unborn baby. If you are breastfeeding while taking Colazal, tell your doctor if you notice diarrhea in your baby.
• Do not use Colazal if you have a known or suspected allergic reaction to Colazal, mesalamine or balsalazide metabolites, aspirin or other salicylates or aminosalicylates (including Kaopectate, Pamprin, Pepto-Bismol, Tricosal, Trilisate, bismuth subsalicylate, choline salicylate, diflunisal, magnesium salicylate, salsalate and others), or any of the components of Colazal capsule.
• Get emergency medical help (call 911) if you have signs of an allergic reaction such as hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.
• While taking Colazal, avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors. This medicine may also lead to severe skin reactions. If you experience any severe skin side effects, stop use of this drug and call your doctor or 911 right away. Ask your doctor how to recognize severe skin reactions.
• Excessive doses of Colazal may lead to salicylate toxicity like: nausea, vomiting and stomach pain, fast or deeper breathing, ringing in ears, and neurologic symptoms such as headache, dizziness, confusion, electrolyte and blood pH imbalance, organ damage (like kidney or liver) and seizures. If you have taken too much Colazal, seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Adults

• In adults in a clinical study over an 8-week period, 103 patients with active mild-to-moderate ulcerative colitis with bleeding were treated with 6.75 grams (g) per day or 2.25 g per day of balsalazide (Colazal).
• Researchers assessed whether treatment led to a reduction in rectal bleeding and improvement in at least one of the following: stool frequency, patient functional assessment, abdominal pain, sigmoidoscopic grade, and physician’s global assessment.
• Results showed a significant difference between high and low doses of Colazal.

Children (5 to 17 years of age)

• In an 8-week clinical study in children with mildly to moderately active ulcerative colitis, 6.75 g per day and 2.25 g per day of Colazal was given to 68 children 5 to 17 years of age.
• Fifteen (45%) patients in the Colazal 6.75 g per day group and 13 (37%) patients in the Colazal 2.25 g per day group showed this clinical improvement (based on a 3-point improvement on the Modified Sutherland Ulcerative Colitis Activity Index [MUCAI]).
• Rectal bleeding improved in 64% of patients treated with Colazal 6.75 g per day and 54% of patients treated with Colazal 2.25 g per day.
• Colonic mucosal appearance upon endoscopy improved in 61% of patients treated with Colazal 6.75 g/day and 46% of patients treated with Colazal 2.25 g/day.

• NSAIDs and medicine toxic to the kidney: May increase the risk of kidney disease when used with Colazal.
• Azathioprine, 6-mercaptopurine and/or any other drugs known to cause blood toxicity: may increase the risk for blood disorders, bone marrow failure, and associated complications.
• Laboratory test interference with urine normetanephrine measurements (normetanephrine is a marker for catecholamine-secreting tumors such as pheochromocytoma): May lead to false elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection. Consider an alternative, selective assay for normetanephrine.

Note that this list is not all-inclusive and includes only common medications that may interact with Colazal. You should refer to the prescribing information for a complete list of interactions. Tell your doctor about all your current medicines and any medicine you start or stop using.