The Crohn's & Colitis Foundation of America estimates over 1 million Americans are afflicted with inflammatory bowel disease (IBD), a disease characterized by inflammation of the gastrointestinal tract. Crohn's disease and ulcerative colitis (UC) are the two main forms of inflammatory bowel disease. Ulcerative colitis is a chronic condition marked by inflammation affecting the lining of the colon (large intestines) only. The severity of the disease varies from person to person. Colazal is prescribed as a treatment option for ulcerative colitis.
Indications
Colazal (balsalazide disodium) is an FDA-approved prescription medication indicated to relieve the signs and symptoms associated with mild to moderately active ulcerative colitis (UC). The drug is indicated for adults and children over 5 years of age, but no information is available for geriatric patients, as indicated by Salix Pharmaceuticals.
Dosage and Administration
Colazal is available as a 750 milligram dose capsule. The medication is administered orally, or as an alternative, the capsule can be broken open and the contents can be mixed with applesauce. Adult patients receive three 750 milligram capsules 3 times a day with or without food for up to 8 weeks, while some adults require 12 weeks of treatment. Pediatric patients ages 5 to 17 receive either one or three 750 milligram capsules 3 times a day for up to 8 weeks. The safety and efficacy of Colazal has not been established beyond 12 weeks in adults and 8 weeks in children, as indicated by Salix.
Side Effects
The two most common side effects of Colazal are headache and abdominal pain. Other side effects include diarrhea, nausea, vomiting, joint pain and respiratory infections. An allergic reaction to Colazal is rare, but symptoms include rash, itching, swelling sever dizziness and breathing difficulties. Other rare, but more serious side effects include mood or urinary changes, yellowing of the eyes or skin, increased heart rate, unusual or extreme tiredness and persistent nausea or vomiting.
Precautions and Warnings
Individuals should notify a physician before taking Colazal if they have pyloric stenosis, liver disease or kidney disease. The FDA warns of prolonged gastric retention of Colazal in individuals with pyloric stenosis. FDA prescribing information warns of the possibility of an exacerbation of the symptoms of ulcerative colitis, as reported by some adult and pediatric individuals taking Colazal. As indicated by the FDA, individuals with a hypersensitivity to salicylates, components of Colazal, or balsalazide metabolites should not be given Colazal. Anaphylaxis, skin reactions, and bronchospasms are all hypersensitivity reactions.
Mechanism of Action
Colazal belongs to a class of medications called aminosalicylates that have anti-inflammatory effects. The active ingredient in Colazal is 5-aminosalicylic acid (5-ASA) and 99 percent reaches the colon intact to provide relieve of inflammation and the associated symptoms. Colazal works locally at the colon and does not affect other tissue linings of the body, according to Salix.
