Balsalazide (bal-SAL-a-zide)

Treats ulcerative colitis.

Brand Name(s):

Colazal

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule, Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Swallow the capsule whole. Do not cut, break, crush, or chew it.
• If you cannot swallow the capsule, you may open it and pour the medicine into a small amount of applesauce. Stir this mixture well and swallow it without chewing. Do not keep the mixture for future use. This mixture may stain your teeth or tongue. Talk with your doctor if you have any concerns about this.
• Drink extra fluids so you will urinate more often and help prevent kidney problems.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how balsalazide works. Tell your doctor if you are also using azathioprine, mercaptopurine, or NSAIDs.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, heart disease, skin problems (including atopic dermatitis, atopic eczema), or stomach or bowel problem (including pyloric stenosis). Tell your doctor if you are on a low-sodium diet.
• This medicine may cause the following problems:
  • Kidney problems, including kidney stones
  • Mesalamine-induced acute intolerance syndrome
  • Heart problems, including myocarditis, pericarditis
  • Liver problems
  • Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP)
• This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Call your doctor if your symptoms do not improve or if they get worse.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Bloody diarrhea, severe cramping, stomach pain, headache
• Change in how much or how often you urinate, difficult or painful urination, lower back or side pain
• Dark urine or pale stools, nausea, vomiting, loss of appetite, yellow skin or eyes
• Fast, slow, or pounding heartbeat
• Fever, chills, cough, stuffy or runny nose, sore throat, body aches
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Joint pain
• Mild diarrhea

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088