The Colazal brand of balsalazide is used to treat mild to moderate active ulcerative colitis in adults and children who are at least 5 years old.
The Giazo brand of balsalazide is used to treat mild to moderate active ulcerative colitis in men who are at least 18 years old.
Balsalazide may also be used for purposes not listed in this medication guide.
Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.
You should not use balsalazide if you are allergic to balsalazide or mesalamine, or to aspirin or other salicylates (including Kaopectate, Pamprin, Pepto-Bismol, Tricosal, Trilisate, and others).
Tell your doctor if you have ever had:
kidney disease;
liver disease; or
a stomach condition called pyloric stenosis.
Balsalazide tablets contain sodium. Talk to your doctor before using this form of balsalazide if you are on a low salt diet.
Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether balsalazide will harm an unborn baby. However, having active ulcerative colitis during pregnancy may cause premature delivery or low birth weight. The benefit of treating ulcerative colitis may outweigh any risks to the baby.
If you are breastfeeding, tell your doctor if you notice diarrhea in the nursing baby.
Balsalazide capsules should not be given to a child younger than 5 years old. Balsalazide tablets should not be given to anyone under 18 years old.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Balsalazide can be taken with or without food.
If you cannot swallow a capsule whole, open it and sprinkle the medicine into a spoonful of applesauce. Swallow the mixture right away. Medicine from the capsule may stain your teeth or tongue yellow/orange when mixed with food. Do not save the mixture for later use.
Call your doctor if your symptoms do not improve, or if they get worse.
Balsalazide is usually taken only for a short time (8 to 12 weeks). Follow your doctor's dosing instructions very carefully.
Store at room temperature away from moisture and heat.
Take the medicine 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.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
pain or burning when you urinate;
worsening colitis symptoms--fever, stomach pain, cramps, or bloody diarrhea;
kidney problems--little or no urinating, swelling, rapid weight gain;
liver problems--upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.
Common side effects may include:
headache;
mild or occasional nausea, vomiting, stomach pain, diarrhea;
joint pain;
fever; or
cold symptoms such as stuffy nose, sneezing, sore throat.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Usual Adult Dose for Ulcerative Colitis -- Active:
Oral capsules:
Usual dose: Three 750 mg capsules orally 3 times a day for up to 8 weeks
-Some patients in the clinical trials required up to 12 weeks of treatment.
-Safety and efficacy beyond 12 weeks have not been established.
GIAZO(R) tablets; male patients:
Three 1.1 gram tablets orally twice a day, with or without food, for up to 8 weeks
-Effectiveness in female patients was not demonstrated in clinical trials.
-Safety and efficacy beyond 8 weeks have not been established.
Use(s): Treatment of mildly to moderately active ulcerative colitis.
Usual Pediatric Dose for Ulcerative Colitis -- Active:
5 years and older, oral capsules:
Three 750 mg capsules orally 3 times a day for up to 8 weeks
OR
One 750 mg capsule orally 3 times a day for up to 8 weeks
Comments:
-Safety and efficacy beyond 8 weeks have not been established
Use(s): Treatment of mildly to moderately active ulcerative colitis.
Other drugs may affect balsalazide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.