Colazal (Balsalazide Disodium) Frequently Asked Questions

Colazal Is Approved for Use in Ulcerative Colitis

Colazal
Colazal is a drug that is approved for treating ulcerative colitis. Image © Pillbox

What Is Colazal?

Colazal (balsalazide disodium) is used to treat mild to moderately active ulcerative colitis. It is approved for use in patients over the age of 5 years. Colazal is an anti-inflammatory medication that is released in the large intestine, where the drug works topically to decrease the inflammation caused by ulcerative colitis.

Colazal is a derivative of 5-aminosalicyclic-acid (5-ASA), which is a class of drug that has been used to treat ulcerative colitis for many years.

There are some people that are allergic to this class of drugs, so tell your healthcare provider of any allergies to 5-ASA drugs. Colazal is a next-generation of the 5-ASA drugs and is designed to be released directly in the colon, where it needs to do the work to reduce inflammation.

Most side effects are mild and include headache and nausea. More serious side effects are rare, but among them is included bloody urine or stool and dizziness. When taking Colazal, contact your doctor with any questions about side effects or new or unusual symptoms.

How Is Colazal Taken?

Colazal is normally taken by adults in doses of three capsules three times per day with or without food. The drug was approved for kids age 5 to 17 after being studied in a small group of children; the two doses studied were one capsule three times a day and three capsules three times a day. Colazal is proven safe if taken for 8 weeks (kids) or 12 weeks (adults).

If capsules can not be swallowed, they may be opened and the contents sprinkled on applesauce. The applesauce should be eaten right away. If Colazal is taken in this way, it may cause a stain on the teeth or on the tongue.

Why Is Colazal Prescribed?

Colazal is prescribed for treating inflammation in the colon that is associated with mild to moderately severe ulcerative colitis.

The majority of the medication is released in the colon, where it can reduce the inflammation.

What Do I Do if I Miss a Dose?

If you miss a dose, take it as soon as you remember. If your next dose should be taken soon, just take that dose. Don't double up or take more than one dose at a time.

Who Should Not Take Colazal?

Colazal is not recommended for people who have an allergy to aspirin or aspirin-like products. Colazal has not been studied for use in children under the age of 5 years.

Tell your doctor if you have ever had any of the following conditions:

  • Liver disease
  • Kidney disease
  • Pyloric stenosis

What Are the Side Effects?

Serious, but rare, side effects of Colazal include bloody urine, dizziness, and rectal bleeding. Minor, more common side effects can including nausea, diarrhea, or headache. See the Colazal side effects page for a list of potential side effects.

Are There Any Sexual Side Effects?

Colazal is not known to cause any sexual side effects in either men or women.

What Medications Can Colazal Interact With?

Colazal has not been studied for interactions with other medications.

It is thought that antibiotics may cause Colazal to be less effective.

Are There Any Food Interactions?

There are no known food interactions with Colazal.

Is Colazal Safe During Pregnancy?

The FDA has classified Colazal as a type B drug. The effect that Colazal has on an unborn child has not been studied extensively. Colazal should only be used during pregnancy if clearly needed. Notify the prescribing doctor if you become pregnant while taking Colazal. It is not known if Colazal could pass into breast milk and affect a nursing infant.

How Long Can Colazal Be Taken Safely?

The safety and efficacy of Colazal after 12 weeks in adults and 8 weeks in children (under the age of 17) are unknown.

Sources:

Salix Pharmaceuticals. "Colazal - UC Treatment." Salix Pharmaceuticals, Inc. 2013. 15 Sept 2013.

U.S. Food and Drug Administration. "Balsalazide Disodium (marketed as Colazal)." Drugs@FDA 11 Apr 2007. 15 Sept 2013.

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