Pronunciation:

bal-SAL-a-zide

Brand Names:

• Colazal

Dosage Forms:

• Capsule

Classifications:

Therapeutic—

Gastrointestinal Agent

Chemical—

Salicylate, Non-Aspirin

Uses of This Medicine:

Balsalazide is used to treat active ulcerative colitis in patients 5 years of age and older. It helps to decrease inflammation in the colon by blocking the production of certain chemicals that cause the bowel to become overactive.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of balsalazide in children below 5 years of age. Safety and efficacy have not been established .

Older adults—

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing the use of balsalazide in the elderly with use in other age groups.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast-feeding—

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Kidney problems—Balsalazide should be used with caution.

• Pyloric stenosis—Balsalazide capsules may take longer to reach the colon.

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Proper Use of This Medicine:

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 right away. Do not keep the mixture for future use .

You may take this medicine with or without food .

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For treatment of ulcerative colitis:
    • Adults—Three 750-milligram (mg) balsalazide capsules three times a day for a total daily dose of 6.75 grams for eight weeks. You may need to take the medicine for up to twelve weeks as ordered by your doctor.
    • Children 5 years of age and older—Three 750-mg balsalazide capsules three times a day for a total daily dose of 6.75 grams for eight weeks or one 750-mg balsalazide capsule three times a day for a total daily dose of 2.25 grams for eight weeks.
    • Children below 5 years of age—Use and dosage must be determined by your doctor .

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is important that your doctor check your progress at regular visits. This will allow your doctor to check for any unwanted effects.

If your symptoms become worse, check with your doctor.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Bloody diarrhea

fever

skin rash

Less common

Bladder pain

bloody or cloudy urine

bloody stools

difficult, burning, or painful urination

frequent urge to urinate

heavy bleeding

lower back or side pain

Incidence not determined

Abdominal pain or tenderness

chills

clay colored stools

dark urine

decreased appetite

dizziness

headache

itching

lab results that show problems with liver

light-colored stools

loss of appetite

nausea and vomiting

stomach pain, continuing

swelling of feet or lower legs

unpleasant breath odor

unusual tiredness or weakness

vomiting of blood

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

Diarrhea

mild headache

muscle aches

sore throat

stuffy or runny nose

Less common

Acid or sour stomach

belching

bloated, full feeling

body aches or pain

congestion

constipation

coughing

cramps

difficulty in moving

dry mouth

dryness of throat

excess air or gas in stomach or intestines

general feeling of discomfort or illness

heartburn

hoarseness

indigestion

joint pain

muscle pain or stiffness

passing of gas

shivering

sleeplessness

sneezing

stomach discomfort or upset

sweating

swelling or inflammation of the mouth

swollen joints

tender, swollen glands in neck

trouble in swallowing

trouble sleeping

unable to sleep

voice changes

weight loss

Incidence not determined

Hair loss, thinning of hair

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.