Balsalazide (Oral Route)

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.

This product is available in the following dosage forms:

• Capsule

Before Using

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.

Pediatric

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 .

Geriatric

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

Breastfeeding

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.

Drug Interactions

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Tamarind

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 problemsa€”Balsalazide should be used with caution.

• Pyloric stenosisa€”Balsalazide capsules may take longer to reach the colon.

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Proper Use

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:
    
    
    
    • Adultsa€”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 oldera€”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 agea€”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

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

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 .

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