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Balsalazide (Oral route)

Pronunciation:

bal-SAL-a-zide

Brand Names:

  • Colazal
  • Giazo

Dosage Forms:

  • Capsule
  • Tablet

Classifications:

Therapeutic—

Gastrointestinal Agent

Chemical—

Salicylate, Non-Aspirin

Uses of This Medicine:

Balsalazide is used to treat an inflammatory bowel disease called ulcerative colitis. Balsalazide capsules are used to treat active ulcerative colitis in patients 5 years of age and older. Balsalazide tablets are used to treat mild to moderately active ulcerative colitis in male patients 18 years of age and older.

Balsalazide works inside the intestines (bowel) to reduce the inflammation and other symptoms of the disease.

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 capsules in children younger than 5 years of age. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of balsalazide tablets in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of balsalazide in the elderly. However, elderly patients are more likely to have blood problems (e.g., neutropenia, pancytopenia) and age-related kidney disease, which may require caution and an adjustment in the dose for patients receiving balsalazide.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersBAnimal 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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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:

  • Allergy to aminosalicylates or salicylates (e.g., aspirin)—Should not be used in patients with this condition.
  • Kidney disease, or history of or
  • Liver disease——Use with caution. May make this condition worse.
  • Pyloric stenosis (tube is too narrow where food passes out of the stomach )—May delay the release of balsalazide into the body.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not stop taking this medicine without first checking with your doctor.

You may take this medicine with or without food. Also, tell your doctor if you are on a low-sodium diet.

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.

Do not change to another brand without checking with your doctor. The number of capsules or tablets that you take depends on the brand and strength of the medicine. If you refill your medicine and it looks different, check with your pharmacist.

Keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days. Do not miss any doses.

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 treatment of ulcerative colitis:
    • For oral dosage form (capsules):
      • Adults—Three 750-milligram (mg) capsules three times a day, for a total daily dose of 6750 mg for 8 weeks. You may need to take the medicine for up to 12 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 6750 mg for 8 weeks or one 750-mg balsalazide capsule three times a day for a total daily dose of 2250 mg for 8 weeks.
      • Children younger than 5 years of age—Use and dose must be determined by your doctor.
    • For oral dosage form (tablets):
      • Adults—Three 1.1-gram (g) tablets two times a day, for a total daily dose of 6.6 g, taken for up to 8 weeks.
      • Children—Use and dose 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 see if this medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for any unwanted effects.

Check with your doctor right away if you have abdominal or stomach pain, bloody diarrhea, cramps, fever, headache, or a rash while you are using this medicine. These may be symptoms of a condition called mesalamine-induced acute intolerance syndrome.

If your symptoms do not improve or if they 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
Rare
Difficult or labored breathing
shortness of breath
tightness in the chest
wheezing
Incidence not known
Abdominal or stomach pain or tenderness
chills
clay colored stools
dark urine
decreased appetite
decreased frequency or amount of urine
dizziness
general feeling of tiredness or weakness
headache
increased blood pressure
increased thirst
itching
joint pain
light-colored stools
loss of appetite
nausea and vomiting
stomach pain, continuing
swelling of the face, fingers, feet, or lower legs
unpleasant breath odor
unusual tiredness or weakness
vomiting of blood
weight gain
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 or full feeling
body aches or pain
bone pain
congestion
constipation
coughing
cramps
difficulty with moving
dry mouth
dryness of the throat
excess air or gas in the stomach or intestines
general feeling of discomfort or illness
heartburn
hoarseness
indigestion
muscle pain or stiffness
pale skin
passing of gas
shivering
sleeplessness
sneezing
stomach discomfort or upset
sweating
swelling or inflammation of the mouth
swollen joints
tender, swollen glands in the neck
trouble with sleeping
trouble with swallowing
troubled breathing with exertion
unable to sleep
unusual bleeding or bruising
voice changes
weight loss
Rare
Back pain
ear congestion
loss of appetite
loss of voice
pain in the ankles or knees
painful, red lumps under the skin, mostly on the legs
unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
Incidence not known
Hair loss or thinning of the 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.


Last Updated: 4/4/2014

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