Balsalazide (Oral route)
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:
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.
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.
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.
|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.|
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.
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 is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Amtolmetin Guacil
- Flufenamic Acid
- Mefenamic Acid
- Niflumic Acid
- Nimesulide Beta Cyclodextrin
- Tiaprofenic Acid
- Tolfenamic Acid
- Varicella Virus Vaccine
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.
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.
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.
- For oral dosage form (capsules):
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.
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:
- More common
- Bloody diarrhea
- 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
- Difficult or labored breathing
- shortness of breath
- tightness in the chest
- Incidence not known
- Abdominal or stomach pain or tenderness
- clay colored stools
- dark urine
- decreased appetite
- decreased frequency or amount of urine
- general feeling of tiredness or weakness
- increased blood pressure
- increased thirst
- 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
- More common
- mild headache
- muscle aches
- sore throat
- stuffy or runny nose
- Less common
- Acid or sour stomach
- bloated or full feeling
- body aches or pain
- bone pain
- difficulty with moving
- dry mouth
- dryness of the throat
- excess air or gas in the stomach or intestines
- general feeling of discomfort or illness
- muscle pain or stiffness
- pale skin
- passing of gas
- stomach discomfort or upset
- 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
- 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
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:
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:
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: 7/4/2017