Balsalazide

Uses

What is Balsalazide used for?

Balsalazide is commonly used to treat a certain bowel disease (ulcerative colitis). It helps to reduce symptoms of ulcerative colitis such as diarrhea, rectal bleeding, and stomach pain. Balsalazide belongs to a class of drugs known as aminosalicylates. It works by decreasing swelling in the colon.

How should I take Balsalazide?

Take this medication by mouth with or without food, usually 3 times daily or as directed by your doctor.

If you have trouble swallowing the capsules, you may open them and sprinkle the contents onto a spoonful of applesauce. Swallow the food/medication mixture right away. Do not prepare a supply in advance.

Dosage is based on your age, medical condition, and response to therapy.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Inform your doctor if your condition worsens or does not improve after several weeks.

How do I store Balsalazide?

Balsalazide is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Balsalazide in the bathroom or the freezer. There may be different brands of Balsalazide that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Balsalazide down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Balsalazide?

Before taking balsalazide, tell your doctor or pharmacist if you are allergic to it; or to other aminosalicylates (such as mesalamine, olsalazine); or to salicylates (e.g., aspirin, salsalate); or to sulfasalazine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: a certain stomach/intestinal condition (e.g., pyloric stenosis), liver disease, kidney disease.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication contains sodium. Consult your doctor or pharmacist if you are on a salt-restricted diet or if you have a condition that could be worsened by an increase in salt intake (such as heart failure).

This medication is similar to aspirin. Children and teenagers should not take aspirin or aspirin-related medications (e.g., salicylates) if they have chickenpox, flu, or any undiagnosed illness, or if they have just been given a live virus vaccine (e.g., varicella vaccine), without first consulting a doctor about Reye’s syndrome, a rare but serious illness.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Balsalazide during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking this Balsalazide. This Balsalazide is pregnancy risk category B according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

• A=No risk,
• B=No risk in some studies,
• C=There may be some risk,
• D=Positive evidence of risk,
• X=Contraindicated,
• N=Unknown

Side effects

What side effects can occur from Balsalazide?

Headache, nausea, vomiting, joint pain, diarrhea, abdominal pain, fever, sore throat, trouble sleeping, or loss of appetite may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Infrequently, balsalazide can worsen ulcerative colitis. Tell your doctor right away if your symptoms worsen after starting this medication (e.g., increased abdominal pain, rectal bleeding).

Tell your doctor right away if any of these rare but very serious side effects occur: signs of kidney problems (such as change in the amount of urine), yellowing eyes/skin, dark urine, unusual/extreme tiredness, severe stomach/abdominal pain, persistent nausea/vomiting, burning/painful urination, fast/pounding heartbeat.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Balsalazide?

Balsalazide is very similar to mesalamine. Do not use mesalamine medications taken by mouth while using balsalazide.

This medication may interfere with certain laboratory tests (including urine normetanephrine levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Balsalazide may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Balsalazide?

Balsalazide may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Balsalazide?

Balsalazide may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Balsalazide.

What is the dose of Balsalazide for an adult?

Usual Adult Dose for Ulcerative Colitis – Active

Mildly to moderately active:

Capsules: 2250 mg orally 3 times a day for up to 8 weeks

In clinical trials, some patients required treatment for up to 12 weeks.

Tablets:

Male patients: 3.3 g orally twice a day for up to 8 weeks

Female patients: Effectiveness has not been established.

Renal Dose Adjustments

The manufacturer recommends caution when administering this drug to patients with known renal dysfunction or a history of renal disease.

Liver Dose Adjustments

The manufacturer recommends caution when administering this drug to patients with liver disease. Liver function testing should be considered in such patients.

What is the dose of Balsalazide for a child?

Usual Pediatric Dose for Ulcerative Colitis – Active

Mildly to moderately active:

Capsules:

5 years or older: 2250 mg orally 3 times a day or 750 mg orally 3 times a day for up to 8 weeks

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Balsalazide available?

Balsalazide is available in the following dosage forms and strengths:

• Capsule
• Tablet

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Balsalazide, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.