Balsalazide

What is Balsalazide?

• Balsalazide (Colazal) is an aminosalicylate used for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older.

Balsalazide structure

What are the uses of this medicine?

• Balsalazide (Colazal) is used for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older.

Limitations of Use:

• Safety and effectiveness of Colazal beyond 8 weeks in pediatric patients 5 years to 17 years of age and 12 weeks in adults have not been established.

How does this medicine work?

• The disodium salt form of balsalazide, an aminosalicylate and oral prodrug that is enzymatically cleaved in the colon to produce the anti-inflammatory agent mesalazine.
• Mesalazine acts locally on the mucosa of the colon where it diminishes inflammation by blocking the production of arachidonic acid metabolites, including leukotrienes, prostaglandins and hydroxyeicosatetraenoic acids, and other inflammatory agents.
• Balsalazide disodium is used to treat chronic inflammatory bowel disease.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• known or suspected hypersensitivity to salicylates, aminosalicylates, or to any of the components of Colazal capsules or balsalazide metabolites.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• azathioprine (Azasan, Imuran)
• mercaptopurine (Purixan)
• nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn)

Is this medicine FDA approved?

• Balsalazide was approved as treatment of mildly to moderately active ulcerative colitis in adults in the United States in 2000 and is available generically and under the brand name Colazal in capsules of 750 mg.

How should this medicine be used?

Recommended dosage: Adults:

• The recommended dosage in adults is 2.25 g (three 750 mg capsules) three times daily for up to 8 weeks.
• Some patients in the adult clinical trials required treatment for up to 12 weeks.

Pediatric Patients 5 Years to 17 Years of Age:

• The recommended dosage in pediatric patients 5 years to 17 years of age is either:

• 2.25 g (three 750 mg capsules) three times daily for up to 8 weeks;

OR:

• 750 mg (one capsule) three times daily for up to 8 weeks.

Administration:

• Balsalazide comes as a capsule to take by mouth.
• It is usually taken three times a day.
• Balsalazide is usually taken for 8 weeks, but it may be taken for up to 12 weeks.
• Continue to take balsalazide even if you feel well.
• Do not stop taking balsalazide without talking to your doctor.
• Evaluate renal function before initiating therapy with Balsalazide.
• Swallow capsules whole.
• Do not cut, break, crush or chew.
• For patients who cannot swallow intact capsules, the capsules may be opened and sprinkled on applesauce, then chewed and swallowed immediately.
• Teeth and/or tongue staining may occur when administered sprinkled on applesauce.
• Drink an adequate amount of fluids.
• Take Balsalazide capsules with or without food.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Capsules: 750 mg

This medicine is available in fallowing brand namesː

• Colazal

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache
• abdominal pain
• diarrhea
• nausea
• vomiting
• respiratory infection
• arthralgia

What special precautions should I follow?

• Renal impairment, including minimal change disease, acute and chronic interstitial nephritis, and renal failure, has been reported in patients given products such as Colazal that release mesalamine into the gastrointestinal tract. Assess renal function at the beginning of treatment and periodically during treatment. Evaluate the risks and benefits in patients with known renal impairment or taking nephrotoxic drugs; monitor renal function. Discontinue if renal function deteriorates.
• Balsalazide is converted to mesalamine, which has been associated with an acute intolerance syndrome that may be difficult to distinguish from an exacerbation of ulcerative colitis. Symptoms may be difficult to distinguish from an exacerbation of ulcerative colitis; monitor for worsening symptoms; discontinue treatment if acute intolerance syndrome is suspected.
• Some patients have experienced a hypersensitivity reaction to sulfasalazine may have a similar reaction to Colazal or to other compounds that contain or are converted to mesalamine. Evaluate patients immediately and discontinue if a hypersensitivity reaction is suspected.
• There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered mesalamine. Evaluate the risks and benefits in patients with known liver impairment.
• Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported with the use of mesalamine, the active moiety of Colazal. Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation.
• Pyloric stenosis or other organic or functional obstruction in the upper gastrointestinal tract may cause prolonged gastric retention of Colazal. Avoid in patients with pyloric stenosis or other organic or functional obstruction.
• Patients with pre-existing skin conditions such as atopic dermatitis and atopic eczema have reported more severe photosensitivity reactions. Advise patients with pre-existing skin conditions to avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors.
• Cases of nephrolithiasis have been reported with the use of mesalamine, the active moiety of Colazal, including stones with 100% mesalamine content. Stones containing mesalamine, the active moiety in Colazal, are undetectable by standard radiography or computed tomography (CT). Ensure adequate fluid intake during treatment with Colazal.
• Use of mesalamine may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection.
• Plan to avoid unnecessary or prolonged exposure to the sunlight and to wear protective clothing, sunglasses, and sunscreen. Balsalazide may make your skin sensitive to sunlight.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• nausea, vomiting and abdominal pain, tachypnea, hyperpnea, tinnitus, and neurologic symptoms (headache, dizziness, confusion, seizures)

Management of overdosage:

• There is no specific antidote for balsalazide overdose; however, conventional therapy for salicylate toxicity may be beneficial in the event of acute overdosage and may include gastrointestinal tract decontamination to prevent further absorption.
• Proper medical care should be sought immediately with appropriate supportive care, including the possible use of emesis, cathartics, and activated charcoal to prevent further absorption.
• Correct fluid and electrolyte imbalance by the administration of appropriate intravenous therapy and maintain adequate renal function.

Can this medicine be used in pregnancy?

• The use of mesalamine, the active moiety of Colazal, during pregnancy have not reliably informed an association with mesalamine and major birth defects, miscarriage, or adverse maternal or fetal outcomes.
• There are adverse effects on maternal and fetal outcomes associated with ulcerative colitis in pregnancy.

Can this medicine be used in children?

• The safety and effectiveness of Colazal in pediatric patients below the age of 5 years have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• BALSALAZIDE DISODIUM

Inactive ingredients:

• SILICON DIOXIDE
• MAGNESIUM STEARATE

Who manufactures and distributes this medicine?

Distributed by:

• Salix Pharmaceuticals, a division of
• Bausch Health US, LLC
• Bridgewater, NJ USA

Manufactured by:

• LGM Pharma Solutions, LLC
• Irvine, CA USA

• Colazal is a trademark of Salix Pharmaceuticals, Inc. or its affiliates.

What should I know about storage and disposal of this medication?

• Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F).

• Dailymed label info on Balsalazide
• FDA Balsalazide