Balsalazide Disodium

BALSALAZIDE DISODIUM- balsalazide disodium capsule
Apotex Corp.

structural-formulaFigure-1750mg-280caps

1 INDICATIONS AND USAGE

Balsalazide disodium capsules are indicated 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 balsalazide beyond 8 weeks in pediatric patients 5 years to 17 years of age and 12 weeks in adults have not been established.

2 DOSAGE AND ADMINISTRATION

2.1 Important Preparation and Administration Instructions

  • Evaluate renal function before initiating therapy with balsalazide disodium capsules [see Warnings and Precaution (5.1)].
  • Swallow balsalazide disodium capsules whole. Do not cut, break, crush or chew the capsules.
  • For patients who cannot swallow intact capsules, balsalazide disodium capsules may also be administered by opening the capsule and sprinkling the capsule contents on applesauce. If the capsules are opened for sprinkling, color variation of the powder inside the capsules ranges from orange to yellow and is expected due to color variation of the active pharmaceutical ingredient.
  • Place a small amount (approximately 10 mL) of applesauce into a clean container.
  • Carefully open the capsules.
  • Sprinkle the capsule contents on the applesauce.
  • Mix the capsule contents with the applesauce. The contents may be chewed, if necessary.
  • Consume the entire amount of applesauce mixture immediately. Do not store the applesauce mixture for future use.
  • Teeth and/or tongue staining may occur in some patients when administered sprinkled on applesauce.
  • Drink an adequate amount of fluids [see Warnings and Precautions (5.7)].
  • Take balsalazide disodium capsules with or without food [see Clinical Pharmacology (12.3)].

2.2 Recommended Dosage in Adults and Pediatric Patients 5 Years to 17 Years of Age

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.

Use of balsalazide in the pediatric population for more than 8 weeks has not been evaluated in clinical trials [see Clinical Studies (14)].

3 DOSAGE FORMS AND STRENGTHS

Balsalazide disodium capsules, USP are available as opaque white capsules containing 750 mg balsalazide disodium, imprinted with “APO B750” in red ink.

4 CONTRAINDICATIONS

Balsalazide disodium capsules is contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates, or to any of the components of balsalazide disodium capsules or balsalazide metabolites [see Warnings and Precautions (5.3), Adverse Reactions (6.2), Description (11)].

5 WARNINGS AND PRECAUTIONS

5.1 Renal Impairment

Renal impairment, including minimal change disease, acute and chronic interstitial nephritis, and renal failure, has been reported in patients given products such as balsalazide disodium capsules that release mesalamine into the gastrointestinal tract. Evaluate renal function prior to initiation of balsalazide disodium capsules and periodically while on therapy. Evaluate the risks and benefits of using balsalazide disodium capsules in patients with known renal impairment, a history of renal disease or taking nephrotoxic drugs [see Drug Interactions (7.2), Use in Specific Populations (8.6)].

5.2 Mesalamine-Induced Acute Intolerance Syndrome

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. Although the exact frequency of occurrence has not been determined, it has occurred in 3% of patients in controlled clinical trials of mesalamine or sulfasalazine. Symptoms include cramping, acute abdominal pain and bloody diarrhea, sometimes fever, headache, and rash. Monitor patients for worsening of these symptoms while on treatment. If acute intolerance syndrome is suspected, promptly discontinue treatment with balsalazide disodium capsules.

5.3 Hypersensitivity Reactions

Some patients have experienced a hypersensitivity reaction to sulfasalazine may have a similar reaction to balsalazide disodium capsules or to other compounds that contain or are converted to mesalamine.

Mesalamine-induced hypersensitivity reactions may present as internal organ involvement, including myocarditis, pericarditis, nephritis, hepatitis, pneumonitis and hematologic abnormalities. Evaluate patients immediately if signs or symptoms of a hypersensitivity reaction are present. Discontinue balsalazide disodium capsules if an alternative etiology for the signs and symptoms cannot be established.

5.4 Hepatic Failure

There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered mesalamine. Because balsalazide is converted to mesalamine, evaluate the risks and benefits of using balsalazide disodium capsules in patients with known liver impairment.

5.5 Upper Gastrointestinal Tract Obstruction

Pyloric stenosis or other organic or functional obstruction in the upper gastrointestinal tract may cause prolonged gastric retention of balsalazide disodium capsules, which would delay mesalamine release in the colon. Avoid balsalazide disodium capsules in patients at risk of upper gastrointestinal tract obstruction.

5.6 Photosensitivity

Patients with pre-existing skin conditions such as atopic dermatitis and atopic eczema have reported more severe photosensitivity reactions. Advise patients to avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors.

5.7 Nephrolithiasis

Cases of nephrolithiasis have been reported with the use of mesalamine, the active moiety of balsalazide disodium capsules, including stones with 100% mesalamine content. Mesalamine-containing stones are radiotransparent and undetectable by standard radiography or computed tomography (CT). Ensure adequate fluid intake during treatment with balsalazide disodium capsules.

5.8 Interference with Laboratory Tests

Use of balsalazide disodium capsules, which is converted to mesalamine, may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection because of the similarity in the chromatograms of normetanephrine and the main metabolite of mesalamine, N-acetyl-5-aminosalicylic acid (N-Ac-5-ASA). Consider an alternative, selective assay for normetanephrine.

6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in labeling:

  • Renal Impairment [see Warnings and Precautions (5.1)]
  • Mesalamine-Induced Acute Intolerance Syndrome [see Warnings and Precautions (5.2)]
  • Hypersensitivity Reactions [see Warnings and Precautions (5.3)]
  • Hepatic Failure [see Warnings and Precautions (5.4)]
  • Upper Gastrointestinal Tract Obstruction [see Warnings and Precautions (5.5)]
  • Photosensitivity [see Warnings and Precautions (5.6)]
  • Nephrolithiasis [see Warnings and Precautions (5.7)]

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