Balsalazide disodium capsules are indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older.

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

Balsalazide Disodium Capsules, USP containing 750 mg balsalazide disodium are available as yellow colored opaque cap imprinted with "1626" in black ink and white colored opaque body.

Balsalazide disodium capsules are contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates, or to any of the components of balsalazide disodium capsules or balsalazide metabolites

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

Balsalazide disodium capsules are an aminosalicylate, and symptoms of salicylate toxicity include: nausea, vomiting and abdominal pain, tachypnea, hyperpnea, tinnitus, and neurologic symptoms (headache, dizziness, confusion, seizures). Severe salicylate intoxication may lead to electrolyte and blood pH imbalance and potentially to other organ (e.g., renal and liver) damage. 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.

Each Balsalazide Disodium Capsules, USP contains 750 mg of balsalazide disodium, a prodrug that is enzymatically cleaved in the colon to produce mesalamine (5-aminosalicylic acid or 5-ASA), an aminosalicylate. Each capsule of balsalazide disodium (750 mg) is equivalent to 267 mg of mesalamine. Balsalazide disodium has the chemical name (E)-5-[[-4-[[(2-carboxyethyl)amino]carbonyl]phenyl]azo]-2-hydroxybenzoic acid, disodium salt, dihydrate. Its structural formula is:

Molecular Weight: 437.31

Molecular Formula: C

Balsalazide disodium is a yellow to orange crystalline powder. It is freely soluble in water and isotonic saline and DMSO, sparingly soluble in methanol and ethanol and practically insoluble in all other organic solvents.

Inactive Ingredients: Each hard gelatin capsule contains colloidal silicon dioxide and magnesium stearate. Additionally, the capsule shell contains gelatin, titanium dioxide, iron oxide yellow, iron oxide black, and iron oxide red. The black ink contains shellac, iron oxide black, and potassium hydroxide. The sodium content of each capsule is approximately 79 mg.

Two randomized, double-blind studies were conducted in adults. In the first trial, 103 patients with active mild-to- moderate ulcerative colitis with sigmoidoscopy findings of friable or spontaneously bleeding mucosa were randomized and treated with balsalazide 6.75 g/day or balsalazide 2.25 g/day. The primary efficacy endpoint was reduction of rectal bleeding and improvement of at least one of the other assessed symptoms (stool frequency, patient functional assessment, abdominal pain, sigmoidoscopic grade, and physician's global assessment [PGA]). Outcome assessment for rectal bleeding at each interim period (weeks 2, 4, and 8) encompassed a 4-day period (96 hours). Results demonstrated a statistically significant difference between high and low doses of balsalazide disodium (Figure 1).

A second study, conducted in Europe, confirmed findings of symptomatic improvement.

A clinical trial was conducted comparing two doses (6.75 g/day and 2.25 g/day) of balsalazide disodium in 68 pediatric patients (age 5 to 17, 23 males and 45 females) with mildly to moderately active ulcerative colitis. 28/33 (85%) patients randomized to 6.75 g/day and 25/35 (71%) patients randomized to 2.25 g/day completed the study. The primary endpoint for this study was the proportion of subjects with clinical improvement (defined as a reduction of at least 3 points in the Modified Sutherland Ulcerative Colitis Activity Index [MUCAI] from baseline to 8 weeks). Fifteen (45%) patients in the balsalazide disodium 6.75 g/day group and 13 (37%) patients in the balsalazide disodium 2.25 g/day group showed this clinical improvement. In both groups, patients with higher MUCAI total scores at baseline were likely to experience greater improvement.

Rectal bleeding improved in 64% of patients treated with balsalazide disodium 6.75 g/day and 54% of patients treated with balsalazide disodium 2.25 g/day. Colonic mucosal appearance upon endoscopy improved in 61% of patients treated with balsalazide disodium 6.75 g/day and 46% of patients treated with balsalazide disodium 2.25 g/day.

Balsalazide Disodium Capsules, USP 750 mg are yellow to orange granular powder filled in size "00" empty hard gelatin capsule having a yellow colored opaque cap imprinted with "1626" in black ink and a white colored opaque body.

NDC 70710-1626-1 in bottles of 280 capsules with child resistant closure

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].

Inform patients that balsalazide disodium capsule may decrease their renal function, especially if they have known renal impairment or are taking nephrotoxic drugs, including NSAIDs, and periodic monitoring of renal function will be performed while they are on therapy. Advise patients to complete all blood tests ordered by their healthcare provider

Inform patients of the signs and symptoms of hypersensitivity reactions. Instruct patients to stop taking balsalazide disodium capsules and report to their healthcare provider if they experience new or worsening symptoms of Acute Intolerance Syndrome (cramping, abdominal pain, bloody diarrhea, fever, headache, and rash) or other symptoms suggestive of mesalamine- induced hypersensitivity

Inform patients with known liver disease of the signs and symptoms of worsening liver function and advise them to report to their healthcare provider if they experience such signs or symptoms

Inform patients of the signs and symptoms of severe cutaneous adverse reactions. Instruct patients to stop taking balsalazide disodium capsules and report to their healthcare provider at first appearance of a severe cutaneous adverse reaction or other sign of hypersensitivity

Advise patients to contact their healthcare provider if they experience signs and symptoms of upper gastrointestinal tract obstruction

Advise patients with pre-existing skin conditions to avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors

Instruct patients to drink an adequate amount of fluids during treatment in order to minimize the risk of kidney stone formation and to contact their healthcare provider if they experience signs or symptoms of a kidney stone (e.g., severe side or back pain, blood in the urine)

Inform elderly patients and those taking azathioprine or 6-mercaptopurine of the risk for blood disorders and the need for periodic monitoring of complete blood cell counts and platelet counts while on therapy. Advise patients to complete all blood tests ordered by their healthcare provider

Instruct patients:

Ahmedabad, India

Pennington, NJ 08534

Rev.: 11/23

NDC 70710-1626-1 in bottle of 280 capsules with child-resistant closure

Balsalazide Disodium Capsules, USP

750 mg

Rx only

Zydus

Product of Taiwan