balsalazide disodium 750 mg cp generic colazal

Uses

Ulcerative Colitis

Balsalazide is used in the management of mildly to moderately active ulcerative colitis. Safety and efficacy of balsalazide therapy have not been established beyond 12 weeks.

Safety and efficacy of balsalazide have been evaluated in 2 randomized, double-blind studies of 8 weeks' duration in patients with mildly to moderately active ulcerative colitis with sigmoidoscopic findings of friable or spontaneously bleeding mucosa. In these studies, improvements in rectal bleeding, stool frequency, or sigmoidoscopic findings were reported in 55-65, 49-59, or 74-79% of patients, respectively, who received balsalazide 6.75 g daily for 8 weeks. Balsalazide also reduced abdominal pain and improved functional assessment scores.

Results of clinical studies indicate that balsalazide 6.75 g daily appears to be at least as effective as sulfasalazine 3 g daily or mesalamine 2.4 g daily in improving symptoms in patients with ulcerative colitis who received the drugs orally for up to 12 weeks. In one randomized, double-blind study, symptomatic improvement or complete remission (defined as asymptomatic or with mild symptoms, sigmoidoscopy grade 0 or 1, and no rectal steroid use within 4 days) was achieved in 88 or 62%, respectively, of patients receiving balsalazide 6.75 mg daily and in 57 or 37%, respectively, of those who received mesalamine 2.4 g daily for 12 weeks. Treatment with balsalazide appears to be associated with more rapid symptomatic improvement (12-14 days earlier) compared to that with mesalamine. However, some clinicians state that a relative therapeutic advantage of balsalazide over mesalamine remains to be established.

Crohn's Disease

Although controlled studies assessing the efficacy of balsalazide are lacking, limited data indicate that use of the drug may be beneficial in the management of Crohn's disease involving the colon.

Dosage and Administration

General

Balsalazide disodium is administered orally 3 times daily.

Dosage

Ulcerative Colitis

Dosage of balsalazide disodium is expressed in terms of balsalazide. The recommended adult dosage of balsalazide is 6.75 g (equivalent to 2.4 g of mesalamine) daily administered as 3 equally divided doses of 2.25 g (three 750-mg capsules 3 times daily) for 8 weeks; some patients may require up to 12 weeks of therapy. The total daily dosage of balsalazide (6.75 g) is equivalent to approximately 2.4 g of mesalamine.

Crohn's Disease

For the management of Crohn's disease (involving the colon), a balsalazide dosage of 2-6 g daily may be used.

Special Populations

No special population dosage recommendations at this time.

Cautions

Contraindications

Known hypersensitivity to salicylates, balsalazide, or its metabolites, or any ingredient in the formulation.

Warnings/Precautions

Major Toxicities

GI Effects

Exacerbation of preexisting symptoms of ulcerative colitis has been reported rarely.

General Precautions

Gastric Retention

Potential for prolonged gastric retention of the drug in patients with pyloric stenosis.

Specific Populations

Pregnancy

Category B. (.)

Nursing Women

It is not known whether balsalazide is distributed in human milk. Because many drugs are excreted in human milk, caution is advised if the drug is administered in nursing women.

Pediatric Use

Safety and efficacy not established in children younger than 18 years of age.

Geriatric Use

Experience in those 65 years of age and older insufficient to determine whether they respond differently from younger adults.

Hepatic Impairment

Safety and efficacy not established in patients with hepatic impairment.

Renal Impairment

Safety and efficacy not established in patients with renal impairment. However, since renal toxicity has been reported in patients receiving other preparations of mesalamine, the manufacturer recommends that balsalazide be used with caution in patients with renal impairment or a history of renal disease.

Common Adverse Effects

Adverse effects occurring in 4% or more of patients receiving balsalazide include headache, abdominal pain, diarrhea, nausea, vomiting, respiratory infection, arthralgia, flatulence, and fatigue.

Some adverse effects (e.g., abdominal pain, fatigue, nausea) appear to occur more frequently in women. The manufacturer states that certain adverse effects (e.g., abdominal pain, rectal bleeding, anemia) may be manifestations of ulcerative colitis.

Drug Interactions

No formal drug interaction studies have been performed.

Oral Anti-Infective Agents

Potential pharmacologic interaction (e.g., interference with release of mesalamine in the colon).

Azathioprine and 6-Mercaptopurine

Potential pharmacokinetic interaction (balsalazide may interfere with metabolism of these drugs by inhibition of thiopurine methyltransferase, an enzyme involved in the metabolism of the immunosuppressants).