Symptom Relief

Percentage of UP Patients Assessed as Normal (DAI Score = 0) (Individual components of Disease Activity Index (DAI)† at endpoint of 6-week 500 mg BID Trial1*)

*6-week, randomized, double-blind, parallel, placebo controlled multicenter trial that assessed the efficacy and safety of 5-ASA suppositories in the treatment of ulcerative proctitis. Disease Activity Index (DAI) was assessed at baseline, 3 and 6 weeks of treatment. Patients kept a written daily diary recording of stool frequency, blood in stools, tenesmus and other observed symptoms or adverse events.

† DAI is a composite of the measures: stool frequency, rectal bleeding, mucosal visualization at endoscopy, and general well-being. Each subscale has four subdivisions of severity from 0 to 3, 0 representing normal status. The DAI score is the sum of all individual subscales, therefore, the DAI has a range of values from 0 to 12. Entry criteria for study patients was a DAI score between 4-11 indicative of mild-to-moderate ulcerative proctitis.

The mean reduction (percent change from baseline) in total DAI score was 74.7% in the 5-ASA group and 34.2% in the placebo group (p<0.001).1

  • Patients (n=94) were treated with either 500 mg 5-ASA or placebo suppositories BID for 6 weeks
  • The effectiveness of 5-ASA suppositories was statistically significant irrespective of sex, extent of proctitis, duration of current episode or duration of disease2
  • Adverse events were mild-to-moderate in nature1



Information on this website is not intended to replace the advice of your physician(s). Please consider what you learn here a starting point for a conversation with your physician. All care of ulcerative proctitis and related conditions must be guided by the appropriate healthcare professional. CANASA® is a prescription drug.

References
1.Williams CN. Efficacy and tolerance of 5-aminosalicylic acid suppositories in the treatment of ulcerative proctitis: A review of two double- blind, placebo controlled trials. Can J Gastroenterol 1990; 4:472-475. 2.CANASA® (Mesalamine, USP) Rectal Suppository 1000 mg Prescribing Information, October 2008.

 

CANASA® is available by prescription only.

CANASA® 1000 mg Suppositories are indicated for the treatment of active ulcerative proctitis.

CANASA® is contraindicated in patients who have demonstrated hypersensitivity to mesalamine (5-aminosalicylic acid) or to the suppository vehicle [saturated fatty acid esters (Hard Fat, NF)], or to salicylates (including Aspirin).

As with other mesalamine containing products, less common but possibly serious side effects such as acute intolerance syndrome, pericarditis and pancolitis may occur.

Patients on CANASA® 1000 mg, especially those on concurrent oral products which contain or release mesalamine and those with pre-existing renal disease, should be carefully monitored with urinalysis, BUN and creatinine testing.

Caution should be exercised when CANASA® suppositories are initially used in patients known to be allergic to sulfasalazine.

CANASA® was generally well tolerated in clinical studies. The most common side effects of CANASA® are dizziness (3%), rectal pain (1.8%), fever (1.2%), rash (1.2%), acne (1.2%), and colitis (1.2%).

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.FDA.gov/medwatch, or call 1-800-FDA-1088.