Individual Symptom Scores

Reduction in Disease Activity Index (DAI)† Component Scores with
Once-Daily CANASA® 1000 mg Suppositories1-3,‡

†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.

‡Data based on a multicenter, randomized equivalence trial of 6 weeks duration that compared the efficacy and safety of mesalamine 1000 mg HS versus 500 mg BID suppositories in 99 patients with mild-to-moderate ulcerative proctitis. The primary outcome variable was total DAI score at week 6.

After 6 weeks of treatment, the efficacy in the 1 g HS treatment group was as effective as in the 500 mg BID treatment group; mean (SD) DAI scores were 1.31 (2.19) for the 1 g HS group and 1.59 (2.30) for the 500 mg BID group (90% CI, -1.03 to 0.64).1-3



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.Lamet M. ; A Multicenter, Randomized Study to Evaluate the Efficacy and Safety of Mesalamine Suppositories 1 g at Bedtime and 500 mg Twice Daily in Patients with Active Mild-to-Moderate Ulcerative Proctitis. Dig Dis Sci 2010 (DOI 10.1007/s10620-010-1334-y) 2.Data on File, Axcan Pharma US Inc 3.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.