CANASA® - How Supplied 1

CANASA® (Mesalamine, USP) 1000 mg Suppositories: CANASA® 1000 mg suppositories for rectal administration are available as bullet shaped, light tan suppositories containing 1000 mg mesalamine supplied in boxes of 30 and 42 individually plastic wrapped suppositories (NDC 58914-501-56 and 58914-501-42).

Store below 25ºC (77ºF), may be refrigerated. Keep away from direct heat, light or humidity.



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. 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.