Classifications: mucous membrane agent; antiinflammatory agent; Therapeutic: antiinflammatory agent
Prototype: Mesalamine (5-ASA)
Pregnancy Category: B
750 mg capsules
A prodrug of mesalamine that remains intact until it reaches the lumen of the colon. Thought to decrease inflammation of
the mucous lining of the colon by blocking cyclooxygenase and inhibiting prostaglandin synthesis in the lining of the colon.
An antiinflammatory agent and a prodrug of 5-ASA.
Treatment of mild to moderate active ulcerative colitis.
Prior hypersensitivity to salicylates, balsalazide.
Hypersensitivity to mesalamine, sulfasalazine, olsalazine, salicylate. Allergic response to any medications; hepatic or
renal impairment; pregnancy (category B), lactation; pyloric stenosis. Safety and efficacy in children are not established.
Route & Dosage
Adult: PO 2250 mg (3 times 750 mg) t.i.d. for 812 wk
- Give in a consistent manner with respect to food intake (i.e., either always with or always without food).
- Store at room temperature, preferably between 15°30° C (59°86° F).
Adverse Effects (≥1%)Body as a Whole: Arthralgia
, fever, pain, back pain. CNS:
Abdominal pain, nausea, diarrhea
, vomiting, rectal bleeding, flatulence, dyspepsia, coughing, anorexia. Respiratory:
No clinically significant interactions established.
Low and variable absorption from the colon. Distribution:
>99% protein bound. Metabolism:
Metabolized in colon by bacterial azoreductases to release 5-aminosalicylic acid and 4-aminobenzoyl-beta-alanine. Elimination:
25% of metabolites excreted in urine.
Assessment & Drug Effects
Patient & Family Education
- Report worsening of S&S of colitis to physician (e.g., diarrhea, abdominal pain, fever, rectal bleeding).