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Pronunciation: OLE-SAL-uh-zeen SO-dee-uhm
Class: GI agent
- Capsules 250 mg
Bioconverted to 5-aminosalicylic acid (mesalamine) in colon. Although mechanism of action is unknown, it probably reduces inflammation of colon topically by preventing production of substances involved in inflammatory process such as arachidonic acid.
Little is systematically absorbed. T max is approximately 1 h. Steady state is 2 to 3 wk (metabolite olsalazine-s).
Once the drug metabolized to 5-aminosalicylic (5-ASA), the drug is slowly absorbed from the colon resulting in high concentration levels. More than 99% of olsalazine and olsalazine-s is protein bound. 74% of 5-ASA is protein bound.
0.1% of dose is metabolized in liver to olsalazine-o-sulfate metabolite. The remainder reaches the colon and is rapidly converted to 5-ASA by colonic bacteria.
Less than 1% is recovered in the urine. A small amount is recovered in the feces. The t ½ (serum) is 0.9 h for olsalazine and 7 days for olsalazine-s.
Indications and Usage
Maintenance of remission of ulcerative colitis in patients intolerant of sulfasalazine.
Hypersensitivity to salicylates or any product component.
Dosage and AdministrationAdults
PO 500 mg twice daily (2 capsules) (total of 1 g/day).
Store at room temperature.
None well documented.
Laboratory Test Interactions
None well documented.
Headache; fatigue; drowsiness; lethargy; depression.
Diarrhea; abdominal pain, cramps; nausea; dyspepsia; bloating; anorexia.
Arthralgia; upper respiratory infection.
Category C .
Safety and efficacy not established.
Patients with history of renal disease or dysfunction may have worsening of renal function.
- Caution patient to notify health care provider of rashes, respiratory difficulty, lethargy, muscle weakness, vomiting, diarrhea or abdominal distention, or worsening of abdominal pain.
- Advise patient not to take double doses if one is missed. If more than 1 dose is missed, tell patient to notify health care provider.
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