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《DIPENTUM (olsalazine sodium capsules)》.pdf
DIPENTUM®
(olsalazine sodium capsules) Rx Only
DESCRIPTION
The active ingredient in DIPENTUM Capsules (olsalazine sodium) is the sodium salt of a
salicylate, disodium 3,3-azobis (6-hydroxybenzoate) a compound that is effectively
bioconverted to 5-aminosalicylic acid (5-ASA), which has anti-inflammatory activity in
ulcerative colitis. Its empirical formula is C H N Na O with a molecular weight of 346.21.
14 8 2 2 6
The structural formula is:
Olsalazine sodium is a yellow crystalline powder, which melts with decomposition at 240°C.
It is the sodium salt of a weak acid, soluble in water and DMSO, and practically insoluble in
ethanol, chloroform, and ether. Olsalazine sodium has acceptable stability under acidic or
basic conditions.
DIPENTUM is supplied in hard gelatin capsules for oral administration. The inert ingredient
in each 250 mg capsule of olsalazine sodium is magnesium stearate. The capsule shell
contains the following inactive ingredients: black iron oxide, caramel, gelatin, and titanium
dioxide.
CLINICAL PHARMACOLOGY
After oral administration, olsalazine has limited systemic bioavailability. Based on oral and
intravenous dosing studies, approximately 2.4% of a single 1.0 g oral dose is absorbed. Less
than 1% of olsalazine is recovered in the urine. The remaining 98 to 99% of an oral dose will
reach the colon, where each molecule is rapidly converted into two molecules of 5
aminosalicylic acid (5-ASA) by colonic bacteria and the low prevailing redox potential found
in this environment. The liberated 5-ASA is absorbed slowly resulting in very high local
concentrations in the colon.
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