DIPENTUM- olsalazine sodium capsule, gelatin coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OLSALAZINE SODIUM (UNII: Y7JEW0XG7I) (OLSALAZINE - UNII:ULS5I8J03O)

Available from:

Meda Pharmaceuticals Inc.

INN (International Name):

OLSALAZINE SODIUM

Composition:

OLSALAZINE SODIUM 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

DIPENTUM is indicated for the maintenance of remission of ulcerative colitis in adult patients who are intolerant of sulfasalazine. DIPENTUM is contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates or their metabolites, or to any of the excipients in DIPENTUM.

Product summary:

Beige colored capsules, containing 250 mg olsalazine sodium imprinted with “DIPENTUM® 250 mg” on the capsule shell, available as: Bottles of 100’s     NDC 0037-6860-10 Store at 20-25°C (77°F). Excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Manufactured for: MEDA PHARMACEUTICALS® Canonsburg, PA 15317 U.S.A. Manufactured by: Societal CDMO Gainesville, LLC Gainesville, GA 30504, USA © 2023 Viatris Inc. DIPENTUM is a registered trademark of Alaven Pharmaceutical LLC, a Viatris Company. Rev. 10/2023 IN-686010-07 Material Code: 6003064-05

Authorization status:

New Drug Application

Summary of Product characteristics

DIPENTUM- OLSALAZINE SODIUM CAPSULE, GELATIN COATED
MEDA PHARMACEUTICALS INC.
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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 mesalamine (5-aminosalicylic acid,5-ASA), an
aminosalicylate. Its
empirical formula is C
H N Na O with a molecular weight of 346.21.
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.
The conversion of olsalazine to mesalamine (5-ASA) in the colon is
similar to that of
sulfasalazine, which is converted into sulfapyridine and mesalamine.
The usual dose of
sulfasalazine for maintenance of remission in patients with ulcerative
colitis is 2 grams
daily, which would provide approximately 0.8 gram of mesalamine to the
colon. More
than 0.9 gram of mesalamine would usually be made available in the
colon from 1 gra