Dipentum

Dipentum

Dipentum Recall

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Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

INDICATIONS AND USAGE: Olsalazine is indicated for the maintenance of remission of ulcerative colitis in patients who are intolerant of sulfasalazine.

History

There is currently no drug history available for this drug.

Other Information

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 C14H8N2Na2O6 with a molecular weight of 346.21. The structural formula is:

Structural formula

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.

Dipentum Manufacturers


  • Meda Pharmaceuticals
    Dipentum (Olsalazine Sodium) Capsule, Gelatin Coated [Meda Pharmaceuticals]
  • Ucb, Inc.
    Dipentum (Olsalazine Sodium) Capsule [Ucb, Inc.]
  • Alaven Pharmaceutical Llc
    Dipentum (Olsalazine Sodium) Capsule, Gelatin Coated [Alaven Pharmaceutical Llc]
  • Carilion Materials Management
    Dipentum (Olsalazine Sodium) Capsule, Gelatin Coated [Carilion Materials Management]

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