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Mesalazine

Generic Name
Mesalazine
Brand Names
Apriso, Asacol, Canasa, Delzicol, Lialda, Mezavant, Pentasa, Rowasa, Salofalk, Zaldyon
Drug Type
Small Molecule
Chemical Formula
C7H7NO3
CAS Number
89-57-6
Unique Ingredient Identifier
4Q81I59GXC

Overview

An anti-inflammatory agent, structurally related to the salicylates and non-steroidal anti-inflammatory drugs like acetylsalicylic acid, which is active in inflammatory bowel disease . Although demonstrably effective in treating and maintaining remission for ulcerative colitis, mesalazine has historically faced a number of issues regarding its lack of stability as a pharmaceutical agent . Throughout the late seventies and the eighties, important research initiatives developed stable mesalazine formulations like the eudragit-S coating of Asacol brand mesalazine and the Pentasa brand's encapsulation of mesalazine within microgranules . In the present day, contemporary research regarding novel methods to stabilize mesalazine continues and interest in the agent's capacity to decrease inflammatory activity and subsequently potentially reduce the risk of colorectal cancer in conditions like ulcerative colitis is maintained.

Background

An anti-inflammatory agent, structurally related to the salicylates and non-steroidal anti-inflammatory drugs like acetylsalicylic acid, which is active in inflammatory bowel disease . Although demonstrably effective in treating and maintaining remission for ulcerative colitis, mesalazine has historically faced a number of issues regarding its lack of stability as a pharmaceutical agent . Throughout the late seventies and the eighties, important research initiatives developed stable mesalazine formulations like the eudragit-S coating of Asacol brand mesalazine and the Pentasa brand's encapsulation of mesalazine within microgranules . In the present day, contemporary research regarding novel methods to stabilize mesalazine continues and interest in the agent's capacity to decrease inflammatory activity and subsequently potentially reduce the risk of colorectal cancer in conditions like ulcerative colitis is maintained.

Indication

适用于溃疡性结肠炎和克罗恩病(Crohn病)。

Associated Conditions

  • Acute Ulcerative Colitis
  • Crohn's Disease Relapse
  • Crohn's Ileocolitis
  • Mild to Moderate Ulcerative Colitis
  • Proctitis
  • Proctitis, Ulcerative
  • Proctosigmoiditis
  • Ulcerative Colitis in Remission
  • Mild Ulcerative Colitis
  • Mild to moderate distal ulcerative colitis
  • Moderate Ulcerative colitis

FDA Approved Products

Mesalamine
Manufacturer:Encube Ethicals Private Limited
Route:RECTAL
Strength:4 g in 60 mL
Approved: 2022/06/02
NDC:21922-045
Mesalamine
Manufacturer:Teva Pharmaceuticals USA, Inc.
Route:ORAL
Strength:400 mg in 1 1
Approved: 2023/02/28
NDC:0093-5907
MESALAMINE
Manufacturer:Lannett Company Inc.
Route:ORAL
Strength:1.2 g in 1 1
Approved: 2023/06/02
NDC:0527-3012
Mesalamine
Manufacturer:Camber Pharmaceuticals, Inc.
Route:RECTAL
Strength:1000 mg in 1 1
Approved: 2024/02/26
NDC:31722-005
Pentasa
Manufacturer:Takeda Pharmaceuticals America, Inc.
Route:ORAL
Strength:500 mg in 1 1
Approved: 2023/10/24
NDC:54092-191

Singapore Approved Products

Salofalk Gastro-resistant Prolonged-release Granules 1.5g/ sachet
Manufacturer:Losan Pharma GmbH, Losan Pharma GmbH (Primary packager and Secondary packager)
Form:GRANULE, DELAYED RELEASE
Strength:1500mg/ sachet
Online:Yes
Approved: 2013/11/08
Approval:SIN14428P
SALOFALK ENEMAS 4 g/60 ml
Manufacturer:Corden Pharma Fribourg AG, Zweigniederlassung Ettingen, Losan Pharma GmbH - Werk Neuenburg
Form:ENEMA
Strength:4 g/60 ml
Online:Yes
Approved: 1999/05/06
Approval:SIN10918P
PENTASA PROLONGED RELEASE TABLETS 1G
Manufacturer:Ferring International Center SA, Pharbil Pharma GmbH
Form:TABLET
Strength:1000 mg
Online:Yes
Approved: 2014/01/09
Approval:SIN14479P
PENTASA PROLONGED RELEASE GRANULES 2G/SACHET
Manufacturer:Ferring International Center SA
Form:GRANULE, DELAYED RELEASE
Strength:2000 mg
Online:Yes
Approved: 2013/12/10
Approval:SIN14456P
Asacol Tablet 800mg
Manufacturer:Haupt Pharma Wulfing GmbH
Form:TABLET, ENTERIC COATED
Strength:800mg
Online:Yes
Approved: 2012/12/12
Approval:SIN14275P

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