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Balsalazide Sodium Tablets

Function and Efficacy

Balsalazide sodium is a prodrug that reaches the colon as the original drug after oral administration and releases 5-aminosalicylic acid (active ingredient) and 4-aminobenzoyl-beta-alanine under the action of colonic bacteria. 5-aminosalicylic acid may play its role in reducing inflammation by blocking the production of arachidonic acid metabolites in the colon.

Ingredients

Balsalazide sodium.

Name Description Content CAS NO. Manufacturer
BalsalazideIngredients

Balsalazide sodium is a prodrug that reaches the colon as the original drug after oral administration and releases 5-aminosalicylic acid (active ingredient) and 4-aminobenzoyl-beta-alanine under the action of colonic bacteria. 5-aminosalicylic acid may play its role in reducing inflammation by blocking the production of arachidonic acid metabolites in the colon.

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80573-04-2 5

Appearance

This product is a film-coated tablet. The tablet core is yellow after removing the film coating.

Indication

Mild to moderately active ulcerative colitis.

Usage and Dosage

Oral administration. 1.5g (3 tablets) each time, 4 times a day, after meals and before bedtime. The course of treatment is 8 weeks.

Adverse Reactions

Rare, adverse reactions include: abdominal pain, diarrhea; occasional digestive system: loss of appetite, constipation, indigestion, abdominal distension, dry mouth, jaundice; respiratory system: cough, pharyngitis, rhinitis.

Precautions

Patients who are allergic to salicylic acid, any ingredient in balsalazide sodium tablets, or balsalazide sodium metabolites are contraindicated.

Special Population Medication

Precautions for children: There is no data on the use of this product in children. Precautions for pregnancy and lactation: This product should be used with caution in pregnant and lactating patients, and can only be used when the doctor determines that the benefits outweigh the risks. 5-aminosalicylic acid can pass through the placental barrier, but the data is limited and insufficient to evaluate possible adverse reactions. Animal experiments have not found teratogenicity. 5-aminosalicylic acid is secreted in breast milk, and its concentration is much lower than that in maternal blood; there are no reports of adverse reactions in breastfeeding infants after mothers took 5-aminosalicylic acid, but the data is limited. Precautions for the elderly: There is no data on the use of this product in elderly patients.

Drug Interactions

Not yet clear.

Storage

Sealed and light-proof.

Packaging Specification

0.5g (calculated as C17H13N3Na2O6)

Validity Period

Tentative 24 months

Manufacturer

Shanxi Zhendong Anxin Biopharmaceutical Co., Ltd.

  • Founded in:

    1992-06-12
  • Address:

    No. 908, Jicheng Road, Huitong Industrial Park, Jinzhong Development Zone, Shanxi Demonstration Zone, Jinzhong City, Shanxi Province
  • Tax NO.:

    91140700602052641X
  • Registered Funds:

    170 million yuan
  • Website:

  • Email:

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