Product Overview
[Drug Name]
Trade Name: Balsalazide
English Name: Balsalazide Sodium Granules
[Ingredients]
Chemical Name: 5-[[4-[[(2-carboxyethyl)carbamoyl]phenylazo]salicylic acid disodium salt dihydrate. Molecular Weight: C₁₇H₁₃N₃Na₂O₆.2(H₂O)
[Properties]
This product is brown-yellow granules with a slightly sweet taste.
[Indications]
For the treatment of mild to moderately active ulcerative colitis.
[Dosage and Administration]
Oral administration. 2.25g (sachet) three times a day, half an hour before meals. A course of treatment is 8 weeks.
[Adverse Reactions]
Occasional headaches, nausea, vomiting, abdominal pain, diarrhea, and joint pain may occur, which may resolve spontaneously.
[Contraindications]
1. Contraindicated in patients with allergies to salicylates.
2. Contraindicated in patients with a history of bronchial asthma.
3. Contraindicated for use in patients with severe heart, liver, or kidney impairment.
[Precautions]
1. If only an increase in bowel movements occurs within a short period (generally two weeks) after starting this medication, this is a natural course of the medication and should be continued.
2. Do not take this medication with antibiotics.
3. If any discomfort occurs during medication, discontinue the medication immediately and seek medical attention. Please read the instructions carefully and follow your doctor's instructions.
[Special Populations]
Precautions for use in children: Not yet available.
Precautions for pregnancy and lactation: Use with caution.
Precautions for the elderly: Not yet available.
[Drug Interactions]
Do not take this medication with antibiotics.
[Pharmacological Actions]
1. Pharmacological Action: Balsalazide sodium is a precursor drug. After oral administration, the original drug reaches the colon. Under the action of colonic bacteria, 5-aminosalicylic acid (the active ingredient) and 4-aminobenzoyl-β-alanine are released. 5-aminosalicylic acid may exert its anti-inflammatory effect by blocking the production of arachidonic acid metabolites in the colon. 2. Toxicology Studies: Genotoxicity: Balsalazide sodium tested negative in the Aimes test, human lymphocyte chromosome aberration test, mouse lymphoma cell TK site mutation test, and mouse micronucleus test. A gene mutation test in Chinese hamster lung cells (CHV79/HGPRT) was positive. The balsalazide metabolite, 4-aminobenzoyl-β-alanine, tested negative in the Aimes test and mouse lymphoma cell TK site mutation test, but positive in a human lymphocyte chromosome aberration test. Another metabolite, N-acetyl-4-aminobenzoyl-β-alanine, tested negative in the Aimes test, mouse lymphoma cell TK site mutation test, and human lymphocyte chromosome aberration test. Reproductive Toxicity: Oral administration of balsalazide sodium up to 2 g/kg/day did not significantly affect fertility or reproductive behavior in rats. Carcinogenicity: Oral administration of balsalazide sodium up to 2 g/kg/day for two years did not result in carcinogenic effects in rats.
[Storage]
Store tightly closed at room temperature.
[Specifications]
0.75g*18 bags
[Packaging Specifications]
Box
[Expiration Date]
24 months
[Approval Number]
National Medicine Standard H20030748
[Manufacturer]
Company Name: Hubei Hendi Pharmaceutical Co., Ltd.
