Aoruixin Balsalazide Sodium Capsules

1. Indications and Usage
Ulcerative Colitis: Indicated for the treatment of mild-to-moderate active ulcerative colitis and for the maintenance of clinical remission.
2. Dosage and Administration
Adults: The usual dosage is 2.25 g (typically 6 capsules of 0.375 g) taken 3 times daily, or 1.5 g taken 4 times daily.
Administration: Should be taken orally, preferably 0.5 hours before meals.
Duration: A typical course is 8 weeks, with a maximum treatment duration of 12 weeks.
3. Mechanism of Action
Prodrug Conversion: Balsalazide consists of 5-ASA linked to a non-toxic carrier molecule. It passes through the upper GI tract unchanged and is cleaved by colonic bacteria into 5-ASA and an inactive metabolite.
Anti-inflammatory Action: The released 5-ASA inhibits the arachidonic acid pathway in the colon, blocking the synthesis of pro-inflammatory prostaglandins and leukotrienes.
4. Safety and Warnings
Renal and Hepatic Function: Contraindicated in patients with severe renal or hepatic impairment. Patients with mild-moderate dysfunction or a history of kidney disease should be monitored closely.
Hypersensitivity: Contraindicated in patients with hypersensitivity to salicylates, balsalazide, or sulfasalazine.
Special Populations: Use with caution in patients with asthma. Safety and efficacy in pediatric patients have not been established.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: Abdominal pain, diarrhea, headache, and nausea.
Infrequent Adverse Reactions: Anorexia, constipation, dyspepsia, flatulence, insomnia, arthralgia, myalgia, and fatigue.
Serious Effects: Toxic nephropathy (manifesting as hematuria, bruising, fever), myocarditis, and hypersensitivity reactions.
6. Drug Interactions
Anticoagulants: May potentiate the effects of oral anticoagulants (e.g., warfarin).
Immunosuppressants: Concomitant use with azathioprine or 6-mercaptopurine may increase the risk of bone marrow suppression.
Antibiotics: Concurrent use with antibiotics is not recommended as it may interfere with colonic bacterial cleavage of the drug.
7. Pharmaceutical Information
Active Ingredient: Balsalazide Sodium.
Chemical Name: Disodium (E)-5-[[4-[(3-carboxyphenyl)amino]benzoyl]azo]salicylate dihydrate.
Strength: Typically 0.375 g or 0.75 g per capsule.
Storage: Store in a tight, light-resistant container, protected from moisture.