Changmei Olsalazine Sodium Capsules

1. Indications and Usage
Ulcerative Colitis: Indicated for the induction of remission and maintenance of remission in patients with mild-to-moderate ulcerative colitis.
Prevention: Used to prevent the recurrence of active ulcerative colitis following surgical resection of the colon and rectum.
2. Dosage and Administration
Adults: The usual dosage is 500 mg (1 or 2 capsules) twice daily, taken with food.
Maintenance: Once remission is achieved, the maintenance dose is typically 500 mg daily. In some cases, the dosage may be increased to a maximum of 1 g daily if symptoms persist.
Administration: Capsules should be swallowed whole with food to minimize gastrointestinal irritation.
3. Mechanism of Action
Anti-inflammatory Activity: Olsalazine is a dimer of 5-aminosalicylic acid (5-ASA) linked by an azo bond. It passes through the upper gastrointestinal tract unchanged and is cleaved by colonic bacteria into two molecules of 5-ASA.
Prostaglandin Inhibition: The resulting 5-ASA acts locally in the colon to inhibit cyclooxygenase and lipoxygenase pathways, thereby reducing the synthesis of pro-inflammatory prostaglandins and leukotrienes.
4. Safety and Warnings
Hepatic and Renal Function: Use with caution in patients with hepatic or renal impairment, as the drug and its metabolites may accumulate.
Hypersensitivity: Contraindicated in patients who have shown hypersensitivity to salicylates or other components of the formulation.
Monitoring: Periodic monitoring of liver and kidney function tests is recommended during long-term therapy.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: Diarrhea (often the most frequent), abdominal pain, nausea, dyspepsia, headache, and arthralgia.
Serious Effects: Rare cases of interstitial nephritis, membranous nephropathy, and severe skin rashes (e.g., exfoliative dermatitis, erythema multiforme) have been reported.
6. Drug Interactions
Anticoagulants: May potentiate the effects of oral anticoagulants (e.g., warfarin), leading to an increased prothrombin time (PT) and risk of bleeding.
Methotrexate: May increase the toxicity of methotrexate.
Azathioprine/6-Mercaptopurine: Concurrent use may increase the risk of bone marrow suppression.
7. Pharmaceutical Information
Active Ingredient: Olsalazine Sodium.
Strength: Typically 250 mg per capsule.
Appearance: Hard gelatin capsules, usually containing yellowish or off-white powder.
Storage: Store in a tight, light-resistant container at a controlled temperature (20-25°C), protected from moisture.