Feining Aminosalicylic Acid Enteric-coated Granules

1. Indications and Usage
Aminosalicylic acid enteric-coated granules are indicated for the treatment of tuberculosis caused by Mycobacterium tuberculosis, both pulmonary and extra-pulmonary. It is effective only against mycobacteria and must be used in combination with other anti-tuberculosis drugs to prevent rapid drug resistance.
2. Dosage and Administration
Adults: Typically 4 to 6 tablets (or equivalent granule dose) taken 4 times a day (total daily dose 16-24g).
Pediatrics: 0.2 to 0.3g/kg/day by weight, divided into 3-4 doses. The maximum daily dose for children should not exceed 12g.
Administration: Take orally. It should be swallowed whole to ensure delayed release in the intestine.
3. Mechanism of Action
Aminosalicylic acid acts primarily by inhibiting the synthesis of mycolic acids, which are essential components of the mycobacterial cell wall. It is bacteriostatic against Tubercle bacilli.
4. Safety and Warnings
Hypersensitivity: Common allergic reactions include rash, drug fever, asthma, and eosinophilia.
Gastrointestinal: Gastric and duodenal ulcers with bleeding may occur.
Organ Function: Monitor for potential liver damage, blood abnormalities (such as granulocytopenia), and blood in urine.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: The most frequent adverse reactions are allergic reactions (itching, rash, drug fever, asthma, eosinophilia) and gastrointestinal bleeding due to gastric ulcers.
Less Common Adverse Reactions: Blood in urine, proteinuria, liver function impairment, and granulocytopenia.
6. Drug Interactions
Isoniazid and Streptomycin: Co-administration can delay the development of drug resistance in these two drugs.
Rifampin: Aminosalicylic acid may affect the absorption of rifampin, leading to reduced serum concentrations. They should be taken at least 6 hours apart.
Anticoagulants: It can enhance the effects of anticoagulants (coumarin or indandione derivatives), requiring dose adjustment.
Probenecid or Benzbromarone: These can decrease renal secretion of aminosalicylic acid, leading to increased serum concentration and toxicity.
Pyrazinamide: There is an antagonistic effect between p-aminobenzoic acid and this product; they should not be used together.
7. Pharmaceutical Information
Composition: The active ingredient is sodium aminosalicylate.
Appearance: The granules are typically white or off-white.
Storage: Store in a tight container, protected from light and moisture.