Hydroxychloroquine sulfate tablets

SaiXifu ® Hydroxychloroquine sulfate tablets

Selected Varieties of the 10th Volume-Based Procurement

The National Essential Drugs, Medicare Category B

[Drug Name]

       Generic name: Hydroxychloroquine sulfate tablets

[Indications]

       Rheumatoid arthritis, juvenile chronic arthritis, discoid and systemic lupus erythematosus, and skin diseases triggered or aggravated by sunlight.

[Dosage and Administration ]

Oral tablets.

  •   Adults (including elderly):

       Initial dose: 400 mg daily in divided doses. Once no further improvement is observed, reduce to a maintenance dose of 200 mg daily. If the therapeutic response diminishes, increase to 400 mg daily. The minimum effective dose should be used, not exceeding 6.5 mg/kg/day (based on ideal body weight, not actual body weight) or 400 mg/day, whichever is lower.

  •   Children:

       The minimum effective dose should be used, not exceeding 6.5 mg/kg/day (based on ideal body weight) or 400 mg/day, whichever is lower. Contraindicated in children under 6 years old. The 200 mg tablets are unsuitable for children weighing less than 35 kg.

       Each dose should be taken with food or milk.

       Hydroxychloroquine has a cumulative effect and may require several weeks to exert therapeutic benefits, while mild adverse effects may occur earlier. If no improvement in rheumatic diseases is observed after 6 months, treatment should be discontinued. For photosensitivity disorders, treatment should be restricted to periods of maximal sun exposure.

[Contraindications]

       • Known hypersensitivity to 4-aminoquinoline compounds.

       • Pre-existing maculopathy.

       • Children under 6 years (200 mg tablets unsuitable for children <35 kg).

[Specification]

       0.2 g

[Validity Period]

        36 months

[Approval Number]

       National Medical Approval Number: H20234411



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