Hydroxychloroquine sulfate tablets

SaiXifu ® Selected in the 4th Round of Fujian Province Volume-Based Procurement

Selected in Hebei Province “3+N” Volume-Based Procurement；National Essential Drug, Category B under National Medical Insurance

[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

[Shelf Life]

36 months

[Approval Number]

National Medical Products Administration Approval Number: H20234411