Plaquenil (Hydroxychloroquine Sulfate) – Autoimmune | HongKong DengYue Medicine

Hydroxychloroquine Sulfate Application Scope

• Used for the treatment and prophylaxis of malaria.

• Indicated for rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), and discoid lupus erythematosus.

• Sometimes used in juvenile idiopathic arthritis.

Hydroxychloroquine Sulfate Characteristics

• Ingredients:

  • Active: Hydroxychloroquine Sulfate

  • Excipients: Standard pharmaceutical excipients

• Properties:​

  • White crystalline powder

  • Slightly bitter taste, odorless

  • Soluble in water

• Packaging Specification:​ Tablets, commonly 0.1 g × 14 tablets / blister pack

• Storage:​

  • Store in a cool, dry place below 25°C

  • Keep away from light and moisture

• Expiry Date: 24–36 months (depending on batch and manufacturer)

• Executive Standard: ​Meets pharmacopeia standards (e.g., ChP / USP)

• Approval Number: According to national drug regulatory authority (e.g., CFDA)

• Date of Revision: FEB 21, 2025 (as per Sanofi Canada product monograph)

• Manufacturer: Sanofi-Aventis Canada Inc.

Guidelines for the Use of Plaquenil

• Dosage and Administration:

  • Recommended Dose:

    • Malaria prophylaxis: 0.4 g once weekly, starting 2 weeks before exposure

    • Rheumatoid arthritis / SLE: 0.2–0.4 g daily (in divided doses if necessary)

    • Malaria treatment: Initial 0.8 g, followed by 0.4 g at 6–8 h, then 0.4 g daily for 2 days

  • Administration: Swallow tablets whole with water after meals to reduce gastrointestinal discomfort

  • Missed Dose:​ Take as soon as remembered; if near next dose, skip the missed one. Do not double dose.

• Adverse Reactions:

  • Common Adverse Reactions:

    • Gastrointestinal discomfort (nausea, vomiting, diarrhea)

    • Headache, dizziness

    • Skin rash, itching

  • Serious Adverse Reactions:

    • Retinopathy (long-term/high-dose use)

    • Cardiotoxicity (rare)

    • Blood dyscrasias (leukopenia, anemia)

    • Severe hypersensitivity reactions

    ​

• Contraindications:

  • Hypersensitivity to hydroxychloroquine or related compounds (chloroquine)

  • Patients with pre-existing retinopathy

  • Children under 6 years (risk of toxicity)

• Precautions:

  • Regular ophthalmologic examination is required during long-term use

  • Use with caution in patients with hepatic or renal impairment

  • Monitor blood counts in prolonged therapy

  • Avoid overdose (narrow therapeutic index)

Hydroxychloroquine Sulfate Interactions

• Antacids: May reduce absorption (separate by ≥4 hours)

• Digoxin: Increases plasma digoxin levels → risk of toxicity

• Insulin & antidiabetic drugs: May enhance hypoglycemic effect

• Drugs prolonging QT interval (e.g., amiodarone, azithromycin): Increased risk of arrhythmia

• Cyclosporine: May increase cyclosporine plasma levels

• Tamoxifen: Increases risk of retinal toxicity

 

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
•  This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.