What is the recommended dosage of Hydroxychloroquine (Plaquenil)?

From the Guidelines

The recommended dosage of Hydroxychloroquine (Plaquenil) is around 5 mg/kg/d, with a maximum dose not exceeding this amount to minimize toxicity risks, as stated in the kdigo 2024 clinical practice guideline for the management of lupus nephritis 1.

Key Considerations

• The dosage should be based on ideal body weight rather than actual weight.
• Doses of 2–3 mg/kg/d may not achieve adequate blood levels and could be associated with higher flare rates.
• A blood hydroxychloroquine level above 0.6 mg/l may be associated with a lower risk of LN flare.
• In patients with eGFR <30 ml/min per 1.73 m², the dose of hydroxychloroquine should be reduced by 25%.

Important Safety Information

• Regular eye examinations are essential during treatment as Plaquenil can cause retinal damage with long-term use, with a recommended screening schedule starting after 1 year of therapy in patients with additional risk factors or after 5 years of therapy otherwise 1.
• Kidney and liver function should be monitored, and dosage may need adjustment in patients with renal impairment.
• The risk of hemolysis in patients who have glucose-6-phosphate dehydrogenase (G6PD) deficiency should be considered, especially in men of African, Asian, or Middle Eastern origin, before starting hydroxychloroquine 1.

Clinical Context

• The American College of Rheumatology, American Academy of Dermatology, Rheumatologic Dermatology Society, and American Academy of Ophthalmology emphasize the importance of effective communication between health care providers in the management of HCQ, and stress that HCQ is a valuable drug and considered safe at doses deemed proper for the treatment of rheumatic diseases in conjunction with appropriate eye screening 1.

From the FDA Drug Label

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions Administer hydroxychloroquine sulfate tablets orally with food or milk. Do not crush or divide the tablets. 2.2 Dosage for Malaria in Adult and Pediatric Patients The recommended prophylaxis dosage is: Adult patients: 400 mg once a week Pediatric patients ≥ 31 kg: 6.5 mg/kg actual body weight (up to 400 mg) once a week Treatment of Uncomplicated Malaria The dosages for the treatment of uncomplicated malaria are: Adult patients: Administer 800 mg initially; subsequently administer 400 mg at 6 hours, 24 hours, and 48 hours after the initial dose (total dosage = 2,000 mg) Pediatric patients ≥ 31 kg: Administer 13 mg/kg (up to 800 mg) initially; subsequently administer 6.5 mg/kg (up to 400 mg) at 6 hours, 24 hours, and 48 hours after the initial dose (total dosage = 31 mg/kg - up to 2,000 mg). 2.3 Dosage for Rheumatoid Arthritis in Adults The recommended dosage is: Initial dosage: 400 mg to 600 mg daily as a single daily dose or two divided doses. Chronic dosage: 200 mg once daily to 400 mg daily, as a single dose or two divided doses. 2.4 Dosage for Systemic Lupus Erythematosus in Adults The recommended dosage is 200 mg given once daily, or 400 mg given once daily or in two divided doses. 2.5 Dosage for Chronic Discoid Lupus Erythematosus in Adults The recommended dosage is 200 mg given once daily, or 400 mg given once daily or in two divided doses.

The recommended dosage of Hydroxychloroquine (Plaquenil) varies depending on the condition being treated:

• Malaria prophylaxis:
  • Adult patients: 400 mg once a week
  • Pediatric patients ≥ 31 kg: 6.5 mg/kg actual body weight (up to 400 mg) once a week
• Treatment of uncomplicated malaria:
  • Adult patients: 800 mg initially, followed by 400 mg at 6,24, and 48 hours (total dosage = 2,000 mg)
  • Pediatric patients ≥ 31 kg: 13 mg/kg (up to 800 mg) initially, followed by 6.5 mg/kg (up to 400 mg) at 6,24, and 48 hours (total dosage = 31 mg/kg - up to 2,000 mg)
• Rheumatoid arthritis:
  • Initial dosage: 400 mg to 600 mg daily
  • Chronic dosage: 200 mg to 400 mg daily
• Systemic lupus erythematosus: 200 mg to 400 mg daily
• Chronic discoid lupus erythematosus: 200 mg to 400 mg daily 2

From the Research

Recommended Dosage of Hydroxychloroquine

The recommended dosage of Hydroxychloroquine (Plaquenil) varies depending on the condition being treated and the patient's weight.

• For patients with systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA), the 2016 American Academy of Ophthalmology (AAO) guidelines recommend limiting the Hydroxychloroquine dose to 5 mg/kg/day or less 3.
• A study found that a maximum daily dose of 5.0 mg/kg based on actual body weight and no greater than 400 mg is advised to reduce the risk of retinopathy 4.
• For COVID-19 prophylaxis, a possible dosing regimen could be an 800 mg loading dose followed by 400 mg twice or 3 times weekly 5.
• Rheumatologists typically prescribe Hydroxychloroquine at a dose of 200-400 mg/day, with some using doses up to 600 mg/day or 6.5 mg/kg/day 6.

Factors Affecting Dosage

Several factors can affect the dosage of Hydroxychloroquine, including:

• Weight: The dosage should be based on the patient's actual body weight 3, 4.
• Renal function: Patients with renal dysfunction may require closer monitoring and adjusted dosing 4.
• Existing retinopathy: Patients with existing retinopathy may require closer monitoring 4.
• Cumulative dose: Patients who have taken a cumulative dose of more than 1000 g may require closer monitoring 4.