What is the maximum dose of Plaquenil (hydroxychloroquine)?

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Last updated: May 2, 2025View editorial policy

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From the Guidelines

The maximum recommended dose of Plaquenil (hydroxychloroquine) is 5 mg/kg of actual body weight per day, not to exceed 400 mg daily for most indications. This dosing guideline is based on the most recent and highest quality study available, which emphasizes the importance of limiting the dose to minimize the risk of retinal toxicity 1. The study highlights that doses above 5 mg/kg increase the risk of retinopathy, with the risk rising to approximately 10% after 10 years of use.

Key Considerations for Dosing

  • The dosing should be calculated based on actual body weight, rather than ideal body weight, as the study suggests that this approach provides a low risk of toxicity 1.
  • For long-term therapy, particularly for rheumatologic conditions like lupus or rheumatoid arthritis, the maintenance dose is typically 200-400 mg daily.
  • Regular eye examinations are necessary for patients on long-term therapy, typically every 6-12 months, to monitor for signs of retinal toxicity.
  • Patients with kidney or liver impairment may require lower doses due to decreased drug clearance.
  • The medication should be taken with food or milk to reduce gastrointestinal side effects.

Importance of Monitoring and Adherence

  • If a patient experiences visual changes, they should immediately report this to their healthcare provider as it could indicate retinal toxicity.
  • Adherence to the recommended dose and regular monitoring can help minimize the risk of adverse effects and ensure the safe use of Plaquenil for the management of conditions like systemic lupus erythematosus, as supported by guidelines 1.

From the Research

Maximum Dose of Plaquenil

The maximum dose of Plaquenil, also known as hydroxychloroquine, is a matter of debate. However, based on current guidelines, the daily dose associated with the best compromise between efficacy and safety is:

  • ≤5 mg/kg/day actual body weight 2

Factors Affecting Dosage

The dosage of Plaquenil may be affected by several factors, including:

  • Body weight: The dose should be set on a body weight basis to minimize the risk of ocular adverse reactions 3, 2
  • Disease severity: The dose may need to be adjusted based on the severity of the disease being treated 3, 2
  • Combination therapy: The dose of Plaquenil may be lowered when used in combination with other disease-modifying agents or biologics 3, 4

Safety Considerations

The use of Plaquenil is generally considered safe, but adverse reactions have been reported, including:

  • Ocular toxicity: Regular retinal examinations are recommended to minimize the risk of ocular adverse reactions 3, 2
  • Cardiotoxicity: Severe life-threatening adverse effects, including cardiomyopathy and conduction defects, have been reported 5

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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