Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Hydroxychloroquine

Generic name
Hydroxychloroquine
Brand name
ATC Code
P01BA02

Pharmacokinetics in children

No information

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dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

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Available formulations

No information is present at this moment.

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Dosages

Juvenile idiopathic arthritis (JIA) and systemic lupus erythematodes (SLE)
  • Oral
    • 1 month up to 18 years
      [2] [3] [4] [5]
      • 5 mg/kg/day in 1 dose. Max: 400 mg/day.

      • Only on prescription or after consultation with a pediatric rheumatologist / immunologist

        In individual cases it may be necessary to increase the dose to a maximum of 6.5 mg/kg/day, but only on prescription from a pediatric rheumatologist / immunologist and after balancing the risk of retinopathy with an increased (cumulative) dose of hydroxychloroquine against the possible insufficient effectiveness of a lower dosage.
Prophylaxis for malaria
  • Oral
    • 1 month up to 18 years
      [1]
      • 6.5 mg/kg/dose once a week. Max single dose: 400 mg/dose.
      • Duration of treatment:

        Prophylaxis should begin one week before arrival in an area with malaria and continue until four to eight weeks after departure from that area.
Treatment of uncomplicated malaria
  • Oral
    • 1 month up to 18 years
      [1]

      • A total dose of up to 2000 mg is administered over 3 days, as follows:
        First dose: 13 mg/kg, maximum one-time dose of 800 mg
        Second dose: 6.5 mg/kg, max 400 mg/dose, 6 hours after first dose
        third dose: 6.5 mg/kg, max 400 mg/dose, 18 hours after second dose
        fourth dose: 6.5 mg/kg, max 400 mg/dose, 24 hours after third dose.

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Renal impaiment in children > 3 months

Be cautious in patients with renal impairment. Dose adjustment may be needed.

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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Gastrointestinal complaints, skin abnormalities, hair loss, myopathy, dizziness, tinnitus, irreversibel retinopathy [ACR], hypoglycemia.

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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Young children are particularly sensitive to 4-aminoquinoline derivatives and relatively small doses can cause very severe intoxication (such as fatal respiratory and circulatory insufficiency).

Hydroxychloroquine can prolong the QT interval: the extent of the prolongation of the QT time may increase with increasing concentration of hydroxychloroquine. Perform an ECG before starting treatment. Be cautious in congenital or documented acquired QT prolongation and / or known risk factors for QT prolongation.

When used in JIA: the therapeutic effect occurs only after a few weeks or months. In cases of severe side effects, the treatment must be discontinued.

Dosages above 5 mg/kg actual body weight have a higher risk for rethinopathy, especially when used longer than 5 years. The risk is also greatly increased in renal impairment  (eGRF < 60 ml/min) and therefore the dose should be adjusted. Monitoring of  plasmalevels (trough) is indicated.

Although evidence on retinopathiy in children is lacking, ophtalmologic examination in children  is recommended before start of treatment and yearly thereafter. Treatment with hydroxychloroquine should be stopped immediately at first signs of retinal abnormalities or new interference with vision (including color vision). 

Retinal abnormalities can show progress even after treatment termination. 

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Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

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Aminoquinolines
P01BA01
Biguanides
P01BB01
Methanolquinolines
P01BC02
P01BC01
Diaminopyrimidines
P01BD01
Artemisinin and derivatives, plain
P01BE03
Artemisinin and derivatives, combinations
P01BF01

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References

  1. Sanofi-Aventis Netherlands BV, SPC Plaquenil (RVG 00853) 17-03-2020, www.geneesmiddeleninformatiebank.nl
  2. Franssen MJAM et al, Werkboek Kinderreumatologie, VU Uitgeverij, 2008, 2e druk
  3. Sectie Kinderreumatologie/immunologie Nederlandse Vereniging voor Kindergeneeskunde, Expert opinion Hydroxychloroquine en rethinopathie, 2019, June
  4. American college of Rheumatology (ACR) , Position statement Screening for Hydroxychloroquine Retinopathy, 2017
  5. Nederlandse Vereniging voor Reumatologie, Standpunt HCQ Retinopathie screening, 2018, November
  6. SWAB in collaboration with CIB, NVZA, NVMM, NVII and NVIC, Medicamenteuze behandelopties bij patiënten met COVID-19 (infecties met SARS-CoV-2), https://swab.nl/nl/covid-19, May, 1, 2020
  7. Yao, X. et al , In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Clin Infect Dis., 2020 Mar 9. pii: ciaa237. doi: 10.1093/cid/ciaa237. [Epub ahead of print]
  8. Magagnoli J, et al, Outcomes of hydroxychloroquine usage in united states veterans hospitalized with covid-19., Preprint, 2020
  9. Perinel S, et al, Towards optimization of hydroxychloroquine dosing in intensive care unit COVID-19 patients, Clin Infect Dis, 2020
  10. Chen Z, et al, Efficacy of hydroxychloroquine in patients with COVID-19: Results of a randomized clinical trial, Preprint, 2020
  11. Mahévas M, et al, No evidence of clinical efficacy of hydroxychloroquine in patients hospitalised for COVID-19 infection and requiring oxygen: Results of a study using routinely collected data to emulate a target trial., Preprint, 2020
  12. Tang W, et al, Hydroxychloroquine in patients with COVID-19: An open-label, randomized, controlled trial, Preprint, 2020

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Changes

Changes