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

Interactions
PK
Renal impairment
References

Hydroxycarbamide

Generic name
Hydroxycarbamide
Brand name
ATC Code
L01XX05

Pharmacokinetics in children

 

  Child Adult
Tmax 0.75 hours 1.2 hours
somewhat longer than the adult values 6-7 hours

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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

Sickle cell anaemia
  • Oral
    • ≥ 9 months
      [1] [2]
      • Initial dose: 15 mg/kg/day in 1 dose
      • Maintenance dose: depending on the clinical response, increase in steps of 2,5-5 mg/kg/day to 15 - 30 mg/kg/day in 1 dose. Max: 35 mg/kg/day.

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Renal impaiment in children > 3 months

Creatinine clearance 30-60 ml/min: 50% of the dose
Creatinine clearance < 30 ml/min: do not use

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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

In children, the side effect profile is similar to that in adults. However, neutropenia was more common in children aged 2–10 years, and dry skin, alopecia, headache and anemia were less common than in adults. In children aged 10–18 years, dry skin, skin ulcer, alopecia, weight gain and anemia were less common than in adults.

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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

No information available on specific warnings and precautions in children.

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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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Methylhydrazines
L01XB01
PROTEINEKINASEREMMERS
L01XE06
L01XE01
Other antineoplastic agents
L01XX02
L01XX24

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References

  1. Addmedica , SmPC Siklos (EU/1/07/397/002,003, 004) Rev 26; 14-10-2024, www.ema.europa.eu
  2. Nova Laboratories Ireland Limited, SmPC Xromi (EU/1/19/1366/001) Rev 8, 04-062024, www.ema.europa.eu

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Changes

Changes