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

Interactions
PK
Renal impairment
References

Raltegravir

Generic name
Raltegravir
Brand name
ATC Code
J05AX08

Pharmacokinetics in children

tmax = approximately 3 hours
t½ = approximately 9 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

Treatment HIV infection
  • Oral
    • Film-coated tablet
      • ≥ 25 kg
        [1]
        • 800 mg/day in 2 doses.
        • NOTE: the dosage of the film-coated tablet cannot be swapped for the chewable tablet because of the different bioavailability.

    • Chewing tablet
      • ≥ 11 kg
        [1]
        • 12 mg/kg/day in 2 doses. Max: 600 mg/day. Equivalent to:
          11-14 kg: 150 mg/day in 2 doses
          14-20 kg: 200 mg/day in 2 doses
          20-28 kg: 300 mg/day in 2 doses
          28-40 kg: 400 mg/day in 2 doses
          > 40 kg:     600 mg/day in 2 doses.
        • NOTE: the dosage of the film-coated tablet cannot be swapped for the chewable tablet because of the different bioavailability.

    • Granules for oral suspension
      • ≥ 4 weeks and 3 up to 20 kg
        [1]
        • 12 mg/kg/day in 2 doses. Max: 200 mg/day.
      • 0 weeks up to 1 week
        [1]
        • 1.5 mg/kg/day in 1 dose. Max: 100 mg/day.
      • 1 week up to 4 weeks
        [1]
        • 6 mg/kg/day in 2 doses. Max: 200 mg/day.

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Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

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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

The frequency, type and severity of the side effects in paediatric and adolescent patients were comparable to those seen 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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Reference

  1. Merck Sharp & Dohme Limited, SmPC Isentress (EU/1/07/436/001-004) 25-06-2019, www.geneesmiddeleninformatiebank.nl

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Changes

Changes