Raltegravir

Generic name
Raltegravir
Brand name
ATC Code
J05AX08
Compare …

Raltegravir

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

tmax = approximately 3 hours
t½ = approximately 9 hours

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

No information is present at this moment.

Available formulations

No information is present at this moment.

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.

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.

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.

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.

Interactions

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

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Reference

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

Changes

Therapeutic Drug Monitoring


Overdose