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

Interactions
PK
Renal impairment
References

Phosphomycin

Generic name
Phosphomycin
Brand name
ATC Code
J01XX01

Pharmacokinetics in children

The pharmacokinetics of intravenously administered phosphomycin in children and adolescents aged 3-15 years and full-term neonates with normal renal function are generally comparable to those in healthy adults:
Cmax (4g): 200 mcg/ml
Cmax (8g): 400 mcg/ml
Vd: 0.3 l/kg Cl: 6.1±1.0 l/hour
t½: 2 hours
In infants and babies aged up to 12 months, the elimination half-life of phosphomycin is extended, dependent on the stage of renal development that has been reached.

After oral administration, the following parameters were found:
Tmax: 2 hours. Taking with food slows (tmax = 4 hours) and reduces the absorption by 15%
Cl: 16.9±3.5 l/hour
t½: 5.7 ±2.8 hours
bioavailability: 37%

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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

Urinary tract infections
  • Oral
    • ≥ 12 years and < 50 kg
      [2]
      • 2 g/dose, once only.
      • Directions for administration:

        Administer 2-3 hours before or after a meal and preferably before going to bed, and after emptying the bladder.

    • ≥ 12 years
      [2]
      • 3 g/dose in 1 dose
      • Directions for administration:

        Administer 2-3 hours before or after a meal and preferably before going to bed, and after emptying the bladder.
Bacterial infections
  • Intravenous
    • Postconceptional age < 40 weeks
      [1]
      • 100 mg/kg/day in 2 doses.
    • Postconceptional age 40 weeks up to 44 weeks
      [1]
      • 200 mg/kg/day in 3 doses.
    • 1 month up to 12 months and < 10 kg
      [1]
      • 200 - 300 mg/kg/day in 3 doses.
    • 1 year up to 12 years and 10 up to 40 kg
      [1]
      • 200 - 400 mg/kg/day in 3 - 4 doses.
    • ≥ 12 years and ≥ 40 kg
      [1]
      • 12 - 24 g/day in 2 - 3 doses. Max single dose: 8 g/dose.
        • Osteomyelitis, nosocomial infections of the lower respiratory tract: 12-24 g/day in 2-3 divided doses
        • Complicated urinary tract infections: 12-16 g/day in 2-3 divided doses
        • Bacteriele meningitis: 16-24 g/day in 3-4 divided doses
Bacterial meningitis
  • Intravenous
    • ≥ 12 years and ≥ 40 kg
      [1]
      • 16 - 24 g/day in 3 - 4 doses.

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Renal impaiment in children > 3 months

In oral administration, adjustment of the dose is not necessary.

In intravenous administration:

increase the initial dose by 100%, max. 8 g each time, then:

creatinine clearance 30-40 ml/min: 60-70% of the standard dose per day in 2-3 doses;

creatinine clearance 20-30 ml/min: 40-60% of the standard dose per day in 2-3 doses;

creatinine clearance 10-20 ml/min: 20-40% of the standard dose per day in 1-3 doses;

 

Patients on dialysis

intermittent haemodialysis: 2 g after every dialysis.

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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

No information is present at this moment.

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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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Glycopeptide antibacterials
J01XA01
Polymyxins
J01XB01
Nitrofuran derivatives
J01XE01
Other antibacterials
J01XX08

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References

  1. InfectoPharm Arzneimittel und Consilium GmbH, SmPC Fomicyt (RVG 115433) 31-07-2015, www.geneesmiddeleninformatiebank.nl
  2. Zambon Nederland B.V., SmPC Monuril (RVG 13066) 01-09-2021, www.geneesmiddeleninformatiebank.nl

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Changes

Changes