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

Interactions
PK
Renal impairment
References

Sulfametrole + trimethoprim

Generic name
Sulfametrole + trimethoprim
Brand name
ATC Code
J01EE03

Pharmacokinetics in children

No information available about the pharmacokinetic parameters in children.

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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

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Dosages

Prophylaxis for pneumonia caused by Pneumocystis jirovecii (PCP)
  • Intravenous
    • 1 month up to 12 years

      • Sulfametrol/trimethoprim: 15/3 mg/kg/day in 2 doses, max: 1600/320 mg/dag

      • Alternative dosing regimens:

        • Sulfametrol/trimethoprim: 30/6 mg/kg/day in 2 doses on 3 consecutive days per week
        • Sulfametrol/trimethoprim: 30/6 mg/kg/day in 2 doses every other day, 3 days a week. 
    • 12 years up to 18 years

      • Sulfametrol/trimethoprim: 800/160 mg/day in 1 dose.

      • Alternative dosing regimens:

        • Sulfametrol/trimethoprim: 400/80 mg/day in 1 dose every day
        • Sulfametrol/trimethoprim: 800/160 mg/day in 2 doses every other day, 3 days a week. 
    • 1 month up to 12 years
      [1]

      • Sulfametrol/trimethoprim: 15/3 mg/kg/day in 2 doses, max: 1600/320 mg/dag

      • Alternative dosing regimens:

        • Sulfametrol/trimethoprim: 30/6 mg/kg/day in 2 doses on 3 consecutive days per week
        • Sulfametrol/trimethoprim: 30/6 mg/kg/day in 2 doses every other day, 3 days a week. 
    • 12 years up to 18 years
      [1]

      • Sulfametrol/trimethoprim: 800/160 mg/day in 1 dose.

      • Alternative dosing regimens:

        • Sulfametrol/trimethoprim: 400/80 mg/day in 1 dose every day
        • Sulfametrol/trimethoprim: 800/160 mg/day in 2 doses every other day, 3 days a week. 
Bacterial infections
  • Oral
    • ≥ 12 years

      • Sulfametrol/trimethoprim: 1600/ 320 mg/day in 2 doses, max: 3200/640 mg/day in 4 doses
Treatment of pneumonia caused by Pneumocystis jirovecii (PCP)
  • Intravenous
    • 1 month up to 18 years

      • Sulfametrol/trimethoprim: 75/15 -100/20 mg/kg/day in 3-4 doses.

      • Duration of treatment:

        14 days

    • 1 month up to 18 years
      [1]

      • Sulfametrol/trimethoprim: 75/15 -100/20 mg/kg/day in 3-4 doses.

      • Duration of treatment:

        14 days

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Renal impaiment in children > 3 months

Adjustment in renal impairment as specified:

GFR 50-80 ml/min/1.73 m2
Adjustment not necessary
GFR 30-50 ml/min/1.73 m2
Adjustment not necessary
GFR 10-30 ml/min/1.73 m2
50 percentage of single dose and dosing interval : 12 uur
GFR < 10 ml/min/1.73 m2
Do not administer

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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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Trimethoprim and derivatives
J01EA01
Intermediate-acting sulfonamides
J01EC02
Combinations of sulfonamides and trimethoprim, incl. derivatives
J01EE01

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References

  1. Rokitan GmbH, SmPC Rokiprim (RVG 09239) 20-07-2021, www.geneesmiddelinformatiebank.nl
  2. Vouloumanou EK et al, Trimethoprim/sulfametrole: evaluation of the available clinical and pharmacokinetic/pharmacodynamic evidence., Int J Antimicrob Agents, 2011, Sep;38(3), 197-216
  3. Rokitan, SmPC Lidaprim forte Ftbl. (16362), https://www.univadis.at/, 01/2017
  4. European Committee on Antimicrobial Susceptibility Testing, Clinical breakpoints - breakpoints and guidance, https://www.eucast.org/clinical_breakpoints, Jan 2, 2023
  5. Dutch Working Party on Antibiotic Policy (SWAB) - Special Interest Group Pediatrics, Expert opinion on high dosing for infections caused by microorganisms susceptible to increased doses, Dec 6, 2022

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Changes

Changes