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

Interactions
PK
Renal impairment
References

Trimethoprim

Generic name
Trimethoprim
Brand name
ATC Code
J01EA01

Pharmacokinetics in children

The following kinetic parameters were found in 36 children aged 0-13 years:

 10 mg/kg one-time (n=18)
[Rylance]		3 mg/kg steady state twice daily (n=18)
[Hoppu]
Cmax 6 ±1.9 mg/l 2.2-2.3 µg/mL
Tmax 2.2 ± 1.2 hours 1.7-2.3 hours
t½ 6.8 ± 1.6 hours 3.7-5.4 hours
Vd 2.24 ± 0.57 l/kg 0.86-1.08 l/kg
Cl 0.241 ± 0.079 l/kg/hour 0.14-0.17 l/kg/hour

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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

Uncomplicated urinary tract infections
  • Oral
    • 3 months up to 5 years
      [5] [6] [7]
      • 6 - 9 mg/kg/day in 2 doses.
      • Duration of treatment:

        see treatment protocol. The duration of treatment can range from 3-5 days.

    • 5 years up to 12 years
      [4]
      • 6 - 9 mg/kg/day in 1 - 2 doses.
      • Duration of treatment:

        see treatment protocol. The duration of treatment can range from 3-5 days.

      • Directions for administration:

        Once-daily doses: take in the evening.

    • 12 years up to 18 years
      [4]
      • 300 mg/day in 1 dose
      • Duration of treatment:

        see treatment protocol. The duration of treatment can range from 3-5 days.

      • Directions for administration:

        Take in the evening
Upper respiratory tract infection
  • Oral
    • 3 months up to 5 years
      [5] [6]
      • 6 - 9 mg/kg/day in 2 doses.
      • Duration of treatment:

        see treatment protocol. The duration of treatment can range from 7-10 days.

    • 5 years up to 12 years
      [4]
      • 6 - 9 mg/kg/day in 1 - 2 doses.
      • Duration of treatment:

        see treatment protocol. The duration of treatment can range from 7-10 days.

    • 12 years up to 18 years
      [4]
      • 400 mg/day in 2 doses.
      • Duration of treatment:

        see treatment protocol. The duration of treatment can range from 7-10 days.
Maintenance treatment for chronic and prophylaxis for recurrent urinary tract infections, prophylaxis for vesicoureteral reflux (VUR), neurogenic bladder, bladder emptying disorders and urinary tract obstruction
  • Oral
    • < 5 years
      [1] [8]
      • 2 mg/kg/day in 1 dose. Max: 50 mg/day.
      • Directions for administration:

        Take in the evening

    • 5 years up to 12 years
      [4]
      • 50 mg/day in 1 dose
      • Directions for administration:

        Take in the evening

    • 12 years up to 18 years
      [4]
      • 100 mg/day in 1 dose
      • Directions for administration:

        Take in the evening

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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
initially the standard dose for 3 days, then half dosage per administration. No interval lengthening.
GFR < 10 ml/min/1.73 m2
Not recommended to be used

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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 safety profile in children does not differ from the safety profile in adults. [SmPC]

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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 in children

fragile X chromosome associated with mental retardation in children [SmPC]

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

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References

  1. Infectopharm, SmPC Infectotrimet 50mg/5ml_100mg/ml Suspension zum Einnehmen (6613406.00.00_6613406.01.00), 12/2017
  2. Hartwig NC, et al, Vademecum pediatrische antimicrobiële therapie, 2005
  3. Sandoz BV, SPC Trimethoprim (RVG 09001), www.cbg-meb.nl, Geraadpleegd 13 aug 2010, http://db.cbg-meb.nl/IB-teksten/h09001.pdf
  4. NVK, Richtlijn Urineweginfecties bij Kinderen, 09-06-2010
  5. Centrafarm BV, SmPC Trimethoprim (RVG 55722) 09-06-2016, www.geneesmiddeleninformatiebank.nl
  6. Hoppu K. , Age differences in trimethoprim pharmacokinetics: need for revised dosing in children? , Clin Pharmacol Ther, 1987, Mar;41(3), 336-43
  7. Rylance GW et al. , Single dose pharmacokinetics of trimethoprim., Arch Dis Child., 1985, Jan;60(1), 29-3
  8. Lidefelt KJ et al. , Single dose treatment of cystitis in children., Acta Paediatr Scand., 1991, Jun-Jul;80(6-7), 648-53
  9. Brendstrup L et al. , Nitrofurantoin versus trimethoprim prophylaxis in recurrent urinary tract infection in children. A randomized, double-blind study. , Acta Paediatr Scand, 1990, Dec;79(12), 1225-34
  10. Pinxteren, van B et al. , NHG-Standaard Urineweginfecties (derde herziening)., Huisarts Wet, 2013, 56(6):, 270-80
  11. UpToDate®, Pediatric Drug information: Trimethoprim Lexicomp® Version 162.0, accessed 2018-08
  12. AVOXA, ABDA-Datenbank Interaktionen, accessed 08/2018
  13. AVOXA, ABDA-Datenbank Wirkstoffdossiers Trimethoprim, accessed 08/2018
  14. Infectopharm, SmPC Infectotrimet 50mg/5ml_100mg/ml Suspension zum Einnehmen (6613406.00.00_6613406.01.00), 12/2017
  15. Infectopharm, SmPC Infectotrimet 50mg/100mg/150mg/200mg Tabletten (6806051.01.00/6806051.02.00/6806051.03.00/6806051.00.00), 10/2016

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Changes

Changes