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

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

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

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

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]

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.

Interactions

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

• ANTIINFECTIVES FOR SYSTEMIC USE
• ANTIBACTERIALS FOR SYSTEMIC USE

SULFONAMIDES AND TRIMETHOPRIM

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

Intermediate-acting sulfonamides
	Sulfadiazine Related Medicines Menu">	J01EC02

Combinations of sulfonamides and trimethoprim, incl. derivatives
	Co-trimoxazole (sulfamethoxazole + trimethoprim) Related Medicines Menu">	J01EE01

References

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

Changes

Therapeutic Drug Monitoring

Overdose