Pharmacokinetics in children

No information available about the pharmacokinetic parameters in children.

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

Bacterial infections
Intravenous 1 month up to 12 years Sulfametrole/trimethoprim: 30/6-45/9 mg/kg/day in 2 doses, max: 1600/320 mg/day 12 years up to 18 years Sulfametrol/trimethoprim: 1600/ 320 mg/day in 2 doses, max: 2400/480 mg/day Oral ≥ 12 years Sulfametrol/trimethoprim: 1600/ 320 mg/day in 2 doses, max: 3200/640 mg/day in 4 doses

Infections (without clinical suspicion of meningitis) caused by microorganisms susceptible at increased exposure ('I')
Intravenous 1 month up to 18 years Sulfametrol/trimethoprim: 45/9 mg/kg/day in 2 doses, max: 2400/480 mg/dag.

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

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.

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

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.

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

• 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.

Trimethoprim and derivatives
	Trimethoprim Related Medicines Menu">	J01EA01

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. 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

Changes

Therapeutic Drug Monitoring

Overdose