Pharmacokinetics in children

Only abstracts from Japanese studies from 1990 are available. These show that t½ in children varies from 1.7 to 4 hours.

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

Renal impaiment in children > 3 months

UTI prophylaxis:
GFR 50-80 ml/min/1.73m²: Adjustment not necessary
GFR 30-50 ml/min/1.73m²: Adjustment not necessary
GFR 10-30 ml/min/1.73m²: 50% of the normal dose each time and the interval between two doses remains the same.
GFR < 10 ml/min/1.73m²: Generalized recommendations cannot be given.

Complicated UTI:
GFR 50-80 ml/min/1.73m²: Adjustment not necessary
GFR 30-50 ml/min/1.73m²: Adjustment not necessary
GFR 10-30 ml/min/1.73m²: 100% of the normal dose each time and the interval between two doses: 24 hours
GFR < 10 ml/min/1.73m²: Generalized recommendations cannot be given.

Clinical consequences

Neurological side effects of quinolones are headaches, dizziness, drowsiness, paraesthesia, peripheral neuropathy, peripheral sensory impairment, vision disorders and confusion. These complaints are usually reversible and dose-dependent. There have been rare reports of convulsions, particularly in patients with a previous history of epilepsy or cerebrovascular insufficiency.

Patients on dialysis

Haemodialysis and peritoneal dialysis: 100% of the normal dose each time and the interval between two doses: 24 hours

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

Animal tests have shown that the use of fluoroquinolones in young test animals causes abnormalities in cartilage formation. These deviations were not demonstrated in the study that was carried out in young children. [Arico et al., Bhattacharya et al.]

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 in children

Caution is needed when giving quinolones to children in the growth phase. Use of this should be limited to cases where there are no other therapeutic possibilities.

There have not been many studies with regard to the safety and effectiveness of norfloxacin in children. Use of this drug should be reserved for situations where other antimicrobial drugs give insufficient results.

In animal research, arthropathy was observed to a varying extent when very high doses were given to young dogs. These side effects have never been reported in humans either: fluoroquinolones are therefore being used to an increasing extent in children if there are no other therapeutic possibilities or if there are serious objections against the use of other broad-spectrum antibiotics.

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

QUINOLONE ANTIBACTERIALS

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

References

1. Arico M, et al, Long-term magnetic resonance survey of cartilage damage in leukemic children treated with fluoroquinolones, Pediatr Infect Dis J, 1995, 14:, 713-4
2. Bhattacharya K, et al, Double-blind, randomized clinical trial for safety and efficacy of norfloxacin for shigellosis in children, Acta Paediatr, 1997, 86, 319-20
3. Koyle MA, et al, Pediatric urinary tract infections: the role of fluoroquinolones, Pediatr Infect Dis J, 2003, 22, 1133-7
4. Iwai N, et al, Basic and clinical studies on norfloxacin in the pediatric field, Jpn J Antibiot, 1990, 43, 1629-48
5. Toyonaga Y, et al, Laboratory and clinical studies on norfloxacin in the pediatric field., Jpn J Antibiot, 1990, 43, 808-25
6. Nakazawa S, et al, Pharmacokinetic, bacteriological and clinical studies in the pediatric field on norfloxacin., Jpn J Antibiot, 1990, 43(5), 799-807
7. Motohiro T, et al, Pharmacokinetics and clinical studies of norfloxacin in the pediatric field, Jpn J Antibiot, 1990, 43, 901-17
8. Fujii R, et al, Evaluation of norfloxacin in the pediatric field. Pediatric Study Group for Norfloxacin, Jpn J Antibiot, 1990, 43, 181-215
9. Mylan B.V., SmPC norfloxacine (RVG 29846) 20-10-2014, www.geneesmiddeleninformatiebank.nl
10. Rademaker CMA et al., Geneesmiddelen-formularium voor kinderen., 2007
11. Bayer Int, DHPC Fluorochinolonen, 29 maart 2019
12. BfArM., Rote-Hand-Brief zu Fluorchinolon-Antibiotika. 08.04.2019. https://www.bfarm.de/SharedDocs/Risikoinformationen/Pharmakovigilanz/DE/RHB/2019/rhb-fluorchinolone.pdf;jsessionid=4D7FF38A3DCDA1F9795930B56FD1B5E8.2_cid329?__blob=publicationFile&v=3, zuletzt aufgerufen am 12.04.2019.

Changes

Therapeutic Drug Monitoring

Overdose