- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
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.
A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.
dose recommendation of formulary compared to licensed use (on-label versus off-label)
No information is present at this moment.
A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.
Available formulations
No information is present at this moment.
A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.
Dosages
| Complicated urinary tract infections |
|---|
|
A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.
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
A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.
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.]
A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.
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.
A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.
Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.
| Fluoroquinolones | ||
|---|---|---|
| J01MA02 | ||
| J01MA12 | ||
A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.
References
- 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
- 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
- Koyle MA, et al, Pediatric urinary tract infections: the role of fluoroquinolones, Pediatr Infect Dis J, 2003, 22, 1133-7
- Iwai N, et al, Basic and clinical studies on norfloxacin in the pediatric field, Jpn J Antibiot, 1990, 43, 1629-48
- Toyonaga Y, et al, Laboratory and clinical studies on norfloxacin in the pediatric field., Jpn J Antibiot, 1990, 43, 808-25
- Nakazawa S, et al, Pharmacokinetic, bacteriological and clinical studies in the pediatric field on norfloxacin., Jpn J Antibiot, 1990, 43(5), 799-807
- Motohiro T, et al, Pharmacokinetics and clinical studies of norfloxacin in the pediatric field, Jpn J Antibiot, 1990, 43, 901-17
- Fujii R, et al, Evaluation of norfloxacin in the pediatric field. Pediatric Study Group for Norfloxacin, Jpn J Antibiot, 1990, 43, 181-215
- Mylan B.V., SmPC norfloxacine (RVG 29846) 20-10-2014, www.geneesmiddeleninformatiebank.nl
- Rademaker CMA et al., Geneesmiddelen-formularium voor kinderen., 2007
- Bayer Int, DHPC Fluorochinolonen, 29 maart 2019
- 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.
A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.
Changes
Changes
