Pharmacokinetics in children

There is no information available about the pharmacokinetics of this drug 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

Treatment of uncomplicated urinary tract infections
Oral 1 month up to 18 years [1] [5] [12] Macrocristalline formulation: 5 - 6 mg/kg/day in 4 doses. Max: 200 mg/day. Delayed release capsules, hard ≥ 12 years [12] [23] 200 mg/day in 2 doses.

Prophylaxis of recurrent urinary tract infections
Oral 1 month up to 18 years [3] [4] [6] [7] [12] [13] [24] Macrocrystalline formulation: 2 mg/kg/day in 1 dose. Max: 100 mg/day. Duration of treatment: 6 months Only treat for longer than 6 months after careful consideration of benefits and risks ( antibiotic resistance and serious side effects (especially liver and lung toxicity)) Directions for administration: Take in the evening.

Short-term prophylaxis in procedures on the urinary tract (catheterization or diagnostics)
Oral ≥ 12 years [12] Macrocrystalline formulation: 200 mg/day in 4 doses.

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 is not required, but nitrofurantoin may possibly be less effective because the excretion is reduced so that the concentration in the urine is lower

GFR 10-30 ml/min/1.73 m2

Contraindicated

GFR < 10 ml/min/1.73 m2

Contraindicated

Clinical consequences

Accumulation in blood and tissue can cause peripheral neuropathy. Paraesthesia (with tingling or a numb sensation) and weakness have been reported, mostly a few days after starting the treatment. In that case, stop the treatment. Sometimes this leads to peripheral polyneuropathy, usually within 2 months. It can be irreversible and even fatal. Nitrofurantoin is concentrated in the urine, causing bactericidal concentrations there. In creatinine clearances of less than 50 ml/min, this bactericidal concentration becomes smaller and at clearances of less than 30 ml/min, no bactericidal concentration occurs in urine, with therapeutic failure as a result.

Patients on dialysis

Contraindicated

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

Gastrointestinal side effects occur most often. Side effects may occur less commonly in children than in adults. This may be due to the lower dosages and the lack of comorbidity/co-medication. Paraesthesia. Peripheral neuropathy, which can be severe or irreversible, can also occur (usually within 2 months). This can be life-threatening. The treatment should then be discontinued immediately.

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

Contra-indications in children

Do not use in neonates (< 1 month) because of the immature erythrocyte-enzyme systems.

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

A macrocrystalline formulation is preferred. The macrocrystalline form (=MC) has a slower dissolving and absorption rate than the microcrystalline form and therefore gives fewer stomach pains.

Stop the treatment immediately if peripheral neuropathy occurs (mostly within 2 months).

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

OTHER 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.

Glycopeptide antibacterials
	Vancomycin Related Medicines Menu">	J01XA01

Polymyxins
	Colistin Related Medicines Menu">	J01XB01

Other antibacterials
	Linezolid Related Medicines Menu">	J01XX08
	Phosphomycin Related Medicines Menu">	J01XX01

References

1. Lohr JA, et al, Three-day therapy of lower urinary tract infections with nitrofurantoin macrocrystals: a randomized clinical trial., J Pediatr, 1981, 99, 980-3
2. Karpman E, et al, Adverse reactions of nitrofurantoin, trimethoprim and sulfamethoxazole in children, J Urol., 2004, 172, 448-53
3. Brendstrup L, et al, Nitrofurantoin versus trimethoprim prophylaxis in recurrent urinary tract infection in children, Acta Paediatr Scand, 1990, 79, 1225-34
4. Carlsen NL, et al, Comparison of long-term, low-dose pivmecillinam and nitrofurantoin in the control of recurrent urinary tract infection in children, J Antimicrob Chemother, 1985, 16, 509-17
5. Jojart G, Comparison of 3-day versus 14-day treatment of lower urinary tract infection in children, Int Urol Nephrol, 1991, 23, 129-34
6. Lohr JA, et al, Prevention of recurrent urinary tract infections in girls, Pediatrics, 1977, 59, 562-5
7. Smellie JM, et al, Controlled trial of prophylactic treatment in childhood urinary-tract infection, Lancet, 1978, 22, 175-8
8. Werkgroep Infectieziekten van de Nederlandse Vereniging voor, Werkboek Infectieziekten bij kinderen, 1999, 109-110
9. Sandoz BV, SPC Nitrofurantoine RVG 18152, dd 7 maart 2009
10. NVK, Richtlijn Urineweginfecties bij Kinderen, 09-06-2010
11. Van Pinxteren B. et al, NHG-Standaard Urineweginfecties(derde herziening) , Huisarts Wet , 2013, 56(6), 270-80
12. Amdipharm Limited, SmPC Furadantine MC (RVG 05748/05749) 08-03-2021, www.geneesmiddeleninformatiebank.nl
13. Williams G et al., Long-term antibiotics for preventing recurrent urinary tract infection in children., Cochrane Database Syst Rev, 2011, Mar 16;(3), CD001534
14. MMI, Gelbe Liste Online, Accessed March 20, 2018
15. APOGEPHA, SmPC Nifurantin® B6 50 mg + 7 mg überzogene Tablette (3000563.00.00), 12/2017
16. Mercury, SmPC Furadantin Retard 100 mg Hartkapsel / Furadantin RP 50 mg Hartkapsel (6338087.00.00, 6338101.00.00), 10/2017
17. Winthrop, SmPC Uro-Tablinen® 50 mg, Tabletten (6165534.00.00), 02/2016
18. APOGEPHA, SmPC Nifurantin® 50 mg Tabletten (6338035.00.00), 12/2017
19. APOGEPHA, SmPC Nifurantin® 100 mg überzogene Tablette / Nifuretten® 20 mg überzogene Tablette (3000549.00.00, 3000551.00.00), 12/2017
20. Apogepha Arzneimittel GmbH, www.apogepha.de, Nitrofurantoin, Accessed August 24, 2018
21. AVOXA, ABDA-Datenbank Wirkstoffdossier Nitrofurantoin, 07/2015
22. Sciele Pharma, Inc., Furadantin® (nitrofurantoin) Oral Suspension (FUR-PI-4), 12/2018
23. Amdipharm Limited, SmPC Furabid (RVG 15290) 19-11-2020, www.geneesmiddeleninformatiebank.nl
24. Nederlands Huisartsen Genootschap (NHG), Standaard Urineweginfecties, https://richtlijnen.nhg.org/standaarden/urineweginfecties#samenvatting-richtlijnen-beleid, April 2020

Changes

Therapeutic Drug Monitoring

Overdose