Pharmacokinetics in children

No information

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

Overfilling and oedema
Oral Premature infants Gestational age < 37 weeks [3] [4] [5] 1 - 2 mg/kg/day in 2 doses. Studies on the use of spironolacton in prematures neonates are only conducted in premature neonates with a postnatal age of 1 month and above. Term neonate [3] [4] [5] 1 - 2 mg/kg/day in 2 doses. 1 month up to 18 years [2] [3] 1 - 3 mg/kg/day in 2 doses. Max: 200 mg/day.

Ascites
Oral 1 month up to 18 years [19] [20] [21] [22] Initial dose: 1 - 3 mg/kg/day in 2 doses. Maintenance dose: increase dose every 3-5 days to a maximum of 6 mg/kg/day in 2 doses. Max: 400 mg/day. There is little evidence for the use of spironolactone in ascites.

Renal impaiment in children > 3 months

Adjustment in renal impairment as specified:

GFR 50-80 ml/min/1.73 m2

Dose adjustment not needed

GFR 30-50 ml/min/1.73 m2

Check renal function and potassium levels regularly. First check within one week after start of treatment.

GFR 10-30 ml/min/1.73 m2

Check renal function and potassium levels regularly. First check within one week after start of treatment.

GFR < 10 ml/min/1.73 m2

A general recommendation is not provided

Clinical consequences

Hyperkalaemia may occur in children with renal impairment. Potassium-sparing diuretics such as spironolactone can increase this risk. No studies have been conducted on the use of spironolactone in renal impairment without hemodialysis.

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

Hyperkalaemia; gynaecomastia in men.

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

Contra-indications in children

mild to serious renal impairment

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

Children and patients with mild renal impairment have a higher risk to develop hyperkalaemia. Watch out for arrhythmia, be careful in combined use with digoxin or corticosteroids. Combine with hydrochlorothiazide in cases of high potassium.

Spironolactone is dissolved in acetem, a mixture of acetylated monoglycerides. The solution must not be administered via a PVC probe because acetem can release plasticizers from the PVC. Administration via a PUR or silicone rubber probe is possible.

Interactions

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

• CARDIOVASCULAR SYSTEM
• DIURETICS

ALDOSTERONE ANTAGONISTS AND OTHER POTASSIUM-SPARING AGENTS

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. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
2. Accord Healthcare Limited, SmPC Spironolacton (RVG 24025) 02-12-2015, www.geneesmiddeleninformatiebank.nl
3. Brand, PLP et al, Werkboek Kinderlongziekten, VU Uitgeverij, 2001
4. Werkgroep Neonatale Farmacologie NVK sectie Neonatologie, Expert opinie, 28 maart 2018
5. Werkgroep Neonatale Farmacologie NVK sectie Neonatologie, Expert opinion, 03/2018
6. MMI, Online GL. Spironolacton-ratiopharm® 100 mg Tabletten, Accessed June 18, 2018.
7. MMI, Online GL. Spironolacton-ratiopharm® 50 mg Tabletten, Accessed June 18, 2018.
8. MMI, Online GL. Spironolacton HEXAL® 50 mg, Tabletten, Accessed June 18, 2018.
9. MMI, Online GL. Spironolacton HEXAL® 100 mg, Tabletten, Accessed June 18, 2018.
10. MMI, Online GL. Spironolacton AAA-Pharma® 100 mg Tabletten, Accessed June 18, 2018.
11. MMI, Online GL. Spironolacton AAA-Pharma® 50 mg Tabletten, Accessed June 18, 2018.
12. Riemser, SmPC Aldactone 50mg überzogene Tabletten (6618622.01.00), 03/2017
13. Riemser, SmPC Aldactone 25mg überzogene Tabletten (6618622.00.00), 03/2017
14. Riemser, SmPC Aldactone 100mg Hartkapseln (6618622.00.01), 02/2016
15. AAA-Pharma, SmPC Spironolacton 100mg Tabletten (1886.01.00), 1/2016
16. Hexal, SmPC Spironolacton 50mg/100mg Tabletten (49180.00.00/49180.01.00), 02/2016
17. Ratiopharm, SmPC Spironolacton 50mg/100mg Tabletten (2351.01.00/763.00.00), 01/2016
18. AAA-Pharma, SmPC Spironolacton 100mg Tabletten (1886.00.00), 1/2016
19. Yachha, S. K., et al, Ascites in childhood liver disease., Indian J Pediatr, 2006, 73(9), 819-24
20. Squires, R. H. , End-stage Liver Disease in Children, Curr Treat Options Gastroenterol, 2001, 4(5), 409-21
21. Sabri, M., et al. , Pathophysiology and management of pediatric ascites., Curr Gastroenterol Rep, 20013, 5(3), 240-6
22. Kramer, R. E., et al., Large-volume paracentesis in the management of ascites in children., J Pediatr Gastroenterol Nutr, 2001, 33(3), 245-9

Changes

Therapeutic Drug Monitoring

Overdose