Pharmacokinetics in children

No information is present at this moment.

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

Congestive heart failure, hypertension

Oral Term neonate Initial dose: 0.03 mg/kg/day in 3 doses. Maintenance dose: titrate depending on the effect to a maximum of 2 mg/kg/day in 3 doses. Because of the risk of severe hypotension, giving a test dose of 0.01 mg/kg first is preferable. 1 month up to 1 year Initial dose: 0.3 mg/kg/day in 3 doses. Maintenance dose: titrate depending on the effect to a maximum of 4 mg/kg/day in 3 doses. Because of the risk of severe hypotension, giving a test dose of 0.1 mg/kg first is preferable. 1 year up to 18 years Initial dose: 0.3 mg/kg/day in 3 doses. Maintenance dose: titrate depending on the effect to a maximum of 6 mg/kg/day in 3 doses. Because of the risk of severe hypotension, giving a test dose of 0.1 mg/kg first is preferable

Renal impaiment in children > 3 months

Adjustment in renal impairment as specified:

GFR 50-80 ml/min/1.73 m2

Dose adjustment is not required.

GFR 30-50 ml/min/1.73 m2

50 percentage of single dose and dosing interval : 8 uur . Then set the dose depending on the effect. The concentrations of creatinine and potassium must be checked within 2 weeks of commencing the treatment and then at least once a year, depending on the clinical condition of the patient.

GFR 10-30 ml/min/1.73 m2

50 percentage of single dose and dosing interval : 8 uur . Then set the dose depending on the effect. The concentrations of creatinine and potassium must be checked within 2 weeks of commencing the treatment and then at least once a year, depending on the clinical condition of the patient.

GFR < 10 ml/min/1.73 m2

Generalized recommendations cannot be given.

Clinical consequences

ACE inhibitors lower the intraglomerular filtration pressure and reduce proteinuria. This means that they probably have a protective effect on renal function in the longer term. For this reason, the highest possible tolerated dose is often given in secondary care in cases of reduced renal function. When commencing an ACE inhibitor, the serum creatinine concentration can rise as a result of a decrease in the intraglomerular filtration pressure.

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

Tickly cough, exanthema, rash, taste loss, proteinuria, nephrotic syndrome, neutropenia and abnormal blood counts. ACE inhibitors can cause hypotension – potentially severe – after starting the treatment and when the dose is increased, particularly in neonates and in certain high-risk groups with severe cardiac failure, renin-dependent hypertension, significant volume depletion and/or sodium depletion or on dialysis. In renal insufficiency and cardiac failure in particular, ACE inhibitors can increase the serum potassium concentration. In premature infants with a very low birthweight, renal function disorders have been reported.

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

In cases of impaired renal function, the dosage should be adjusted. Caution is needed in neonates: even very low doses can result in severe hypotensive reactions – the dosage should be determined according to the clinical picture. A clinically-based setting is also indicated in severe cardiac failure, severe volume depletion and/or salt depletion, severe renin-dependent hypertension, dialysis and where a considerable drop in blood pressure is risky such as in ischemic heart disease and cerebrovascular conditions. Because of the risk of neutropenia, advise the patient to warn the doctor immediately during the first three months of the treatment if there are signs of infection. In particular in reduced renal function and above all when this also involves collagen disorders or treatment with immunosuppressants, the blood counts (in particular the leukocyte count) should be checked because of the elevated risk of neutropenia. Caution is needed in renal artery stenosis and when combined with diuretics. Only administer when hydration is sufficient. In infants, the renal function, blood pressure and saturation need to be checked before use and regularly during use.

Interactions

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

• CARDIOVASCULAR SYSTEM
• AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

ACE INHIBITORS, PLAIN

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

ACE inhibitors, plain
	Benazepril Related Medicines Menu">	C09AA07
	Enalapril Related Medicines Menu">	C09AA02
	Lisinopril Related Medicines Menu">	C09AA03
	Perindopril Related Medicines Menu">	C09AA04
	Ramipril Related Medicines Menu">	C09AA05

References

1. Friedman WF, et al, New concepts and drugs in the treatment of congestive heart failure., Pediatr Clin North Am, 1984, 31, 1197-227
2. Levy M, et al., Captopril pharmacokinetics, blood pressure response and plasma renin activity in normotensive children with renal scarring., Dev Pharmacol Ther, 1991, 16, 185-93
3. Pereira CM, et al., The pharmacokinetics of captopril in infants with congestive heart failure., Ther Drug Monit., 1991, 13, 209-14
4. Mirkin BL, et al., Efficacy and safety of captopril in the treatment of severe childhood hypertension: report of the International Collaborative Study Group, Pediatrics, 1985, 75, 1091-100
5. Montigny M, et al., Captopril in infants for congestive heart failure secondary to a large ventricular left-to-right shunt., Am J Cardiol., 1989, 63, 631-3
6. National High Blood Pressure Education Program Working Group on High Blood Pressure in Children and Adolescents., Fourth report on the diagnosis, evaluation, and treatment of high blood pressure in children and adolescents., Pediatrics, 2004, 114, 555-76
7. Scammell AM, et al., Captopril in treatment of infant heart failure: a preliminary report., Int J Cardiol., 1987, 16, 295-301
8. Shaw NJ, et al, Captopril in heart failure secondary to a left to right shunt, Arch Dis Child, 1988, 63, 360-3
9. Orchard EA, et al, Use of captopril in paediatric congestive cardiac failure: early effects on blood pressure and renal function, Arch Dis Child, 2010, 95, 566-7
10. Gantenbein MH, et al, Side effects of angiotensin converting enzyme inhibitor (captopril) in newborns and young infants, J Perinat Med, 2008, 36, 448-52
11. Sunder RA, et al, Captopril induced hyperkalemia in a child, Paediatr Anaesth, 2009, 19, 404-5
12. Tan LH, et al, Captopril induced reversible acute renal failure in a premature neonate with double outlet right ventricle and congestive heart failure, World J Pediatr, 2011, Feb;7(1), 89-91

Changes

Therapeutic Drug Monitoring

Overdose