- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
The following pharmacokinetic parameters are reported in children ages 6 months-17 years with hypertnesion(Trachtman et al. 2015, Hogg et al. 2007):
| Dose (range) | Mean 0,15 mg/kg | Median 0,1 mg/kg (0,03-0,14) | Mean0,15 mg/kg | Median 0,2 mg/kg (0,17-0,23) |
| Age, mean (range) | (6 month-6 years) | 14,9 (7-17) year | (6-15 years) | 13 (7-17) year |
| n= | 17 | 12 | 29 | 8 |
| Cmax mean (ng/ml) | 22 | 20,9 | 44 | 47,7 |
| Median Tmax (hour) (range) | (5-6) | 5 (4-8,1) | (5-6) | 5 (4-8) |
| Mean t½ (hour) | 9,4 | 9 | ||
| mean Cl/F (l/hour/70 kg) | 17,9 | 18,6 |
The pharmacokinetic parameters of lisinopril in children from 6 years of age are similar to the pharmacokinetic parameters in adults. The Cmax in children less than 6 years of age is lower than in older children. Nevertheless, children under 6 years of age do not appear to require higher mg / kg doses for lowering blood pressure.
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
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Available formulations
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Dosages
| Hypertension, proteinuria |
|---|
|
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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 : 24 uurThen titrate 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 : 48 uurThen titrate 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.
Patients on dialysis
50% of the usual single dose and interval between 2 doses: 12 hours. Then titrate dose depending on effect up to the highest tolerated dose.
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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here
Side effects
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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
No information available on specific warnings and precautions in children.
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Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
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| ACE inhibitors, plain | ||
|---|---|---|
| C09AA07 | ||
| C09AA01 | ||
| C09AA02 | ||
| C09AA04 | ||
| C09AA05 | ||
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References
- AstraZeneca BV, SmPC Zestril 10 mg (RVG 12561) 31-12-2019, www.geneesmiddeleninformatiebank.nl
- Hogg, R. J., et al, A multicenter study of the pharmacokinetics of lisinopril in pediatric patients with hypertension., Pediatr Nephrol, 2007, 22(5), 695-701
- Soffer, B. et al, A double-blind, placebo-controlled, dose-response study of the effectiveness and safety of lisinopril for children with hypertension, Am J Hypertens, 2003, 16(10), 795-800
- Recla, S., et al, Medical therapy in dilated cardiomyopathy and pulmonary arterial banding in children., J Heart Lung Transplant, 2013, 32(10), 1045-6
- Rupp, S. et al, Upgraded heart failure therapy leads to an improved outcome of dilated cardiomyopathy in infants and toddlers., Cardiol Young, 2015, 25(7), 1300-5
- Nakanishi, K., et al, Efficacy and safety of lisinopril for mild childhood IgA nephropathy: a pilot study., Pediatr Nephrol, 2009, 24(4), 845-9
- Raes, A., et al, Lisinopril in paediatric medicine: a retrospective chart review of long-term treatment in children., J Renin Angiotensin Aldosterone Syst, 2007, 8(1), 3-12
- Shima, Y., et al, Lisinopril versus lisinopril and losartan for mild childhood IgA nephropathy: a randomized controlled trial (JSKDC01 study), Pediatr Nephrol, 2019, 34(5), 837-846
- Trachtman, H., et al, Pharmacokinetics, Pharmacodynamics, and Safety of Lisinopril in Pediatric Kidney Transplant Patients: Implications for Starting Dose Selection., Clin Pharmacol Ther, 2015, 98(1), 25-33
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Changes
Changes
