Lisinopril

Generic name
Lisinopril
Brand name
ATC Code
C09AA03

Lisinopril

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.

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

Hypertension, proteinuria
  • Oral
    • ≥ 6 years and 20 up to 50 kg
      • Initial dose: 2.5 mg/day in 1 dose. Max: 20 mg/day.
    • ≥ 6 years and ≥ 50 kg
      • Initial dose: 5 mg/day in 1 dose. Max: 40 mg/day.
    • 1 month up to 6 years
      • Initial dose: 0.05 mg/kg/day in 1 dose. Max: 0.2 mg/kg/day.
    • ≥ 6 years and < 20 kg
      • Initial dose: 0.05 mg/kg/day in 1 dose. Max: 0.2 mg/kg/day.

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 uur
Then 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 uur
Then 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.

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

Side effects

No information is present at this moment.

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.

Interactions

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

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
C09AA07
C09AA01
C09AA02
C09AA04
C09AA05

References

  1. AstraZeneca BV, SmPC Zestril 10 mg (RVG 12561) 31-12-2019, www.geneesmiddeleninformatiebank.nl
  2. 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
  3. 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
  4. Recla, S., et al, Medical therapy in dilated cardiomyopathy and pulmonary arterial banding in children., J Heart Lung Transplant, 2013, 32(10), 1045-6
  5. 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
  6. Nakanishi, K., et al, Efficacy and safety of lisinopril for mild childhood IgA nephropathy: a pilot study., Pediatr Nephrol, 2009, 24(4), 845-9
  7. 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
  8. 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
  9. 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

Changes

Therapeutic Drug Monitoring


Overdose