Ramipril

Generic name
Ramipril
Brand name
ATC Code
C09AA05
Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

The tmax of the active metabolite ramiprilat is 2-3 hours. In addition, following average kinetic data is known from studies with 30 children in the age range 2 to 16 years:

Dosing Cmax (ng/ml) T½ (hours) V/F (l/kg) Cl/F (ml/kg/min)
0.05 mg/kg 7.2 22.65 16.34 7.49
0.2 mg/kg 33.4 9.34 9.38 11.79

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
  • Oral
    • 3 years up to 18 years
      • Initial dose: 1.25 mg/m²/day in 1 dose
      • Maintenance dose: Titrate depending on the blood pressure to a maximum of 6 mg/m²/day in 1 dose

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 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 : 24 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.

Patients on dialysis

Haemodialysis: 50% of the normal dose each time and the interval between two doses: 24 hours.

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

The nature and seriousness of the side effects in children are comparable with those in adults; the following side effects do however occur commonly in children: tachycardia, tremors, rhinitis, conjunctivitis and urticaria.

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
C09AA03
C09AA04

References

  1. Group ET et al, Strict blood-pressure control and progression of renal failure in children, N Engl J Med, 2009, Oct 22;361(17), 1639-50
  2. Wuhl E, et al, Antihypertensive and antiproteinuric efficacy of ramipril in children with chronic renal failure, Kidney Int, 2004, Aug;66(2), 768-7
  3. Seeman T, et al, Regression of left-ventricular hypertrophy in children and adolescents with hypertension during ramipril monotherapy., Am J Hypertens., 2007, Sep;20(9), 990-6
  4. Sanofi-aventis Netherlands B.V., SmPC Tritace (RVG 13294, 13295, 13296, 13297) 21 januari 2015, www.geneesmiddeleninformatiebank.nl
  5. EMA, Ramipril: Public Assessment Report for paediatric studies submitted in accordance with Article 45 of Regulation (EC) No1901/2006, www.hma.eu, Geraadpleegd 29 september 2015,
  6. Lurbe E, et al, Management of high blood pressure in children and adolescents: recommendations of the European Society of Hypertension, J Hypertens, 2009, Sep;27(9), 1719-42
  7. MMI, Gelbe Liste Online., Accessed July 11, 2018
  8. Sanofi, SmPC Delix 2,5mg/5mg/10mg Tabletten (45696.01.00), 02/2018
  9. Hexal, SmPC Ramipril Hexal® 1,25mg/2,5mg/5mg/7,5mg/10mg Tabletten (53329.00.00), 03/2017
  10. van den Belt SM, et al., Early Proteinuria Lowering by Angiotensin-Converting Enzyme Inhibition Predicts Renal Survival in Children with CKD, J Am Soc Nephrol., 2018, 29, 2225-33

Changes

Therapeutic Drug Monitoring


Overdose