Losartan

Generic name
Losartan
Brand name
ATC Code
C09CA01
Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

Losartan:
T½ = 1.93-2.41 hours
Tmax = 1.05-2.03 hours

Active metabolite:
T½ = 4.83-5.72 hours
Tmax = 4.46-6.01 hours
 

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, Marfan syndrome
  • Oral
    • 1 month up to 18 years and < 50 kg
      • Losartan-Potassium: 0.7 mg/kg/day in 1 dose. Max: 1.4mg/kg/day, but not exceeding 50 mg/day.
    • 1 month up to 18 years and ≥ 50 kg
      • Losartan-Potassium: 0.7 mg/kg/day in 1 dose. Max: 1.4mg/kg/day, but not exceeding 100 mg/day.

Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

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

Headaches, infections of the upper respiratory tract, hypotension

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

For use in exceptional circumstances, after consulting a nephrologist. Very little experience with children.

Caution is needed in cases of volume depletion and/or salt depletion (inter alia as a result of the use of diuretics, a low-salt diet, vomiting or diarrhoea), severe cardiac failure, renovascular hypertension, dialysis, hyperkalaemia, bilateral renal artery stenosis or unilateral stenosis to a solitary kidney (for instance after a kidney transplant), angina pectoris, hypertrophic cardiomyopathy, aortic or mitral valve stenosis and primary hyperaldosteronism. Caution is also needed in angioedema resulting from the use of an ACE inhibitor.

Liver dysfunction [11]
Losartan is not recommended for children with impaired liver function.

Kidney dysfunction [11]
Due to lack of data, losartan is not recommended for children with a glomerular filtration rate below 10 ml/min/1.73 m². Kidney function should be monitored regularly during treatment with losartan as it may decrease. This is especially important when losartan is given under other conditions that may affect renal function (fever, dehydration). The simultaneous use of losartan and ACE inhibitors has been shown to affect renal function. Therefore, simultaneous use is not recommended.

Interactions

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

ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), 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.

Angiotensin II receptor blockers (ARBs), plain
C09CA06
C09CA08
C09CA03

References

  1. Shahinfar S, et al, A double-blind, dose-response study of losartan in hypertensive children, Am J Hypertens., 2005, Feb;18(2 Pt 1):, 183-90
  2. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
  3. Ellis D, et al, Antihypertensive and renoprotective efficacy and safety of losartan. A long-term study in children with renal disorders, Am J Hypertens, 2004, Oct;17(10), 928-35
  4. Webb NJ, et al, Randomized, double-blind, controlled study of losartan in children with proteinuria, Clin J Am Soc Nephrol, 2010, Mar;5(3), 417-24
  5. CHMP, Public Assesment report Cozaar , 2010
  6. Webb NJ, et al, A randomized, open-label, dose-response study of losartan in hypertensive children, Clin J Am Soc Nephrol, 2014, Aug;9(8), 1441-8
  7. Lacro RV, et al, Atenolol versus losartan in children and young adults with Marfan’s syndrome, N Eng J Med, 2014, Nov;371(22), 2061-71
  8. 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
  9. XX, Online GL. Gelbe Liste Online | Gelbe Liste, Accessed June 25, 2018
  10. MSD SHARP & DOHME GMBH, SmPC LORZAAR® 2,5 mg/ml Pulver und Lösungsmittel zur Herstellung einer Suspension zum Einnehmen (77187.00.00), 03/2018
  11. Hexal AG, SmPC Losartan HEXAL 12,5 mg, 25 mg, 50 mg, 75 mg, 100 mg Filmtabletten (60863.00.00), SmPC Losartan HEXAL 12,5 mg, 25 mg, 50 mg, 75 mg, 100 mg Filmtabletten (60863.00.00), 09/2014
  12. MSD SHARP & DOHME GMBH, SmPC LORZAAR® START 12,5 mg, LORZAAR® PROTECT 50 mg, 100 mg Filmtabletten (41542.00.00), 01/2019
  13. Henning Arzneimittel, SmPC Losartan Hennig 25 mg, 50 mg, 100 mg Filmtabletten (72941.00.00), 03/2018
  14. Hexal AG, SmPC Losartan HEXAL 12,5 mg, 25 mg, 50 mg, 75 mg, 100 mg Filmtabletten (60863.00.00), SmPC Losartan HEXAL 12,5 mg, 25 mg, 50 mg, 75 mg, 100 mg Filmtabletten (60863.00.00), 09/2014
  15. CHMP, Public Assesment report Cozaar, 2010

Changes

Therapeutic Drug Monitoring


Overdose