- 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
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
No information is present at this moment.
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Available formulations
No information is present at this moment.
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Dosages
| Hypertension, proteinuria, Marfan syndrome |
|---|
|
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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.
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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 in children
Headaches, infections of the upper respiratory tract, hypotension
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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 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.
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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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| Angiotensin II receptor blockers (ARBs), plain | ||
|---|---|---|
| C09CA06 | ||
| C09CA08 | ||
| C09CA03 | ||
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References
- 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
- Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
- 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
- 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
- CHMP, Public Assesment report Cozaar , 2010
- 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
- Lacro RV, et al, Atenolol versus losartan in children and young adults with Marfans syndrome, N Eng J Med, 2014, Nov;371(22), 2061-71
- 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
- XX, Online GL. Gelbe Liste Online | Gelbe Liste, Accessed June 25, 2018
- MSD SHARP & DOHME GMBH, SmPC LORZAAR® 2,5 mg/ml Pulver und Lösungsmittel zur Herstellung einer Suspension zum Einnehmen (77187.00.00), 03/2018
- 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
- MSD SHARP & DOHME GMBH, SmPC LORZAAR® START 12,5 mg, LORZAAR® PROTECT 50 mg, 100 mg Filmtabletten (41542.00.00), 01/2019
- Henning Arzneimittel, SmPC Losartan Hennig 25 mg, 50 mg, 100 mg Filmtabletten (72941.00.00), 03/2018
- 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
- CHMP, Public Assesment report Cozaar, 2010
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Changes
Changes
