Pharmacokinetics in children

In two pharmacokinetic studies with a single dose, the pharmacokinetic properties of candesartan were studied in hypertensive children aged 1 to < 6 years and 6 to < 17 years.
In children aged from 1 to < 6 years, 10 children with bodyweights ranging from 10 to <25 kg received a single dose of 0.2 mg/kg as an oral suspension. No correlation was determined between Cmax, the AUC and the age or weight. No data has been gathered about the clearance; no data is therefore known in this population about any link between clearance and weight or age.
In children aged from 6 to < 17 years, 22 children received a single dose of 16 mg as a tablet. No correlation was determined between Cmax, the AUC and the age. The bodyweight did however seem to be significantly correlated to the Cmax (p=0.012) and to the AUC (p=0.011). No data has been gathered about the clearance; no data is therefore known in this population about any link between clearance and weight or age.
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 children aged > 6 years showed comparable exposure to adults who received the same dose.
The pharmacokinetics of candesartan cilexetil have not been studied in paediatric patients aged < 1 year.

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

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

Side effects in children are similar to those in adults, but they occur with a higher frequency; the following adverse reactions have been reported in children only: sinus arrhythmia, nasopharyngitis, fever, oropharyngeal pain.

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

Atacand has not been studied in children with a glomerular filtration rate of less than 30 ml/min/1.73m².
In children with an elevated risk of intravascular volume depletion (e.g. patients who are being treated with diuretics, in particular patients who also have reduced renal function), the start of therapy with candesartan should be under strict medical supervision and a lower initial dose should be considered

Interactions

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

• CARDIOVASCULAR SYSTEM
• AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

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.

Reference

1. AstraZeneca BV,, SmPC Atacand 4 mg (RVG 21704) 25 november 2013

Changes

Therapeutic Drug Monitoring

Overdose