- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
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Interactions - PK
- Renal impairment
- References
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.
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
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Available formulations
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Dosages
| Hypertension |
|---|
|
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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
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.
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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 in children
Children younger than 1 year, because of the effect that candesartan has on the RAAS system and thereby on the normal development of the kidney.
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
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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 | ||
|---|---|---|
| C09CA01 | ||
| C09CA08 | ||
| C09CA03 | ||
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Reference
- AstraZeneca BV,, SmPC Atacand 4 mg (RVG 21704) 25 november 2013
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Changes
Changes
