- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
The systemic exposure and peak plasma concentration of valsartan using the solution are about 1.7 times and 2.2 times higher than with the tablets
A study of 26 hypertensive paediatric patients (aged 1 to 16 years) receiving a single dose of the liquid formulation of valsartan (average 0.9 to 2.0 mg/kg, with 80 mg as the maximum) showed that the valsartan clearance (in litres/hour/kg) was similar over the age group 1 to 16 years and similar to clearance in adults after administration of the same formulation.
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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.
Use in pediatric patients with creatinine clearance <30 ml/min and pediatric patients undergoing dialysis was not investigated. Therefore, valsartan is not recommended in these patients. No dose adjustment is required for pediatric patients with creatinine clearance > 30 ml/min. Kidney function and potassium levels should be closely monitored during treatment with valsartan. Especially in the presence of other conditions (fever, dehydration) that may affect renal function. (SmPC Diovan Liquid formulation)
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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
Abdominal pain, nausea, vomiting and dizziness are reported In children and adolescents more often than in adults. Hyperkalaemia has been reported more often in cases where there is underlying chronic renal disease.
In children aged 1-6 years, the most commonly reported side effects were vomiting, diarrhea, decreased appetite and hyperkalemia.
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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
Severe hepatic impairment, billiary cirrhosis or cholestasis.
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
Diovan liquid solution is not bio-equivalent to the tablets. Switching over from Diovan tablets to the liquid formulation of Diovan is therefore not recommended unless clinically necessary. The dose should be halved when switching from tablets to the liquid formulation. When switching from the liquid formulation to the tablet, the dose should be left unchanged. Make allowances for underdosing.
The blood pressure must be monitored carefully when switching either way and the dose must be titrated depending on the blood pressure and tolerance.
The risk of hyperkalemia may be higher in children aged 1-6 years compared with children aged 6-18 years.
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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 | ||
| C09CA01 | ||
| C09CA08 | ||
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References
- Novartis Pharma BV, SPC Diovan drank (RVG 107481) 16-09-2019, www.geneesmiddeleninformatiebank.nl
- Novartis Pharma BV, SmPC Diovan tabletten (RVG 32137) 09-04-2015, www.geneesmiddeleninformatiebank.nl
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Changes
Changes
