- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
Two studies on the pharmacokinetics of rosuvastatin (as tablets) in children and adolescents with heterozygous familial hypercholesterolemia aged 10 to 17 or 6 to 17 years (214 patients in total) showed that the bioavailability of children and adolescents is comparable or less than that of adult patients. [SmPC Crestor® 06/19]
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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
| Heterozygous familial hypercholesterolaemia |
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| Homozygous familial hypercholesterolaemia |
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Renal impaiment in children > 3 months
- GFR ≥ 50: no dose adjustment is needed
- GFR 30-50: start 5 mg/day, maintain maximum maintenance dose.
- GFR 10-30: start 5 mg/day, 50% of maximum maintenance dose.
- GFR <10: general advice is not given.
Clinical consequences
With impaired renal function, the AUC of rosuvastatin increases. This increases the risk of adverse reactions.
Clinical implications:
Myopathy, including myositis, and rabdomyolysis have been reported rarely, especially at daily doses greater than 20 mg and with predisposing factors, such as moderate renal impairment (ClCr 30-60 ml/min).
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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
In children and adolescents, the increase in CK levels by more than 10 times of the upper normal value and the occurrence of muscle symptoms after exercise and increased physical activity were observed more frequently in comparison to adults.
No effect on growth, weight, BMI or sexual maturation was observed.
[SmPC Crestor, SmPC Rosuvador]
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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
Because there is no data on the safety and the effectiveness at age < 6 it is recommended that rosuvastatin should not be used in children of < 6 years. The effects of rosuvastatin on physical and sexual development in children and adolescents who use it for longer than 2 years are unknown. The treatment in children (6–17 years; teenager status in boys: Tanner stage ≥ 2, girls: ≥ 1 year after menarche) should be initiated by a specialist doctor.
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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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| HMG CoA reductase inhibitors | ||
|---|---|---|
| C10AA05 | ||
| C10AA03 | ||
| C10AA01 | ||
| Bile acid sequestrants | ||
|---|---|---|
| C10AC01 | ||
| Other lipid modifying agents | ||
|---|---|---|
| C10AX09 | ||
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References
- AstraZeneca BV, SmPC Crestor (RVG 30823) 5-12-2016, www.geneesmiddeleninformatiebank.nl
- NKFK Workinggroup Acute Kidney Impairment, Extrapolation of KNMP risk analysis "Impaired renal function" for adults to children, 20 Dec 2021
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Changes
Changes
