Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Simvastatin

Generic name
Simvastatin
Brand name
ATC Code
C10AA01

Pharmacokinetics in children

There is no data on the pharmacokinetics in children and adolescents.

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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
  • Oral
    • 10 years up to 18 years
      • 10 - 40 mg/day in 1 dose. Max: 40 mg/day.
      • Directions for administration:

        Take in the evening.

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Renal impaiment in children > 3 months

The dose does not need to be adjusted for moderate renal function disorders. If the patient has a severe renal insufficiency (creatinine clearance < 30 ml/min) caution is recommended for dosages above 10 mg/day.

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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

Patients 10-17 years treated with simvastatin had an adverse experience profile generally similar to that of patients treated with placebo. Doses greater than 40 mg have not been studied in this population. In this limited controlled study, there was no detectable effect on growth or sexual maturation in the adolescent boys or girls, or any effect on menstrual cycle length in girls. Long-term effects on physical, intellectual, and sexual maturation are unknown. (SmPC Zocor)

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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

No information available on specific warnings and precautions in children.

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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
C10AA07
Bile acid sequestrants
C10AC01
Other lipid modifying agents
C10AX09

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Reference

  1. Merck Sharp & Dohme BV, SPC Zocor (RVG 13193) 22-06-2015, www.geneesmiddeleninformatiebank.nl

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Changes

Changes