Ezetimibe + simvastatin

Generic name
Ezetimibe + simvastatin
Brand name
ATC Code
C10BA02
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Ezetimibe + simvastatin

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

The absorption and metabolization of ezetimibe are the same in children, adolescents (10-18 years) and adults – see also the monograph on ezetimibe.

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

Homozygous familial hypercholesterolaemia; primary hypercholesterolaemia
  • Oral
    • 10 years up to 18 years

      • Ezetimibe/simvastatin: 10 mg/10 mg per day in a single dose in the evening.
        Increase if necessary at intervals of at least 4 weeks to a maximum of 10 mg/40 mg per day in the evenings.

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

No information is present at this moment.

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

Clinical experience in children and adolescents (ages 10 to 17 yrs) is limited to homozygous and heterozygous familial hypercholesterolaemia and sitosterolaemia. Treatment in children (10–17 years; adolescent status in boys: Tanner stage ≥ 2, girls: ≥ 1 year after menarche) should be adjusted by a specialist doctor. The long-term effects (> 33 weeks) have not been determined in children aged between 10 and 18 years. Because of the lack of clinical data, use in children aged < 10 years is not recommended.

Interactions

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

LIPID MODIFYING AGENTS, COMBINATIONS

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. Merck Sharp & Dome Ltd, SmPC Inegy (RVG 30927) 02-04-2014, www.cbg-meb.nl

Changes

Therapeutic Drug Monitoring


Overdose