Heterozygous familial hypercholesterolaemia

Active Ingredient: Rosuvastatin

Indication for Rosuvastatin

Population group: only children (1 year - 12 years old) , adolescents (12 years - 18 years old)

Therapeutic intent: Curative procedure

For this indication, competent medicine agencies globally authorize below treatments:

For patients 6-9 years old 5-10 mg once daily and for patients 10-17 years old 5-20 mg once daily

For:

Dosage regimens

Regimen A, in the case that patient age in years is ≥ 6 and patient age in years is ≤ 9 :

Oral, between 5 milligrams rosuvastatin and 10 milligrams rosuvastatin, once daily. The maximum allowed total dose is 10 milligrams rosuvastatin daily.

Regimen B, in the case that patient age in years is ≥ 10 :

Oral, between 5 milligrams rosuvastatin and 20 milligrams rosuvastatin, once daily. The maximum allowed total dose is 20 milligrams rosuvastatin daily.

Detailed description

Children and adolescents 6 to 17 years of age (Tanner Stage <II-V)

In children and adolescents with heterozygous familial hypercholesterolaemia the usual start dose is 5 mg daily.

In children 6 to 9 years of age with heterozygous familial hypercholesterolaemia, the usual dose range is 5-10 mg orally once daily. Safety and efficacy of doses greater than 10 mg have not been studied in this population.
In children 10 to 17 years of age with heterozygous familial hypercholesterolaemia, the usual dose range is 5-20 mg orally once daily. Safety and efficacy of doses greater than 20 mg have not been studied in this population.

Titration should be conducted according to the individual response and tolerability in paediatric patients, as recommended by the paediatric treatment recommendations. Children and adolescents should be placed on standard cholesterol-lowering diet before rosuvastatin treatment initiation; this diet should be continued during rosuvastatin treatment.

Dosage considerations

It may be given at any time of day, with or without food.

Active ingredient

Rosuvastatin
Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase. Rosuvastatin increases the number of hepatic LDL receptors on the cell-surface, enhancing uptake and catabolism of LDL and it inhibits the hepatic synthesis of VLDL, thereby reducing the total number of VLDL and LDL particles. Read more about Rosuvastatin

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