ROSUDEX FILM-COATED TABLET 20MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Rosuvastatin Calcium eqv to Rosuvastatin

Available from:

GLORIOUS DEXA SINGAPORE PTE. LTD.

ATC code:

C10AA07

Pharmaceutical form:

TABLET, FILM COATED

Composition:

Rosuvastatin Calcium eqv to Rosuvastatin 20mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

PT. Dexa Medica

Authorization status:

ACTIVE

Authorization date:

2022-10-06

Summary of Product characteristics

At one year, rosuvastatin increased HDL-C and reduced LDL-C, hsCRP,
total cholesterol, and serum triglyceride levels (p<0.001 for all
versus placebo).
_CHILDREN AND ADOLESCENTS WITH HYPERCHOLESTEROLEMIA_
In a double blind, randomized, multicenter, placebo-controlled,
12-week study (n=176, 97 male and 79 female) followed by a 40-week
(n=173, 96 male and 77 female), open label, rosuvastatin dose
titration phase, 10-17 years of age (Tanner stage II-V, females at
least 1 year
postmenarche) with heterozygous familial hypercholesterolemia received
rosuvastatin 5, 10, or 20 mg or placebo daily for 12 weeks and then
all received rosuvastatin daily for 40 weeks. At study entry,
approximately 30% of the patients were 10-13 years and approximately
17%,
18%, 40%, and 25% were Tanner stage II, III, IV, and V, respectively.
Rosuvastatin reduced LDL-C (primary end point), total cholesterol, and
ApoB levels. Results are shown in TABLE 3 below.
TABLE 3 — LIPID-MODIFYING EFFECTS OF ROSUVASTATIN IN CHILDREN AND
ADOLESCENTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
(LEAST-SQUARES MEAN PERCENT CHANGE FROM BASELINE TO WEEK 12)
At the end of the 40-week, open label, titration to goal, dosing up to
a maximum of 20 mg once daily, 70 of 173 patients (40.5%) had achieved
the LDL-C goal of less than 110 mg/dl (2.8 mmol/l).
After 52 weeks of study treatment, no effect on growth or sexual
maturation was detected (see WARNINGS AND PRECAUTIONS).
PHARMACOKINETICS:
Rosuvastatin is administered orally in the active form with peak
plasma levels occurring 5 hours after dosing. Exposure increases
linearly
over the dose range. The half-life is 19 hours and does not increase
with increasing dose. Absolute bioavailability is 20%. There is
minimal
accumulation on repeated once daily dosing.
Rosuvastatin undergoes first pass extraction in the liver which is the
primary site of cholesterol synthesis and LDL-C clearance.
Rosuvastatin is approximately 90% bound to plasma proteins, mostly
albumin. The parent compound, accounts for greater than 90% of