Šalis: Singapūras
kalba: anglų
Šaltinis: HSA (Health Sciences Authority)
Rosuvastatin Calcium eqv to Rosuvastatin
GLORIOUS DEXA SINGAPORE PTE. LTD.
C10AA07
TABLET, FILM COATED
Rosuvastatin Calcium eqv to Rosuvastatin 20mg
ORAL
Prescription Only
PT. Dexa Medica
ACTIVE
2022-10-06
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 Perskaitykite visą dokumentą