资料单张
ASPEN SIMVASTATIN 10 MG (TABLET)
ASPEN SIMVASTATIN 20 MG (TABLET)
ASPEN SIMVASTATIN 40 MG (TABLET)
SCHEDULING STATUS:
S4
PROPRIETARY NAME
(and dosage form):
ASPEN SIMVASTATIN 10 MG (TABLET)
ASPEN SIMVASTATIN 20 MG (TABLET)
ASPEN SIMVASTATIN 40 MG (TABLET)
COMPOSITION
Each tablet contains:
ASPEN SIMVASTATIN 10 MG:
Simvastatin
10 mg (active ingredient), 2,50% m/m ascorbic acid (antioxidant), 0,02%
m/m butylated hydroxyanisole (antioxidant)
ASPEN SIMVASTATIN 20 MG: Simvastatin 20 mg (active ingredient), 5,0% m/m
ascorbic acid (antioxidant), 0,04% m/m butylated hydroxyanisole (antioxidant)
ASPEN SIMVASTATIN 40 MG: Simvastatin 40 mg (active ingredient), 10,00% m/m
ascorbic acid (antioxidant), 0,08% m/m butylated hydroxyanisole (antioxidant)
PHARMACOLOGICAL CLASSIFICATION
A 7.5 Serum-cholesterol reducers
PHARMACOLOGICAL ACTION
Simvastatin is a cholesterol-lowering agent derived synthetically from a fermentation
product of Aspergillus terreus. After oral ingestion simvastatin, an inactive lactone, is hydrolysed to the corresponding
beta-hydroxyacid, the active form. This is a principal metabolite and an inhibitor of 3-hydroxy-3-methylglutaryl-
coenzyme A (HMG-CoA) reductase , the enzyme that catalyses the conversion of HMG-CoA to mevalonate, an early and
rate-limiting step in the biosynthesis of cholesterol. As a result, simvastatin, reduces total plasma cholesterol, low-density
lipoprotein (LDL)- and very low-density lipoprotein (VLDL)-cholesterol concentrations. Apolipoprotein B is also
decreased.
In addition, simvastatin moderately increases high-density lipoprotein (HDL)-cholesterol and variably reduces plasma
triglycerides.
Pharmacokinetics:
There is extensive first-pass extraction by the liver, with oral bioavailability of the active medicine or metabolites being
less than 5%. More than 95
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