LOVANCO TABLET 20MG

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

LOVASTATIN

Available from:

DUOPHARMA (M) SDN. BHD.

INN (International Name):

LOVASTATIN

Units in package:

100 Tablets; 250 Tablets; 500 Tablets

Manufactured by:

DUOPHARMA (M) SDN. BHD.

Summary of Product characteristics

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[REVISION DATE: 24.07.2019]
[DUOPHARMA (M) SDN BHD]
LOVANCO TABLET
DESCRIPTION: LOVANCO TABLET is a round scored tablet, white in colour
with markings “DUO 2” and a “Flower”.
COMPOSITION: Each tablet contains Lovastatin 20 mg.
PHARMACODYNAMICS: Lovastatin which has been isolated from Aspergillus
terreus, is a hypolipidaemic agent; it is a competitive inhibitor of
3-hydroxy-3-methylglutarylcoenzyme A reductase (HMG-CoA
reductase), the rate-determining enzyme for cholesterol synthesis.
Lovastatin reduces total and low-density lipoprotein (LDL)-Cholesterol
and very low density lipoprotein (VLDL)-cholesterol. It tends to
reduce triglycerides and to increase high-density lipoprotein
concentrations. Lovastatin and the other HMG-CoA reductase inhibitors
are considered to exert their hypocholesterolaemic action by
stimulating
and increase in LDL-receptors on hepatocyte membranes thereby
increasing the clearance of LDL from the circulation.
PHARMACOKINETICS:
Lovastatin is absorbed from the gastro-intestinal tract and is
hydrolysed in the liver to its active β-hydroxyacid form. Three other
metabolites have also been isolated. Lovastatin undergoes extensive
first-
pass extraction in the liver, its primary site of action, and less
than 5% of the oral dose has been reported to reach the circulation.
Peak plasma concentrations occur within 2 to 4 hours, and steady state
concentrations are achieved after 2 to 3 days with daily
administration. Both lovastatin and its β-hydroxyacid metabolite are
extensively bound to plasma proteins. It is mainly excreted in the
bile about 85%
of the administered dose has been recovered from the faeces and about
10% from the urine. Lovastatin has been shown to be effective in
uncomplicated, well-controlled insulin dependent (Type 1) and
non-insulin dependent (Type 2) diabetic patients with primary
hypercholesterolemia. Reduction of plasma metabolites are extensively
bound to plasma proteins. It is mainly excreted in the bile about 85%
of
the administered dose has been recove