VALCORE TABLET 10MG20MG

Pays: Singapour

Langue: anglais

Source: HSA (Health Sciences Authority)

Ingrédients actifs:

Ezetimibe; Simvastatin

Disponible depuis:

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

Code ATC:

C10BA02

forme pharmaceutique:

TABLET

Composition:

Ezetimibe 10mg; Simvastatin 20 mg

Mode d'administration:

ORAL

Type d'ordonnance:

Prescription Only

Fabriqué par:

Watson Pharma Private Limited

Statut de autorisation:

ACTIVE

Date de l'autorisation:

2020-04-17

Résumé des caractéristiques du produit

151352_S1 - P: Ezetimibe / Simvastatin (Valcore), SG, Tablet, All
strengths SMPC , Teva
01
29.01.2024
GP
190x500 mm
Actavis Ltd., Zejtun ZTN 3000, MALTA
7.3 pt
Black
VALCORE TABLET
I. THERAPEUTIC CLASS
VALCORE TABLET is a lipid-lowering product that selectively inhibits
the intestinal absorption of cholesterol and related plant
sterols and inhibits the endogenous synthesis of cholesterol.
II. ACTIVE INGREDIENTS
VALCORE TABLET is available for oral use as tablets containing 10 mg
of ezetimibe, and 10 mg of simvastatin (VALCORE TABLET
10 MG/10 MG) or 20 mg of simvastatin (VALCORE TABLET 10 MG/20 MG).
III. INDICATIONS
_PRIMARY HYPERCHOLESTEROLEMIA_
VALCORE TABLET is indicated as adjunctive therapy to diet for the
reduction of elevated total cholesterol (total-C), low-density
lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B),
triglycerides (TG), and non-high-density lipoprotein cholesterol (non-
HDL-C), and to increase high-density lipoprotein cholesterol (HDL-C)
in patients with primary (heterozygous familial and non-
familial) hypercholesterolemia or mixed hyperlipidemia.
_HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HOFH)_
VALCORE TABLET is indicated for the reduction of elevated total-C and
LDL-C levels in patients with HoFH, as an adjunct to other
lipid-lowering treatments (e.g., LDL apheresis) or if such treatments
are unavailable.
IV. CLINICAL PHARMACOLOGY
_IV A. MECHANISM OF ACTION_
EZETIMIBE-SIMVASTATIN TABLET
Plasma cholesterol is derived from intestinal absorption and
endogenous synthesis. Ezetimibe-Simvastatin Tablet contains
ezetimibe and simvastatin, two lipid-lowering compounds with
complementary mechanisms of action. Ezetimibe-Simvastatin
Tablet reduces elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and
increases HDL-C through dual inhibition of cholesterol
absorption and synthesis.
_EZETIMIBE_
Ezetimibe inhibits the intestinal absorption of cholesterol. Ezetimibe
is orally active and has a mechanism of action that differs
from other classes of cholesterol-reducing compounds (e.g., statins,
b