LIVALO

Nazione: Indonesia

Lingua: indonesiano

Fonte: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Principio attivo:

PITAVASTATIN CALCIUM

Commercializzato da:

TANABE INDONESIA - Indonesia

INN (Nome Internazionale):

PITAVASTATIN CALCIUM

Dosaggio:

4 MG

Forma farmaceutica:

TABLET SALUT SELAPUT

Confezione:

DRUM @ 50.000-300.000 TABLET SALUT SELAPUT (BULK)

Prodotto da:

TANABE INDONESIA - Indonesia

Data dell'autorizzazione:

2019-02-28

Scheda tecnica

1
HMG-CoA Reductase Inhibitor
LIVALO
(Pitavastatin Calcium 2mg & Pitavastatin Calcium 4mg)
LIVALO 2: REG. NO. DKL1925202817A1
LIVALO 4: REG. NO. DKL1925202817B1
(COMPOSITION AND DESCRIPTION)
PHYSICOCHEMISTRY
NONPROPRIETARY NAME: Pitavastatin calcium
CHEMICAL NAME: (+)-Monocalcium bis{(3R,5S,6E)-7-[2-cyclopropyl-
4-(4-fluorophenyl)-3-quinolyl]-3,5-dihydroxy-6-
heptenoate}
CHEMICAL STRUCTURE:
MOLECULAR FORMULA: C
50
H
46
CaF
2
N
2
O
8
MOLECULAR WEIGHT: 880.98
DESCRIPTION:
A white to pale yellowish odorless powder. It is freely soluble in
pyridine or in tetrahydrofuran, soluble in ethylene
glycol, slightly soluble in methanol, very slightly soluble in ethanol
(99.5) or in water, practically insoluble in
acetonitrile or in diethyl ether. It dissolves in dilute hydrochloric
acid.
Brand Name
LIVALO 2
LIVALO 4
Active
Ingredient
Each tablet contains 2 mg of
pitavastatin calcium
Each tablet contains 4 mg of
pitavastatin calcium
Inactive
Ingredients
Lactose, hydroxypropyl cellulose, hydroxypropyl methylcellulose,
magnesium
aluminometasilicate, magnesium stearate, triethyl citrate, hydrated
silicon
dioxide, titanium oxide, carnauba wax, food yellow No. 5 (sunset
yellow FCF)
Color /
Dosage Form
Slightly light-colored yellow-red round
scored film-coated tablet with a
secant line.
Light yellow, round scored film-
coated tablet with a secant line.
Appearance
Diameter: 7.1
㎜
Thickness: 2.9
㎜
Weight:125 mg
Diameter: 8.6
㎜
Thickness: 3.9
㎜
Weight:249 mg
ID Code
202
203
(ACTIONS)
CLINICAL PHARMACOLOGY
1.
MECHANISM OF ACTION
Pitavastatin competitively inhibits HMG-CoA reductase, which is a
rate-determining enzyme involved with
biosynthesis of cholesterol, in a manner of competition with the
substrate so that it inhibits cholesterol synthesis
in the liver. As a result, the expression of LDL-receptors followed by
the uptake of LDL from blood to liver is
accelerated and then the plasma TC decreases. Further, the sustained
inhibition of cholesterol synthesis in the
liver decreases levels of very low density lipoproteins.
2.
PHAR