Simvoget 20mg Film-Coated Tablet

Ülke: Filipinler

Dil: İngilizce

Kaynak: FDA (Food And Drug Administration)

Aktif bileşen:

Simvastatin

Mevcut itibaren:

Getz Pharma (Phils.) Inc.

INN (International Adı):

Simvastatin

Doz:

20mg

Farmasötik formu:

Film-Coated Tablet

Paketteki üniteler:

Alu/Alu Blister Pack x 10's (Box of 10's and 30's) and l's (Box of 1's) (Physician's sa, Alu/Alu Blister Pack x 10's (Box of 1

Tarafından üretildi:

Getz Pharma (Private) Limited, Pakistan

Yetkilendirme tarihi:

2022-07-15

Ürün özellikleri

DESCRIPTION
Simvastatin (Simvoget
®
)
is a lipid-lowering agent that is derived
synthetically from a fermentation product of _Aspergillus terreus._
Chemically simvastatin is butanoic acid, 2,2-dimethyl, 1,2,3,7,8,
8a-hexahydro-3, 7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-
pyran-2-yl) ethyl]-1-naphthalenyl ester,[1S-[1
α
,3
α
,7
β
,8
β
(2S*,4S*),
8a
β
]]. Its molecular formula is C
25
H
38
O
5
and structural formula is:
FORMULATION
Simvastatin (Simvoget
®
)
is available for oral administration as:
1. Simvastatin (Simvoget
®
)
Tablets 10mg
Each film-coated tablet contains:
Simvastatin USP… 10mg
2. Simvastatin (Simvoget
®
)
Tablets 20mg
Each film-coated tablet contains:
Simvastatin USP…20mg
3. Simvastatin (Simvoget
®
)
Tablets 40mg
Each film-coated tablet contains:
Simvastatin USP…40mg
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
After oral ingestion, simvastatin, which is an inactive lactone, is
hydrolyzed to the corresponding
β
-hydroxyacid form. This is an
inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA)
reductase. This enzyme catalyzes the conversion of HMG-CoA
to mevalonate, which is an early and rate-limiting step in the
biosynthesis of cholesterol.
PHARMACOKINETICS
Simvastatin is absorbed from the gastrointestinal tract and is
hydrolysed to its active
β
-hydroxyacid form. Other active metabolites
have been detected and a number of inactive metabolites are also
formed. Simvastatin undergoes extensive first pass metabolism
in the liver, its primary site of action. Less than 5% of the oral
dose
has been reported to reach the circulation as active metabolites.
Both simvastatin and its
β
-hydroxyacid metabolite are about 95%
bound to plasma proteins. It is mainly excreted in the faeces via
the bile as metabolites. About 10 to 15% is recovered in the urine,
mainly in inactive forms. The half-life of active metabolite is 1.9
hours.
THERAPEUTIC INDICATIONS
_Reductions in Risk of CHD Mortality and Cardiovascular Events:_
In patients at high risk of coronary events because of existing
c