LOVASTATIN tablet

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

LOVASTATIN (UNII: 9LHU78OQFD) (LOVASTATIN - UNII:9LHU78OQFD)

Sẵn có từ:

Mylan Institutional Inc.

INN (Tên quốc tế):

LOVASTATIN

Thành phần:

LOVASTATIN 20 mg

Loại thuốc theo toa:

PRESCRIPTION DRUG

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

LOVASTATIN- LOVASTATIN TABLET
MYLAN INSTITUTIONAL INC.
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DESCRIPTION
Lovastatin is a cholesterol lowering agent isolated from a strain of
_Aspergillus terreus_. After oral
ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to
the corresponding β-hydroxyacid
form. This is a principal metabolite and 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.
Lovastatin is [1S-[1α( _R_*),3α,7β,8β(2 _S_*,4
_S_*),8aβ]]-1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-
(tetrahydro-4-hydroxy- 6-oxo-2 _H_-pyran-2-yl)ethyl]-1-naphthalenyl
2-methylbutanoate. The molecular
formula of lovastatin is C
H
O
and its molecular weight is 404.55. Its structural formula is:
Lovastatin, USP is a white, nonhygroscopic crystalline powder that is
insoluble in water and sparingly
soluble in ethanol, methanol, and acetonitrile.
Lovastatin tablets, USP are supplied as 10 mg, 20 mg and 40 mg tablets
for oral administration. In
addition to the active ingredient lovastatin, each tablet contains the
following inactive ingredients:
butylated hydroxyanisole, lactose monohydrate, magnesium stearate,
microcrystalline cellulose and
pregelatinized starch (corn). Lovastatin Tablets, 20 mg also contain
D&C Yellow No. 10 Aluminum
Lake. Lovastatin Tablets, 40 mg also contain D&C Red No. 30 Aluminum
Lake and D&C Yellow No.
10 Aluminum Lake.
CLINICAL PHARMACOLOGY
The involvement of low density lipoprotein cholesterol (LDL-C) in
atherogenesis has been well
documented in clinical and pathological studies, as well as in many
animal experiments. Epidemiological
and clinical studies have established that high LDL-C and low high
density lipoprotein cholesterol
(HDL-C) are both associated with coronary heart disease. However, the
risk of developing coronary
heart disease is continuous and graded over the range of cholesterol
levels and many coronary events
do occur in patients with tota