LOVASTATIN tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Blenheim Pharmacal, Inc.

INN (Διεθνής Όνομα):

LOVASTATIN

Σύνθεση:

LOVASTATIN 20 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Therapy with lovastatin should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease.  Lovastatin should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk. Primary Prevention Of Coronary Heart Disease: In individuals without symptomatic cardiovascular disease, average to moderately elevated total-C and LDL-C, and below average HDL-C, lovastatin tablets are indicated to reduce the risk of: -  Myocardial infarction -  Unstable angina -  Coronary revascularization procedures (See CLINICAL PHARMACOLOGY, Clinical Studies.) Coronary Heart Disease: Lovastatin tablets are indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower total-C and LDL-C to

Περίληψη προϊόντος:

Lovastatin Tablets, USP are available as follows: 10 mg — Each white, round, flat faced beveled edge tablet imprinted with on one side and 633 on the other side contains 10 mg of lovastatin. Tablets are supplied in bottles of 60 (NDC 0228-2633-06), with a child-resistant closure and 500 (NDC 0228-2633-50), without a child-resistant closure. 20 mg — Each pink, round, flat faced beveled edge tablet imprinted with on one side and 634 on the other side contains 20 mg of lovastatin. Tablets are supplied in bottles of 60 (NDC 0228-2634-06), with a child-resistant closure and 500 (NDC 0228-2634-50), without a child-resistant closure. 40 mg — Each yellow, round, flat faced beveled edge tablet imprinted with on one side and 635 on the other side contains 40 mg of lovastatin. Tablets are supplied in bottles of 60 (NDC 0228-2635-06), with a child-resistant closure and 500 (NDC 0228-2635-50), without a child-resistant closure. Dispense in a tight, light-resistant container as defined in the USP. Store between 5°-25°C (41°-77°F). Protect from light and store in a well-closed, light-resistant container. Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue, Elizabeth, NJ 07207 USA 40-8843 Revised — January 2008

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

LOVASTATIN- LOVASTATIN TABLET
BLENHEIM PHARMACAL, INC.
----------
LOVASTATIN TABLETS, USP
40-8843
REVISED – JANUARY 2008
RX ONLY
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 [1_S_-[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 404.54. Its structural formula is:
Lovastatin is a white, nonhygroscopic crystalline powder that is
insoluble in water and sparingly
soluble in ethanol, methanol, and acetonitrile.
Each tablet for oral administration, contains 10 mg, 20 mg, or 40 mg
of lovastatin. In addition, each
tablet contains the following inactive ingredients: lactose
monohydrate, magnesium stearate,
microcrystalline cellulose, and pregelatinized starch. Butylated
hydroxyanisole is added as a
preservative. The 20 mg tablet also contains D&C Red #30 aluminum
lake. The 40 mg tablet also
contains D&C Yellow #10 HT 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
24
36
5
(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 total cholesterol (