LOVASTATIN tablet

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Teva Pharmaceuticals USA, Inc.

INN (nemzetközi neve):

LOVASTATIN

Összetétel:

LOVASTATIN 10 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Therapy with Lovastatin Tablets should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin Tablets 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. 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 in Adults .) 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 target levels. Therapy with lipid-altering agent

Termék összefoglaló:

Lovastatin Tablets USP, 10 mg are available as light peach, unscored, round, flat beveled tablets debossed “926” on one side and “TEVA” on the other side. Packaged in bottles of 60 (NDC 0093-0926-06) and 1000 (NDC 0093-0926-10). Lovastatin Tablets USP, 20 mg are available as light blue, unscored, round, flat beveled tablets, debossed “576” on one side and “TEVA” on the other side. Packaged in bottles of 60 (NDC 0093-0576-06) and 1000 (NDC 0093-0576-10). Lovastatin Tablets USP, 40 mg are available as light green, unscored, round, flat beveled tablets, debossed “928” on one side and “TEVA” on the other side. Packaged in bottles of 60 (NDC 0093-0928-06) and 1000 (NDC 0093-0928-10). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Lovastatin Tablets, USP must be protected from light. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured In Croatia By: Pliva Hrvatska d.o.o. Zagreb, Croatia Manufactured For: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054 Rev. V 8/2020

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

LOVASTATIN- LOVASTATIN TABLET
TEVA PHARMACEUTICALS USA, INC.
----------
LOVASTATIN TABLETS, USP
RX ONLY
DESCRIPTION
Lovastatin, USP is a cholesterol lowering agent isolated from a strain
of _Aspergillus terreus_. After oral
ingestion, lovastatin, USP, 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, USP 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. Its structural
formula is:
C
H O M.W. 404.55
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, USP, each tablet
contains the following inactive ingredients:
lactose monohydrate, magnesium stearate, microcrystalline cellulose,
and pregelatinized corn starch.
Butylated hydroxyanisole (BHA) is added as a preservative. Lovastatin
Tablets USP, 10 mg also contain
FD&C Yellow #6 Aluminum Lake. Lovastatin Tablets USP, 20 mg also
contain FD&C Blue #1
Aluminum Lake. Lovastatin Tablets USP, 40 mg also contain D&C Yellow
#10 Aluminum Lake, FD&C
Blue #1 Aluminum Lake, and FD&C Yellow #6 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
hea