LOVASTATIN tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Golden State Medical Supply

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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 agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Lovastatin Tablets are indicated as an adjunct to diet for the reduction of elevated total-C and LDL-C levels in patients with primary hypercholesterolemia (Types IIa and IIb 2 ), when the response to diet restricted in saturated fat and cholesterol and to other nonpharmacological measures alone has been inadequate. 2 Classification of Hyperlipoproteinemias Lipid Elevations Type Lipoproteins elevated major minor I chylomicrons TG ↑→C IIa LDL C — IIb LDL, VLDL C TG III (rare) IDL C/TG — IV VLDL TG ↑→C V (rare) chylomicrons, VLDL TG ↑→C IDL = intermediate-density lipoprotein. Lovastatin Tablets are indicated as an adjunct to diet to reduce total-C, LDL-C and apolipoprotein B levels in adolescent boys and girls who are at least one year post-menarche, 10 to 17 years of age, with heFH if after an adequate trial of diet therapy the following findings are present: - LDL-C remains > 189 mg/dL or - LDL-C remains > 160 mg/dL and : - there is a positive family history of premature cardiovascular disease or - two or more other CVD risk factors are present in the adolescent patient Prior to initiating therapy with lovastatin, secondary causes for hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be excluded, and a lipid profile performed to measure total-C, HDL-C, and TG. For patients with TG less than 400 mg/dL (< 4.5 mmol/L), LDL-C can be estimated using the following equation: LDL-C = total-C - [0.2 x (TG) + HDL-C] For TG levels > 400 mg/dL (> 4.5 mmol/L), this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation. In hypertriglyceridemic patients, LDL-C may be low or normal despite elevated total-C. In such cases, Lovastatin Tablets are not indicated. The National Cholesterol Education Program (NCEP) Treatment Guidelines are summarized below: Risk Category LDL Goal (mg/dL) LDL Level at Which to Initiate Therapeutic Lifestyle Changes (mg/dL) LDL Level at Which to Consider Drug Therapy (mg/dL) CHD 1 or CHD risk equivalents (10 year risk > 20%) < 100 ≥ 100 ≥ 130 (100 to 129: drug optional) 2 2+ Risk factors (10 year risk ≤ 20%) < 130 ≥ 130 10 year risk 10 to 20%: ≥ 130 10 year risk < 10%: ≥ 160 0 to 1 Risk factor 3 < 160 ≥ 160 ≥ 190 (160 to 189: LDL-lowering drug optional) - CHD, coronary heart disease - Some authorities recommend use of LDL-lowering drugs in this category if an LDL-C level of < 100 mg/dL cannot be achieved by therapeutic lifestyle changes. Others prefer use of drugs that primarily modify triglycerides and HDL-C, e.g., nicotinic acid or fibrate. Clinical judgment also may call for deferring drug therapy in this subcategory. - Almost all people with 0 to 1 risk factor have a 10 year risk < 10%; thus, 10 year risk assessment in people with 0 to 1 risk factor is not necessary. After the LDL-C goal has been achieved, if the TG is still ≥ 200 mg/dL, non-HDL-C (total-C minus HDL-C) becomes a secondary target of therapy. Non-HDL-C goals are set 30 mg/dL higher than LDL-C goals for each risk category. At the time of hospitalization for an acute coronary event, consideration can be given to initiating drug therapy at discharge if the LDL-C is ≥ 130 mg/dL (see NCEP Treatment Guidelines above). Since the goal of treatment is to lower LDL-C, the NCEP recommends that LDL-C levels be used to initiate and assess treatment response. Only if LDL-C levels are not available, should the total-C be used to monitor therapy. Although Lovastatin Tablets may be useful to reduce elevated LDL-C levels in patients with combined hypercholesterolemia and hypertriglyceridemia where hypercholesterolemia is the major abnormality (Type IIb hyperlipoproteinemia), it has not been studied in conditions where the major abnormality is elevation of chylomicrons, VLDL or IDL (i.e., hyperlipoproteinemia types I, III, IV, or V). 2 The NCEP classification of cholesterol levels in pediatric patients with a familial history of hypercholesterolemia or premature cardiovascular disease is summarized below: Category Total-C (mg/dL) LDL-C (mg/dL) Acceptable < 170 < 110 Borderline 170 to 199 110 to 129 High ≥ 200 ≥ 130 Children treated with lovastatin in adolescence should be re-evaluated in adulthood and appropriate changes made to their cholesterol-lowering regimen to achieve adult goals for LDL-C. Hypersensitivity to any component of this medication. Active liver disease or unexplained persistent elevations of serum transaminases (see WARNINGS ). Concomitant administration with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, HIV protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin, nefazodone and cobicistat-containing products) (see WARNINGS , Myopathy/Rhabdomyolysis ). (See PRECAUTIONS , Pregnancy and Nursing Mothers .) Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia. Moreover, cholesterol and other products of the cholesterol biosynthesis pathway are essential components for fetal development, including synthesis of steroids and cell membranes. Because of the ability of inhibitors of HMG-CoA reductase such as lovastatin to decrease the synthesis of cholesterol and possibly other products of the cholesterol biosynthesis pathway, lovastatin is contraindicated during pregnancy and in nursing mothers. Lovastatin should be administered to women of childbearing age only when such patients are highly unlikely to conceive. If the patient becomes pregnant while taking this drug, lovastatin should be discontinued immediately and the patient should be apprised of the potential hazard to the fetus (see PRECAUTIONS , Pregnancy ).

Περίληψη προϊόντος:

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 51407-251-60), 90 (NDC 51407-251-90) and 1000 (NDC 51407-251-10). 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 (NDC51407-252-60), 90 (NDC 51407-252-90) and 1000 (NDC51407-252-10). 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 51407-253-60), 90 (NDC 51407-253-90) and 1000 (NDC 51407-253-10). 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 Marketed by: GSMS, Inc. Camarillo, CA 93012 USA

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

LOVASTATIN- LOVASTATIN TABLET
GOLDEN STATE MEDICAL SUPPLY
----------
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
24
36
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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 co