Lovastatin Tablets USP

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Prescription Drug Name:

ID:

096d8092-9961-4cf7-b3c8-8b94ee8a31f2

Code:

34391-3

DESCRIPTION

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displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

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 ß-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-[1 α(R*),3 α,7ß,8ß(2S*,4S*), 8aß]]-1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)ethyl]-1-naphthalenyl 2-methylbutanoate. The empirical formula of lovastatin is C₂₄H₃₆0₅ and its molecular weight is 404.55. Its structural formula is: Lovastatin 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: lactose monohydrate, magnesium stearate, microcrystalline cellulose and corn starch. Butylated hydroxyanisole (BHA) is added as a preservative. In addition the 10 mg tablets also contain red iron oxide and yellow iron oxide; the 20 mg tablets also contain FD&C blue No. 2; and the 40 mg tablets also contain D&C yellow No. 10 and FD&C blue No. 2.

CLINICAL PHARMACOLOGY

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displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

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 total cholesterol (total-C) and LDL-C in the lower end of this range. Lovastatin has been shown to reduce elevated LDL-C concentrations. LDL is formed from very low-density lipoprotein (VLDL) and is catabolized predominantly by the high affinity LDL receptor. The mechanism of the LDL-lowering effect of lovastatin may involve both reduction of VLDL-C concentration, and induction of the LDL receptor, leading to reduced production and/or increased catabolism of LDL-C. Apolipoprotein B also falls substantially during treatment with lovastatin. Lovastatin is a specific inhibitor of HMG-CoA reductase, the enzyme which catalyzes the conversion of HMG-CoA to mevalonate. The conversion of HMG-CoA to mevalonate is an early step in the biosynthetic pathway for cholesterol.

INDICATIONS AND USAGE

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displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Therapy with lovastatin tablets USP should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin tablets USP 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.

CONTRAINDICATIONS

id: 286ecf47-91cd-45f4-8709-aca25ce914f0
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

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).

OVERDOSAGE

id: dbf395a3-f95f-49f8-9907-11b129a8cb44
displayName: DRUG ABUSE AND DEPENDENCE SECTION
FDA Article Code: 42227-9

After oral administration of lovastatin to mice, the median lethal dose observed was >15 g/m². Five healthy human volunteers have received up to 200 mg of lovastatin as a single dose without clinically significant adverse experiences. A few cases of accidental overdosage have been reported; no patients had any specific symptoms, and all patients recovered without sequelae. The maximum dose taken was 5 g to 6 g. Until further experience is obtained, no specific treatment of overdosage with lovastatin can be recommended. The dialyzability of lovastatin and its metabolites in man is not known at present.

DOSAGE AND ADMINISTRATION

id: d84c5051-d67c-4bd2-94d9-e6475bd83570
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

The patient should be placed on a standard cholesterol-lowering diet before receiving lovastatin tablets and should continue on this diet during treatment with lovastatin tablets (see NCEP Treatment Guidelines for details on dietary therapy). Lovastatin tablets should be given with meals.

HOW SUPPLIED

id: be6a7400-2aa8-495e-8626-429775c2a346
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Lovastatin Tablets USP, for oral administration, are available as: 10 mg: Peach, round, flat faced beveled edge tablets, debossed with “E” over “70” on one side and plain on the other side and suppled as: NDC 68001-213-06 bottles of 60 NDC 68001-213-00 bottles of 100 NDC 68001-213-08 bottles of 1000 20 mg: Light blue, round, flat faced beveled edge tablets, debossed with “E” over “72” on one side and plain on the other side and supplied as: NDC 68001-224-06 bottles of 60 NDC 68001-224-00 bottles of 100 NDC 68001-224-08 bottles of 1000 40 mg: Green, round, flat faced beveled edge tablets, debossed with “E” over “74” on one side and plain on the other side and supplied as: NDC 68001-214-06 bottles of 60 NDC 68001-214-00 bottles of 100 NDC 68001-214-08 bottles of 1000 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Store in a dry place. Keep tightly closed. Protect from light. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured By: Sandoz Inc. Princeton, NJ 08540 For BluePoint Laboratories Rev 05/14

Package/Label Display Panel

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displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Lovastatin Tablets USP, 10 mg, 100 Tablets NDC 68001-213-00

Package/Label Display Panel

id: 5989a248-46e6-46f2-90d4-b365b51e8e62
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Lovastatin Tablets USP, 20 mg, 100 Tablets NDC 68001-224-00

Package/Label Display Panel

id: 82f7f574-6d97-4579-a940-74fda8192ab5
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Lovastatin Tablets USP, 40 mg, 100 Tablets NDC 68001-214-00

Package/Label Display Panel

id: d31800ac-3f39-4fcc-8c13-cebd5df8aaaa
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Lovastatin Tablets USP, 10 mg, 100 Tablets NDC 68001-213-00 Product of Hungary

Package/Label Display Panel

id: 70f1f999-3e39-43f6-8e65-3e843b8a2fcd
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Lovastatin Tablets USP, 10 mg, 100 Tablets NDC 68001-213-00 Product of India

Package/Label Display Panel

id: fbef16b9-36eb-49c6-befe-b0298ba2ebf3
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Lovastatin Tablets USP, 20 mg, 100 Tablets NDC 68001-224-00 Product of Hungary

Package/Label Display Panel

id: 9f8a1252-d5c0-41ba-b0e7-b9919f7483bd
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Lovastatin Tablets USP, 20 mg, 100 Tablets NDC 68001-224-00 Product of India

Package/Label Display Panel

id: fa6f9770-a29d-4d06-85be-f039b2886d91
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Lovastatin Tablets USP, 40 mg, 100 Tablets NDC 68001-214-00 Product of Hungary

Package/Label Display Panel

id: 6e2da44d-7acb-4596-9fad-429e9c32f6b9
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Lovastatin Tablets USP, 40 mg, 100 Tablets NDC 68001-214-00 Product of India