Lovastatin (Lovastatin)

Trade Name : Lovastatin

Eon Labs, Inc.

TABLET

Strength 10 mg/1

LOVASTATIN HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Lovastatin (Lovastatin) which is also known as Lovastatin and Manufactured by Eon Labs, Inc.. It is available in strength of 10 mg/1 per ml. Read more

Lovastatin (Lovastatin) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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About GNH

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Rx only

Lovastatin is a cholesterol lowering agent isolated from a strain of . After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the corresponding u00df-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-[1 u03b1(*),3 u03b1,7,8(2*,4*), 8a]]-1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2-pyran-2-yl)ethyl]-1-naphthalenyl 2-methylbutanoate. The empirical formula of lovastatin is CH0 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.

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 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.

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.

Hypersensitivity to any component of this medication.
Active liver disease or unexplained persistent elevations of serum transaminases (see ).
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 , ).
(See and ).
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. 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 ).

No data

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After oral administration of lovastatin to mice, the median lethal dose observed was >15 g/m.
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.

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

Lovastatin tablets, USP, for oral administration, are available as:
10 mg:
NDC 0185-0070-60 bottles of 60
NDC 0185-0070-09 bottles of 90
NDC 0185-0070-01 bottles of 100
NDC 0185-0070-05 bottles of 500
NDC 0185-0070-10 bottles of 1000
20 mg:
NDC 0185-0072-60 bottles of 60
NDC 0185-0072-09 bottles of 90
NDC 0185-0072-01 bottles of 100
NDC 0185-0072-05 bottles of 500
NDC 0185-0072-10 bottles of 1000
40 mg:
NDC 0185-0074-60 bottles of 60
NDC 0185-0074-09 bottles of 90
NDC 0185-0074-01 bottles of 100
NDC 0185-0074-05 bottles of 500
NDC 0185-0074-10 bottles of 1000
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [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.
Sandoz Inc.
Princeton, NJ 08540
Rev. 07/17
MF0070REV07/17

NDC 0185-0070-60
Lovastatin Tablets USP
10 mg
Rx only
60 Tablets
Sandoz

NDC 0185-0072-60
Lovastatin Tablets USP
20 mg
Rx only
60 Tablets
Sandoz

NDC 0185-0074-60
Lovastatin Tablets USP
40 mg
Rx only
60 Tablets
Sandoz

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Lovastatin (Lovastatin)

Trade Name : Lovastatin

TABLET

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Lovastatin (Lovastatin)

Trade Name : Lovastatin

TABLET

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

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QUICK LINKS

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