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fluvastatin sodium

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Overview

What is Lescol?

LESCOL is a water-soluble cholesterol lowering agent which acts through the inhibition of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase.

Fluvastatin sodium is [*,*-()]-(±)-7-[3-(4-fluorophenyl)-1-(1-methylethyl)-1-indol-2-yl]-3,5-dihydroxy-6-heptenoic acid, monosodium salt. The empirical formula of fluvastatin sodium is CHFNO•Na, its molecular weight is 433.46 and its structural formula is:

This molecular entity is the first entirely synthetic HMG-CoA reductase inhibitor, and is in part structurally distinct from the fungal derivatives of this therapeutic class.

Fluvastatin sodium is a white to pale yellow, hygroscopic powder soluble in water, ethanol and methanol. LESCOL is supplied as capsules containing fluvastatin sodium, equivalent to 20 mg or 40 mg of fluvastatin, for oral administration. LESCOL XL is supplied as extended-release tablets containing fluvastatin sodium, equivalent to 80 mg of fluvastatin, for oral administration.

Active Ingredient:

Inactive Ingredients in capsules:

Capsules may also include:

Inactive Ingredients in extended-release tablets:



What does Lescol look like?



What are the available doses of Lescol?

LESCOL Capsules: 20 mg, 40 mg;

LESCOL XL Tablets: 80 mg ()

What should I talk to my health care provider before I take Lescol?

How should I use Lescol?

Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other non-pharmacologic measures alone has been inadequate.

Dose range: 20 mg to 80 mg/ day.

LESCOL/LESCOL XL can be administered orally as a single dose, with or without food.

Do not break, crush or chew LESCOL XL tablets or open LESCOL capsules prior to administration.

Do not take two LESCOL 40 mg capsules at one time.

Since the maximal effect of a given dose is seen within 4 weeks, periodic lipid determinations should be performed at this time and dosage adjusted according to the patient’s response to therapy and established treatment guidelines.

For patients requiring LDL-C reduction to a goal of ≥25%, the recommended starting dose is 40 mg as one capsule in the evening, 80 mg as one LESCOL XL tablet administered as a single dose at any time of the day or 80 mg in divided doses of the 40 mg capsule given twice daily. For patients requiring LDL-C reduction to a goal of <25% a starting dose of 20 mg may be used.


What interacts with Lescol?

Sorry No Records found


What are the warnings of Lescol?

Sorry No Records found


What are the precautions of Lescol?

Sorry No Records found


What are the side effects of Lescol?

Sorry No records found


What should I look out for while using Lescol?

Hypersensitivity to any component of this medication ()

Active liver disease or unexplained, persistent elevations in serum transaminases (, )

Women who are pregnant or may become pregnant (, )

Nursing mothers (, )


What might happen if I take too much Lescol?

To date, there has been limited experience with overdosage of fluvastatin. If an overdose occurs, it should be treated symptomatically with laboratory monitoring and supportive measures should be instituted as required.  The dialyzability of fluvastatin sodium and of its metabolites in humans is not known at present [].

In the pediatric population, there have been reports of overdosage with fluvastatin sodium in children including a 2 year-old and the other 3 years of age, either of whom may have possibly ingested fluvastatin sodium. The maximum amount of fluvastatin sodium that could have been ingested was 80 mg (4 x 20 mg capsules). Vomiting was induced by ipecac in both children and no capsules were noted in their emesis. Neither child experienced any adverse symptoms and both recovered from the incident without problems.

In the postmarketing experience there have been reports of accidental ingestion of LESCOL tablets in infants up to 3 years of age. In one case, increased serum CPK values were noted. There have been reports of intentional overdose in adolescents with the development of hepatic enzyme elevations, convulsions and gastroenteritis/vomiting/diarrhea. One case of intentional overdose as suicide attempt in a 15 year-old female reported ingestion of 2,800 mg LESCOL XL with hepatic enzyme elevation.


How should I store and handle Lescol?

Store at 20° to 25°C (68° to 77°F).[See USP Controlled Room Temperature]DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.Store at 20° to 25°C (68° to 77°F).[See USP Controlled Room Temperature]DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.Store at 20° to 25°C (68° to 77°F).[See USP Controlled Room Temperature]DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.LESCOL (fluvastatin sodium) Capsules20 mgBrown and light brown imprinted twice with “” and “20” on one half and “LESCOL” and the LESCOL (fluvastatin sodium) logo twice on the other half of the capsule.40 mg Brown and gold imprinted twice with “” and “40” on one half and “LESCOL” and the LESCOL (fluvastatin sodium) logo twice on the other half of the capsule.LESCOL XL (fluvastatin sodium) Extended-Release Tablets 80 mgYellow, round, slightly biconvex film-coated tablet with beveled edges debossed with “LESCOL XL” on one side and “80” on the other.Bottles of 30 tablets…………………………………………………………………………………...NDC 0078-0354-15Bottles of 100 tablets…………………………………………………………………………………...NDC 0078-0354-05Store and DispenseStore at 25ºC (77ºF); excursions permitted to 15ºC to 30ºC (59ºF -86ºF) [see USP Controlled Room Temperature]. Dispense in a tight container. Protect from light.LESCOL (fluvastatin sodium) Capsules20 mgBrown and light brown imprinted twice with “” and “20” on one half and “LESCOL” and the LESCOL (fluvastatin sodium) logo twice on the other half of the capsule.40 mg Brown and gold imprinted twice with “” and “40” on one half and “LESCOL” and the LESCOL (fluvastatin sodium) logo twice on the other half of the capsule.LESCOL XL (fluvastatin sodium) Extended-Release Tablets 80 mgYellow, round, slightly biconvex film-coated tablet with beveled edges debossed with “LESCOL XL” on one side and “80” on the other.Bottles of 30 tablets…………………………………………………………………………………...NDC 0078-0354-15Bottles of 100 tablets…………………………………………………………………………………...NDC 0078-0354-05Store and DispenseStore at 25ºC (77ºF); excursions permitted to 15ºC to 30ºC (59ºF -86ºF) [see USP Controlled Room Temperature]. Dispense in a tight container. Protect from light.LESCOL (fluvastatin sodium) Capsules20 mgBrown and light brown imprinted twice with “” and “20” on one half and “LESCOL” and the LESCOL (fluvastatin sodium) logo twice on the other half of the capsule.40 mg Brown and gold imprinted twice with “” and “40” on one half and “LESCOL” and the LESCOL (fluvastatin sodium) logo twice on the other half of the capsule.LESCOL XL (fluvastatin sodium) Extended-Release Tablets 80 mgYellow, round, slightly biconvex film-coated tablet with beveled edges debossed with “LESCOL XL” on one side and “80” on the other.Bottles of 30 tablets…………………………………………………………………………………...NDC 0078-0354-15Bottles of 100 tablets…………………………………………………………………………………...NDC 0078-0354-05Store and DispenseStore at 25ºC (77ºF); excursions permitted to 15ºC to 30ºC (59ºF -86ºF) [see USP Controlled Room Temperature]. Dispense in a tight container. Protect from light.LESCOL (fluvastatin sodium) Capsules20 mgBrown and light brown imprinted twice with “” and “20” on one half and “LESCOL” and the LESCOL (fluvastatin sodium) logo twice on the other half of the capsule.40 mg Brown and gold imprinted twice with “” and “40” on one half and “LESCOL” and the LESCOL (fluvastatin sodium) logo twice on the other half of the capsule.LESCOL XL (fluvastatin sodium) Extended-Release Tablets 80 mgYellow, round, slightly biconvex film-coated tablet with beveled edges debossed with “LESCOL XL” on one side and “80” on the other.Bottles of 30 tablets…………………………………………………………………………………...NDC 0078-0354-15Bottles of 100 tablets…………………………………………………………………………………...NDC 0078-0354-05Store and DispenseStore at 25ºC (77ºF); excursions permitted to 15ºC to 30ºC (59ºF -86ºF) [see USP Controlled Room Temperature]. Dispense in a tight container. Protect from light.LESCOL (fluvastatin sodium) Capsules20 mgBrown and light brown imprinted twice with “” and “20” on one half and “LESCOL” and the LESCOL (fluvastatin sodium) logo twice on the other half of the capsule.40 mg Brown and gold imprinted twice with “” and “40” on one half and “LESCOL” and the LESCOL (fluvastatin sodium) logo twice on the other half of the capsule.LESCOL XL (fluvastatin sodium) Extended-Release Tablets 80 mgYellow, round, slightly biconvex film-coated tablet with beveled edges debossed with “LESCOL XL” on one side and “80” on the other.Bottles of 30 tablets…………………………………………………………………………………...NDC 0078-0354-15Bottles of 100 tablets…………………………………………………………………………………...NDC 0078-0354-05Store and DispenseStore at 25ºC (77ºF); excursions permitted to 15ºC to 30ºC (59ºF -86ºF) [see USP Controlled Room Temperature]. Dispense in a tight container. Protect from light.LESCOL (fluvastatin sodium) Capsules20 mgBrown and light brown imprinted twice with “” and “20” on one half and “LESCOL” and the LESCOL (fluvastatin sodium) logo twice on the other half of the capsule.40 mg Brown and gold imprinted twice with “” and “40” on one half and “LESCOL” and the LESCOL (fluvastatin sodium) logo twice on the other half of the capsule.LESCOL XL (fluvastatin sodium) Extended-Release Tablets 80 mgYellow, round, slightly biconvex film-coated tablet with beveled edges debossed with “LESCOL XL” on one side and “80” on the other.Bottles of 30 tablets…………………………………………………………………………………...NDC 0078-0354-15Bottles of 100 tablets…………………………………………………………………………………...NDC 0078-0354-05Store and DispenseStore at 25ºC (77ºF); excursions permitted to 15ºC to 30ºC (59ºF -86ºF) [see USP Controlled Room Temperature]. Dispense in a tight container. Protect from light.LESCOL (fluvastatin sodium) Capsules20 mgBrown and light brown imprinted twice with “” and “20” on one half and “LESCOL” and the LESCOL (fluvastatin sodium) logo twice on the other half of the capsule.40 mg Brown and gold imprinted twice with “” and “40” on one half and “LESCOL” and the LESCOL (fluvastatin sodium) logo twice on the other half of the capsule.LESCOL XL (fluvastatin sodium) Extended-Release Tablets 80 mgYellow, round, slightly biconvex film-coated tablet with beveled edges debossed with “LESCOL XL” on one side and “80” on the other.Bottles of 30 tablets…………………………………………………………………………………...NDC 0078-0354-15Bottles of 100 tablets…………………………………………………………………………………...NDC 0078-0354-05Store and DispenseStore at 25ºC (77ºF); excursions permitted to 15ºC to 30ºC (59ºF -86ºF) [see USP Controlled Room Temperature]. Dispense in a tight container. Protect from light.LESCOL (fluvastatin sodium) Capsules20 mgBrown and light brown imprinted twice with “” and “20” on one half and “LESCOL” and the LESCOL (fluvastatin sodium) logo twice on the other half of the capsule.40 mg Brown and gold imprinted twice with “” and “40” on one half and “LESCOL” and the LESCOL (fluvastatin sodium) logo twice on the other half of the capsule.LESCOL XL (fluvastatin sodium) Extended-Release Tablets 80 mgYellow, round, slightly biconvex film-coated tablet with beveled edges debossed with “LESCOL XL” on one side and “80” on the other.Bottles of 30 tablets…………………………………………………………………………………...NDC 0078-0354-15Bottles of 100 tablets…………………………………………………………………………………...NDC 0078-0354-05Store and DispenseStore at 25ºC (77ºF); excursions permitted to 15ºC to 30ºC (59ºF -86ºF) [see USP Controlled Room Temperature]. Dispense in a tight container. Protect from light.LESCOL (fluvastatin sodium) Capsules20 mgBrown and light brown imprinted twice with “” and “20” on one half and “LESCOL” and the LESCOL (fluvastatin sodium) logo twice on the other half of the capsule.40 mg Brown and gold imprinted twice with “” and “40” on one half and “LESCOL” and the LESCOL (fluvastatin sodium) logo twice on the other half of the capsule.LESCOL XL (fluvastatin sodium) Extended-Release Tablets 80 mgYellow, round, slightly biconvex film-coated tablet with beveled edges debossed with “LESCOL XL” on one side and “80” on the other.Bottles of 30 tablets…………………………………………………………………………………...NDC 0078-0354-15Bottles of 100 tablets…………………………………………………………………………………...NDC 0078-0354-05Store and DispenseStore at 25ºC (77ºF); excursions permitted to 15ºC to 30ºC (59ºF -86ºF) [see USP Controlled Room Temperature]. Dispense in a tight container. Protect from light.LESCOL (fluvastatin sodium) Capsules20 mgBrown and light brown imprinted twice with “” and “20” on one half and “LESCOL” and the LESCOL (fluvastatin sodium) logo twice on the other half of the capsule.40 mg Brown and gold imprinted twice with “” and “40” on one half and “LESCOL” and the LESCOL (fluvastatin sodium) logo twice on the other half of the capsule.LESCOL XL (fluvastatin sodium) Extended-Release Tablets 80 mgYellow, round, slightly biconvex film-coated tablet with beveled edges debossed with “LESCOL XL” on one side and “80” on the other.Bottles of 30 tablets…………………………………………………………………………………...NDC 0078-0354-15Bottles of 100 tablets…………………………………………………………………………………...NDC 0078-0354-05Store and DispenseStore at 25ºC (77ºF); excursions permitted to 15ºC to 30ºC (59ºF -86ºF) [see USP Controlled Room Temperature]. Dispense in a tight container. Protect from light.LESCOL (fluvastatin sodium) Capsules20 mgBrown and light brown imprinted twice with “” and “20” on one half and “LESCOL” and the LESCOL (fluvastatin sodium) logo twice on the other half of the capsule.40 mg Brown and gold imprinted twice with “” and “40” on one half and “LESCOL” and the LESCOL (fluvastatin sodium) logo twice on the other half of the capsule.LESCOL XL (fluvastatin sodium) Extended-Release Tablets 80 mgYellow, round, slightly biconvex film-coated tablet with beveled edges debossed with “LESCOL XL” on one side and “80” on the other.Bottles of 30 tablets…………………………………………………………………………………...NDC 0078-0354-15Bottles of 100 tablets…………………………………………………………………………………...NDC 0078-0354-05Store and DispenseStore at 25ºC (77ºF); excursions permitted to 15ºC to 30ºC (59ºF -86ºF) [see USP Controlled Room Temperature]. Dispense in a tight container. Protect from light.LESCOL (fluvastatin sodium) Capsules20 mgBrown and light brown imprinted twice with “” and “20” on one half and “LESCOL” and the LESCOL (fluvastatin sodium) logo twice on the other half of the capsule.40 mg Brown and gold imprinted twice with “” and “40” on one half and “LESCOL” and the LESCOL (fluvastatin sodium) logo twice on the other half of the capsule.LESCOL XL (fluvastatin sodium) Extended-Release Tablets 80 mgYellow, round, slightly biconvex film-coated tablet with beveled edges debossed with “LESCOL XL” on one side and “80” on the other.Bottles of 30 tablets…………………………………………………………………………………...NDC 0078-0354-15Bottles of 100 tablets…………………………………………………………………………………...NDC 0078-0354-05Store and DispenseStore at 25ºC (77ºF); excursions permitted to 15ºC to 30ºC (59ºF -86ºF) [see USP Controlled Room Temperature]. Dispense in a tight container. Protect from light.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

LESCOL is a competitive inhibitor of HMG-CoA reductase, the rate limiting enzyme that converts 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) to mevalonate, a precursor of sterols, including cholesterol. The inhibition of cholesterol biosynthesis reduces the cholesterol in hepatic cells, which stimulates the synthesis of LDL receptors and thereby increases the uptake of LDL particles. The end result of these biochemical processes is a reduction of the plasma cholesterol concentration.

Non-Clinical Toxicology
Hypersensitivity to any component of this medication ()

Active liver disease or unexplained, persistent elevations in serum transaminases (, )

Women who are pregnant or may become pregnant (, )

Nursing mothers (, )

Although specific drug interaction studies have not been conducted with brimonidine tartrate ophthalmic solution the possibility of an additive or potentiating effect with CNS depressants (alcohol, barbiturates, opiates, sedatives, or anesthetics) should be considered. Alpha-agonists, as a class, may reduce pulse and blood pressure. Caution in using concomitant drugs such as beta-blockers (ophthalmic and systemic), antihypertensives and/or cardiac glycosides is advised.

Tricyclic antidepressants have been reported to blunt the hypotensive effect of systemic clonidine. It is not known whether the concurrent use of these agents with brimonidine tartrate ophthalmic solution in humans can lead to resulting interference with the IOP-lowering effect. No data on the level of circulating catecholamines after brimonidine tartrate ophthalmic solution are available. Caution, however, is advised in patients taking tricyclic antidepressants which can affect the metabolism and uptake of circulating amines.

R

habdomyolysis with acute renal failure secondary to

myoglobinuria

have been reported with

LESCOL

/LESCOL XL

and other drugs in this class.

LESCOL/LESCOL XL should be prescribed with caution in patients with predisposing factors for myopathy. These factors include advanced age (>65 years), renal impairment, and inadequately treated hypothyroidism.

The risk of myopathy and/or rhabdomyolysis with statins is increased with concurrent therapy with cyclosporine, erythromycin, fibrates or niacin. Myopathy was not observed in a clinical trial in 74 patients involving patients who were treated with LESCOL/LESCOL XL together with niacin. Isolated cases of myopathy have been reported during post-marketing experience with concomitant administration of LESCOL/LESCOL XL and colchicine. No information is available on the pharmacokinetic interaction between LESCOL/LESCOL XL and colchicine.

Uncomplicated myalgia has also been reported in LESCOL-treated patients []. In clinical trials, uncomplicated myalgia has been observed infrequently in patients treated with LESCOL at rates indistinguishable from placebo. Myopathy, defined as muscle aching or muscle weakness in conjunction with increases in CPK values to greater than 10 times the upper limit of normal, was <0.1% in fluvastatin clinical trials. Myopathy should be considered in any patient with diffuse myalgias, muscle tenderness or weakness, and/or marked elevation of CPK.

There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use. IMNM is characterized by: proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; muscle biopsy showing necrotizing myopathy without significant inflammation; improvement with immunosuppressive agents.

All patients should be advised to promptly report to their physician unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever or if muscle signs and symptoms persist after discontinuing LESCOL/LESCOL XL.

LESCOL/LESCOL XL therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. LESCOL/LESCOL XL therapy should also be temporarily withheld in any patient experiencing an acute or serious condition predisposing to the development of renal failure secondary to rhabdomyolysis, e.g., sepsis; hypotension; major surgery; trauma; severe metabolic, endocrine, or electrolyte disorders; or uncontrolled epilepsy. 

The following serious adverse reactions are discussed in greater detail in other sections of the label:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Interactions

Interactions

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