Fluvastatin Sodium

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Overview

What is Fluvastatin Sodium?

Fluvastatin sodium 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)-1indol-2-yl]-3,5-dihydroxy-6-heptenoic acid, monosodium salt. The 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 (hydrated form) is a white to pale yellow, brownish-pale yellow, or reddish-pale yellow hygroscopic powder soluble in water, ethanol and methanol. Fluvastatin sodium extended-release tablets contain fluvastatin sodium (hydrated form), equivalent to 80 mg of fluvastatin, for oral administration.

Active Ingredient:

Inactive Ingredients:

What does Fluvastatin Sodium look like?

What are the available doses of Fluvastatin Sodium?

Fluvastatin sodium extended-release tablets: 80 mg ()

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

How should I use Fluvastatin Sodium?

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.

Fluvastatin sodium extended-release tablets can be administered orally as a single dose, with or without food.

Do not break, crush or chew fluvastatin sodium extended-release tablets prior to administration.

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 one fluvastatin sodium extended-release tablet, 80 mg administered as a single dose at any time of the day. For patients requiring LDL-C reduction to a goal of < 25% a starting dose of 20 mg may be used.

What interacts with Fluvastatin Sodium?

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What are the warnings of Fluvastatin Sodium?

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What are the precautions of Fluvastatin Sodium?

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What are the side effects of Fluvastatin Sodium?

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What should I look out for while using Fluvastatin Sodium?

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What might happen if I take too much Fluvastatin Sodium?

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 fluvastatin capsules 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 fluvastatin sodium extended-release tablets with hepatic enzyme elevation.

How should I store and handle Fluvastatin Sodium?

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Fluvastatin sodium extended-release tablets are available as: 80 mg - white to off-white, film-coated, round tablets, debossed with “TV” on one side of the tablet and “7446” on the other side of the tablet, in bottles of 30 and 100. (NDC 0093-7446-56, NDC 0093-7446-01)Fluvastatin sodium extended-release tablets are available as: 80 mg - white to off-white, film-coated, round tablets, debossed with “TV” on one side of the tablet and “7446” on the other side of the tablet, in bottles of 30 and 100. (NDC 0093-7446-56, NDC 0093-7446-01)

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Fluvastatin sodium 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

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The potential for increased sedation when guanfacine is given with other CNS-depressant drugs should be appreciated.

The administration of guanfacine concomitantly with a known microsomal enzyme inducer (phenobarbital or phenytoin) to two patients with renal impairment reportedly resulted in significant reductions in elimination half-life and plasma concentration. In such cases, therefore, more frequent dosing may be required to achieve or maintain the desired hypotensive response. Further, if guanfacine is to be discontinued in such patients, careful tapering of the dosage may be necessary in order to avoid rebound phenomena (see above).

Rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with fluvastatin capsules/fluvastatin sodium extended-release tablets and other drugs in this class.

Fluvastatin sodium extended-release tablets 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 fluvastatin sodium extended-release tablets together with niacin. Isolated cases of myopathy have been reported during postmarketing experience with concomitant administration of fluvastatin sodium extended-release tablets and colchicine. No information is available on the pharmacokinetic interaction between fluvastatin sodium extended-release tablets and colchicine.

Uncomplicated myalgia has also been reported in fluvastatin sodium treated patients []. In clinical trials, uncomplicated myalgia has been observed infrequently in patients treated with fluvastatin sodium 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 fluvastatin sodium extended-release tablets.

Fluvastatin sodium extended-release tablet therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. Fluvastatin sodium extended-release tablet 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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Review

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

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