Home Drug Guide Fluvastatin Sodium

Drug Guide

Generic Name

Fluvastatin Sodium

Brand Names Lescol, Lescol XL

Classification

Therapeutic: Lipid-lowering agent

Pharmacological: HMG-CoA reductase inhibitor (statin)

FDA Approved Indications

Primary hyperlipidemia
Heterozygous familial hypercholesterolemia
Secondary prevention of cardiovascular disease

Mechanism of Action

Inhibits HMG-CoA reductase, the enzyme responsible for converting HMG-CoA to mevalonate, a precursor of cholesterol, thereby decreasing cholesterol synthesis in the liver.

Dosage and Administration

Adult: Initially 20-80 mg once daily, with or without food. Dose adjustment based on response. Max dose: 80 mg/day.

Pediatric: Not generally recommended for pediatric use.

Geriatric: Start at the lower end of the dosing range; monitor closely due to increased risk of adverse effects.

Renal Impairment: Use with caution; dose adjustments may be necessary.

Hepatic Impairment: Contraindicated in active liver disease or persistent unexplained elevations of hepatic transaminases.

Pharmacokinetics

Absorption: Well absorbed, with about 30-50% bioavailability.

Distribution: Extensively distributed with high plasma protein binding (~98%).

Metabolism: Metabolized primarily in the liver via hydroxylation by CYP2C9.

Excretion: Primarily in feces; small amounts in urine.

Half Life: Approximately 1.2 hours, but the extended-release form (Lescol XL) has a half-life of about 3-4 hours.

Contraindications

Active liver disease
Unexplained persistent elevations of hepatic transaminases
Known hypersensitivity to fluvastatin

Precautions

Use with caution in patients with hepatic impairment, alcohol use disorder, or concomitant use of drugs affecting CYP2C9.
Monitor liver function and lipid levels periodically.

Adverse Reactions - Common

Headache (Rare)
Gastrointestinal disturbances (nausea, abdominal pain, constipation) (Common)

Adverse Reactions - Serious

Myopathy/rhabdomyolysis (Rare)
Hepatotoxicity (Rare)

Drug-Drug Interactions

Cyclosporine, gemfibrozil, cyclosporine, other CYP3A4 inhibitors increase risk of myopathy
-warfarin: may increase bleeding risk

Drug-Food Interactions

Grapefruit juice: avoid due to CYP3A4 inhibition

Drug-Herb Interactions

N/A

Nursing Implications

Assessment: Monitor lipid levels, liver function tests, creatine kinase levels in patients with risk factors for myopathy.

Diagnoses:

Risk for muscle injury related to statin therapy.
Impaired liver function related to medication effects.

Implementation: Administer as prescribed, usually once daily. Monitor for signs of muscle pain, weakness, or liver dysfunction.

Evaluation: Assess lipid profile and adverse effects; ensure therapeutic goals are met, to a safe extent.

Patient/Family Teaching

Take medication as directed, consistent timing.
Report unexplained muscle pain, tenderness, or weakness immediately.
Limit alcohol intake and avoid grapefruit juice.
Maintain regular liver function testing as prescribed.

Special Considerations

Black Box Warnings:

Potential for rhabdomyolysis that can lead to renal failure.
Risk of hepatotoxicity, especially in the initial months of therapy.

Genetic Factors: Genetic polymorphisms may affect drug metabolism and response.

Lab Test Interference: May elevate liver enzymes and creatine kinase levels.

Overdose Management

Signs/Symptoms: Muscle weakness, nausea, vomiting, diarrhea, abdominal pain, increased liver enzymes.

Treatment: Supportive care, symptomatic treatment, and monitoring; no specific antidote.

Storage and Handling

Storage: Store at room temperature, 20-25°C (68-77°F).

Stability: Stable under recommended storage conditions.