• Adjunctive management of primary hypercholesterolemia and mixed dyslipidemia.
• Secondary prevention of coronary revascularization in patients with clinically evident coronary heart disease.
• Slows the progression of coronary atherosclerosis in patients with coronary artery disease.

Contraindicated in:

• Hypersensitivity
• Lactation: Lactation.
• Active liver disease or unexplained persistent elevations in AST and ALT.

Use Cautiously in:

• History of liver disease
• Alcoholism
• Renal impairment
• OB: Use statin therapy during pregnancy only if potential maternal benefit justifies potential fetal risk (if needed, consider using a more water-soluble agent [pravastatin or rosuvastatin] that is less likely to cross the placenta)
• Rep: Women of reproductive potential.

CV: chest pain, peripheral edema.

Derm: photosensitivity, rash/pruritus.

Endo: hyperglycemia.

GI: ↑ liver enzymes, abdominal pain/cramps, constipation, dyspepsia, flatulence, nausea, vomiting.

MS: arthritis, back pain, immune-mediated necrotizing myopathy, myopathy, RHABDOMYOLYSIS.

Neuro: amnesia, confusion, dizziness, fatigue, headache, insomnia, memory loss.

Resp: bronchitis, cough, pharyngitis, rhinitis, sinusitis.

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS).

Drug-Drug:

• Concurrent use with gemfibrozil, erythromycin, colchicine, cyclosporine, azole antifungals, or large doses of niacin may ↑ risk of myopathy (concurrent use with gemfibrozil should be avoided; use ↓ doses with cyclosporine, and fluconazole).
• Concurrent ingestion with cholestyramine orcolestipol ↓ absorption of fluvastatin.
• Blood levels are ↑ by cimetidine, omeprazole, and concurrent ingestion of alcohol.
• May ↑ glyburide levels
• Concurrent use with rifampin ↓ blood levels.
• May slightly ↑ serum digoxin levels.
• May ↑ risk of bleeding withwarfarin.

(Generic available)

• Capsules: 20 mg; 40 mg;
• Extended-release tablets: 80 mg;

• PO (Adults): 20–40 mg (immediate-release) once daily at bedtime. May be ↑ to 40 mg twice daily (immediate-release) or 80 mg once daily (extended-release); Concurrent use of fluconazole or cyclosporine: Dose should not exceed 20 mg twice daily.

Lescol, Lescol XL

• Inhibits 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, an enzyme which is responsible for catalyzing an early step in the synthesis of cholesterol.

• Lowering of total and LDL cholesterol and triglycerides. Slightly increases HDL cholesterol.
• Slows the progression of coronary atherosclerosis with resultant decrease in incidence of coronary heart disease-related events.

Therapeutic Classification: lipid-lowering agents

Pharmacologic Classification: hmg coa reductase inhibitors

Absorption: 98% absorbed after oral administration but undergoes extensive first-pass hepatic metabolism resulting in 24% bioavailability.

Distribution: Enters breast milk; remainder of distribution unknown.

Protein Binding: >98%.

Metabolism/Excretion: After extensive hepatic metabolism, 5% is excreted in urine, 90% in feces.

Half-life: 1.2 hr.

(cholesterol-lowering effect)

• Instruct patient to take medication as directed. Take missed doses as soon as remembered; if more than 12 hr since last dose, wait and take the next dose at the regular time. Do not double doses. Advise patient to read Patient Information sheet prior to therapy and with each Rx refill. Fluvastatin helps control but does not cure elevated serum cholesterol levels.
• Advise patient that fluvastatin should be used in conjunction with diet restrictions (fat, cholesterol, carbohydrates, alcohol), exercise, and cessation of smoking.
• Instruct patient to notify health care professional if signs of liver injury or if unexplained muscle pain, tenderness, or weakness occurs, especially if accompanied by fever, malaise, nausea, vomiting, tiredness, dark-colored urine, yellow skin or eyes, or stomach pain.
• Advise patient to use sunscreen and wear protective clothing to prevent photosensitivity reactions.
• Advise patient to notify health care professional of medication regimen before treatment or surgery.
• Rep: May cause fetal harm. Serum cholesterol and triglycerides increase during normal pregnancy, and cholesterol is essential for fetal development. Instruct females of reproductive potential to use effective contraception during therapy and to notify health care professional immediately if pregnancy is planned or suspected, and to avoid breastfeeding during therapy.
• Emphasize the importance of follow-up exams to determine effectiveness and to monitor for side effects.

FLOO-va-stat-in

NDC Code^*

• 0078- Novartis Pharmaceuticals Corporation
  • 0078-0354- Lescol XL
    • 0078-0354-05- 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0078-0354-05)

• 0078- Novartis Pharmaceuticals Corporation
  • 0078-0354- Lescol XL
    • 0078-0354-15- 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0078-0354-15)

• 0093- Teva Pharmaceuticals USA, Inc.
  • 0093-7442- Fluvastatin
    • 0093-7442-01- 100 CAPSULE in 1 BOTTLE (0093-7442-01)

• 0093- Teva Pharmaceuticals USA, Inc.
  • 0093-7442- Fluvastatin
    • 0093-7442-56- 30 CAPSULE in 1 BOTTLE (0093-7442-56)

• 0093- Teva Pharmaceuticals USA, Inc.
  • 0093-7443- Fluvastatin
    • 0093-7443-01- 100 CAPSULE in 1 BOTTLE (0093-7443-01)

• 0093- Teva Pharmaceuticals USA, Inc.
  • 0093-7443- Fluvastatin
    • 0093-7443-56- 30 CAPSULE in 1 BOTTLE (0093-7443-56)

• 0093- Teva Pharmaceuticals USA, Inc.
  • 0093-7446- Fluvastatin Sodium
    • 0093-7446-01- 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-7446-01)

• 0093- Teva Pharmaceuticals USA, Inc.
  • 0093-7446- Fluvastatin Sodium
    • 0093-7446-56- 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-7446-56)

• 0378- Mylan Pharmaceuticals Inc.
  • 0378-8020- Fluvastatin Sodium
    • 0378-8020-77- 90 CAPSULE in 1 BOTTLE, PLASTIC (0378-8020-77)

• 0378- Mylan Pharmaceuticals Inc.
  • 0378-8020- Fluvastatin Sodium
    • 0378-8020-93- 30 CAPSULE in 1 BOTTLE, PLASTIC (0378-8020-93)

• 0378- Mylan Pharmaceuticals Inc.
  • 0378-8021- Fluvastatin Sodium
    • 0378-8021-77- 90 CAPSULE in 1 BOTTLE, PLASTIC (0378-8021-77)

• 0378- Mylan Pharmaceuticals Inc.
  • 0378-8021- Fluvastatin Sodium
    • 0378-8021-93- 30 CAPSULE in 1 BOTTLE, PLASTIC (0378-8021-93)

• 0781- Sandoz Inc
  • 0781-8017- FLUVASTATIN SODIUM ER
    • 0781-8017-01- 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-8017-01)

• 0781- Sandoz Inc
  • 0781-8017- FLUVASTATIN SODIUM ER
    • 0781-8017-31- 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-8017-31)