Adult Dosing

Primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemias

• Immediate release
• Start 20 mg PO in the evening; 40 mg PO daily to bid if LDL reduction goal >25%
• Range: 20-80 mg/day
• Max: 80 mg/day; divide dose bid if on 80 mg/day

• Extended release
• 80 mg PO Daily

Cardiovascular event risk reduction

• Immediate release
• Start 20 mg PO in the evening; 40 mg PO qd-bid if LDL reduction goal >25%
• Range: 20-80 mg/day
• Max: 80 mg/day; divide dose bid if on 80 mg/day

• Extended release
• 80 mg PO Daily

Atherosclerosis

• Immediate release
• Start 20 mg PO in the evening; 40 mg PO qd-bid if LDL reduction goal >25%
• Range: 20-80 mg/day
• Max: 80 mg/day; Divide dose bid if on 80 mg/day

• Extended release
• 80 mg PO Daily

• Do not cut/crush/chew ER form
• Drug may be taken without regard to meals, efficacy is enhanced if drug is taken in the evening. Monitor closely for signs of myositis

Pediatric Dosing

Heterozygous familial hypercholesterolemia

10-16 yrs

• Immediate release
• Start 20 mg PO in the evening; increase dose q6 wks
• Range: 20-80 mg/day
• Max: 80 mg/day; Divided dose bid if on 80 mg/day

• Extended release
• 80 mg PO qd

[Outline]

• Adult Dosing
• Pediatric Dosing

• Adjunctive management of primary hypercholesterolemia and mixed dyslipidemia
• Reduction of elevated total-C, LDL-C, apo B, and triglyceride cholesterol levels, and to increase HDL-C levels

• Adjunctive management of heterozygous familial hypercholesterolemia in children
• Reduction of elevated total-cholesterol (C), LDL-C, and apolipoprotein (apo) B levels in adolescent boys and girls at least 1 yr post-menarche whose response to dietary restriction is inadequate and who have the following: LDL-C 190 mg/dL, or LDL-C 160 mg/dL and there is a positive family history of premature CV disease, or 2 or more other CV disease risk factors are present

• Secondary prevention of coronary events in patients with clinically evident coronary heart disease
• Slowing the progression of coronary atherosclerosis in patients with coronary artery disease

• Hypersensitivity to any of the ingredients of the product
• Active hepatic disease
• Unexplained elevated LFTs
• Pregnancy
• Lactation

• N/A

Renal Dose Adjustment

• Severe renal impairment: Caution advised with doses >40 mg/day
• Hemodialysis: dose adjustments not defined

Hepatic Dose Adjustment

• Use with caution in patients who consume significant amounts of alcohol or in patients w/ hx of liver disease
• Active liver disease or unexplained increases in LFT's: contraindicated

• Fluvastatin is indicated as an adjunct to diet, exercise, and weight reduction in obese patients. Before starting therapy, an attempt should be made to control hypercholesterolemia with appropriate diet, exercise, and weight reduction
• Exclude secondary causes of hypercholesterolemia (eg, poorly controlled diabetes, hypothyroidism) before starting therapy
• Dose-related, persistent elevations of transaminase levels to more than 3 times the upper limit of normal have been reported. Perform liver function tests before initiation of therapy and at 12 weeks following initiation of treatment or elevation in dose
• If elevated serum transaminase levels develop during treatment, repeat monitoring more frequently
• Rhabdomyolysis with renal dysfunction secondary to myoglobinuria has been reported with fluvastatin. Temporarily withhold therapy in any patient experiencing an acute or serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis
• Myopathy may present as diffuse myalgias, muscle tenderness or weakness, with marked elevation of CPK. Advise patients to promptly report unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever. Discontinue therapy if myopathy is diagnosed
• Immune-mediated necrotizing myopathy (IMNM) characterized by proximal muscle weakness and elevated serum creatine kinase has been reported with statin use, and may persist despite discontinuation of statin treatment
• Risk of myopathy and/or rhabdomyolysis increases with concomitant gemfibrozil, erythromycin, or niacin
• Safety and efficacy not established in children younger than 9 years of age for Heterozygous familial hypercholesterolemia
• Use with caution if administering drugs that affect steroid levels or activity

Cautions: Use cautiously in

• Hx of hepatic disease
• Renal impairment
• Alcohol use
• Geriatric population
• Trauma
• Major Surgery
• Sepsis/Acute infection

Lescol, Lescol XL interacts with :

	Acenocoumarol
	Amaryl
	Avandia
	Chlorpropamide
	Coumadin
	DiaBeta
	Diabinese
	Glimepiride
	Glipizide
	Glucotrol
	Glucotrol XL
	Glucovance
	Glyburide
	Glynase
	Jantoven
	Nateglinide
	Orinase
	Rosiglitazone
	Starlix
	Tolbutamide
	Warfarin

Pregnancy Category:X

Breastfeeding: Limited published data exist to define the safety of breastfeeding. Manufacturer reports that fluvastatin is excreted in breast milk. Due to potential for serious adverse reactions and disruption of infant lipid metabolism, fluvastatin should not be used during breastfeeding. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 1 June 2010).

• MUSC: Rhabdomyolysis, myalgia, arthritis, myopathy, arthropathy, back pain
• RESP: Sinusitis, bronchitis, cough, pharyngitis, rhinitis
• GI: Nausea, vomiting, dyspepsia, diarrhea, abdominal pain/cramps, flatulence, constipation, hepatotoxicity, elevated liver enzymes, pancreatitis
• PSYCHIATRIC: Insomnia, anxiety, depression
• CNS: Headache, dizziness,fatigue
• DERM: Dermatomyositis, photosensitivity, toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome
• GU: UTI, acute renal failure
• MISC: Hypersensitivity, angioedema, anaphylaxis, lupus erythematosus, vasculitis, influenza-like symptoms, accidental trauma, allergy

• HMG-CoA Reductase Inhibitor; Inhibits HMG-CoA reductase, an enzyme which is responsible for catalyzing an early step in the synthesis of cholesterol. Reduces plasma cholesterol concentration
• Metabolized by liver; CYP450: 2C9 (primary), 2C8, 3A4 substrate; 2C9 inhibitor
• Excreted in feces 90% (<2% unchanged) and urine 5%
• Half-life: ~3 hrs (IR), 9h (Extended release)

US Trade Name(s)

• Lescol
• Lescol XL

US Availability

fluvastatin (generic)

• CAPS: 20, 40 mg

Lescol

• CAPS: 20, 40 mg

Lescol XL

• Extended Release TABS: 80 mg

Canadian Trade Name(s)

• Lescol
• Lescol XL

Canadian Availability

Lescol

• CAPS: 20, 40 mg

Lescol XL

• ETABS: 80 mg

UK Trade Name(s)

• Lescol
• Lescol XL
• Luvinista XL
• Stefluvin XL

UK Availability

fluvastatin (generic)

• CAPS: 20, 40 mg

Lescol

• CAPS: 20, 40 mg

Lescol XL, Luvinista XL, Stefluvin XL

• ETABS: 80 mg

Australian Trade Name(s)

• Lescol
• Lescol XL
• Vastin

Australian Availability

Lescol, Vastin

• CAPS: 20, 40 mg

Lescol XL

• ETABS: 80 mg

[Outline]

Endocrine/Metabolic

Antihyperlipidemic Agents

HMG-CoA Reductase Inhibitors (Statins)

Cardiovascular

Antihyperlipidemic Agents

HMG-CoA Reductase Inhibitors (Statins)

Pricing data from www.DrugStore.com in U.S.A.

• Lescol 40 MG CAPS [Bottle] (NOVARTIS)
  30 mg = $109.19
  90 mg = $293.96
• Lescol 20 MG CAPS [Bottle] (NOVARTIS)
  30 mg = $117.59
  90 mg = $317.07
• Lescol XL 80 MG TB24 [Bottle] (NOVARTIS)
  30 mg = $145.99
  90 mg = $425.95

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

• 24 HR Lescol XL 80 MG Extended Release Tablet (Novartis Pharmaceuticals Corporation)
• Lescol 20 MG Oral Capsule (Novartis Pharmaceuticals Corporation)
• Lescol 40 MG Oral Capsule (Novartis Pharmaceuticals Corporation)