lescol xl
Pharmaranks rates Lescol XL 3.4/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Lescol XL (Fluvastatin Sodium) is a HMG-CoA reductase inhibitor used to treat Coronary Artery Disease, Hypercholesterolemia, Hyperlipoproteinemias, Hypertriglyceridemia.
Fluvastatin Sodium · by Sandoz
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Fluvastatin Sodium
- Drug class
- Hmg-Coa Reductase Inhibitor
- Form
- Tablet, extended release
- Strength
- Fluvastatin Sodium EQ 80MG Base
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Sandoz
- What the pharmacy pays
- ~$85.52 for 30 — not your price
- FDA application
- NDA021192
What is Lescol XL?
From the FDA label:Fluvastatin sodium inhibits 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Fluvastatin sodium is [ R *, S *-( E )]-(±)-7-[3-(4-fluorophenyl)-1-(1-methylethyl)-1 H -indol-2-yl]-3,5-dihydroxy-6-heptenoic acid, monosodium salt. The empirical formula of fluvastatin sodium is C 24 H 25 FNO 4 •Na, its molecular weight is 433.46 g/mol and its structural formula is: Fluvastatin sodium is a white to pale yellow, hygroscopic powder soluble in water, ethanol and methanol. Fluvastatin sodium is supplied as extended-release tablets containing 84.24 mg of fluvastatin sodium, equivalent to 80 mg of fluvastatin, for oral use. Fluvastatin sodium extended-release tablets contain the following inactive ingredients: hydroxypropyl cellulose, hydroxypropyl methyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 8000, potassium bicarbonate, povidone, titanium dioxide, and yellow iron oxide. Fluvastatin sodium structural formula
How to use
Fluvastatin sodium extended-release tablets can be taken with or without food and may be taken at any time of the day. ( 2.1 ) • Do not break, crush or chew fluvastatin sodium extended-release tablets prior to administration. ( 2.1 ) • Adults : The recommended starting dose is 80 mg (administered as one 80 mg fluvastatin sodium extended-release tablet once daily). ( 2.2 ) Children : The recommended dose is 80 mg once daily in pediatric patients 10 years of age and older who require 80 mg of fluvastatin. Fluvastatin sodium extended-release tablets are not recommended for dosage initiation in pediatric patients because the recommended starting dosage cannot be achieved with the available strength of 80 mg. ( 2.3 ) 2.1 Important Dosage Information • Take fluvastatin sodium extended-release tablets orally once daily as a single dose, with or without food. • Do not break, crush, or chew fluvastatin sodium extended-release tablets. • Fluvastatin sodium extended-release tablet is only available as an 80 mg tablet. Fluvastatin sodium extended-release tablets cannot be titrated [see Dosage and Administration (2.2, 2.3)] . • For patients that require a high-intensity statin or are unable to achieve their LDL-C goal receiving fluvastatin sodium extended-release tablets 80 mg daily, prescribe alternative LDL-C-lowering treatment. • Assess LDL-C when clinically appropriate, as early as 4…
Side effects
The following serious adverse reactions are discussed in greater detail in other sections of the label: • Myopathy and Rhabdomyolysis [see Warnings and Precautions ( 5.1 )] • Immune-Mediated Necrotizing Myopathy [see Warnings and Precautions ( 5.2 )] • Hepatic Dysfunction [see Warnings and Precautions ( 5.3 )] • Increases in HbA1c and Fasting Serum Glucose Levels [see Warnings and Precautions ( 5.4 )] Most frequent adverse reactions occurring in ≥ 2.5% of subjects treated with fluvastatin sodium extended-release tablets and more than placebo are: influenza-like symptoms, sinusitis, dyspepsia, urinary tract infection, bronchitis, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In the fluvastatin capsule, clinical trials there were 2326 patients treated with fluvastatin (age range, 18 to 75 years, 44% women, 94% White, 4% Black or African American, 2% other ethnicities) with a median treatment duration of 24 weeks. The most common adverse reactions that led to treatment discontinuation and…
Warnings
Important safety information
Myopathy and Rhabdomyolysis : Risk factors include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, and concomitant use with certain other drugs. Discontinue fluvastatin sodium extended-release tablets if markedly elevated creatine kinase (CK) levels occur, or myopathy is diagnosed or suspected. Temporarily discontinue fluvastatin sodium extended-release tablets in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis. Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing fluvastatin sodium extended-release tablets dosage. Instruct patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. ( 5.1 ) • Immune-Mediated Necrotizing Myopathy (IMNM) : Rare reports of IMNM, an autoimmune myopathy, have been reported with statin use. Discontinue fluvastatin sodium extended-release tablets if IMNM is suspected.( 5.2 ) • Hepatic Dysfunction : Increases in serum transaminases have occurred, some persistent. Rare reports of fatal and non-fatal hepatic failure have occurred. Consider testing liver enzyme before initiating therapy and as clinically indicated thereafter. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue fluvastatin sodium extended-release tablets ( 5.3 ) 5.1 Myopathy and Rhabdomyolysis Fluvastatin sodium extended-release tablets may cause myopathy (muscle pain, tenderness, or weakness associated with elevated creatine kinase [CK]) and rhabdomyolysis. Acute kidney injury secondary to myoglobinuria and rare fatalities have occurred as a result of rhabdomyolysis with statins, including fluvastatin sodium extended-release tablets . Myopathy, defined as muscle aching or muscle weakness in conjunction with increases in CK, values to greater than 10 times the upper limit of normal (ULN) was < 0.1% in fluvastatin clinical trials [see Adverse Reactions ( 6.1 )] . Risk Factors for Myopathy Risk factors for myopathy include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, and concomitant use with certain other drugs (including other lipid-lowering therapies) [see Drug Interactions ( 7.1 )] . Steps to Prevent or Reduce the Risk of Myopathy and Rhabdomyolysis Avoid concomitant use of fluvastatin sodium extended-release tablets with gemfibrozil, cyclosporin, and fluconazole. When used concomitantly with fluvastatin sodium extended-release tablets, lipid modifying doses (≥ 1 g/day) of niacin, fibrates, and colchicine may also increase the risk of myopathy and rhabdomyolysis [see Drug Interactions ( 7.1 )] . Discontinue fluvastatin sodium extended-release tablets if markedly elevated CK levels occur or if myopathy is either diagnosed or suspected. Muscle symptoms and CK increases may resolve if fluvastatin sodium extended-release tablets are discontinued. Temporarily discontinue fluvastatin sodium extended-release tablets in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis, e.g., sepsis, shock, severe hypovolemia, major surgery, trauma, severe metabolic, endocrine, or electrolyte disorders, or uncontrolled epilepsy. Inform patients of the risk of myopathy and rhabdomyolysis when starting fluvastatin sodium extended-release tablets. Instruct patients to promptly report any unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. 5.2 Immune-Mediated Necrotizing Myopathy There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use, including reports of recurrence when the same or a different statin was administered. IMNM is characterized by proximal muscle weakness and elevated serum CK, which persist despite discontinuation of statin treatment; positive anti-HMG CoA reductase antibody, muscle biopsy showing necrotizing myopathy, and improvement with immunosuppressive agents. Additional neuromuscular and serologic testing may be necessary. Treatment with immunosuppressive agents may be required. Discontinue fluvastatin sodium extended-release tablets if IMNM is suspected. 5.3 Hepatic Dysfunction Increases in serum transaminases have been reported with use of fluvastatin sodium extended-release tablets [see Adverse Reactions ( 6.1 )] . In most cases, these changes appeared soon after initiation, were transient, were not accompanied by symptoms, and resolved or improved on continued therapy or after a brief interruption in therapy. Persistent increases to more than three times the ULN in serum transaminases have occurred in approximately 1.1% of patients receiving fluvastatin in clinical trials. Marked persistent increases of hepatic transaminases have also occurred with fluvastatin. There have been rare post-marketing reports of fatal and non-fatal hepatic failure in patients taking statins, including fluvastatin sodium extended-release tablets. Patients who consume substantial quantities of alcohol and/or have a history of liver disease may be at increased risk for hepatic injury. Consider liver enzyme testing before fluvastatin sodium extended-release tablets initiation and thereafter, when clinically indicated. Fluvastatin sodium extended-release tablets are contraindicated in patients with acute liver failure or decompensated cirrhosis [see Contraindications ( 4 )] . If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue fluvastatin sodium extended-release tablets. 5.4 Increases in HbA1c and Fasting Serum Glucose Levels Increases in HbA1c and fasting serum glucose levels have been reported with statins, including fluvastatin sodium extended-release tablets. Optimize lifestyle measures, including regular exercise, maintaining a healthy body weight, and making healthy food choices.
Who should not take Lescol XL
Fluvastatin sodium extended-release tablets are contraindicated in patients with: • Acute liver failure or decompensated cirrhosis [see Warnings and Precautions ( 5.3 )] . • Hypersensitivity to fluvastatin or any of the excipients in fluvastatin sodium extended-release tablets. Hypersensitivity reactions, including anaphylaxis, angioedema, and Stevens-Johnson syndrome have been reported [see Adverse Reactions ( 6.2 )] . • Acute liver failure or decompensated cirrhosis ( 4 ) • Hypersensitivity to fluvastatin or any excipient in fluvastatin sodium extended-release tablets ( 4 )
Overdose — what happens if you take too much
No specific antidotes for fluvastatin sodium extended-release tablets are known. In the event of an overdose of fluvastatin sodium extended-release tablets, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Gemfibrozil : Avoid use with fluvastatin sodium extended-release tablets. ( 7.1 ) • Cyclosporine and Fluconazole : Avoid use with fluvastatin sodium extended-release tablets. ( 7.1 ) • Fibrates, Lipid-modifying doses (≥ 1 g/day) of Niacin, and Colchicine : Consider if the benefit of concomitant use with fluvastatin sodium extended-release tablets outweighs the increased risk of myopathy and rhabdomyolysis. If concomitant use is decided, monitor patients for signs and symptoms of myopathy, particularly during initiation of therapy and during upward dose titration. ( 7.1 ) • Warfarin : Obtain an International Normalized Ratio (INR) before starting and frequently enough after initiation or discontinuation to ensure that no significant alteration in INR occurs. Once the INR is stable, monitor INR at regular intervals. ( 7.2 ) • Glyburide : Monitor blood glucose levels when fluvastatin sodium extended-release tablets are initiated. ( 7.2 ) • Phenytoin : Monitor plasma phenytoin levels when fluvastatin sodium extended-release tablets treatment is initiated. ( 7.2 ) 7.1 Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with Fluvastatin Sodium Extended-Release Tablets Table 3 includes a list of drugs that increase the risk of myopathy and rhabdomyolysis when used concomitantly with fluvastatin and instructions for preventing or managing them [see Warnings and Precautions ( 5.1 ), Clinical Pharmacology ( 12.3 )] . Table 3. Drug Interactions That Increase the Risk of Myopathy and Rhabdomyolysis with Fluvastatin Sodium Extended-Release Tablets Gemfibrozil Clinical impact There is an increased risk of myopathy/rhabdomyolysis when fluvastatin sodium extended-release tablets are administered with gemfibrozil Intervention Avoid concomitant use of gemfibrozil with fluvastatin sodium extended-release tablets. Cyclosporine Clinical impact Cyclosporine coadministration increases fluvastatin exposure. The risk of myopathy and rhabdomyolysis may be increased with concomitant use of cyclosporine with fluvastatin sodium extended-release tablets. Intervention Avoid concomitant use of cyclosporine with fluvastatin sodium extended-release tablets. Fluconazole Clinical impact Fluconazole coadministration increases fluvastatin exposure. The risk of myopathy and rhabdomyolysis may be increased with concomitant use of fluconazole with fluvastatin sodium extended-release tablets. Intervention Avoid concomitant use of fluconazole with fluvastatin sodium extended-release tablets. Niacin Clinical impact Risk of myopathy and rhabdomyolysis may be enhanced with concomitant use with lipid-modifying doses (≥ 1 g/day) of niacin with fluvastatin sodium extended-release tablets. Intervention Consider if the benefit of using lipid-modifying doses (≥ 1 g/day) of niacin concomitantly with fluvastatin sodium extended-release tablets outweighs the increased risk of myopathy and rhabdomyolysis. If concomitant use is decided, monitor patients for signs and symptoms of myopathy, particularly during initiation of therapy and during upward dose titration. Fibrates Clinical impact Fibrates may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis may be increased with concomitant use of fibrates with fluvastatin sodium extended-release tablets. Intervention Consider if the benefit of using fibrates concomitantly with fluvastatin sodium extended-release tablets outweighs the increased risk of myopathy and rhabdomyolysis. If concomitant use is decided, monitor patients for signs and symptoms of myopathy, particularly during initiation of therapy and during upward dose titration. Colchicine Clinical impact Cases of myopathy and rhabdomyolysis have been reported with concomitant use of colchicine with fluvastatin. Intervention Consider if the benefit of using colchicine concomitantly with fluvastatin sodium extended-release tablets outweighs the increased risk of myopathy and rhabdomyolysis. If concomitant use is decided, monitor patients for signs and symptoms of myopathy, particularly during initiation of therapy and during upward dose titration. 7.2 Fluvastatin Sodium Extended-Release Tablets Effects on Other Drugs Table 4 presents fluvastatin sodium extended-release tablets’ effects on other drugs and instructions for preventing or managing them. Table 4. Fluvastatin Sodium Extended-Release Tablets’ Effects on Other Drugs Warfarin Clinical impact There are postmarketing reports of clinically evident bleeding and/or increased INR in patients taking concomitant statins and warfarin. Intervention In patients taking warfarin, obtain an INR before starting fluvastatin sodium extended-release tablets and frequently enough after initiation or discontinuation to ensure that no significant alteration in INR occurs. Once the INR is stable, monitor INR at regularly recommended intervals. Glyburide Clinical impact Concomitant administration of fluvastatin and glyburide increased glyburide exposures [see Clinical Pharmacology ( 12.3 )] . Intervention Monitor blood glucose levels when fluvastatin sodium extended-release tablets are initiated. Phenytoin Clinical impact Concomitant administration of fluvastatin and phenytoin increased phenytoin exposures [see Clinical Pharmacology ( 12.3 )] . Intervention Monitor plasma phenytoin levels when fluvastatin sodium extended-release tablets are initiated.
Drug class
How this class works, per HMG-CoA Reductase Inhibitors - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Lescol XL ranks — best-rated HMG-CoA reductase inhibitor for:
Dosage forms
Tablet, extended release
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Lescol XL treat?
- Lescol XL (Fluvastatin Sodium) may be used to treat coronary artery disease, hypercholesterolemia, hyperlipoproteinemias, hypertriglyceridemia, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Lescol XL work?
- Lescol XL is a HMG-CoA reductase inhibitor. Statins block HMG-CoA reductase, the key enzyme the liver uses to make cholesterol. With less cholesterol being produced, the liver pulls more LDL ("bad") cholesterol out of the blood, lowering overall blood cholesterol levels.
- How is Lescol XL rated?
- pharmaranks gives Lescol XL a composite score of 3.4 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Lescol XL cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $85.52 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins. Pharmacies pay less for a same-class option, Atorvaliq — about $0.92 on the same basis.
- Is there a coupon or discount for Lescol XL?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Lescol XL. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Lescol XL?
- Lescol XL is marketed by Sandoz. You can see Sandoz's full profile, rating, and other products on pharmaranks.
- Is Lescol XL a brand-name or generic drug?
- Lescol XL is a brand-name product with the active ingredient Fluvastatin Sodium.
- Is Lescol XL available over the counter?
- No. Lescol XL is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Lescol XL come in?
- Lescol XL is currently marketed as tablet, extended release, per the FDA's National Drug Code Directory.
- What class of drug is Lescol XL?
- Lescol XL is classified as hmg-coa reductase inhibitor, per the FDA's Established Pharmacologic Class.
- Is Lescol XL FDA-registered?
- Lescol XL is on record with the U.S. FDA under application number NDA021192. You can verify this on its official FDA label.
- Has Lescol XL been recalled by the FDA?
- Lescol XL has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Lescol XL safe?
- There's no single safe-or-not verdict. pharmaranks gives Lescol XL a recall-safety score of 68/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Lescol XL?
- Lescol XL's side effects are taken directly from its FDA label. From the label: The following serious adverse reactions are discussed in greater detail in other sections of the label: • Myopathy and Rhabdomyolysis [see Warnings and Precautions ( 5.1 )] • Immune-Mediated Necrotizing Myopathy [see Warnings and Precautions ( 5.2 )] • Hepatic Dysfunction [see Warnings and Precautio… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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lescol xl
68/100