Product image of Lescol Xl (Fluvastatin Sodium) supplied by GNH India

Lescol Xl

Active Ingredient:
Fluvastatin Sodium
Origin:
EU

Lescol Xl (Fluvastatin Sodium)

Fluvastatin Sodium, the active ingredient in Lescol XL, is a statin presented as an oral tablet for oral use. It lowers elevated cholesterol levels in adults at risk of cardiovascular disease by reducing low‑density lipoprotein (LDL) and total cholesterol. Lescol XL is classified as a lipid‑lowering agent and is indicated for the management of primary and mixed dyslipidaemia, as well as for secondary prevention of cardiovascular events.

GNH India supplies Lescol XL as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Ethyx Pharmaceuticals

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Indications & Clinical Uses

Lescol XL is a statin that acts on the cholesterol synthesis pathway to treat dyslipidaemia and related cardiovascular conditions.

  • Primary hypercholesterolemia: reduces LDL‑C and total cholesterol levels.
  • Mixed dyslipidaemia: lowers triglycerides and raises HDL‑C while decreasing LDL‑C.
  • Secondary prevention of cardiovascular disease: helps prevent myocardial infarction, stroke and revascularisation in patients with established atherosclerotic disease.
  • Familial hypercholesterolaemia (heterozygous): provides additional LDL‑C reduction when diet and other therapies are insufficient.

How It Works

  • Fluvastatin Sodium competitively inhibits HMG‑CoA reductase, the key enzyme in hepatic cholesterol biosynthesis. This inhibition decreases intracellular cholesterol, leading to up‑regulation of LDL receptors on hepatocyte surfaces, which enhances clearance of circulating LDL particles and lowers overall plasma cholesterol concentrations.

Side Effects

Fluvastatin Sodium may cause a range of adverse reactions, from mild to serious.

Common Side Effects

  • Headache: mild to moderate intensity.
  • Myalgia: muscle aches without weakness.
  • Gastrointestinal discomfort: nausea, abdominal pain or diarrhoea.
  • Elevated liver enzymes: transient increases in ALT/AST.
  • Dizziness: occasional light‑headedness.

Serious or Rare Side Effects

  • Rhabdomyolysis: severe muscle breakdown with dark urine.
  • Hepatotoxicity: marked elevation of liver transaminases.
  • Acute renal failure: secondary to rhabdomyolysis.
  • Severe allergic reactions: rash, angioedema or anaphylaxis.
  • Thrombocytopenia: low platelet count.
  • Cognitive impairment: rare reports of memory loss or confusion.

Precautions & Warnings

Before initiating therapy, consider patient‑specific factors and monitor appropriately.

  • Liver function: assess baseline ALT/AST and repeat if clinically indicated.
  • Renal impairment: adjust dose in moderate to severe renal dysfunction.
  • Drug‑induced myopathy: avoid concomitant strong CYP3A4 inhibitors.
  • Pregnancy and lactation: use only if potential benefit justifies potential risk.
  • Elderly patients: start at lower dose and monitor for adverse effects.
  • Store at ambient temperature: keep below 25 °C, in the original container, protected from moisture and direct sunlight.

Avoid Interactions

Fluvastatin Sodium can interact with several medicines, affecting its efficacy or safety.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., itraconazole, clarithromycin): may increase fluvastatin exposure and risk of myopathy.
  • Gemfibrozil: synergistic increase in muscle toxicity.
  • Cyclosporine: elevates plasma concentrations, heightening adverse effect risk.

Moderate Interactions (Monitor Closely)

  • Antacids (aluminum or magnesium): may reduce absorption; separate dosing by at least 2 hours.
  • Warfarin: may enhance anticoagulant effect; monitor INR.
  • Digoxin: possible increase in serum levels; observe for toxicity.
  • Niacin: combined therapy can increase risk of liver enzyme elevations.
  • St. John’s Wort: may reduce fluvastatin levels via CYP3A4 induction.

Frequently Asked Questions

Lescol XL contains fluvastatin sodium, a statin indicated for lowering elevated cholesterol and triglyceride levels. It is prescribed to treat primary and mixed dyslipidaemia and to reduce the risk of cardiovascular events such as heart attack and stroke in adults.

Fluvastatin sodium inhibits the enzyme HMG‑CoA reductase, which is essential for cholesterol synthesis in the liver. By blocking this step, the drug lowers intracellular cholesterol, prompting the liver to increase LDL‑receptor expression and clear more LDL cholesterol from the bloodstream.

The appropriate dose of Lescol XL is determined by the prescribing clinician based on the patient’s lipid profile, cardiovascular risk, age, renal function and concomitant medications. Dosage adjustments are made to achieve target cholesterol levels while minimizing adverse effects.

Fluvastatin sodium is generally contraindicated during pregnancy because cholesterol synthesis is essential for fetal development. It should only be used if the potential benefit outweighs the risk. Limited data are available for breastfeeding; therefore, caution is advised and alternatives are preferred.

To place an order, submit an enquiry on the product page at gnhindia.com specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

Lescol XL (fluvastatin) is a moderate‑intensity statin with a relatively short half‑life compared with agents such as atorvastatin or rosuvastatin. It may be preferred in patients who require a lower potency statin or who have specific drug‑interaction concerns, though efficacy in LDL‑C reduction is comparable when dose‑adjusted.

Lescol XL tablets should be stored at ambient temperature, below 25 °C. Keep them in the original packaging to protect from moisture and light, and store out of reach of children.

Lescol XL is taken orally, usually once daily in the evening with or without food, as directed by the prescriber. Swallow the tablet whole with a glass of water; do not crush or chew unless specifically instructed.

The most serious adverse reactions include rhabdomyolysis, a severe form of muscle breakdown that can lead to kidney failure, and significant liver enzyme elevations indicating hepatotoxicity. Patients should report unexplained muscle pain, weakness, dark urine, or jaundice promptly.

Lescol XL is contraindicated in patients with active liver disease, unexplained persistent elevations of hepatic transaminases, known hypersensitivity to fluvastatin or any excipients, and in women who are pregnant or may become pregnant unless the benefit justifies the risk.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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