GNH USA

Europe — EMA

Lescol Xl 80

GNH USA supplies Lescol XL 80 (Fluvastatin), a HMG‑CoA reductase inhibitor for hypercholesterolemia and cardiovascular disease prevention.

Fluvastatin Sodium

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What is Fluvastatin Sodium?

Fluvastatin, the active ingredient in Lescol XL 80, is a HMG‑CoA reductase inhibitor presented as an 80 mg tablet for oral use. It treats hypercholesterolemia and is employed for primary and secondary prevention of cardiovascular disease in adult patients. It is indicated for patients with elevated low‑density lipoprotein cholesterol levels and is part of a comprehensive lipid‑lowering strategy that includes diet and lifestyle modification.

GNH USA supplies Lescol XL 80 as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, with a focus on quality assurance and regulatory compliance.

What is Fluvastatin Sodium used for?

Lescol XL 80 (fluvastatin) is used to manage disorders of lipid metabolism and reduce cardiovascular risk.

- Hypercholesterolemia: lowers low‑density lipoprotein (LDL) cholesterol and total cholesterol, helping achieve target lipid levels in patients with elevated LDL. - Primary prevention of cardiovascular disease: reduces the incidence of myocardial infarction, stroke, and related events in individuals without established atherosclerotic disease but with risk factors. - Secondary prevention of cardiovascular disease: decreases the risk of recurrent cardiovascular events in patients with a history of myocardial infarction, angina, or peripheral arterial disease.

What are the side effects of Fluvastatin Sodium?

Fluvastatin may cause a range of adverse reactions, from mild to serious, that should be monitored during therapy.

Common Side Effects: - Headache: mild to moderate headache reported in some patients. - Muscle pain (myalgia): occasional muscle discomfort without significant creatine kinase elevation. - Gastrointestinal upset: nausea, abdominal discomfort, or dyspepsia may occur. - Elevated liver enzymes: transient increases in ALT or AST are observed.

Serious or Rare Side Effects: - Rhabdomyolysis: severe muscle breakdown with marked CK rise, potentially leading to renal failure. - Hepatotoxicity: significant elevation of liver transaminases or clinically apparent hepatitis. - Severe allergic reactions: rash, angioedema, or anaphylaxis requiring immediate medical attention. - Myocardial infarction (rare): isolated reports of acute coronary events have been described.

What precautions apply to Fluvastatin Sodium?

Before initiating Lescol XL 80, clinicians should consider several precautionary measures to ensure safe use.

- Liver function monitoring: obtain baseline ALT/AST and repeat periodically during therapy. - Renal impairment: assess kidney function; use with caution in severe renal disease. - Drug interaction review: evaluate concomitant medications that affect CYP3A4 metabolism. - Pregnancy and lactation: contraindicated; classified as Category X due to teratogenic risk. - Muscle symptoms: discontinue if unexplained muscle pain accompanied by elevated CK levels. - Store at ambient temperature: keep below 25 °C, protect from moisture in the original packaging.

What does Fluvastatin Sodium interact with?

Fluvastatin can interact with other medicines, altering its plasma concentration or increasing toxicity risk.

Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., itraconazole, clarithromycin): may raise fluvastatin levels and risk of myopathy. - Gemfibrozil: combined use markedly increases risk of rhabdomyolysis. - Cyclosporine: elevates statin exposure, heightening potential for muscle toxicity.

Moderate Interactions (Monitor Closely): - Warfarin: fluvastatin may potentiate anticoagulant effect; monitor INR closely. - Grapefruit juice: can modestly increase plasma concentrations; advise limited consumption.

Frequently asked questions

What is Lescol XL 80 used for?+
Lescol XL 80 contains fluvastatin, a statin indicated for the treatment of hypercholesterolemia and for both primary and secondary prevention of cardiovascular disease. It helps lower LDL‑cholesterol and total cholesterol, reducing the risk of heart attacks, strokes, and related vascular events in patients with elevated lipid levels.
How does fluvastatin work?+
Fluvastatin works by inhibiting HMG‑CoA reductase, the key enzyme in hepatic cholesterol synthesis. This inhibition reduces intracellular cholesterol, prompting the liver to increase the number of LDL receptors on its surface, which enhances removal of LDL particles from the bloodstream and lowers overall plasma cholesterol.
What is the usual dose of Lescol XL 80?+
The dose of Lescol XL 80 is determined by the prescribing clinician based on the patient’s lipid profile, cardiovascular risk, and overall health status. The prescriber may start with a standard dose and adjust it as needed to achieve target cholesterol levels while monitoring safety.
Is Lescol XL 80 safe in pregnancy or breastfeeding?+
Lescol XL 80 is classified as Pregnancy Category X, meaning it is contraindicated during pregnancy because it may cause fetal harm. It is also not recommended for breastfeeding mothers, as the drug can be excreted in breast milk and may affect the infant.
How do I order Lescol XL 80 from GNH USA?+
To order Lescol XL 80, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA supplies hospitals, pharmacies and procurement teams worldwide, and will request verification of trade or institutional credentials before providing pricing, availability, shipping details and required import documentation.
How does Lescol XL 80 compare with other statins?+
Lescol XL 80 (fluvastatin) is a moderate‑intensity statin with a relatively long half‑life, allowing once‑daily dosing. Compared with high‑intensity statins such as atorvastatin or rosuvastatin, fluvastatin generally achieves smaller LDL‑cholesterol reductions but may have a lower incidence of certain drug‑drug interactions, especially with CYP3A4 substrates.
How should Lescol XL 80 be stored and handled?+
Lescol XL 80 tablets should be stored at ambient temperature, below 25 °C, in their original packaging to protect them from moisture and light. Keep the container tightly closed and out of reach of children.
How is Lescol XL 80 administered?+
Lescol XL 80 is taken orally as a whole tablet, usually once daily in the evening, unless otherwise directed by a healthcare professional. The tablet should be swallowed with water and not crushed or chewed.
What are the most serious risks associated with Lescol XL 80?+
The most serious risks include rhabdomyolysis, a severe form of muscle breakdown that can lead to kidney failure, and hepatotoxicity, which may present as significant elevations in liver enzymes or clinical hepatitis. Patients should report unexplained muscle pain, weakness, or dark urine promptly.
Who should not use Lescol XL 80?+
Lescol XL 80 should not be used by individuals who are pregnant or breastfeeding, those with active liver disease, or patients with known hypersensitivity to fluvastatin or any tablet excipients. Caution is also advised for patients with severe renal impairment or those taking contraindicated medications.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Fluvastatin Sodium
Route
Oral Use
Manufacturer
Ethyx Pharmaceuticals
Origin
EU

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