Lescol XL Capsule

Fluvastatin acts by competitively inhibiting HMG-CoA reductase, the enzyme for cholesterol synthesis. It reduces total cholesterol, triglycerides, LDL and VLDL concentrations in plasma. It also increases HDL concentrations.

General Dosing Information: Fluvastatin 20 mg to 80 mg/day. This can be administered orally as a single dose, with or without food. Do not break, crush or chew or open capsules prior to administration. Do not take two Fluvastatin 40 mg at one time. Since the maximal effect of a given dose is seen within 4 weeks, periodic lipid determinations should be performed at this time and dosage adjusted according to the patient’s response to therapy and established treatment guidelines.

Adult Patients with Hypercholesterolemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia: The recommended starting dose is one 40 mg Fluvastatin capsule in the evening, or one 40 mg capsule twice daily. Do not take two 40 mg capsules at one time. The recommended starting dose for is one 80 mg administered as a single dose at any time of the day.

Pediatric Patients (10-16 years of age) with Heterozygous Familial Hypercholesterolemia: The recommended starting dose is one 20 mg Fluvastatin capsule. Dose adjustments, up to a maximum daily dose administered either as 40 mg twice daily or 80 mg once daily should be made at 6 week intervals. Doses should be individualized according to the goal of therapy.

• Cyclosporine: Combination increases Lescol XL exposure. Limit dose to 20 mg
• Fluconazole: Combination increases Lescol XL exposure. Limit dose to 20 mg
• Concomitant lipid-lowering therapies: Use with fibrates or lipid-modifying doses (≥1 g/day) of niacin increases the risk of adverse skeletal muscle effects.
• Glyburide: Monitor blood glucose levels when Lescol XL dose is changed
• Phenytoin: Monitor plasma phenytoin levels when Lescol XL treatment is initiated or when the dosage is changed
• Warfarin and coumarin derivates: Monitor prothrombin times when Lescol XL co-administration is initiated, discontinued, or the dosage changed.

• Hypersensitivity to any component of this medication Active liver disease or unexplained, persistent elevations in serum transaminases
• Women who are pregnant or may become pregnant
• Nursing mothers

Most frequent adverse reactions (rate ≥2% and > placebo) are: headache, dyspepsia, myalgia, abdominal pain and nausea.

Pregnancy:  Fluvastatin is contraindicated in women who are pregnant or may become pregnant. Serum cholesterol and triglycerides increase during normal pregnancy, and cholesterol or cholesterol derivatives are essential for fetal development. Fluvastatin may cause fetal harm when administered to pregnant women. Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia. Fluvastatin should be administered to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards. If the patient becomes pregnant while taking this drug, Fluvastatin should be discontinued and the patient should be apprised of the potential hazard to the fetus.

Nursing Mothers: Fluvastatin is secreted into the breast milk of animals and because HMG-CoA reductase inhibitors have the potential to cause serious adverse reactions in nursing infants, women who require treatment with Fluvastatin should be advised not to breastfeed their infants

Skeletal muscle effects (e.g. myopathy and rhabdomyolysis): Risks increase with advanced age (>65), uncontrolled hypothyroidism, renal impairment, and combination use with cyclosporine, or gemfibrozil.

Patients should be advised to report promptly any symptoms of myopathy. This therapy should be discontinued if myopathy is diagnosed or suspected.

Liver enzyme abnormalities: Persistent elevations in hepatic transaminases can occur. Check liver enzyme tests before initiating therapy and as clinically indicated thereafter.

Other Anti-anginal & Anti-ischaemic drugs, Statins

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.