Fluvastatin is an HMG-CoA reductase inhibitor (statin) used as an adjunct to diet for:

• Lowering elevated total cholesterol (TC), LDL-C, Apo B, and triglycerides (TG), and increasing HDL-C in adults with primary hypercholesterolemia and mixed dyslipidemia
• Reducing TC, LDL-C, and Apo B in boys and post-menarchal girls (10–16 years) with heterozygous familial hypercholesterolemia who have not responded adequately to dietary therapy
• Decreasing the likelihood of revascularization procedures in patients with clinically evident coronary heart disease (CHD)
• Slowing the progression of atherosclerosis in patients with CHD

Fluvastatin works by competitively inhibiting HMG-CoA reductase, a key enzyme involved in cholesterol synthesis. It lowers plasma levels of total cholesterol, triglycerides, LDL, and VLDL, while increasing HDL levels.

General Dosing Information: Fluvastatin is prescribed at 20 mg to 80 mg daily. It can be taken orally as a single dose, with or without food. Capsules should not be broken, crushed, chewed, or opened before use. Taking two 40 mg capsules at the same time is not recommended. Since the maximum effect of a dose is usually observed within 4 weeks, lipid levels should be checked at that time and the dose adjusted according to the patient’s response and clinical guidelines.

Adult Patients with Hypercholesterolemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia: The recommended initial dose is one 40 mg capsule in the evening, or 40 mg twice daily. Two 40 mg capsules should not be taken together at once. An alternative starting regimen is 80 mg once daily, taken as a single dose at any time of the day.

Pediatric Patients (10–16 years of age) with Heterozygous Familial Hypercholesterolemia: The usual starting dose is 20 mg once daily. Dose adjustments may be made at intervals of 6 weeks, up to a maximum of 40 mg twice daily or 80 mg once daily. Dosing should be individualized based on treatment goals.

• Cyclosporine: Co-administration increases fluvastatin levels; limit the dose to 20 mg.
• Fluconazole: Co-administration increases fluvastatin exposure; limit the dose to 20 mg.
• Concomitant lipid-lowering therapies: Use with fibrates or high-dose niacin (≥1 g/day) increases the risk of skeletal muscle adverse effects.
• Glyburide: Monitor blood glucose levels when adjusting fluvastatin dosage.
• Phenytoin: Monitor plasma phenytoin levels when initiating or modifying fluvastatin therapy.
• Warfarin and coumarin derivatives: Monitor prothrombin time when fluvastatin is started, stopped, or dose-adjusted.

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

The most commonly reported adverse reactions (≥2% and greater than placebo) include headache, dyspepsia, muscle pain (myalgia), abdominal pain, and nausea.

Pregnancy: Fluvastatin is contraindicated in women who are pregnant or may become pregnant. During normal pregnancy, serum cholesterol and triglyceride levels increase, and cholesterol derivatives are essential for fetal development. Fluvastatin may cause fetal harm if administered during pregnancy. Since atherosclerosis is a chronic condition, discontinuation of lipid-lowering therapy during pregnancy is unlikely to significantly affect long-term outcomes.Fluvastatin should only be used in women of childbearing potential if they are unlikely to conceive and have been informed about potential risks. If pregnancy occurs during treatment, the drug should be discontinued and the patient informed about possible harm to the fetus.

Nursing Mothers: Fluvastatin is excreted into animal breast milk. As HMG-CoA reductase inhibitors may cause serious adverse effects in nursing infants, women who require treatment with fluvastatin should avoid breastfeeding.

Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): The risk is higher in elderly patients (>65 years), those with uncontrolled hypothyroidism, renal impairment, or when used together with cyclosporine or gemfibrozil.

Patients should be instructed to immediately report any symptoms suggestive of myopathy. Treatment should be discontinued if myopathy is diagnosed or suspected.

Liver enzyme abnormalities: Persistent increases in hepatic transaminases may occur. Liver function tests should be performed prior to starting therapy and periodically thereafter as clinically indicated.

Other Anti-anginal & Anti-ischaemic drugs, Statins

Store below 30°C, protected from light and moisture. Keep out of reach of children.