Lesterol

• Primary hypercholesterolemia and mixed dyslipidemia: Reduce elevated TC, LDL-C, Apo B, TG, and increase HDL-C in adult patients.
• Heterozygous familial hypercholesterolemia: In boys and post-menarchal girls, 10 to 16 years of age, after failing an adequate trial of diet therapy.
• Reduce the risk of revascularization procedures: in patients with clinically evident CHD.
• Slow the progression of atherosclerosis: in patients with CHD.

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.

Adult Dose (Hypercholesterolemia & Mixed Dyslipidemia):

• Initially: 20-40 mg once daily in the evening.
• May be increased at intervals of 4 weeks to max 80 mg/day in divided doses.

Child Dose (Heterozygous familial hypercholesterolaemia, 10-16 years):

• Initially: 20 mg once daily.
• If necessary, may increase dose at 6-weekly intervals to 40 mg bid or 80 mg once daily.

Renal Impairment (CrCl <30 mL/min):

• Not to exceed 40 mg/day.

Hepatic Impairment: Contraindicated in active liver disease or unexplained transaminase elevations.

* Use as directed by the registered physician

Common Side Effects (rate ≥2% and > placebo):

• Headache
• Dyspepsia
• Myalgia
• Abdominal pain
• Nausea

Use in Pregnancy: Highly unsafe during pregnancy. Studies have shown significant harmful effects to the developing baby.

Precautions:

• Skeletal muscle effects (myopathy and rhabdomyolysis): Risks increase with advanced age (>65), uncontrolled hypothyroidism, renal impairment, and combination use with cyclosporine or gemfibrozil.
• Report any symptoms of myopathy promptly.
• Check liver enzyme tests before initiating therapy and as clinically indicated thereafter.
• Diabetic patients should monitor blood glucose levels.
• Avoid during pregnancy and lactation.

Overdose: Overdose may cause muscle pain, liver enzyme elevation. Gastric lavage and supportive measures.

Storage: Keep below 30°C, away from light and moisture. Keep out of reach of children.