Fluvastatin

Introduction: Fluvastatin belongs to a group of medicines called statins. It is used to lower cholesterol and to reduce the risk of heart disease. Cholesterol is a fatty substance that builds up in your blood vessels and causes narrowing, which may lead to a heart attack or stroke.

How it works: 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.

Important Information: This medicine can be taken with a meal or on an empty stomach. Try to take it at the same time each day. Treatment program should also include a healthy diet, regular exercise, smoking cessation, moderation of alcohol intake and weight reduction.

• 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.

Statins

HMG-CoA reductase inhibitor

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.

Fluvastatin inhibits HMG-CoA reductase enzyme to reduce cholesterol production in the liver, resulting in decreased blood cholesterol levels.

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

Oral capsule. Can be taken with or without food, but better to take at a fixed time. Swallow whole, do not break, crush or chew or open capsules.

If you miss a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose.

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

• Headache
• Dyspepsia
• Myalgia
• Abdominal pain
• Nausea

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.

Contraindications:

• Active liver disease or unexplained persistently raised serum aminotransferase concentrations
• Porphyria
• Pregnancy and lactation
• Hypersensitivity to any component

Drug Interactions:

• Bleeding and increased prothrombin time with coumarin anticoagulants.
• May increase risk of myopathy and rhabdomyolysis with HIV protease inhibitors, colchicine, bezafibrate, ciprofibrate or niacin, ciclosporin and fluconazole.
• Reduced bioavailability with rifampicin.

Food Interactions:

• Caution is advised when consuming alcohol. Please consult your doctor.

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

Use in Lactation: Unsafe during breastfeeding. Data suggests the drug may cause toxicity to the baby.

Pediatric Use: Dosage available for children 10-16 years with heterozygous familial hypercholesterolemia.

Geriatric Use: Elderly patients (>65) have higher risk of muscle effects. Use with caution.

Renal Impairment: Use with caution in severe kidney disease (CrCl <30 mL/min). Max 40 mg/day.

Hepatic Impairment: Do not use in active liver disease. Not recommended in severe liver disease.

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.

Fluvastatin Capsule