A lipid-lowering agent belonging to the statin class. It works by inhibiting HMG-CoA reductase, the key enzyme in cholesterol biosynthesis, thereby reducing total cholesterol, LDL-C, and triglycerides while increasing HDL-C. Used primarily in the prevention and treatment of cardiovascular disease associated with hyperlipidemia.
Indications:
- Primary hypercholesterolemia (elevated LDL-C).
- Mixed dyslipidemia (elevated LDL-C and triglycerides).
- Secondary prevention of major cardiovascular events in patients with coronary heart disease.
- Slowing progression of atherosclerosis.
- Reduction of total cholesterol and LDL-C in pediatric patients (1016 years) with heterozygous familial hypercholesterolemia.
Main Active Ingredient:
- Fluvastatin sodium 80 mg (extended-release tablet).
Precautions:
- Contraindicated in patients with active liver disease or unexplained persistent elevations of liver transaminases.
- Contraindicated in pregnancy and breastfeeding.
- Use with caution in patients with renal impairment or history of alcohol abuse.
- Monitor liver function tests before initiation and periodically during therapy.
- Risk of myopathy and rhabdomyolysis increases with higher doses and in elderly patients.
- Discontinue immediately if unexplained muscle pain, weakness, or dark urine occurs.
- Not established for use in children <10 years of age.
Side Effects:
- Headache.
- Dizziness.
- Fatigue.
- Nausea.
- Dyspepsia.
- Diarrhea.
- Constipation.
- Elevated liver enzymes.
- Abdominal pain.
- Rash.
- Insomnia.
- Myopathy.
- Rhabdomyolysis.
- Hepatitis.
- Jaundice.
- Angioedema.
- Anaphylaxis.
Drug-Drug Interactions:
- Increased risk of myopathy with: Ciclosporin, fibrates, niacin, colchicine.
- CYP2C9 inhibitors.
- Warfarin.
- Rifampicin and phenytoin.
Fluvastatin sodium,Hydroxypropyl cellulose,Hypromellose,Magnesium stearate,Microcrystalline cellulose,Povidone,Sodium stearyl fumarate,Talc,Titanium dioxide,Iron oxides.