Amvastan Tablet 20 mg

Composition:

Each film-coated tablet contains:

• Active ingredient: Atorvastatin 20 mg (as atorvastatin calcium trihydrate)

• Excipients: Calcium carbonate, lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, sucrose stearate, magnesium stearate, Opadry white Y 1-7000

Indications:

Amvastan is indicated as an adjunct to diet for the treatment of:

• Primary hypercholesterolemia (familial and non-familial heterozygous) and mixed dyslipidemia (Fredrickson Type IIa and IIb) to lower elevated total cholesterol, LDL-C, ApoB, and triglycerides, and to increase HDL-C

• Hypertriglyceridemia (Fredrickson Type IV) in patients unresponsive to diet alone

• Dysbetalipoproteinemia (Fredrickson Type III) when diet therapy is inadequate

• Homozygous familial hypercholesterolemia (HoFH) to reduce total cholesterol and LDL-C, when response to diet and other non-pharmacological measures is inadequate

• Heterozygous familial hypercholesterolemia in boys and post-menarche girls aged 10-17 years, with LDL-C ≥190 mg/dL or LDL-C ≥160 mg/dL with family history of early cardiovascular disease or two or more CVD risk factors

• Cardiovascular disease prevention: to reduce the risk of myocardial infarction, stroke, revascularization procedures, and hospitalization due to angina in patients with multiple risk factors, including those without clinically evident coronary heart disease (e.g., age >55, smoking, hypertension, genetic predisposition)

Contraindications:

• Hypersensitivity to any component of the product

• Active liver disease or unexplained persistent elevations in hepatic transaminases (>3 times the upper limit of normal)

• Pregnancy and breastfeeding

• Women of childbearing potential not using adequate contraception

Dosage and Administration:

• Treatment should begin with a standard cholesterol-lowering diet and maintained throughout therapy

• Tablets can be taken at any time of day, with or without food

• Initial dose: 10-20 mg once daily

• Patients requiring >45% LDL-C reduction: starting dose of 40 mg may be considered

• Maximum dose: 80 mg once daily

• Lipid levels should be assessed within 2–4 weeks and dosage adjusted accordingly

Special populations:

• Pediatric (10–17 years): Start with 10 mg once daily; max dose 20 mg/day. Dose adjustments should be made at intervals of ≥4 weeks

• HoFH patients: 10–80 mg/day as adjunctive therapy or monotherapy when others are unavailable

• CVD prevention in adults: start at 10 mg/day

Storage:

Store below 25°C. Keep out of reach of children.