Basic Information
DR. REDDY'S ATORVASTATIN FILM COATED TABLET 20MG USP
TABLET, FILM COATED
Regulatory Information
SIN16921P
December 26, 2023
Prescription Only
Therapeutic
ORAL
January 24, 2024
June 4, 2025
XC10AA05
Company Information
Active Ingredients
Detailed Information
Contraindications
**Contraindications** Atorvastatin is contraindicated in patients: - with hypersensitivity to the active substance or to any of the excipients used in this medication. - with active liver disease or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal (ULN) - during pregnancy, breast-feeding, or in women of child-bearing potential not using appropriate contraceptive measures. Atorvastatin should be administered to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards to the fetus. - concomitantly treated with glecaprevir/pibrentasvir.
Indication Information
**4.1 Therapeutic Indications** Hypercholesterolaemia Atorvastatin is indicated as an adjunct to diet for reduction of elevated total cholesterol (total-C), low density lipoprotein-cholesterol (LDL-C), apolipoprotein B (apo B), and triglycerides (TG) in adults, adolescents and children aged 10 years or older with primary hypercholesterolaemia, heterozygous familial hypercholesterolaemia, or combined (mixed) hyperlipidaemia (Fredrickson Types IIa and IIb), elevated serum TG levels (Fredrickson Type IV), and for patients with dysbetalipoproteinemia (Fredrickson Type III) when response to diet and other nonpharmacological measures is inadequate. Atorvastatin also raises high density lipoprotein cholesterol (HDL-C) and lowers the LDL/HDL and total-C/HDL ratios. Atorvastatin is also indicated to reduce total-C and LDL-C in adults with homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable. Prevention of cardiovascular disease Atorvastatin is indicated to reduce the risk of myocardial infarction (MI) in adult hypertensive patients without clinically evident coronary heart disease (CHD), but with at least three additional risk factors for CHD such as age ≥55 years, male sex, smoking, left ventricular hypertrophy, other specified abnormalities on electrocardiogram (ECG), microalbuminuria or proteinuria, ratio of plasma total-C to HDL-C ≥6, or premature family history of CHD. In adults with type 2 diabetes and without clinically evident CHD, but with multiple risk factors for CHD such as retinopathy, albuminuria, smoking or hypertension, atorvastatin is indicated to: - Reduce the risk of MI. - Reduce the risk of stroke. In adults with clinically evident CHD, atorvastatin is indicated to: - Reduce the risk of non-fatal MI. - Reduce the risk of fatal and non-fatal stroke. - Reduce the risk for revascularization procedures. - Reduce the risk of hospitalization for congestive heart failure (CHF). - Reduce the risk of angina.