Rosuvastatin

What it is and how it works

Mechanism of Action Rosuvastatin is an inhibitor of HMG-CoA reductase, the rate‑limiting enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to mevalonate, a precursor of cholesterol.

Indications

Rosuvastatin tablets are indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one add itional CV risk factor. As an adjunct to diet to: O Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. O Reduce LDL-C and slow the progression of atherosclerosis in adults. O Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: O Primary dysbetalipoproteinemia. O Hypertriglyceridemia.

Dosage and administration (summary)

Take orally with or without food, at any time of day. Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating rosuvastatin tablets, and adjust dosage if necessary. Adults: Recommended dosage range is 5 to 40 mg once daily. Pediatric Patients with HeFH : Recommended dosage range is 5 to 10 mg once daily for patients aged 8 to less than 10 years of age, and 5 to 20 mg once daily for patients aged 10 years and older. Pediatric Patients with HoFH : Recommended dosage is 20 mg once daily for patients aged 7 years and older. Asian Patients: Initiate at 5 mg once daily. Consider risks and benefits of treatment if not adequately controlled at doses up to 20 mg once daily.

Contraindications

Rosuvastatin tablets are contraindicated in the following conditions: Acute liver failure or decompensated cirrhosis . Hypersensitivity to rosuvastatin or any excipients in rosuvastatin tablets. Hypersensitivity reactions including rash, pruritus, urticaria, and angioedema have been reported with rosuvastatin tablets . Acute liver failure or decompensated cirrhosis. Hypersensitivity to rosuvastatin or any excipients in rosuvastatin tablets.

Warnings and precautions

Myopathy and Rhabdomyolysis: Risk factors include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs, and higher rosuvastatin dosage. Asian patients may be at higher risk for myopathy. Discontinue rosuvastatin if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Temporarily discontinue rosuvastatin in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis.

Pregnancy

Pregnancy Risk Summary Discontinue rosuvastatin when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. Rosuvastatin decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol.

Storage and supply

Rosuvastatin tablets USP are supplied as: Manufacturer: Recipharm Pharmaservices Private Limited Manufacturer: Biocon Pharma Limited NDC 70377-006-11: 5 mg. Yellow, round, biconvex, film-coated tablets, debossed with '5' on one side and 'B' on other side; bottle of 30 tablets NDC 70377-006-11: 5 mg.

Source: Rosuvastatin Calcium (Rosuvastatin Calcium) — US FDA prescribing information, 2025-05-30, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.