Rosuvastatin 5 mg Tablets — Generic For Crestor — Aurobindo

These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS.

ROSUVASTATIN tablets, for oral use

Initial U.S. Approval: 2003

Recent Major Changes

Indications and Usage (1) 07/2024

Indications And Usage

Rosuvastatin tablets are an HMG Co-A reductase inhibitor (statin) indicated: (1)

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 additional CV risk factor.

As an adjunct to diet to:

reduce LDL-C in adults with primary hyperlipidemia.

reduce LDL-C and slow the progression of atherosclerosis in adults.

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:

Primary dysbetalipoproteinemia.

Hypertriglyceridemia.

Dosage And Administration

Take orally with or without food, at any time of day. (2.1)

Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating rosuvastatin tablets, and adjust dosage if necessary. (2.1)

Adults: Recommended dosage range is 5 to 40 mg once daily. (2.1)

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. (2.2)

Pediatric Patients with HoFH: Recommended dosage is 20 mg once daily for patients aged 7 years and older. (2.2)

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. (2.4)

Patients with Severe Renal Impairment (not on hemodialysis): Initiate at 5 mg once daily; do not exceed 10 mg once daily. (2.5)

See full prescribing information for rosuvastatin tablets dosage and administration modifications due to drug interactions. (2.6)

Dosage Forms And Strengths

Tablets: 5 mg, 10 mg, 20 mg, and 40 mg of rosuvastatin. (3)

Contraindications

Acute liver failure or decompensated cirrhosis. (4)

Hypersensitivity to rosuvastatin or any excipients in rosuvastatin tablets. (4)

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. Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing rosuvastatin dosage. Instruct patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. (5.1)
• Immune-Mediated Necrotizing Myopathy (IMNM): Rare reports of IMNM, an autoimmune myopathy, have been reported with statin use. Discontinue rosuvastatin if IMNM is suspected. (5.2)
• Hepatic Dysfunction: Increases in serum transaminases have occurred, some persistent. Rare reports of fatal and non-fatal hepatic failure have occurred. Consider testing liver enzymes before initiating therapy and as clinically indicated thereafter. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue rosuvastatin. (5.3)

• 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. Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing rosuvastatin dosage. Instruct patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. (5.1)
• Immune-Mediated Necrotizing Myopathy (IMNM): Rare reports of IMNM, an autoimmune myopathy, have been reported with statin use. Discontinue rosuvastatin if IMNM is suspected. (5.2)
• Hepatic Dysfunction: Increases in serum transaminases have occurred, some persistent. Rare reports of fatal and non-fatal hepatic failure have occurred. Consider testing liver enzymes before initiating therapy and as clinically indicated thereafter. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue rosuvastatin. (5.3)

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. Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing rosuvastatin dosage. Instruct patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. (5.1)

Immune-Mediated Necrotizing Myopathy (IMNM): Rare reports of IMNM, an autoimmune myopathy, have been reported with statin use. Discontinue rosuvastatin if IMNM is suspected. (5.2)

Hepatic Dysfunction: Increases in serum transaminases have occurred, some persistent. Rare reports of fatal and non-fatal hepatic failure have occurred. Consider testing liver enzymes before initiating therapy and as clinically indicated thereafter. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue rosuvastatin. (5.3)

Adverse Reactions

Most frequent adverse reactions (rate ≥2%) are headache, nausea, myalgia, asthenia, and constipation. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

See full prescribing information for details regarding concomitant use of rosuvastatin with other drugs that increase the risk of myopathy and rhabdomyolysis. (7.1)

Aluminum and Magnesium Hydroxide Combination Antacids: Administer rosuvastatin at least 2 hours before the antacid. (7.2)

Warfarin: Obtain INR prior to starting rosuvastatin. Monitor INR frequently until stable upon initiation, dose titration or discontinuation. (7.3)

Use In Specific Populations

Pregnancy: May cause fetal harm. (8.1)

Lactation: Breastfeeding not recommended during treatment with rosuvastatin. (8.2)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 9/2024