Rosuvastatin 5 mg Tablets — Generic For Crestor

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 Calcium is an HMG Co-A reductase inhibitor (statin) indicated: (1)

o reduce 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).

o Primary dysbetalipoproteinemia.

o 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 calcium, 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 calcium 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 calcium. (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 calcium dosage. Asian patients may be at higher risk for myopathy. Discontinue rosuvastatin calcium if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Temporarily discontinue rosuvastatin calcium 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 calcium 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 calcium 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 calcium. (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 calcium dosage. Asian patients may be at higher risk for myopathy. Discontinue rosuvastatin calcium if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Temporarily discontinue rosuvastatin calcium 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 calcium 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 calcium 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 calcium. (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 calcium dosage. Asian patients may be at higher risk for myopathy. Discontinue rosuvastatin calcium if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Temporarily discontinue rosuvastatin calcium 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 calcium 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 calcium 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 calcium. (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 Novadoz Pharmaceuticals LLC at 1-855-668-2369 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 calcium with other drugs that increase the risk of myopathy and rhabdomyolysis. (7.1)

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

Warfarin: Obtain INR prior to starting rosuvastatin calcium. 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 calcium. (8.2)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 11/2024