Crestor

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE CRESTOR is 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 additional CV risk factor. • As an adjunct to diet to: ∘ Reduce low-density lipoprotein cholesterol (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. CRESTOR is 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 2 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 CRESTOR, 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 CRESTOR dosage and administration modifications due to drug interactions. ( 2.6 ) 2.1 General Dosage and Administration Information • Administer CRESTOR orally as a single dose at any time of day, with or without food. Swallow the tablets whole. • Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating CRESTOR, and adjust the dosage if necessary. • If a dose is missed, advise patients not to take an extra dose. Resume treatment with the next dose. • When taking CRESTOR with an aluminum and magnesium hydroxide combination antacid, administer CRESTOR at least 2 hours before the antacid [see Drug Interactions (7.2) ]. 2.2 Recommended Dosage in Adult Patients • The dosage range for CRESTOR is 5 to 40 mg orally once daily. • The recommended dose of CRESTOR depends on a patient’s indication for usage, LDL-C, and individual risk for CV events. 2.3 Recommended Dosage in Pediatric Patients Dosage in Pediatric Patients 8 Years of Age and Older with HeFH The recommended dosage range is 5 mg to 10 mg orally once daily in patients aged 8 years to less than 10 years and 5 mg to 20 mg orally once daily in patients aged 10-years and older. Dosage in Pediatric Patients 7 Years of Age and Older with HoFH The recommended dosage is 20 mg orally once daily. 2.4 Dosing in Asian Patients Initiate CRESTOR at 5 mg once daily due to increased rosuvastatin plasma concentrations. Consider the risks and benefits of CRESTOR when treating Asian patients not adequately controlled at doses up to 20 mg once daily [see Warnings and Precautions (5.1) , Use in Specific Populations (8.8) , and Clinical Pharmacology (12.3) ] . 2.5 Recommended Dosage in Patients with Renal Impairment In patients with severe renal impairment (CLcr less than 30 mL/min/1.73 m2) not on hemodialysis, the recommended starting dosage is 5 mg once daily and should not exceed 10 mg once daily [see Warnin