General Dosage and Administration Information

•

Administer CRESTOR orally as a single dose at any time of day, with or without food. The tablet should be swallowed 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 take an extra dose. Resume treatment with the next dose.

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 cardiovascular events.

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.

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)].

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 Warnings and Precautions (5.1) and Use in Specific Populations (8.6)].

There are no dosage adjustment recommendations for patients with mild and moderate renal impairment.

Dosage and Administration Modifications Due to Drug Interactions

CRESTOR Dosage Modifications Due to Drug Interactions

Table 1 displays dosage modifications for CRESTOR due to drug interactions [see Warnings and Precautions (5.1) and Drug Interactions (7.1)].

CRESTOR Administration Modifications Due to Drug Interactions

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)].