Rosuvastatin

Preview FDA label, Glenmark Pharmaceutials Inc., USA, oral, effective 2026-08-07. Full label on DailyMed

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using. Not yet reviewed by a ClinDose pharmacist.

Dosing in kidney impairment

Recommended Dosage in Patients with Renal Impairment In patients with severe renal impairment (CL cr less than 30 mL/min/1.73 m 2 ) not on hemodialysis, the recommended starting dosage is 5 mg orally once daily and should not exceed 10 mg orally once daily [see Warnings and Precautions and Use in Specific Populations]. There are no dosage adjustment recommendations for patients with mild and moderate renal impairment.

Dosing in liver impairment

Hepatic Impairment Rosuvastatin is contraindicated in patients with acute liver failure or decompensated cirrhosis. Chronic alcohol liver disease is known to increase rosuvastatin exposure. Patients who consume substantial quantities of alcohol and/or have a history of liver disease may be at increased risk for hepatic injury [see Contraindications, Warning and Precautions and Clinical Pharmacology].

Preparation and administration

General Dosage and Administration Information

Administer rosuvastatin tablets 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 rosuvastatin tablets, 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 rosuvastatin tablets with an aluminum and magnesium hydroxide combination antacid, administer rosuvastatin tablets at least 2 hours before the antacid [see Drug Interactions] .