Pravastatin

Preview FDA label, Safecor Health LLC, oral, effective 2026-07-01. 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, the recommended starting dosage is pravastatin sodium 10 mg once daily. The maximum recommended dosage of pravastatin sodium tablets in patients with severe renal impairment is 40 mg once daily [see Clinical Pharmacology ]. The recommended dosage of pravastatin sodium tablets for patients with mild or moderate renal impairment is the same as patients with normal renal function.

Dosing in liver impairment

Hepatic Impairment Pravastatin shows a large inter-subject variability in pharmacokinetics in patients with liver cirrhosis [ Clinical Pharmacology ] . Pravastatin is contraindicated in patients with acute liver failure or decompensated cirrhosis [see Contraindications , Warnings and Precautions ].

Preparation and administration

Important Dosage and Administration Information Take pravastatin sodium tablets orally once daily as a single dose at any time of the day, with or without food. For patients that require a high-intensity statin or are unable to achieve their LDL-C goal receiving pravastatin sodium tablets 80 mg daily, prescribe alternative LDL-C-lowering treatment.

Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating pravastatin sodium tablets, and adjust the dosage if necessary.

Dosage and Administration Modifications Due to Drug Interactions In patients taking a bile acid sequestrant, administer pravastatin sodium tablets at least 1 hour before or 4 hours after the bile acid sequestrant [see Drug Interactions ]. Concomitant use of pravastatin sodium tablets with the following drugs requires dosage modifications of pravastatin sodium tablets [see Warnings and Precautions and Drug Interactions ] : º Cyclosporine In patients taking cyclosporine, the recommended starting dosage is pravastatin sodium 10 mg once daily.

The maximum recommended dosage of pravastatin sodium tablets in patients taking cyclosporine is 20 mg once daily. º Clarithromycin and Erythromycin The maximum recommended dosage is pravastatin sodium tablets 40 mg once daily.