Statin Dose Discontinued, May Affect Patients with Renal Impairment

The update removes the 10mg dose from the labeling of Pravachol
The update removes the 10mg dose from the labeling of Pravachol

The Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Pravachol (pravastatin sodium; Bristol Myers Squibb) which removes the 10mg dose from the labeling. According to the updated prescribing information, patients with severe renal impairment who require the 10mg daily starting dose should be switched to generic pravastatin. 

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In addition, the Drug Interactions section has been updated with information regarding the potential for other macrolides (eg, erythromycin, azithromycin) to increase statin exposure when these drugs are used concomitantly. Pravastatin should be used cautiously with macrolide antibiotics due to a potentially increased risk of myopathies.

Pravachol is an HMG-CoA reductase inhibitor indicated for the treatment of dyslipidemia. The 20mg, 40mg, and 80mg strength tablets are still available.

For more information call (800) 21-5072 or visit BMSmedinfo.com.

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