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Drug DescriptionSide Effects & Drug InteractionsWarnings & Precautions
Clinical PharmacologyOverdosage & ContraindicationsIndications & DosagePatient Info

Pravachol

[Pravastatin]


Patient Info
Information for Patients

Patients should be advised to report promptly unexplained muscle pain, tenderness or weak-ness, particularly if accompanied by malaise or fever (see WARNINGS: Skeletal Muscle).

Drug Interactions

Text Continues Below



Immunosuppressive Drugs, Gemfibrozil, Niacin (Nicotinic Acid), Erythromycin: See WARNINGS:

Skeletal Muscle.

Cytochrome P450 3A4 Inhibitors:

In vitro and in vivo data indicate that pravastatin is not metabolized by cytochrome P450 3A4 to a clinically significant extent. This has been shown in studies with known cytochrome P450 3A4 inhibitors (see diltiazem and itraconazole below). Other examples of cytochrome P450 3A4 inhibitors include ketoconazole, mibefradil, and ery-thromycin. Diltiazem: Steady-state levels of diltiazem (a known, weak inhibitor of P450 3A4) had no effect on the pharmacokinetics of pravastatin. In this study, the AUC and C max of another HMG-CoA reductase inhibitor which is known to be metabolized by cytochrome P450 3A4 increased by factors of 3.6 and 4.3, respectively.

Itraconazole:

The mean AUC and C max for pravastatin were increased by factors of 1.7 and 2.5, respectively, when given with itraconazole (a potent P450 3A4 inhibitor which also inhibits p-glycoprotein transport) as compared to placebo. The mean t was not affected by itracona-zole, suggesting that the relatively small increases in C max and AUC were due solely to increased bioavailability rather than a decrease in clearance, consistent with inhibition of p-glycoprotein transport by itraconazole.

This drug transport system is thought to affect bioavailability and excretion of HMG-CoA reductase inhibitors, including pravastatin. The AUC and C max of another HMG-CoA reductase inhibitor which is known to be metabolized by cytochrome P450 3A4 increased by factors of 19 and 17, respectively, when given with itraconazole. Antipyrine: Since concomitant administration of pravastatin had no effect on the clearance of antipyrine, interactions with other drugs metabolized via the same hepatic cytochrome isozymes are not expected.

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