Lovastatin drug interactions

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Lovastatin
ALTOPREV® FDA Package Insert
Indications and Usage
Dosage and Administration
Dosage Forms and Strengths
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Description
Clinical Pharmacology
Nonclinical Toxicology
Clinical Studies
How Supplied/Storage and Handling
Labels and Packages
Clinical Trials on Lovastatin
ClinicalTrials.gov

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]

Drug Interactions

Drug interaction studies have not been performed with Altoprev®. The types, frequencies and magnitude of drug interactions that may be encountered when Altoprev® is administered with other drugs may differ from the drug interactions encountered with the lovastatin immediate-release formulation. In addition, as the drug exposure with Altoprev® 60 mg is greater than that with lovastatin immediate-release 80 mg (maximum recommended dose), the severity and magnitude of drug interactions that may be encountered with Altoprev® 60 mg are not known. It is therefore recommended that the following precautions and recommendations for the concomitant administration of lovastatin immediate-release with other drugs be interpreted with caution, and that the monitoring of the pharmacologic effects of Altoprev® and/or other concomitantly administered drugs be undertaken where appropriate.

Strong CYP 3A Inhibitors

Lovastatin is metabolized by CYP3A4 but has no CYP3A inhibitory activity; therefore it is not expected to affect the plasma concentrations of other drugs metabolized by CYP3A. Strong inhibitors of CYP3A (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, clarithromycin, telithromycin, HIV protease inhibitors, boceprevir, telaprevir, and nefazodone), increase the risk of myopathy by reducing the elimination of lovastatin. The use of lovastatin with strong CYP3A inhibitors is contraindicated [see Contraindications (4), Warnings and Precautions (5.1 ), andClinical Pharmacology (12.3)].

Erythromycin

Do not use Altoprev concomitantly with erythromycin [see Contraindications (4) and Warnings and Precautions (5.1)].

Interactions With Lipid-Lowering Drugs That Can Cause Myopathy When Given Alone

The risk of myopathy is also increased by the following lipid-lowering drugs that are not strong CYP3A inhibitors, but which can cause myopathy when given alone. [seeWarnings and Precautions (5.1)].

Gemfibrozil – Avoid the concomitant use of Altoprev with gemfibrozil [see Warnings and Precautions (5.1)].

Other fibrates - Use caution when prescribing Altoprev with other fibrates. [see Warnings and Precautions (5.1)].

Niacin (nicotinic acid) (≥1 g/day) - Use caution when prescribing Altoprev with lipid-modifying (≥1 g/day) doses of niacin. [see Warnings and Precautions (5.1)].

Cyclosporine

Avoid the concomitant use of Altoprev with cyclosporine [see Warnings and Precautions (5.1)].

Danazol, Diltiazem, Dronedarone or Verapamil

Do not exceed 20 mg of Altoprev daily in patients receiving concomitant therapy with danazol, diltiazem, dronedarone, or verapamil. [see Dosage and Administration (2.3), Warnings and Precautions (5.1), and Clinical Pharmacology (12.3)].

Amiodarone

Do not exceed 40 mg of Altoprev daily in patients receiving concomitant therapy with amiodarone. [see Dosage and Administration (2.3), Warnings and Precautions (5.1)].

Coumarin Anticoagulants

In a small clinical trial in which lovastatin was administered to warfarin treated patients, no effect on prothrombin time was detected. However, another HMG-CoA reductase inhibitor has been found to produce a less than two second increase in prothrombin time in healthy volunteers receiving low doses of warfarin. Also, bleeding and/or increased prothrombin time has been reported in a few patients taking coumarin anticoagulants concomitantly with lovastatin. In patients taking anticoagulants, prothrombin time should be determined before starting Altoprev and frequently enough during early therapy to ensure that no significant alteration of prothrombin time occurs. Once a stable prothrombin time has been documented, prothrombin times can be monitored at the intervals usually recommended for patients on coumarin anticoagulants. If the dose of Altoprev is changed, the same procedure should be repeated. Lovastatin therapy has not been associated with bleeding or with changes in prothrombin time in patients not taking anticoagulants.

Colchicine

Cases of myopathy, including rhabdomyolysis have been reported with lovastatin coadministered with colchicine. Exercise caution when prescribing Altoprev with colchicine.

Ranolazine

The risk of myopathy, including rhabdomyolysis, may be increased by concomitant administration of ranolazine. Exercise caution when prescribing Altoprev with ranolazine. Dose adjustment of Altoprev may be necessary during coadministration with ranolazine.

Propranolol

In normal volunteers, there was no clinically significant pharmacokinetic or pharmacodynamic interaction with concomitant administration of single doses of lovastatin and propranolol.

Digoxin

In patients with hypercholesterolemia, concomitant administration of lovastatin and digoxin resulted in no effect on digoxin plasma concentrations.

Oral Hypoglycemic Agents

In pharmacokinetic studies of lovastatin immediate-release in hypercholesterolemic non-insulin dependent diabetic patients, there was no drug interaction with glipizide or with chlorpropamide.[1]

References

  1. "ALTOPREV (LOVASTATIN) TABLET, EXTENDED RELEASE [SHIONOGI INC.]". Retrieved 13 February 2014.

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