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Altoprev

Generic Name: Lovastatin
Drug Category: Statin
Litigation Alert Level: High
This drug has been approved for use by males and females over the age of 18 years old for a maximum duration of 5 years.

Approved Uses

Indicated as an adjunctive therapy to diet for:

Prevention of Coronary Heart Disease:

In patients without symptomatic coronary heart disease (CHD), but at high risk, Altoprev is indicated to reduce the risk of: myocardial infarction, unstable angina, and coronary revascularization procedures.

Coronary Heart Disease:

• Slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower Total-C and LDL-C to target levels.

Hyperlipidemia:

• The reduction of elevated Total-C, LDL-C, Apo B, and TG, and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and non-familial) and mixed dyslipidemia (Fredrickson types IIa and IIb).

Altoprev has not been studied in Fredrickson Types I, III, and V dyslipidemias.

The usual recommended starting dose in elderly patients (age≥65 years) is 20 mg once a day given in the evening at bedtime. Higher doses should be used only after careful consideration of the potential risks and benefits.

Skeletal muscle effects (e.g., myopathy and rhabdomyolysis) Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with HMG-CoA reductase inhibitors, including Altoprev. Predisposing factors include advanced age (≥ 65), female gender, uncontrolled hypothyroidism, and renal impairment.

There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use.

It is recommended that liver enzyme tests be obtained prior to initiating therapy with Altoprev and repeated as clinically indicated. There have been rare postmarketing reports of fatal and nonfatal hepatic failure in patients taking statins, including lovastatin.

The drug should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of chronic liver disease. Active liver disease or unexplained transaminase elevations are contraindications to the use of Altoprev.

There have been rare postmarketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use. These cognitive issues have been reported for all statins.

Altoprev is contraindicated with the following:

  • Concomitant administration of strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, posaconazole, voriconazole, clarithromycin, telithromycin, HIV protease inhibitors, boceprevir, telaprevir, and nefazodone)
  • Concomitant administration of erythromycin
  • Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
  • Women who are pregnant or may become pregnant
  • Nursing mothers

Avoid the combined use of Altoprev with gemfibrozil.

Avoid the combined use of Altoprev with cyclosporine.

Avoid grapefruit juice.

In patients taking Danazol, Diltiazem, Dronedarone, or Verapamil the dose of Altoprev should not exceed 20 mg/day.

In patients taking Amiodarone the dose of Altoprev should not exceed 40 mg/day.

Concomitant use of ranolazine and Altoprev may increase the risk of myopathy, including rhabdomyolysis.

There have been cases of myopathy, including rhabdomyolysis, reported in patients receiving lovastatin co-administered with colchicine.

Use caution when prescribing other fibrates or lipid-lowering doses (≥ 1 g/day) of niacin with Altoprev, as these agents can cause myopathy when given alone and the risk is increased when they are coadministered with Altoprev.

Caution should also be exercised if an HMG-CoA reductase inhibitor or other agent used to lower cholesterol levels is administered to patients also receiving other drugs (e.g., spironolactone, cimetidine) that may decrease the levels or activity of endogenous steroid hormones.

Use caution when prescribing Altoprev with lipid-modifying (≥1 g/day) doses of niacin.

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.

Altoprev is contraindicated for use in pregnant women since safety in pregnant women has not been established and there is no apparent benefit to therapy with Altoprev during pregnancy. Because HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, Altoprev may cause fetal harm when administered to pregnant women.

Altoprev is contraindicated during breastfeeding.

GoToSource

Off-label Uses

• Use in patients under the age of 18. GoToSource

• Use to slow progression of aortic valve disease in aortic sclerosis and mild aortic stenosis. GoToSource

• Recurrent or metastatic squamous cell carcinoma of the head and neck or of the cervix. GoToSource

Adverse Events

Cognitive impairment (memory loss and confusion), increased blood sugar and glycosylated hemoglobin (HbA1c) levels and liver injury. GoToSource

Myopathy (disease of skeletal muscle) and rhabdomyolysis (breakdown of muscle tissue). GoToSource

Litigation

Lawsuits filed for rhabdomyolysis, kidney failure, diabetes and death. 

The material contained in GoToPills is for informational purposes only and not intended to replace the judgment, evaluation and treatment of physicians, pharmacists and other healthcare providers. GoToPills does not provide medical advice, diagnoses or treatment. Always seek the advice of your physician or other qualified health provider regarding a medical condition or treatment.

 

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Site Last Updated March 29, 2024