Lovastatin
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alonso Alvarado, M.D. [2]
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Overview
Lovastatin is a HMG-CoA Reductase Inhibitor that is FDA approved for the {{{indicationType}}} of prevention of coronary heart disease, hyperlipidemia, limitations of use. Common adverse reactions include abdominal pain, constipation, arthralgia.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Hyperlipidemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia (Fredrickson Types IIa and IIb)
- Dosing Information
- 20-60 mg/day, in single doses taken in the evening at bedtime.
Prevention of Coronary Heart Disease
- Dosing Information
- 20 to 60 mg ORALLY once daily at bedtime; adjust dose at intervals of 4 weeks or more
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information about Off-Label Guideline-Supported Use of Lovastatin in adult patients.
Non–Guideline-Supported Use
Atrial Fibrillation, Prophylaxis
Cerebrovascular Accident, Prophylaxis
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Lovastatin FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information about Off-Label Guideline-Supported Use of Lovastatin in pediatric patients.
Non–Guideline-Supported Use
There is limited information about Off-Label Non–Guideline-Supported Use of Lovastatin in pediatric patients.
Contraindications
- Concomitant administration of strong CYP3A inhibitors.
- Concomitant administration of erythromycin.
- Hypersensitivity to any component of this product.
- Women who are pregnant or may become pregnant.
- Because HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol. Additionally, there is no apparent benefit to therapy during pregnancy, and safety in pregnant women has not been established. If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus and the lack of known clinical benefit with continued use during pregnancy.
- Nursing mothers.
- Because another drug in this class passes into breast milk, and because HMG-CoA reductase inhibitors have the potential to cause serious adverse reactions in nursing infants.
Warnings
Skeletal Muscle Effects
Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with HMG-CoA reductase inhibitors, including Altoprev®. These risks can occur at any dose level, but increase in a dose-dependent manner. Predisposing factors for myopathy include advanced age (≥65 years), female gender, renal impairment, and inadequately treated hypothyroidism. In a clinical study (EXCEL) in which patients were carefully monitored and some interacting drugs were excluded, there was one case of myopathy among 4933 patients randomized to lovastatin 20-40 mg daily for 48 weeks, and 4 among 1649 patients randomized to 80 mg daily. There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use. IMNM is characterized by: proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; muscle biopsy showing necrotizing myopathy without significant inflammation; improvement with immunosuppressive agents. All patients starting therapy with Altoprev®, or whose dose of Altoprev® is being increased, should be advised of the risk of myopathy, including rhabdomyolysis, and told to report promptly any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever or if muscle signs and symptoms persist after discontinuing Altoprev. Altoprev therapy should be discontinued immediately if myopathy is diagnosed or suspected. Altoprev® therapy should be discontinued if markedly elevated creatine kinase (CK) levels occur or myopathy is diagnosed or suspected. Altoprev® therapy should also be temporarily withheld in any patient experiencing an acute or serious condition predisposing to the development of renal failure secondary to rhabdomyolysis, e.g., sepsis; hypotension; dehydration; major surgery; trauma; severe metabolic, endocrine, and electrolyte disorders; or uncontrolled epilepsy. Drug Interactions that can cause skeletal muscle effects
- Strong CYP3A Inhibitors
- The risk of myopathy and rhabdomyolysis is increased by high levels of statin activity in plasma. Lovastatin is metabolized by the cytochrome P450 isoform 3A4. Certain drugs which inhibit this metabolic pathway can raise the plasma levels of lovastatin and may increase the risk of myopathy. Co-administration of these drugs with Altoprev is contraindicated. If treatment with strong CYP3A inhibitors is unavoidable, therapy with Altoprev should be suspended during the course of treatment.
- Erythromycin
- Co-administration of erythromycin with Altoprev is contraindicated. If treatment with erythromycin is unavoidable, therapy with Altoprev should be suspended during the course of treatment.
- Gemfibrozil
- Avoid the combined use of Altoprev with gemfibrozil.
- Other lipid-lowering drugs (other fibrates, or lipid-lowering doses (≥ 1 g/day) of niacin
- 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. Carefully weigh the expected benefit of further alterations in lipid levels by the combined use of lovastatin with other fibrates or niacin against the potential risks of these combinations.
- Cyclosporine
- Avoid the combined use of Altoprev with cyclosporine.
- Danazol, diltiazem, dronedarone or verapamil with higher doses of lovastatin
- Do not exceed 20 mg of Altoprev daily in patients receiving concomitant therapy with danazol, diltiazem, dronedarone or verapamil. Weigh carefully the benefits of the use of Altoprev in patients receiving danazol, diltiazem, dronedarone or verapamil against the risks of these combinations.
- Amiodarone
- Do not exceed 40 mg of Altoprev daily in patients receiving concomitant therapy with amiodarone. Avoid the combined use of Altoprev at doses exceeding 40 mg daily with amiodarone unless the clinical benefit is likely to outweigh the increased risk of myopathy. The concomitant use of higher doses of a closely related member of the HMG-CoA reductase inhibitor class with amiodarone increased the risk of myopathy/rhabdomyolysis.
- Colchicine
- There have been cases of myopathy, including rhabdomyolysis, reported in patients receiving lovastatin coadministered with colchicine. Use caution when prescribing Altoprev with colchicine.
- Ranolazine
- Concomitant use of ranolazine and Altoprev may increase the risk of myopathy, including rhabdomyolysis. Consider dose adjustment of Altoprev if coadministering with ranolazine.
Prescribing recommendations for interacting agents are summarized in the table below.
Adverse Reactions
Clinical Trials Experience
Central Nervous System
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Cardiovascular
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Respiratory
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Gastrointestinal
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Hypersensitive Reactions
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Miscellaneous
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Condition 2
Central Nervous System
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Cardiovascular
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Respiratory
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Gastrointestinal
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Hypersensitive Reactions
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Miscellaneous
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Postmarketing Experience
(Description)
Drug Interactions
- Drug 1
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- Drug 4
- Drug 5
Drug 1
(Description)
Drug 2
(Description)
Drug 3
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Drug 4
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Drug 5
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Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
(Description)
Pregnancy Category (AUS):
(Description)
Labor and Delivery
(Description)
Nursing Mothers
(Description)
Pediatric Use
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Geriatic Use
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Gender
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Race
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Renal Impairment
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Hepatic Impairment
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Females of Reproductive Potential and Males
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Immunocompromised Patients
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Others
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Administration and Monitoring
Administration
(Oral/Intravenous/etc)
Monitoring
Condition 1
(Description regarding monitoring, from Warnings section)
Condition 2
(Description regarding monitoring, from Warnings section)
Condition 3
(Description regarding monitoring, from Warnings section)
IV Compatibility
Solution
Compatible
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Not Tested
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Variable
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Incompatible
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Y-Site
Compatible
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Not Tested
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Variable
- Solution 1
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Incompatible
- Solution 1
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Admixture
Compatible
- Solution 1
- Solution 2
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Not Tested
- Solution 1
- Solution 2
- Solution 3
Variable
- Solution 1
- Solution 2
- Solution 3
Incompatible
- Solution 1
- Solution 2
- Solution 3
Syringe
Compatible
- Solution 1
- Solution 2
- Solution 3
Not Tested
- Solution 1
- Solution 2
- Solution 3
Variable
- Solution 1
- Solution 2
- Solution 3
Incompatible
- Solution 1
- Solution 2
- Solution 3
TPN/TNA
Compatible
- Solution 1
- Solution 2
- Solution 3
Not Tested
- Solution 1
- Solution 2
- Solution 3
Variable
- Solution 1
- Solution 2
- Solution 3
Incompatible
- Solution 1
- Solution 2
- Solution 3
Overdosage
Acute Overdose
Signs and Symptoms
(Description)
Management
(Description)
Chronic Overdose
Signs and Symptoms
(Description)
Management
(Description)
Pharmacology
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Lovastatin
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Mechanism of Action
(Description)
Structure
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Pharmacodynamics
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Pharmacokinetics
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Nonclinical Toxicology
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Clinical Studies
Condition 1
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Condition 2
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Condition 3
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How Supplied
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Storage
There is limited information regarding Lovastatin Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
(Patient Counseling Information)
Precautions with Alcohol
Alcohol-Lovastatin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Lovastatin Brand Names in the drug label.
Look-Alike Drug Names
- (Paired Confused Name 1a) — (Paired Confused Name 1b)
- (Paired Confused Name 2a) — (Paired Confused Name 2b)
- (Paired Confused Name 3a) — (Paired Confused Name 3b)
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.