Drug Detail:Altocor (Lovastatin [ loe-va-sta-tin ])
Drug Class: Statins
Usual Adult Dose for Hyperlipidemia
Immediate-release formulation:
Initial dose: 20 mg orally once a day with the evening meal
Maintenance dose: 10 to 80 mg orally once a day or in 1 or 2 divided doses
Extended-release formulation: 20 to 60 mg orally once a day with the evening meal
Comments:
- Patients should be on a standard cholesterol-lowering diet prior to initiating drug therapy and should continue on this diet during treatment.
- This drug has not been studied in Fredrickson Types I, III, and V hyperlipidemia.
Uses:
- Hyperlipidemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia: For the reduction of elevated total-C and LDL-C, Apo B, and TG, and to increase HDL-C
- Coronary Heart Disease (CHD): To slow the progression of coronary atherosclerosis in patients with CHD as part of a treatment strategy to lower total-C and LDL-C to target levels
- Primary Prevention of Coronary Heart Disease: To reduce the risk of myocardial infarction, unstable angina, and coronary revascularization procedures in patients with average to moderately elevated total-C and LDL-C and below average HDL-C, and no symptomatic cardiovascular disease
Usual Adult Dose for Prevention of Cardiovascular Disease
Immediate-release formulation:
Initial dose: 20 mg orally once a day with the evening meal
Maintenance dose: 10 to 80 mg orally once a day or in 1 or 2 divided doses
Extended-release formulation: 20 to 60 mg orally once a day with the evening meal
Comments:
- Patients should be on a standard cholesterol-lowering diet prior to initiating drug therapy and should continue on this diet during treatment.
- This drug has not been studied in Fredrickson Types I, III, and V hyperlipidemia.
Uses:
- Hyperlipidemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia: For the reduction of elevated total-C and LDL-C, Apo B, and TG, and to increase HDL-C
- Coronary Heart Disease (CHD): To slow the progression of coronary atherosclerosis in patients with CHD as part of a treatment strategy to lower total-C and LDL-C to target levels
- Primary Prevention of Coronary Heart Disease: To reduce the risk of myocardial infarction, unstable angina, and coronary revascularization procedures in patients with average to moderately elevated total-C and LDL-C and below average HDL-C, and no symptomatic cardiovascular disease
Usual Pediatric Dose for Heterozygous Familial Hypercholesterolemia
10 years or older:
Immediate-release: 10 to 40 mg orally once a day
Extended-release: Not recommended
Comments:
- Doses should be individualized; dosage adjustments should be made no earlier than every 4 weeks
- This drug is indicated to reduce total cholesterol, LDL-C, and apolipoprotein B levels.
- Doses greater than 40 mg/day have not been studied in pediatric patients; this drug has not been studied in pre-pubertal patients.
Uses: As an adjunct to diet in pediatric patients over 10 years old with heterozygous familial hypercholesterolemia who are at least one year post-menarche and whose
- LDL-C remains greater than 189 mg/dL or
- LDL-C remains greater than 160 mg/dL and there is a positive family history of premature cardiovascular disease (CVD) or in the presence of 2 or more other CVD risk factors
Renal Dose Adjustments
CrCl less than 30 mL/min: Dosage increases above 20 mg orally once a day should be done with careful monitoring for adverse reactions
Liver Dose Adjustments
Active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels: Contraindicated
- Use caution in patients who consume substantial quantities of alcohol and/or have a past history of liver disease
Dose Adjustments
Elderly: Due to age being a predisposing factor for myopathy, elderly patients should initiate therapy at the lowest dose and higher doses should only be used after careful consideration of the potential risks and benefits
DRUG INTERACTIONS:
- Concomitant administration of strong CYP450 3A4 inhibitors (including erythromycin) is contraindicated
- Avoid coadministration with gemfibrozil, cyclosporine, and grapefruit juice
- Lovastatin should not exceed 20 mg/day when coadministered with danazol, diltiazem, dronedarone, and verapamil
- Lovastatin dose should not exceed 40 mg/day when coadministered with amiodarone
- Caution is advised when coadministered with other lipid-lowering medications
Precautions
CONTRAINDICATIONS:
- Hypersensitivity to active substance or any product ingredients
- Active liver disease or unexplained persistent serum transaminase elevations
- Concomitant administration with strong CYP450 3A4 inhibitors
- Concomitant administration with erythromycin
- Pregnancy; this drug should not be administered to women of childbearing age unless she is highly unlikely to conceive
- Lactation
Safety and efficacy have not been established in patients younger than 10 years with HeFH (heterozygous familial hypercholesterolemia) or in pre-pubertal adolescents.
Consult WARNINGS section for additional precautions.
Dialysis
There are no data on the pharmacokinetics of lovastatin in patients on hemodialysis. Based on the pharmacokinetics of this drug, supplemental doses after dialysis do not appear to be necessary.
Other Comments
Administration advice:
- Extended-release tablets of lovastatin should be swallowed whole and not chewed or crushed.
Laboratory considerations:
- Cholesterol levels should be monitored periodically with consideration given to reducing the dosage if cholesterol levels fall significantly below the targeted range.
- All patients should have a baseline serum creatine kinase (CK) enzyme level measured and if at any time after initiating therapy a patient complains of muscle soreness, tenderness, or pain another CK level should be drawn for comparison. If elevated, the drug should be discontinued.
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