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Details with Side Effects
Therapy with lipid-altering agents should be one component of multiple risk factor intervention in individuals who require modifications of their lipid profile. Drug therapy is recommended as an adjunct to a diet restricted in saturated fat and cholesterol only when the response to diet and other non-pharmacological measures has been inadequate.
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
- Coronary revascularization procedures
Coronary Heart Disease
Altoprev® is indicated to 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.
Altoprev® is indicated as an adjunct to diet for 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).
Limitations of Use
Altoprev® has not been studied in Fredrickson Types I, III, and V.
DOSAGE AND ADMINISTRATION
Hyperlipidemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia (Fredrickson Types IIa and IIb)
The recommended dosing range is 20-60 mg/day, in single doses taken in the evening at bedtime.
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 [see Use In Specific Populations and WARNINGS AND PRECAUTIONS, Skeletal Muscle Effects].
Co-administration with Other Drugs
Patients Taking Danazol, Diltiazem, Dronedarone, or Verapamil
The dose of Altoprev should not exceed 20 mg/day [see WARNINGS AND PRECAUTIONS, Skeletal Muscle Effects].
Patients Taking Amiodarone
Dosage in Patients With Renal Impairment
In patients with severe renal impairment (creatinine clearance < 30 mL/min), dosage increases above 20 mg/day should only be considered if the expected benefit exceeds the increased risk of myopathy/rhabdomyolysis. [see WARNINGS AND PRECAUTIONS, Skeletal Muscle Effects and CLINICAL PHARMACOLOGY, Pharmacokinetics ].
Dosage Forms And Strengths
Altoprev® (lovastatin) Extended-Release Tablets are supplied as round, convex shaped tablets containing 20 mg, 40 mg and 60 mg of lovastatin.
Storage And Handling
Altoprev® lovastatin extended-release tablets are supplied as round, convex shaped tablets containing 20 mg, 40 mg and 60 mg of lovastatin.
NDC 59630-628-30: 20 mg extended-release orange-colored tablets imprinted with Andrx logo and 20 on one side, bottles of 30.
NDC 59630-629-30: 40 mg extended-release peach-colored tablets imprinted with Andrx logo and 40 on one side, bottles of 30.
NDC 59630-630-30: 60 mg extended-release light peach-colored tablets imprinted with Andrx logo and 60 on one side, bottles of 30.
Store at 20-25°C (68-77°F) - Excursions Permitted to 15°C -30°C (59°F -86°F) [See USP Controlled Room Temperature]. Avoid excessive heat and humidity.
Manufactured by: Watson Laboratories - Florida Ft. Lauderdale, Fl 33314. Distributed by: Shionogi, Inc. Florham Park, NJ 07932. Rev. 06/2012 190258-3
Last reviewed on RxList: 1/25/2013
This monograph has been modified to include the generic and brand name in many instances.
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