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.

Hyperlipidemia

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.

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.

Elderly Patients

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

The dose of Altoprev should not exceed 40 mg/day. [see WARNINGS AND PRECAUTIONS, Skeletal Muscle Effects and DRUG INTERACTIONS].

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.

Storage

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.