"Feb. 28, 2012 -- Memory loss, confusion, high blood sugar, and type 2 diabetes are possible side effects of the popular cholesterol-lowering drugs known as statins, the FDA warns.
Brand name and generic versions of statin drugs must c"...
Therapy with ALTOCOR™ (Lovastatin) Extended-Release Tablets should be a component of multiple risk factor intervention in those individuals with dyslipidemia who are at risk for atherosclerotic
vascular disease. ALTOCOR™ (lovastatin extended-release tablets) should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower Total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk.
ALTOCOR™ (lovastatin extended-release tablets)
Primary Prevention of Coronary Heart Disease
In individuals without symptomatic cardiovascular disease, average to moderately elevated Total-C and LDL-C, and below average HDL-C, ALTOCOR™ (lovastatin extended-release tablets) is indicated to reduce the risk of:
- Myocardial infarction
- Unstable angina
- Coronary revascularization procedures
(See CLINICAL PHARMACOLOGY, Clinical Studies)
Coronary Heart Disease
ALTOCOR™ (lovastatin extended-release tablets) 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.
Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for artherosclerotic vascular disease due to hypercholesterolemia
ALTOCOR™ (lovastatin extended-release tablets) 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, see Table VI) when the response to diet restricted in saturated fat and cholesterol and to other non-pharmacological measures alone has been inadequate.
Prior to initiating therapy with ALTOCOR™ (lovastatin extended-release tablets) , secondary causes for hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be excluded, and a lipid profile performed to measure Total-C, HDL-C, and TG. For patients with TG less than 400 mg/dL ( < 4.5 mmol/L), LDL-C can be estimated using the following equation:
LDL-C = Total-C - [0.2 × (TG) + HDL-C]
For TG levels > 400 mg/dL ( > 4.5 mmol/L), this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation. In hypertriglyceridemic patients, LDL-C may be low or normal despite elevated Total-C. In such cases, ALTOCOR™ (lovastatin extended-release tablets) is not indicated.
The National Cholesterol Education Program (NCEP) Treatment Guidelines are summarized below:
Table V: NCEP Treatment Guidelines: LDL-C Goals and Cutpoints
for Therapeutic Lifestyle Changes and Drug Therapy in Different Risk Categories
|Risk Category|| LDL Goal
| LDL Level at Which to Initiate Therapeutic
| LDL Level at Which to Consider Drug
| CHD† or CHD riskequivalents
(10-year risk > 20%)
|< 100||≥ 100|| ≥ 130
(100-129: drug optional)††
| 2+ Risk factors
(10-year risk ≤ 20%)
|< 130||≥ 130||10-year risk 10%-20%: ≥ 130|
|10-year risk < 10%: ≥ 160|
|0-1 Risk factor†††||< 160||≥ 160|| ≥ 190
(160-189: LDL-loweringdrug optional)
|† CHD, coronary heart disease
†† Some authorities recommend use of LDL-lowering drugs in this category if an LDL-C level of < 100mg/dL cannot be achieved by therapeutic lifestyle changes. Others prefer use of drugs that primarily modify triglycerides and HDL-C, e.g., nicotinic acid or fibrate. Clinical judgement also may call for deferring drug therapy in this subcategory.
††† Almost all people with 0-1 risk factor have 10-year risk < 10%; thus, 10-year risk assessment in people with 0-1 risk factor is not necessary.
After the LDL-C goal has been achieved, if the TG is still ≥ 200 mg/dL, non-HDL-C (Total-C minus HDL-C) becomes a secondary target of therapy. Non-HDL-C goals are set 30 mg/dL higher than LDL-C goals for each risk category.
At the time of hospitalization for an acute coronary event, consideration can be given to initiating drug therapy at discharge if the LDL-C is > 130 mg/dL (see NCEP Guidelines above).
Since the goal of treatment is to lower LDL-C, the NCEP recommends that LDL-C levels be used to initiate and assess treatment response. Only if LDL-C levels are not available, should the Total-C be used to monitor therapy.
Although ALTOCOR™ (lovastatin extended-release tablets) may be useful to reduce elevated LDL-C levels in patients with combined hypercholesterolemia and hypertriglyceridemia where hypercholesterolemia is the major abnormality (Type IIb hyperlipoproteinemia), it has not been studied in conditions where the major abnormality is elevation of chylomicrons, VLDL or IDL (i.e., hyperlipoproteinemia types I, III, IV, or V). [See Table VI]
Table VI: Classification of Hyperlipoproteinemias
|Type||Lipoproteins Elevated||Lipid Elevations|
|V (rare)||Chylomicrons, VLDL||TG||↑→TC|
|TC = total cholesterol; TG = triglycerides;
LDL = low-density lipoprotein;
VLDL = very low-density lipoprotein; IDL = intermediate-density lipoprotein
↑→ = increased or no change
DOSAGE AND ADMINISTRATION
The patient should be placed on a standard cholesterol-lowering diet before receiving ALTOCOR™ (lovastatin extended-release tablets) and should continue on this diet during treatment with ALTOCOR™ (lovastatin extended-release tablets) (see NCEP Treatment Guidelines for details on dietary therapy).
The usual recommended starting dose is 20, 40, or 60 mg once a day given in the evening at bedtime. The recommended dosing range is 10-60 mg/day, in single doses. Doses should be individualized according to the recommended goal of therapy (see NCEP Guidelines and CLINICAL PHARMACOLOGY). A starting dose of 10 mg may be considered for patients requiring smaller reductions. Adjustments should be made at intervals of 4 weeks or more.
Cholesterol levels should be monitored periodically and consideration should be given to reducing the dosage of ALTOCOR™ (lovastatin extended-release tablets) if cholesterol levels fall significantly below the targeted range.
Dosage in Patients Taking Cyclosporin
In patients taking cyclosporin concomitantly with ALTOCOR™ (see WARNINGS, Myopathy/Rhabdomyolysis), therapy should begin with 10 mg of ALTOCOR™ (lovastatin extended-release tablets) and should not exceed 20 mg/day.
Dosage in Patients Taking Amiodarone or Verapamil
In patients taking amiodarone or verapamil concomitantly with ALTOCORTM, the dose should not exceed 40 mg/day (see WARNINGS, Mypoathy/Rhabdomyolysis and PRECAUTIONS: DRUG INTERACTIONS, Other Drug Interactions).
Concomitant Lipid-Lowering Therapy
Use of ALTOCOR™ (lovastatin extended-release tablets) with fibrates or niacin should generally be avoided. However, if ALTOCOR™ (lovastatin extended-release tablets) is used in combination with gemfibrozil, other fibrates, or lipid-lowering doses ( ≥ 1 g/day) of niacin, the dose of ALTOCOR™ should not exceed 20 mg (see WARNINGS, Myopathy/Rhabdomyolysis and PRECAUTIONS: DRUG INTERACTIONS).
Dosage in Patients with Renal Insufficiency
In patients with severe renal insufficiency (creatinine clearance < 30 mL/min), dosage increases above 20 mg/day should be carefully considered and, if deemed necessary, implemented cautiously (see CLINICAL PHARMACOLOGY and WARNINGS, Myopathy/Rhabdomyolysis).
ALTOCOR™ (Lovastatin) Extended-Release Tablets are supplied as round, convex shaped tablets containing 10 mg, 20 mg, 40 mg and 60 mg of lovastatin.
NDC 62022-760-30: 10 mg extended-release dark orange-colored tablets imprinted with Andrx logo and 10 on one side, bottles of 30.
NDC 62022-770-30: 20 mg extended-release orange-colored tablets imprinted with Andrx logo and 20 on one side, bottles of 30.
NDC 62022-780-30: 40 mg extended-release peach-colored tablets imprinted with Andrx logo and 40 on one side, bottles of 30.
NDC 62022-781-30: 60 mg extended-release light peach-colored tablets imprinted with Andrx logo and 60 on one side, bottles of 30.
Store at controlled room temperature 20°- 25° C (68°- 77°F) Avoid excessive heat and humidity.
Distributed by: Andrx Laboratories, Inc. Weston, Florida 33331. Rev. date: 7/03.
Last reviewed on RxList: 4/3/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Altocor Information
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