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Altoprev (Lovastatin) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Therapy with ALTOPREV® 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. ALTOPREV® 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.

ALTOPREV®

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, ALTOPREV® is indicated to reduce the risk of:

  • Myocardial infarction
  • Unstable angina
  • Coronary revascularization procedures

(See CLINICAL PHARMACOLOGY, Clinical Studies.)

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

Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia.

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, see Table VI) when the response to diet restricted in saturated fat and cholesterol and to other non-pharmacological measures alone has been inadequate.

General Recommendations

Prior to initiating therapy with ALTOPREV®, 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 x (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, ALTOPREV® 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

† 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.

Risk CategoryLDL Goal (mg/dL)LDL Level at Which to
Initiate Therapeutic
Lifestyle Changes
(mg/dL)
LDL Level at Which to Consider Drug Therapy (mg/dL)
CHD or CHD risk
equivalents
(10-year risk
>20%)
<100≥100≥130 (100-129: drug optional)††
2+ Risk factors
(10-year risk
≤20%)
<130≥13010-year risk 10%-20%: ≥130
10-year risk <10%:≥160
0-1 Risk factor†††<160≥160≥190
(160-189: LDL-lowering
drug optional)

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 LDLC levels are not available, should the Total-C be used to monitor therapy.

Although ALTOPREV® 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

TC = total cholesterol; TG = triglycerides; LDL = low-density lipoprotein;

VLDL = very low-density lipoprotein; IDL = intermediate-density lipoprotein

↑→ = increased or no change

Lipid Elevations
Type      Lipoproteins ElevatedMajorMinor
I (rare)      ChylomicronsTG↑→TC
II a      LDLTC-
IIb      LDL,VLDLTCTG
III (rare)      IDLTC/TG-
IV      VLDLTG↑→TC
V (rare)      Chylomicrons, VLDLTG↑→TC

DOSAGE AND ADMINISTRATION

The patient should be placed on a standard cholesterol-lowering diet before receiving ALTOPREV® and should continue on this diet during treatment with ALTOPREV® (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 20-60 mg/day, in single doses. Doses should be individualized according to the recommended goal of therapy (see NCEP Guidelines and CLINICAL PHARMACOLOGY). For patients requiring smaller reductions in cholesterol levels, ALTOPREV® is not recommended; immediate-release lovastatin could be considered. Adjustments should be made at intervals of 4 weeks or more. See below for dosage recommendations in special populations (i.e., elderly patients, or patients with complicated medical conditions or renal insufficiency) or for patients receiving concomitant therapy (i.e. cyclosporine, amiodarone, verapamil, fibrates or niacin).

Cholesterol levels should be monitored periodically and consideration should be given to reducing the dosage of ALTOPREV® if cholesterol levels fall significantly below targeted range.

Elderly Patients or Patients with Complicated Medical Conditions

The usual recommended starting dose in elderly patients (age>65 years) or patients with complicated medical conditions (renal insufficiency, diabetes) 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 NCEP Guidelines and WARNINGS, Myopathy/Rhabdomyolysis). For patients requiring smaller reductions in cholesterol levels, ALTOPREV® is not recommended; immediate-release lovastatin could be considered. (See WARNINGS, Myopathy/Rhabdomyolysis).

Dosage in Patients Taking Cyclosporine

Patients taking cyclosporine should not begin therapy with ALTOPREV® (See WARNINGS, Myopathy/Rhabdomyolysis); immediate-release lovastatin could be considered.

Dosage in Patients Taking Amiodarone or Verapamil

In patients taking amiodarone or verapamil concomitantly with ALTOPREV®, the dose should not exceed 20 mg/day (see WARNINGS, Myopathy/Rhabdomyolysis and PRECAUTIONS, Drug Interactions, Other Drug Interactions).

Concomitant Lipid-Lowering Therapy

Use of ALTOPREV® with fibrates or niacin should generally be avoided. However, if ALTOPREV® is used in combination with gemfibrozil, other fibrates, or lipid-lowering doses (> 1 g/day) of niacin, the dose of ALTOPREV® 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).

HOW SUPPLIED

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.

Rx only

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