Apo-Pravastatin

Apo-Pravastatin Indications/Uses

pravastatin

Manufacturer:

Apotex

Distributor:

Pharmaforte
Full Prescribing Info
Indications/Uses
Therapy with lipid-altering agents should be considered a component of multiple risk factor intervention in those individuals at increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Pravastatin should be used in addition to a diet restricted in saturated fat and cholesterol when the response to diet and other non-pharmacological measures alone has been inadequate (see NCEP Guideline as follows).
Hypercholesterolemia: APO-PRAVASTATIN is indicated as an adjunct to diet [at least an equivalent of the American Heart Association (AHA) Step 1 diet] for the reduction of elevated Total and Low Density Lipoprotein Cholesterol (LDL-C) levels in patients with primary hypercholesterolemia (Types IIa and IIb), when the response to diet and other non-pharmacologic measures alone has been inadequate.
Prior to initiating therapy with APO-PRAVASTATIN, secondary causes for hypercholesterolemia, such as obesity, poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy or alcoholism, should be excluded and it should be determined that patients for whom treatment with APO-PRAVASTATIN is being considered have an elevated LDL-C level as the cause for an elevated total serum cholesterol. A lipid profile should be performed to measure Total Cholesterol, High Density Lipoprotein Cholesterol (HDL-C) and Triglycerides (TG).
For patients with total triglycerides less than 4.52 mmol/L (400 mg/dL), LDL-C can be estimated using the following equation: LDL-C=Total Cholesterol-(HDL-C)-1/5 TG.
When total triglyceride levels exceed 4.52 mmol/L (400 mg/dL), this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation.
The U.S. National Cholesterol Education Program's (NCEP) Treatment Guidelines are summarized as follows: See Table 1.

Click on icon to see table/diagram/image

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.
As with other lipid-lowering therapy, APO-PRAVASTATIN is not indicated when hypercholesterolemia is due to hyperalphalipoproteinemia (elevated HDL-C). The efficacy of pravastatin has not been evaluated in conditions where the major abnormality is elevation of chylomicrons, VLDL or LDL (i.e. hyperlipoproteinemia or dyslipoproteinemia types I, III, IV or V).
Primary Prevention of Coronary Events: In hypercholesterolemic patients without clinically evident coronary heart disease, APO-PRAVASTATIN is indicated as an adjunct to diet to: Reduce the risk of myocardial infarction; Reduce the risk for undergoing myocardial revascularization procedures; Reduce the risk of cardiovascular mortality with no increase in death from noncardiovascular causes.
Secondary Prevention of Cardiovascular Events: In patients with total cholesterol in the normal to moderately elevated range who have clinically evident coronary heart disease, APO-PRAVASTATIN is indicated to: Reduce the risk of total mortality; Reduce the risk of death due to coronary heart disease; Reduce the risk of myocardial infarction; Reduce the risk of undergoing myocardial revascularization procedures; Reduce the risk of stroke and transient ischemic attack (TIA); Reduce total hospitalization.
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