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Hyperlipidemia
Hypertriglyceridemia
Dose Adjustments
Precautions
Dialysis
Other Comments
Comments:
-Following initiation and/or upon titration, lipid levels should be evaluated
within 2 to 4 weeks and dosages adjusted accordingly.
Uses: As an adjunct to diet in the following conditions: to reduced total
cholesterol (total-C), LDL-C, apolipoprotein B (apo B), and triglyceride (TG)
levels, and to increase high density lipoprotein (HDL-C) in patients with
primary hypercholesterolemia (heterozygous familial and nonfamilial) and
mixed dyslipidemia (Fredrickson Types IIa and IIb); for the treatment of
elevated TG levels (Fredrickson Type IV); and for the treatment of primary
dysbetalipoproteinemia (Fredrickson Type III) in patients who do not respond
adequately to diet
Dose Adjustments
Concomitant lipid lowering therapy:
-This drug may be used with bile acid resins; the combination of HMG-CoA
reductase inhibitors (statins) and fibrates should be used with caution.
In patients taking cyclosporine or HIV protease inhibitors (tipranavir
plus ritonavir) or the hepatitis C protease inhibitor (telaprevir):
-Avoid use with atorvastatin
In patients with HIV taking lopinavir plus ritonavir:
-Use with caution; lowest effective dose of atorvastatin should be used
Concomitant therapy with clarithromycin, itraconazole, or in
patients with HIV taking a combination of saquinavir plus ritonavir,
darunavir plus ritonavir, fosamprenavir, or fosamprenavir plus
ritonavir:
-Maximum dose: 20 mg/day; appropriate clinical assessment is
recommended to ensure the lowest effective dose is employed
Concomitant therapy with the HIV protease inhibitor nelfinavir or
the hepatitis C protease inhibitor boceprevir:
-Maximum dose: 40 mg/day; appropriate clinical assessment is
recommended to ensure the lowest effective dose is employed
Precautions
Safety and efficacy have not been established in pre-pubertal patients or
patients younger than 10 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
-May be taken orally once a day at any time, with or without food
General:
-This drug has not been studied in conditions where the major lipoprotein
abnormality is elevation of chylomicrons (Fredrickson Types I and V).
-Dosages should be individualized according to patient characteristics,
including goals of therapy and response to therapy.
-Drug therapy should only be one component of multiple risk factor
intervention in individuals at significantly increased risk for atherosclerotic
vascular disease due to hypercholesterolemia; patients should be placed on
this drug only when a diet restricted in saturated fat and cholesterol and
other nonpharmacologic measures have proven inadequate.
-Patients with CHD or multiple risk factors for CHD may start this drug
simultaneously with diet.
Monitoring:
-Hepatic: Measure liver enzyme tests prior to initiating therapy, if
signs/symptoms of liver injury occur, and as clinically indicated throughout
therapy
-Metabolic: Following initiation or upon titration if this drug, lipid levels
should be analyzed within 2 to 4 weeks and the dosage adjusted accordingly;
periodic testing of lipid levels should be performed to determine goal
attainment
Patient advice: