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Atorvastatin / Ezetimibe Dosage

Applies to the following strengths: 10 mg-10 mg; 20 mg-10 mg; 40 mg-10 mg; 80 mg-10 mg

Usual Adult Dose for Hyperlipidemia

All doses expressed as ezetimibe-atorvastatin:

Initial dose: 10/10 or 10/20 mg orally once a day
Initial dose for patients who require a larger reduction in LDL-C (greater than 55%): 10/40 mg orally once a day
Dose range: 10/10 to 10/80 mg once a day
-After initiation and/or upon titration, lipid levels should be analyzed within 2 or more weeks and dose adjusted accordingly

Patients with Homozygous Familial Hypercholesterolemia:
Initial dose: Dosage: 10/40 or 10/80 orally once a day
-Use as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable

Comments:
-Lipid-altering agents should be used as 1 component of multiple risk factor intervention in patients at risk for atherosclerotic vascular disease due to hypercholesterolemia.
-No incremental benefit of this combination drug on cardiovascular morbidity and mortality over and above that demonstrated for atorvastatin has been established.
-This drug has not been studied in Fredrickson type I, III, IV, and V dyslipidemias.

Uses: To treat primary hyperlipidemia and homozygous familial hypercholesterolemia as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

Contraindicated in patients with active liver disease or unexplained persistent elevations in hepatic transaminase levels

Dose Adjustments

Concomitant use of bile acid sequestrant:
-Administration of this drug should occur 2 or more hours before, or 4 or more hours after administration of the bile acid sequestrant

Drug Interactions Associated with Increased Risk of Myopathy/Rhabdomyolysis:
-Avoid concomitant administration with cyclosporine, tipranavir plus ritonavir, telaprevir, or gemfibrozil.
-Maximum dose: ezetimibe 10 mg/atorvastatin 20 mg when used with clarithromycin, itraconazole, saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir, elbasvir, and grazoprevir; monitor closely to ensure lowest dose of ezetimibe-atorvastatin is used.
-Maximum dose: ezetimibe 10 mg/atorvastatin 40 mg when used with nelfinavir or boceprevir; monitor closely to ensure lowest dose of ezetimibe-atorvastatin is used.
-Use with caution and at the lowest dose necessary with lopinavir plus ritonavir.

Precautions

CONTRAINDICATIONS:
-Active liver disease or unexplained persistent elevations of hepatic transaminase levels
-Hypersensitivity to active substances or any components in product
-Women who are pregnant or may become pregnant
-Nursing mothers

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Hemodialysis:
-Atorvastatin: Since this drug is highly bound to plasma proteins, hemodialysis is not expected to enhance clearance
-Ezetimibe: Data not available

Peritoneal Dialysis Clearance: Data not available

Other Comments

Administration advice:
-Take orally with or without food
-Swallow whole; do not crush, dissolve or chew
-For patients who are concomitantly receiving a bile acid sequestrant, this drug should be taken 2 or more hours before or 4 or more hours after taking the bile acid sequestrant

General:
-No incremental benefit of ezetimibe-atorvastatin on cardiovascular morbidity and mortality over and above that demonstrated for atorvastatin has been established.
-This combination drug has not been studied in Fredrickson Type I, III, IV, and V dyslipidemia.
-Grapefruit juice contains one or more components that inhibit CYP450 3A4 and can increase plasma concentrations of atorvastatin, especially with excessive grapefruit juice consumption (1.2 liters or more per day).

Monitoring:
-Obtain liver enzymes prior to initiation and as clinically indicated
-Consider monitoring creatine phosphokinase (CPK)
-Monitor for signs and symptoms of myopathy, especially in patients with risk factors

Patient advice:
-Patients should be instructed to adhere to their diet plan and a regular exercise program.
-Patients should be instructed to report any unexplained muscle pain, tenderness, or weakness, especially if accompanied by malaise or fever.
-Patients should be instructed to discuss all medication with their physician including herbal supplements and use of grapefruit as drug interactions are possible.
-Women of child-bearing potential should be advised to use an effective method of birth control; if interested in becoming pregnant, they should speak with their health care provider.
-Patients should be advised against breastfeeding while using this drug.
-Patients should be counseled about excessive alcohol use during therapy.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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