Generic Name and Formulations:
Ezetimibe/atorvastatin; 10mg/10mg, 10mg/20mg, 10mg/40mg, 10mg/80mg; tabs.

Company:
Merck & Co., Inc.
Indications for LIPTRUZET:
To reduce elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and to increase HDL-C in primary (heterozygous familial and non-familial) or mixed hyperlipidemia. To reduce elevated total-C and LDL-C in homozygous familial hypercholesterolemia (HoFH), as an adjunct to other lipid-lowering treatments (eg, LDL apheresis) or if such treatments are unavailable. Limitations of use: No incremental benefit on cardiovascular morbidity/mortality over and above that demonstrated for atorvastatin has been established. Not studied in Fredrickson type I, III, IV, and V dyslipidemias.

Adult:
Swallow whole. Usual range: 10mg/10mg to 10mg/80mg. Initially 10mg/10mg or 10mg/20mg; for LDL-C reduction >55%: may start at 10mg/40mg; monitor lipids within ≥2wks and adjust dose as needed. HoFH: 10mg/40mg or 10mg/80mg. Concomitant bile acid sequestrants: give Liptruzet dose either ≥2hrs before or ≥4hrs after bile acid sequestrant administration. Concomitant lopinavir/ritonavir: use lowest dose. Concomitant clarithromycin, itraconazole, saquinavir/ritonavir, darunavir/ritonavir, fosamprenavir, or fosamprenavir/ritonavir: max 10mg/20mg. Concomitant nelfinavir or boceprevir: max 10mg/40mg.

Children:
Not established.

Pharmacological Class:
Cholesterol absorption inhibitor + HMG-CoA reductase inhibitor.

Contraindications:
Active liver disease. Unexplained persistent elevated hepatic transaminases. Pregnancy (Category X). Nursing mothers.

Warnings/Precautions:
Increased risk of myopathy/rhabdomyolysis (with high doses). Discontinue if elevated CPK (>10 X ULN) levels occur or myopathy is diagnosed or suspected; withhold if a predisposition in renal failure secondary to rhabdomyolysis develops. Monitor liver function prior to starting therapy and repeat as clinically indicated. History of liver disease or renal impairment; monitor closely. Substantial alcohol consumption. Elderly.

Interactions:
See Adult dose. Avoid with concomitant cyclosporine, tipranavir/ritonavir, telaprevir, gemfibrozil. Potentiated by strong CYP3A4 inhibitors, grapefruit juice (>1.2L/day). Caution with lopinavir/ritonavir, colchicine, fenofibrates, niacin ≥1g/day; consider dose reduction of Liptruzet. May increase serum levels of digoxin (monitor), oral contraceptives. May be antagonized by cholestyramine, CYP3A4 inducers (eg, efavirenz, rifampin); coadminister rifampin simultaneously. Monitor oral anticoagulants. Caution with drugs that decrease levels or activity of endogenous steroid hormones (eg, ketoconazole, spironolactone, cimetidine).

Adverse Reactions:
Increased ALT/AST, musculoskeletal pain, arthralgia, abdominal pain, nausea; increased in HbA1c or fasting serum glucose; myopathy, rhabdomyolysis; rare: immune-mediated necrotizing myopathy.

How Supplied:
Tabs—30, 90