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Liptruzet

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Liptruzet

INDICATIONS

Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated 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.

Primary Hyperlipidemia

LIPTRUZET® is indicated for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and non-high-density lipoprotein cholesterol (non-HDL-C), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia.

Homozygous Familial Hypercholesterolemia (HoFH)

LIPTRUZET is indicated for the reduction of elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.

Limitations Of Use

No incremental benefit of LIPTRUZET on cardiovascular morbidity and mortality over and above that demonstrated for atorvastatin has been established. LIPTRUZET has not been studied in Fredrickson type I, III, IV, and V dyslipidemias.

DOSAGE AND ADMINISTRATION

Recommended Dosing

The dosage range of LIPTRUZET is 10/10 mg/day to 10/80 mg/day. The recommended starting dose of LIPTRUZET is 10/10 mg/day or 10/20 mg/day. LIPTRUZET can be administered as a single dose at any time of the day, with or without food. The recommended starting dose for patients who require a larger reduction in LDL-C (greater than 55%) is 10/40 mg/day. After initiation and/or upon titration of LIPTRUZET, lipid levels should be analyzed within 2 or more weeks and dosage adjusted accordingly.

Patients should swallow LIPTRUZET tablets whole. Tablets should not be crushed, dissolved, or chewed.

Patients With Homozygous Familial Hypercholesterolemia

The dosage of LIPTRUZET in patients with homozygous familial hypercholesterolemia is 10/40 mg/day or 10/80 mg/day. LIPTRUZET should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable.

Coadministration With Other Drugs

Bile Acid Sequestrants

Dosing of LIPTRUZET should occur either greater than or equal to 2 hours before or greater than or equal to 4 hours after administration of a bile acid sequestrant [see DRUG INTERACTIONS].

Cyclosporine, Clarithromycin, Itraconazole, or Certain Protease Inhibitors

In patients taking cyclosporine or the HIV protease inhibitors (tipranavir plus ritonavir) or the hepatitis C protease inhibitor (telaprevir), therapy with LIPTRUZET should be avoided. In patients with HIV taking lopinavir plus ritonavir, caution should be used when prescribing LIPTRUZET and the lowest dose necessary employed. In patients taking clarithromycin, itraconazole, or in patients with HIV taking a combination of saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, or fosamprenavir plus ritonavir, therapy with LIPTRUZET should be limited to 10/20 mg, and appropriate clinical assessment is recommended to ensure that the lowest dose necessary of LIPTRUZET is employed. In patients taking the HIV protease inhibitor nelfinavir or the hepatitis C protease inhibitor boceprevir, therapy with LIPTRUZET should be limited to 10/40 mg, and appropriate clinical assessment is recommended to ensure that the lowest dose necessary of LIPTRUZET is employed. [See WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS]

Other Concomitant Lipid-Lowering Therapy

The combination of LIPTRUZET and gemfibrozil is not recommended [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].

HOW SUPPLIED

Dosage Forms And Strengths

  • LIPTRUZET® 10 mg/10 mg (ezetimibe 10 mg/atorvastatin 10 mg) tablets are white to off-white capsule-shaped, biconvex film-coated tablets with code “257” on one side.
  • LIPTRUZET® 10 mg/20 mg (ezetimibe 10 mg/atorvastatin 20 mg) tablets are white to off-white capsule-shaped, biconvex film-coated tablets with code “333” on one side.
  • LIPTRUZET® 10 mg/40 mg (ezetimibe 10 mg/atorvastatin 40 mg) tablets are white to off-white capsule-shaped, biconvex film-coated tablets with code “337” on one side.
  • LIPTRUZET® 10 mg/80 mg (ezetimibe 10 mg/atorvastatin 80 mg) tablets are white to off-white capsule-shaped, biconvex film-coated tablets with code “357” on one side.

Storage And Handling

Tablets LIPTRUZET 10 mg/10 mg are white to off-white capsule-shaped, biconvex film-coated tablets with code “257” on one side.

They are supplied as follows:

NDC 0006-0257-02 unit of use packages of 30 (one carton containing one multi-fold wallet with two 15count blister cards)

NDC 0006-0257-03 unit of use packages of 90 (three cartons each containing one multi-fold wallet with two 15-count blister cards)

Tablets LIPTRUZET 10 mg/20 mg are white to off-white capsule-shaped, biconvex film-coated tablets with code “333” on one side.

They are supplied as follows:

NDC 0006-0333-02 unit of use packages of 30 (one carton containing one multi-fold wallet with two 15count blister cards)

NDC 0006-0333-03 unit of use packages of 90 (three cartons each containing one multi-fold wallet with two 15-count blister cards)

Tablets LIPTRUZET 10 mg/40 mg are white to off-white capsule-shaped, biconvex film-coated tablets with code “337” on one side.

They are supplied as follows:

NDC 0006-0337-02 unit of use packages of 30 (one carton containing one multi-fold wallet with two 15count blister cards)

NDC 0006-0337-03 unit of use packages of 90 (three cartons each containing one multi-fold wallet with two 15-count blister cards)

Tablets LIPTRUZET 10 mg/80 mg are white to off-white capsule-shaped, biconvex film-coated tablets with code “357” on one side.

They are supplied as follows:

NDC 0006-0357-02 unit of use packages of 30 (one carton containing one multi-fold wallet with two 15count blister cards)

NDC 0006-0357-03 unit of use packages of 90 (three cartons each containing one multi-fold wallet with two 15-count blister cards)

Storage of Unit of Use Packages of 30 and 90

Store LIPTRUZET at 20 to 25°C (68 to 77°F), excursions permitted between 15 to 30°C (between 59 to 86°F) [see USP Controlled Room Temperature].

Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA. Issued: 05/2014

Last reviewed on RxList: 5/29/2014
This monograph has been modified to include the generic and brand name in many instances.

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