Total Cost
Free shipping on all orders

Powered by GeniusRx

omega-3 ethyl esters 1 gm cap generic lovaza, triklo

Out of Stock Manufacturer PRASCO LABS 66993072632
Out of Stock

Uses

Dyslipidemias

Hypertriglyceridemia

Omega-3-acid ethyl esters is used as an adjunct to dietary therapy to reduce triglyceride concentrations in adults with severe hypertriglyceridemia (triglyceride concentration of 500 mg/dL or greater). Efficacy of the drug in reducing the risk of pancreatitis or the risk of cardiovascular morbidity or mortality in patients with very high triglyceride concentrations has not been established.

The Third Report of the National Cholesterol Education Program (NCEP) (Adult Treatment Panel [ATP] III) stated that the initial treatments of choice are nondrug therapies and measures (lifestyle modifications) specific for the type of dyslipidemia specific for the type of dyslipidemia, including dietary management (e.g., restriction of saturated fat and cholesterol intake, addition of plant stanol/sterols and viscous fiber to diet), weight control, an appropriate program of physical activity, and management of potentially contributory disease.(See Adjunctive Measures under Warnings/Precautions: General Precautions, in Cautions.) Drug therapy is not a substitute for but an adjunct to these nondrug therapies and measures, which should be continued when drug therapy is initiated.

Safety and efficacy of omega-3-acid ethyl esters in the management of hypertriglyceridemia have been established in several randomized controlled studies. In 2 randomized, double-blind, placebo-controlled studies of 6 or 16 weeks' duration, 84 patients with very high triglyceride concentrations (median baseline triglyceride concentration of 792 mg/dL) were randomized to receive either omega-3-acid ethyl esters (4 g daily as Lovaza capsules) or placebo. In these studies, patients who received omega-3-acid ethyl esters had reductions of approximately 45% in triglyceride concentrations, 42% in very low-density lipoprotein (VLDL)-cholesterol concentrations, and 14% in non-high-density lipoprotein (non-HDL)-cholesterol (total cholesterol minus HDL-cholesterol) concentrations; increases of approximately 9% in HDL-cholesterol concentrations also were reported.

In a double-blind, placebo- and active-controlled study, 254 patients with severe hypertriglyceridemia (median baseline triglyceride concentration of 675 mg/dL) were randomized to receive 4.8 g of omega-3-acid ethyl esters (as Omtryg capsules) daily, 4 capsules daily of another omega-3-acid ethyl esters preparation (each capsule contains at least 900 mg of ethyl esters from omega-3 fatty acids from fish oils), or placebo for 12 weeks. In this study, patients treated with omega-3-acid ethyl esters (Omtryg) had reductions of approximately 25% in triglyceride concentrations, 21% in VLDL-cholesterol concentrations, and 9% in non-HDL-cholesterol concentrations; no changes in HDL-cholesterol concentrations were reported. Patients treated with 4 capsules daily of the other omega-3-acid ethyl esters preparation had reductions of approximately 27% in triglyceride concentrations, 18% in VLDL-cholesterol concentrations, and 4% in non-HDL-cholesterol concentrations; no changes in HDL-cholesterol concentrations were reported.

Treatment with omega-3-acid ethyl esters may result in increases in low-density lipoprotein (LDL)-cholesterol and non-HDL-cholesterol concentrations in some individuals. In clinical studies with omega-3-acid ethyl esters, median baseline LDL-cholesterol concentrations (89 mg/dL) were increased by approximately 45% following therapy with omega-3-acid ethyl esters. Therefore, patients receiving omega-3-acid ethyl esters should be monitored periodically to ensure that LDL-cholesterol concentrations do not increase excessively.

Omega-3-acid ethyl esters has been used to reduce high (200-499 mg/dL) triglyceride concentrations in adults. However, because target LDL-cholesterol goal has been determined by ATP III to be the primary treatment objective in this patient population, most patients are expected to receive hydroxymethylglutaryl-CoA (HMG-CoA) reductase inhibitors (statins) as initial therapy. Thus, although monotherapy with omega-3-acid ethyl esters has been shown to reduce triglyceride concentrations by approximately 28% in patients with high triglyceride concentrations, some experts state that efficacy of the drug in this patient population should be further evaluated in patients receiving concomitant statin therapy. Studies evaluating effects of omega-3-acid ethyl esters on triglyceride, LDL-cholesterol, and non-HDL-cholesterol concentrations in patients receiving concomitant statin therapy are ongoing. Meanwhile, limited data from several small studies in patients with hypertriglyceridemia indicate that addition of omega-3-acid ethyl esters (4 g daily) to existing atorvastatin (40 mg daily) or simvastatin (10-40 mg daily) therapy for at least 5 weeks further reduced triglyceride or VLDL-cholesterol concentrations by an additional 14-30 or 25-40%, respectively.

Prevention of Cardiovascular Events

Marine- and plant-derived omega-3 fatty acids (i.e., EPA, DHA, α-linolenic acid) have been evaluated for use for primary or secondary prevention of coronary heart disease (CHD). Data from epidemiologic as well as prospective, randomized, controlled studies suggest that higher intakes of dietary or supplemental omega-3 fatty acids reduce the risk of cardiovascular events or CHD mortality; however, conflicting data exist.

The American College of Cardiology (ACC)/American Heart Association (AHA) guideline for management of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults states that nondrug therapies (i.e., lifestyle modifications), which include adherence to a heart-healthy diet, regular exercise, avoidance of tobacco products, and maintenance of a healthy weight, are the foundation of atherosclerotic cardiovascular disease (ASCVD) prevention. The guideline also states that nonstatin therapies (e.g., omega-3-acid ethyl esters) do not provide acceptable ASCVD risk reduction benefits compared to their potential for adverse effects in the routine prevention of ASCVD. However, nonstatin drugs may be useful as adjuncts to statin therapy in high-risk patients (e.g., patients with ASCVD, patients with LDL-cholesterol concentrations of 190 mg/dL or higher, patients with diabetes mellitus) who have a less-than-anticipated response to statins, are unable to tolerate even a less-than-recommended intensity of a statin, or are completely intolerant to statin therapy. When a nonstatin drug is required, selection of the nonstatin drug should be based on a favorable benefit-risk ratio (i.e., demonstrated benefit of ASCVD risk reduction outweighs risks of adverse effects and drug interactions) and patient preferences. For additional details on prevention of ASCVD, and also consult the most recent ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults (available at http://www.cardiosource.org or http://my.americanheart.org). (See Prevention of Cardiovascular Events under Dosage and Administration: Dosage.)

Dosage and Administration

General

Patients should be placed on a standard cholesterol-lowering diet before initiation of omega-3-acid ethyl esters therapy and should remain on this diet during treatment with the drug. For recommendations on dietary and other nondrug therapies (i.e., lifestyle modifications), consult the most recent AHA/ACC Guideline on Lifestyle Management to Reduce Cardiovascular Risk (available at http://www.cardiosource.org or http://my.americanheart.org).

Administration

In clinical studies, omega-3-acid ethyl esters (Lovaza) was administered with meals. The manufacturer states that Omtryg capsules should be administered with meals.

Omega-3-acid ethyl esters capsules should be swallowed whole and should not be broken, crushed, dissolved, or chewed.

Dosage

Dyslipidemias

The recommended adult dosage of omega-3-acid ethyl esters (as Lovaza) for the management of severe hypertriglyceridemia (triglyceride concentration of 500 mg/dL or greater) is 4 g daily administered as a single dose or in 2 equally divided doses.

The recommended adult dosage of omega-3-acid ethyl esters (as Omtryg) for the management of severe hypertriglyceridemia (triglyceride concentration of 500 mg/dL or greater) is 4.8 g daily administered as a single dose or in 2 equally divided doses.

Prevention of Cardiovascular Events

Although it is not clear that dietary or supplemental omega-3 fatty acids reduces the risk of cardiovascular events or total mortality, the American Heart Association (AHA) suggests that patients with or without documented coronary heart disease (CHD) incorporate omega-3 fatty acids in their diet. For primary prevention, AHA suggests that patients consume a variety of fish (preferably fatty fish such as herring, mackerel, salmon, sardines, or tuna) at least twice weekly; patients also are encouraged to include oils and foods rich in α-linolenic acid (e.g., canola/flaxseed/soybean oils, flaxseeds, English walnuts) in their diet. For secondary prevention, AHA suggests that patients consume approximately 1 g of a combination of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) daily. Intake of EPA and DHA preferably should be achieved through dietary means (i.e., consumption of fatty fish); if intake cannot be achieved with diet alone, supplements containing EPA and DHA may be considered, but only in consultation with a clinician.

The Third Report of the National Cholesterol Education Program (NCEP) (Adult Treatment Panel [ATP] III) has not recommended a specific amount of omega-3 fatty acids for daily intake but does support AHA's recommendation that fish be included as part of a CHD risk-reduction diet. ATP III states that higher dietary intakes (1-2 g daily) of omega-3 fatty acids are an option for secondary prevention; however, more definitive clinical trials are required before such high dosages can be strongly recommended for either primary or secondary prevention.

Special Populations

No special population recommendations at this time.

Cautions

Contraindications

Known hypersensitivity (e.g., anaphylactic reaction) to omega-3-acid ethyl esters or any ingredient in the formulation.

Warnings/Precautions

Sensitivity Reactions

Fish Sensitivity

Omega-3-acid ethyl esters is obtained from the oil of several fish sources. It is not known whether patients with hypersensitivity to fish and/or shellfish are at an increased risk of allergic reaction to omega-3-acid ethyl esters; therefore, these preparations should be used with caution in such patients. Anaphylactic reactions have been reported during postmarketing experience.

Major Toxicities

Hepatic Effects

Increases in alanine aminotransferase (ALT) concentrations without a concurrent increase in aspartate aminotransferase (AST) concentrations have been reported in some patients. ALT and AST concentrations should be monitored periodically during therapy with omega-3-acid ethyl esters in patients with hepatic impairment.

Recurrent Atrial Fibrillation or Flutter

Recurrent atrial fibrillation or flutter has been observed in patients with symptomatic paroxysmal or persistent atrial fibrillation receiving omega-3-acid ethyl esters. In a placebo-controlled study in such patients, 53% of those randomized to receive omega-3-acid ethyl esters experienced first recurrent symptomatic atrial fibrillation or flutter events within 24 weeks of initiating therapy compared with 45% of those randomized to receive placebo. Although the clinical importance of these results is not known, there is a possible association between the use of omega-3-acid ethyl esters and more frequent recurrences of symptomatic atrial fibrillation or flutter in patients with paroxysmal or persistent atrial fibrillation, especially within 2-3 months of initiation of therapy.

Omega-3-acid-ethyl esters is not indicated for the treatment of atrial fibrillation or flutter.

General Precautions

Laboratory Monitoring

Prior to initiating therapy with omega-3-acid ethyl esters, lipoprotein profiles should be evaluated to confirm the presence of persistent hypertriglyceridemia. During omega-3-acid ethyl esters therapy, lipoprotein profiles should be obtained periodically to monitor clinical response (i.e., reduction in triglyceride concentrations) or adverse effects (i.e., excessive increases in low-density lipoprotein [LDL]-cholesterol concentrations).

ALT and AST concentrations should be monitored periodically during therapy with omega-3-acid ethyl esters.(See Hepatic Effects under Warnings/Precautions: Major Toxicities, in Cautions.)

Adjunctive Measures

Prior to initiating therapy with omega-3-acid ethyl esters, vigorously attempt to control serum triglyceride concentrations with appropriate dietary regimens, exercise, weight reduction, and treatment of any underlying disorder that might be the cause of triglyceride abnormalities (e.g., diabetes mellitus, hypothyroidism).

Drugs known to exacerbate hypertriglyceridemia (e.g., β-adrenergic blockers, thiazides, estrogens) should be discontinued or changed, if possible, before initiating triglyceride-lowering drug therapy.

Prolongation of Bleeding Time

Prolongation of bleeding time has been observed with omega-3 fatty acids; however, such prolongation has not exceeded normal limits and was not associated with clinically significant bleeding episodes. Although additional blood testing is not required for patients receiving omega-3-acid ethyl esters, patients should be monitored for manifestations of bleeding prior to and during therapy with the drug.(See Drug Interactions: Drugs Affecting Coagulation.) Hemorrhagic diatheses have been reported during postmarketing experience.

Specific Populations

Pregnancy

Category C.

Lactation

Omega-3-acid ethyl esters are distributed into milk. Because the effects of omega-3-acid ethyl esters on nursing infants are not known, caution is advised when the drug is used in nursing women.

Pediatric Use

Safety and efficacy of omega-3-acid ethyl esters have not been established in pediatric patients.

Geriatric Use

Experience in patients older than 65 years of age is limited. No substantial differences in safety and efficacy were observed between patients older than 60 years of age and younger patients.

Common Adverse Effects

Adverse effects reported in 3% or more of patients receiving omega-3-acid ethyl esters and more frequently than with placebo include eructation, dyspepsia, and taste perversion.

Drug Interactions

Drugs Affecting Coagulation

Concomitant use of omega-3-acid ethyl esters with anticoagulants has not been adequately evaluated; monitor (e.g., PT/INR) periodically during concomitant therapy with anticoagulants or other drugs affecting coagulation (e.g., antiplatelet agents).

Drugs Metabolized by Hepatic Microsomal Enzymes

Free forms of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) at a concentration of 23 mcM have been shown to cause modest inhibition of cytochrome P-450 (CYP) isoenzymes 1A2, 2A6, 2C9, 2C19, 2D6, 2E1, and 3A in vitro. However, because free forms of EPA and DHA are undetectable in systemic circulation (less than 1 mcM), clinically important interactions with drugs metabolized by the cytochrome P-450 enzyme system are not expected to occur in humans.

HMG-CoA Reductase Inhibitors (Statins)

Atorvastatin

Concomitant use of omega-3-acid ethyl esters (4 g daily) with atorvastatin (80 mg daily) for 14 days did not affect the rate or extent of exposure to atorvastatin, 2-hydroxyatorvastatin, or 4-hydroxyatorvastatin at steady state.

Rosuvastatin

Concomitant use of omega-3-acid ethyl esters (4 g daily) with rosuvastatin (40 mg daily) for 14 days did not affect the rate or extent of exposure to rosuvastatin at steady state.

Simvastatin

Concomitant use of omega-3-acid ethyl esters (4 g daily) with simvastatin (80 mg daily) for 14 days did not affect the rate or extent of exposure to simvastatin or β-hydroxysimvastatin at steady state.

Write Your Own Review

Your meds on autopilot. Forever.