omega-3 triglycerides




Zuellig Pharma
Full Prescribing Info
Omega-3-acid ethyl esters.
Each capsule contains omega-3-acid ethyl esters 90 1000 mg, comprising eicosapentaenoic acid (EPA) ethyl ester (460 mg) and docosahexaenoic acid (DHA) ethyl ester (380 mg).
Excipients/Inactive Ingredients: Capsule Core: α-tocopherol. Capsule Shell: Gelatin, glycerol and purified water, medium-chain triglycerides, lecithin (soya).
Pharmacotherapeutic Group: Omega-3-triglycerides including other esters and acids. ATC Code: C10AX06.
Pharmacodynamics: The omega-3 series polyunsaturated fatty acids, EPA and DHA, are essential fatty acids.
Omacor is active on the plasma lipids by lowering triglyceride levels, which results in a fall in very low density lipoprotein (VLDL), and the substance is also active on haemostasis and blood pressure.
Omacor reduces the synthesis of triglycerides in the liver because EPA and DHA are poor substrates for the enzymes responsible for triglyceride synthesis and they inhibit esterification of other fatty acids.
The increase in peroxisomes of β-oxidation of fatty acids in the liver also contributes to the fall in triglycerides, by reducing the quantity of free fatty acids available for their synthesis. The inhibition of this synthesis lowers VLDL.
Omacor increases LDL-cholesterol in some patients with hypertriglyceridaemia. Arises in high-density lipoprotein (HDL)-cholesterol is only small, significantly smaller than seen after administration of fibrates, and not consistent.
The long-term lipid-lowering effect (after >1 year) is not known. Furthermore, there is no strong evidence that lowering triglycerides reduces the risk of ischaemic heart disease.
During treatment with Omacor, there is a fall in thromboxane A2 production and a slight increase in bleeding time. No significant effect has been observed on the other coagulation factors.
Eleven thousand three hundred twenty four (11,324) patients, with recent (<3 months) myocardial infarction and receiving recommended preventative treatment associated with a Mediterranean diet, were randomized in the GISSI-Prevenzione study in order to receive Omacor (n=2836), vitamin E (n=2830), Omacor + vitamin E (n=2830) or no treatment (n=2828). GISSI-P was a multicentre, randomized, open-label study performed in Italy.
The results observed over 3.5 years, with Omacor 1 g/day, have shown a significant reduction of a combined endpoint including all-cause death, nonfatal myocardial infarction and nonfatal stroke [decrease in relative risk of 15% (2-26) p=0.0226 in patients taking Omacor alone compared to control, and of 10% (1-18) p=0.0482 in patients taking Omacor with or without vitamin E]. A reduction of the 2nd pre-specified endpoint criteria including cardiovascular deaths, nonfatal myocardial infarction and nonfatal stroke has been shown [decrease in relative risk of 20% (5-32) p=0.0082 in patients taking Omacor alone compared to control, decrease in relative risk of 11% (1-20) p=0.0526 in patients taking Omacor with or without vitamin E]. The secondary analysis for each component of the primary endpoints has shown a significant reduction of all cause deaths and cardiovascular deaths, but no reduction of nonfatal cardiovascular events or fatal and nonfatal strokes.
Pharmacokinetics: The following is a detailed description of how omega-3 polyunsaturates are metabolized by the body.
During and after absorption, there are 3 main pathways for the metabolism of the omega-3 fatty acids: The fatty acids are first transported to the liver where they are incorporated into various categories of lipoproteins and then channelled to the peripheral lipid stores; the cell membrane phospholipids are replaced by lipoprotein phospholipids and the fatty acids can then act as precursors for various eicosanoids; the majority is oxidized to meet energy requirements.
The concentration of omega-3 fatty acids, EPA and DHA, in the plasma phospholipids corresponds to the EPA and DHA incorporated into the cell membranes.
Animal pharmacokinetic studies have shown that there is a complete hydrolysis of the ethyl ester accompanied by satisfactory absorption and incorporation of EPA and DHA into the plasma phospholipids and cholesterol esters.
Post Myocardial Infarction (Following a Heart Attack): Supplemental treatment in secondary prevention after myocardial infarction (heart attack) in addition to other standard therapy (eg, statins, antiplatelet medicinal products, β-blockers, ACE inhibitors).
Hypertriglyceridaemia (High Blood Lipids): Endogenous Hypertriglyceridaemia: As a supplement to diet when dietary measures alone are insufficient to produce an adequate response. Type IV in monotherapy (used alone); type IIb/III in combination with statins, when control of triglycerides is insufficient.
Dosage/Direction for Use
Post Myocardial Infarction (Following a Heart Attack): 1 capsule daily.
Hypertriglyceridemia (High Blood Lipids): Initial Treatment: 2 capsules daily. If adequate response is not obtained, the dose may be increased to 4 capsules daily.
Missed Dose: Do not take a double dose to compensate for the missed dose.
There is no information regarding the use of Omacor in children and adolescents, in elderly patients >70 years, or in patients with hepatic impairment, and only limited information regarding the use in patients with renal impairment (kidney disease).
Administration: The capsules may be taken with food to avoid gastrointestinal disturbances.
There are no special recommendations. Treatment should be symptomatic.
Hypersensitivity to omega-3 polyunsaturates, soya or to any of the excipients of Omacor.
Special Precautions
During treatment with Omacor, there is a fall in thromboxane A2 production. No significant effect has been observed on the other coagulation factors. Some studies with omega-3-acids demonstrated a prolongation of bleeding time, but the bleeding time reported in these studies has not exceeded normal limits and did not produce clinically significant bleeding episodes.
Clinical studies have not been done to thoroughly examine the combined effect of Omacor and concomitant anticoagulants. Patients receiving treatment with Omacor and an anticoagulant or other drug affecting coagulation (eg, acetylsalicylic acid, warfarin, coumarin) should be monitored periodically (see Interactions).
In some patients, a small but significant increase (within normal values) in aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) was reported, but there are no data indicating an increased risk for patients with hepatic impairment. Alanine aminotransferase and ASAT levels should be monitored in patients with any signs of liver damage (in particular with the high dosage ie, 4 capsules).
Omacor is not indicated for exogenous hypertriglyceridaemia (type 1 hyperchylomicronaemia). There is only limited experience in secondary endogenous hypertriglyceridaemia (especially uncontrolled diabetes) so the physician should check the patient carefully before prescribing Omacor if the patient suffers from this condition.
Effects on the Ability to Drive or Operate Machinery: Effects on ability to drive and use machines have not been studied. Nevertheless, Omacor is expected to have no or negligible influence on the ability to drive and use machines.
Use in Pregnancy: There are no adequate data from the use of Omacor in pregnant women. The potential risk for humans is unknown. Therefore, Omacor should not be used during pregnancy unless clearly necessary.
Use in Lactation: There are no data on the excretion of Omacor in human milk. Omacor should not be used during lactation.
Use In Pregnancy & Lactation
Use in Pregnancy: There are no adequate data from the use of Omacor in pregnant women. The potential risk for humans is unknown. Therefore, Omacor should not be used during pregnancy unless clearly necessary.
Use in Lactation: There are no data on the excretion of Omacor in human milk. Omacor should not be used during lactation.
Adverse Reactions
Like all medicines, Omacor may cause adverse reactions, although not everybody experiences them. If any adverse reaction is noticed that is not mentioned as follows, or if any of the adverse reaction gets serious, inform the physician or pharmacist.
The frequencies of adverse reactions are ranked according to the following: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000).
Immune System Disorders: Rare: Hypersensitivity (allergic reaction).
Metabolism and Nutrition Disorders: Uncommon: Hyperglycaemia (high blood sugar), gout.
Nervous System Disorders: Uncommon: Dizziness, dysgeusia (abnormal taste sensation), headache.
Vascular Disorders: Uncommon: Hypotension (low blood pressure).
Respiratory, Thoracic and Mediastinal Disorders: Uncommon: Epistaxis.
Gastrointestinal Disorders: Common: Gastrointestinal disorders (including abdominal distention and pain, constipation, diarrhea, dyspepsia, flatulence, eructation, gastroesophageal reflux disease, nausea or vomiting). Uncommon: Gastrointestinal haemorrhage (symptoms include blood in the faeces and abdominal pain).
Hepatobiliary Disorders: Uncommon: Liver disorders including increased transaminases (ALAT and ASAT).
Skin and Subcutaneous Tissue Disorders: Uncommon: Rash. Rare: Urticaria (red, itchy rash).
Drug Interactions
Inform the physician or pharmacist if the patient is taking or have recently taken any other medicines including medicines obtained without a prescription.
If the patient is taking an oral anticoagulant or any other drug that affects coagulation [eg, acetylsalicylic acid or nonsteroidal anti-inflammatory drugs (NSAIDs)] (see Precautions).
Increased bleeding time has been seen when Omacor is given in conjunction with acetylsalicylic acid and warfarin, but without haemorrhagic complications (see Precautions).
Acetylsalicylic Acid: Patients should be informed about potential increased bleeding time.
Warfarin and Coumarin: The prothrombin time/international normalized ratio (PT/INR) must be monitored during combination treatment with Omacor among patients receiving blood-thinning therapy, and when treatment with Omacor is discontinued.
Caution For Usage
Incompatibilities: Not applicable.
Do not store above 30°C. Do not freeze.
Shelf-Life: 30 months.
ATC Classification
C10AX06 - omega-3-triglycerides incl. other esters and acids ; Belongs to the class of other lipid modifying agents.
Soft-gelatin cap (oblong, transparent gelatin cap containing a pale yellow oil) 28's.
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