Omega 3 triglycerides instructions for use. Omacor: instructions for use

Omega 3 triglycerides are a complex substance consisting of a mixture of ethyl esters extracted from polyunsaturated fatty acids. The greatest importance for the human body are two acids that are classified as essential: eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Omega 3 triglycerides are an official drug approved by the US Food and Drug Administration and recognized in 40 countries. Below you will find instructions for using Omega 3 triglycerides.

Release form and composition

Omega 3 triglycerides are available in gelatin capsules for oral use. One capsule contains 1000 mg of the compound active ingredient in the following percentage ratio: 46 - 50% EPA and 37 - 40% DHA, up to 17% ethyl esters of other organic acids. An auxiliary substance that facilitates the absorption of ethyl esters by the human body is alpha-tocopherol, contained in an amount of 4–5 mg. The capsule shell contains the following components: gelatin, glycerol, water.

pharmachologic effect

EPA and DHA are absorbed by the mucous membranes of the walls of the gastrointestinal tract when swallowing the capsule without damaging the integrity of the shell, or by the mucous membranes of the oral cavity and walls of the gastrointestinal tract when chewing or resorption of the gelatin capsule. Through the mucous membranes, ethyl esters penetrate into the blood plasma, where they attach to transport proteins, which primarily produce selective movement of sodium and potassium ions, which allows optimizing the therapeutic effect by forming strong covalent bonds with heart cells. During metabolism in the liver, the synthesis of very low-density lipoproteins is inhibited, which in turn makes it possible to reduce the amount of low-density lipoproteins. In this regard, the drug in question belongs to the pharmacological group of lipid-lowering drugs.

The pharmacodynamics of this drug allows the following therapeutic effect to be achieved:

Strong bonds of the active substance with sodium and potassium ion channels help block the triggering of the arrhythmia mechanism in the myocardium susceptible to chronic coronary heart disease.
Helps reduce total cholesterol and triglyceride levels.
Inhibits the biosynthesis of thromboxane type “A2” and moderately reduces the rate of blood clotting, which helps prevent diseases of the human circulatory system.
Slightly increases the amount of high-density lipoproteins (“good” cholesterol) by reducing the level of low- and very low-density lipoproteins.
The rate and productivity of fatty acids is increased by stimulating the activity of peroxide P. As a result, the amount of free acids that are necessary for the synthesis of triglycerides is minimized.

Pharmacokinetics are realized in three main ways:

After undergoing metabolism in the liver, the metabolites EPA, DHA and esters of other acids are carried by lipoproteins to peripheral tissues with large reserves of lipids.
Partial replacement of the original phospholipids that make up cell membranes with phospholipids containing active metabolites of the active substance.
Oxidation of EPA, DHA and other acids in the form of esters with subsequent transformation into the energy potential of the human body.

The final elimination of the remaining active fatty acid esters through the intestines and kidneys occurs within a maximum of 48 hours. However, the therapeutic effect persists after discontinuation of the course of treatment with omega 3 triglycerides for a long period, which is directly dependent on the duration of the course of therapy or prophylaxis. The longer the course of treatment with this drug, the longer the therapeutic effect lasts.

Indications for use

Chronic heart failure. It is used in complex therapy with drugs aimed at stopping heart attacks and general restorative drugs aimed at maintaining and stabilizing the functioning of the cardiovascular system.
Hyperglyceridemia, pure type. Omega 3 triglycerides are used as a monotherapeutic drug, or as a main component of complex therapy.
Combined type hyperglyceridemia. Omega 3 triglycerides are used as part of complex therapy. The main therapeutic drug is selected based on an analysis of the patient’s blood composition.
Hyperlipidemias occurring with elevated levels of triglycerides in human plasma. The drug is used as part of complex therapy, in which the main drug is lipid-lowering drugs (usually belonging to the group of reductase inhibitors).

Indications for the use of Omega 3 triglycerides as prophylaxis

The main indication for the use of the drug in question for prophylactic purposes is a history of stroke or myocardial infarction that occurred against the background of coronary heart disease or contributing to the occurrence of coronary heart disease.

Directions for use and dosage

Omega 3 triglyceride capsules are for oral use and are consumed in one of two ways:

Swallow the medicine without chewing, drinking plenty of water. In this case, absorption occurs in the gastrointestinal tract by more than 99%.
Chew or slowly dissolve the capsule until the active substance is completely released into the oral cavity, followed by swallowing. Washing down the capsule with water after resorption or mechanical damage to the gelatin shell is at the discretion of the person taking the medication. In this case, absorption in percentage terms is distributed approximately as follows: 30% of the active substances are absorbed by the mucous membranes of the oral cavity and esophagus, and 70% by the mucous membranes of the gastrointestinal tract.

Contraindications for use

Individual intolerance to the main or auxiliary substances included in the composition of the drug.
Pregnancy and lactation when breastfeeding. Its use during this period has not been sufficiently studied.

Interaction with other drugs

Lipid-lowering drugs (primarily statins and fibrates). This is due to the ability of drugs to mutually enhance their effects on the body. Adjustment of the dosage of medications by the treating specialist is required. This is not a reason for refusing to use one of the drugs, since for a number of diseases such a combination is recommended/mandatory to achieve the required therapeutic effect (for example, hyperlipidemia occurring against the background of a high level of triglycerides in the blood plasma).
Anticoagulants and other drugs that reduce blood clotting. Considering that omega 3 triglycerides can also have a moderate effect on blood clotting, reducing the latter, adjustment of the dosage of drugs is required if their combined use is necessary (for example, for the prevention of thrombosis).

For better absorption of the drug and to reduce the likelihood of side effects, it is recommended to take capsules while eating. For prophylactic purposes, a dose of one capsule per day is prescribed. For therapeutic purposes, a dose of two capsules is prescribed daily. The maximum daily dosage is four capsules at a time or two capsules every twelve hours. The duration of the course of treatment is chosen by the doctor in accordance with the individual characteristics of the patient’s body and the type of disease/pathology. The average course of treatment is three months. If the course lasts up to six months, after six months of therapy/prophylaxis it is necessary to take a break of at least two weeks. Then the course can be repeated.

Side effects

Dyspeptic symptoms of various types: nausea, indigestion, bloating, constipation or diarrhea.
Allergic reactions in the form of skin rashes and itching.
Moderate decrease in blood pressure, accompanied by dizziness and/or headaches.
Gastroenteritis. It rarely develops with long-term use of Omega 3 triglycerides, usually in the presence of a predisposition to this disease.
Dry mucous membranes (especially in the nose). In most cases, it can be observed during long-term treatment when using maximum dosages of the drug.
Acne.
Impaired sense of taste.
Reversible liver dysfunction.

Release form, composition and packaging

Capsules soft gelatin, transparent, size 20; the contents of the capsules are a light yellow oily liquid.

Composition of the capsule shell: gelatin, glycerol, purified water.

28 pcs. - polyethylene bottles (1) - cardboard packs.
100 pieces. - polyethylene bottles (1) - cardboard packs.

Clinical and pharmacological group

Lipid-lowering drug

pharmachologic effect

Lipid-lowering drug. Contains polyunsaturated essential fatty acids of the omega-3 class - eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) - belong to essential fatty acids (NEFA).

Omacor reduces the content of triglycerides as a result of a decrease in the concentration of VLDL, in addition, it actively affects hemostasis, reducing the synthesis of thromboxane A 2 and slightly increasing blood clotting time.

Delays the synthesis of triglycerides in the liver (by inhibiting the esterification of EPA and DHA).

A decrease in triglyceride levels is facilitated by an increase in peroxisome beta-oxidation of fatty acids (a decrease in the amount of free fatty acids available for triglyceride synthesis).

The increase in HDL is very slight and is not permanent. It is significantly less than after taking fibrates.

The results of observations (for 3.5 years) of patients taking Omacor at a dose of 1 g/day showed a significant reduction in the combined indicator, including mortality from all causes, as well as non-fatal myocardial infarction and stroke.

Pharmacokinetics

During and after the absorption of omega-3 fatty acids, there are 3 main pathways for their metabolism:

- fatty acids are first delivered to the liver, where they are included in various categories of lipoproteins and sent to peripheral lipid reserves;

— phospholipids of cell membranes are replaced by phospholipids of lipoproteins, after which fatty acids can act as precursors of various eicosanoids;

- Most fatty acids are oxidized to meet energy needs.

The concentration of omega-3 fatty acids - EPA and DHA - in blood plasma phospholipids corresponds to the concentration of these fatty acids included in cell membranes.

Indications for use of the drug

Secondary prevention of myocardial infarction (as part of combination therapy with statins, antiplatelet drugs, beta-blockers, ACE inhibitors).

Hypertriglyceridemia: endogenous hypertriglyceridemia - as an addition to the diet if it is insufficiently effective:

- type IV (as monotherapy);

- type IIb/III (in combination with statins - in the case when the concentration of triglycerides remains high).

Dosage regimen

The drug is taken orally during meals.

For secondary prevention of myocardial infarction It is recommended to take 1 capsule/day.

At treatment of hypertriglyceridemia The initial dose of Omacor is 2 caps./day. If there is no therapeutic effect, the dose may be increased to 4 caps./day.

The duration of treatment is determined individually.

Side effect

Determination of the frequency of side effects: often (1-10%); uncommon (0.1-1%); rarely (0.01-0.1%); very rare (less than 0.01%), including isolated cases.

From the digestive system: often - dyspepsia, nausea; uncommon - abdominal pain, gastrointestinal disorders, gastritis, pain in the upper abdomen, gastroenteritis; rarely - liver dysfunction; very rarely - bleeding from the lower gastrointestinal tract; in isolated cases - increased activity of liver enzymes.

From the side of the central nervous system: infrequently - dizziness, dysgeusia (taste perversion); rarely - headache.

Allergic reactions: infrequently - hypersensitivity reactions.

From the side of metabolism: rarely - hyperglycemia; in isolated cases - an increase in the need for insulin (the need to increase the standard dose).

From the cardiovascular system: very rarely - decreased blood pressure.

From the respiratory system: very rarely - dry nose.

Dermatological reactions: rarely - acne, itchy rash; very rarely - urticaria; in isolated cases - rosacea, rash, hyperemia/erythema, urticaria in the chest, neck, and shoulders.

During the research: very rarely - an increase in the number of leukocytes in the peripheral blood, an increase in LDH levels; in isolated cases - increased CPK levels, myalgia, increased AST, ALT, increased body weight. Moderate increases in transaminases (AST, ALT) have been reported in patients with hypertriglyceridemia.

Contraindications to the use of the drug

- exogenous hypertriglyceridemia (hyperchylomicronemia) (type I according to the Fredrickson classification);

- pregnancy;

- lactation period (breastfeeding);

- hypersensitivity to the components of the drug.

WITH caution the drug should be prescribed for severe liver dysfunction, simultaneously with fibrates, simultaneously with oral anticoagulants, for severe injuries, surgical operations (due to the risk of increased bleeding time), elderly patients (over 70 years old), as well as children and adolescents aged up to 18 years of age (efficacy and safety have not been established).

Use of the drug during pregnancy and lactation

The drug is contraindicated for use during pregnancy and lactation (breastfeeding).

Use for liver dysfunction

WITH caution the drug should be prescribed for severe liver dysfunction. In patients with impaired liver function (especially when taking the drug at a dose of 4 caps./day), regular monitoring of liver function is necessary (determining the activity of AST and ALT).

Use for renal impairment

Patients with impaired renal function no dose adjustment is required.

special instructions

Due to a moderate increase in bleeding time (when taking Omacor in a high dose - 4 capsules), constant medical supervision of patients on anticoagulant therapy is required, and, if necessary, appropriate adjustment of the dose of the anticoagulant. Carrying out this therapy does not eliminate the need for routine monitoring provided for in the treatment of such patients.

Increased bleeding time should be taken into account in patients with an increased risk of hemorrhage (eg, as a result of severe trauma, surgery).

The available experience in studying secondary endogenous hypertriglyceridemia (especially in uncontrolled diabetes mellitus) is very limited.

There is no clinical experience regarding the treatment of hypertriglyceridemia in combination with fibrates, therefore the simultaneous use of Omacor with fibrates is not recommended.

When taking Omacor, a moderate increase in the activity of liver transaminases is possible.

In patients with impaired liver function (especially when taking a high dose of 4 capsules), regular monitoring of liver function is necessary (determining the activity of AST and ALT).

Patients with impaired renal function do not require dose adjustment.

There is no information on the use of Omacor in children, elderly patients over 70 years of age, or in patients with impaired liver function.

Use in pediatrics

Efficiency and safety of using Omacor in children and adolescents under 18 years of age not installed.

Impact on the ability to drive vehicles and operate machinery

Omacor does not affect the ability to perform work that requires high concentration and speed of psychomotor reactions.

Overdose

Symptoms: Side effects may occur or their severity may increase.

Treatment: carry out symptomatic therapy.

Drug interactions

When Omacor is used simultaneously with oral anticoagulants, there is a risk of increased bleeding time.

Prescribing Omacor together with warfarin does not lead to any hemorrhagic complications. However, when taking Omacor and warfarin in combination or stopping the course of treatment with Omacor, monitoring of prothrombin time is necessary.

Conditions for dispensing from pharmacies

The drug is available with a prescription.

Storage conditions and periods

List B. The drug should be stored in a dry place, out of reach of children, at a temperature not exceeding 25°C; do not freeze. Shelf life - 3 years.

In this article you can read the instructions for use of the drug Omacor. Reviews of site visitors - consumers of this medicine, as well as the opinions of specialist doctors on the use of Omacor in their practice are presented. We kindly ask you to actively add your reviews about the drug: whether the medicine helped or did not help get rid of the disease, what complications and side effects were observed, perhaps not stated by the manufacturer in the annotation. Analogues of Omacor in the presence of existing structural analogues. Use for the treatment of hypertriglyceridemia and omega 3 deficiency, prevention of myocardial infarction in adults, children, as well as during pregnancy and lactation. Composition of the drug.

Omacor- polyunsaturated essential fatty acids of the omega-3-eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) class - belong to the essential fatty acids (NEFA).

Delays the synthesis of triglycerides in the liver (by inhibiting the esterification of EPA and DHA).

A decrease in triglyceride levels is facilitated by an increase in peroxisome beta-oxidation of fatty acids (a decrease in the amount of free fatty acids available for triglyceride synthesis).

The increase in high-density lipoprotein (HDL) concentrations is minimal and significantly lower than after taking fibrates.

Clinical results from studies of Omacor at a dose of 1 g per day for 3.5 years showed a significant reduction in the composite indicator, including overall mortality from all causes, as well as non-fatal myocardial infarction and stroke.

Compound

Omega-3 polyunsaturated fatty acids ethyl esters + excipients.

Pharmacokinetics

During and after the absorption of omega-3 fatty acids, there are 3 main pathways for their metabolism:

fatty acids are first delivered to the liver, where they are included in various categories of lipoproteins and sent to peripheral lipid stores;
phospholipids of cell membranes are replaced by phospholipids of lipoproteins, after which fatty acids can act as precursors of various eicosanoids;
Most fatty acids are oxidized to meet energy needs.

The concentration of omega-3-EPA and DHA fatty acids in blood plasma phospholipids corresponds to the concentration of these fatty acids included in cell membranes.

Indications

Hypertriglyceridemia:

endogenous hypertriglyceridemia type 4 according to the Fredrickson classification (in monotherapy) as an addition to a lipid-lowering diet if it is insufficiently effective;
endogenous hypertriglyceridemia type 2b or 3 according to the Fredrickson classification (in combination with lipid-lowering drugs - HMG-CoA reductase inhibitors (statins)).

Secondary prevention of myocardial infarction (as part of combination therapy): in combination with HMG-CoA reductase inhibitors (statins), antiplatelet agents, beta-blockers, ACE inhibitors.

Release forms

1000 mg capsules in packs of 28 or 100 pieces (sometimes mistakenly called tablets).

Instructions for use and dosage regimen

The drug is taken orally, simultaneously with meals.

For hypertriglyceridemia, the initial dose of Omacor is 2 capsules per day. If there is no therapeutic effect, the dose may be increased to the maximum daily dose - 4 capsules. The duration of treatment and repeated courses are determined on the recommendation of a doctor.

For secondary prevention of myocardial infarction, it is recommended to take 1 capsule per day. The duration of treatment and repeated courses are determined on the recommendation of a doctor.

Side effect

hypersensitivity reactions;
hyperglycemia;
dizziness;
dysgeusia (taste perversion);
headache;
pronounced decrease in blood pressure;
dryness of the nasal mucosa;
dyspepsia;
nausea;
abdominal pain;
gastrointestinal disorders (gastroesophageal reflux disease, belching, vomiting, constipation);
bleeding from the lower gastrointestinal tract;
skin itching;
rash;
hives;
increase in the content of leukocytes in the blood;
hemorrhagic diathesis;
with long-term use of the drug Omacor in large doses (4 g per day), belching with the smell or taste of fish is possible.

Contraindications

exogenous hypertriglyceridemia (hyperchylomicronemia) (type 1 according to the Fredrickson classification);
pregnancy;
lactation period (breastfeeding);
age under 18 years (efficacy and safety have not been established);
hypersensitivity to the active substance, excipients, as well as to soy.

Use during pregnancy and breastfeeding

There are no clinical data on the use of the drug during pregnancy.

Omacor should be prescribed during pregnancy with caution, only after a careful assessment of the risk-benefit ratio, when the benefit to the mother outweighs the potential risk to the fetus.

The use of Omacor is contraindicated during lactation. If taking Omacor is necessary during lactation, breastfeeding should be discontinued.

Use in children

Contraindicated in children and adolescents under 18 years of age (efficacy and safety have not been established).

special instructions

Due to a moderate increase in bleeding time (when taking a high dose - 4 capsules), monitoring is required for patients who have disorders of the blood coagulation system, as well as those receiving anticoagulant therapy or drugs that affect the hemostatic system (acetylsalicylic acid as an antiplatelet agent, non-steroidal anti-inflammatory drugs (NSAIDs)), and, if necessary, appropriate adjustment of the dose of the anticoagulant or agents affecting the hemostatic system.

In patients with impaired liver function (especially when taking a high dose - 4 capsules), regular monitoring of liver function (AST and ALT) is necessary.

The use of Omacor together with warfarin does not lead to any hemorrhagic complications. However, with the combined use of Omacor and warfarin or discontinuation of treatment with Omacor, monitoring of prothrombin time or MHO (international normalized ratio) is necessary.

Impact on the ability to drive vehicles and operate machinery

No studies have been conducted on the effect of the drug Omacor on the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

During treatment with Omacor, care must be taken when driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug interactions

When Omacor is used simultaneously with oral anticoagulants and other drugs that affect the hemostatic system, the risk of increased bleeding time increases.

There are no data on simultaneous use with fibrates in the treatment of hypertriglyceridemia.

Analogues of the drug Omacor

The drug Omacor has no structural analogues for the active substance. The drug is unique in its composition of active ingredients.

Analogs by pharmacological group (hypolipidemic drugs):

Alisat is super;
Alli;
Allicor;
Allilchep;
Allitera;
Alpha lipoic acid;
Atheroclephitis;
Vitanorm;
Vitrum Omega 3;
Kwai;
Clam;
Xenalten;
Xenical;
Curdlipid;
Lacrinate;
Kelp;
Lysivit C;
Lipoic acid;
Lipothioxone;
Listata;
Octolipen;
Optinate;
Orlimax;
Orlistat;
Orsoten;
Orsoten slim;
Polysponin;
Pollinat;
Splatinate;
Thioctacid 600;
Thiolipon;
Tribestan;
Tritinate;
Tykveol;
Urso 100;
Ursodeoxycholic acid;
PhytoTransit;
Ezetrol;
Eikonol;
Euphytol;
Exhol;
Espa Lipon.

If there are no analogues of the drug for the active substance, you can follow the links below to the diseases for which the corresponding drug helps, and look at the available analogues for the therapeutic effect.

Content

The drug Omacor contains Omega-3 triglycerides, which provide a hypolipidemic effect (eliminate lipid deficiency). Doctors prescribe medication for elevated levels of lipid substances in the blood, which can cause myocardial infarction. The instructions for the drug will help you understand the features of its use.

Omacor tablets

The drug Omacor belongs to the group of anti-sclerotic agents based on eicosapentaenoic and docosahexaenoic acids, which are Omega-3 acids. They regulate glyceride and lipid levels, helping to prevent the risk of myocardial infarction and other diseases associated with triglyceride concentrations. Omacor has its own application characteristics.

Composition of the drug Omacor

The drug is available in the form of transparent gelatin capsules containing a yellowish oily liquid. They are packaged in polyethylene bottles of 28 and 100 pieces. The composition of the contents of the capsule and shell is presented in the table:

Pharmacodynamics and pharmacokinetics

The drug reduces triglyceride levels by reducing the concentration of very low density lipoproteins (VLDL), as well as actively influencing hemostasis, reducing the synthesis of thromboxane A2. The medication inhibits the synthesis of triglycerides in the liver, since docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) suppress the esterification (reaction of ester formation) of fatty acids, interact with the enzymes creatine phosphokinase (a participant in the process of energy metabolism) and lactate dehydrogenase (a participant in the formation of lactic acid) .

A decrease in triglyceride levels is affected by a decrease in the level of free fatty acids, which are involved in the synthesis of triglycerides. Medical statistics show that patients taking 1 g of the drug per day significantly reduce the risk of mortality, stroke and non-fatal myocardial infarction. Omega-3 fatty acids are absorbed in the small intestine and metabolized in three ways:

They are transported to the liver, where they become part of various categories of lipoproteins and replenish peripheral lipid reserves.
Phospholipids of cell membranes are replaced by phospholipids of lipoproteins, fatty acids are precursors of eicosanoids.
Most fatty acids undergo β-oxidation to meet the body's energy needs.

Indications for use of Omacor

Prevention of secondary myocardial infarction in combination therapy with other standard treatments: antiaggregation drugs, statins, angiotensin-converting enzyme (ACE) inhibitors, beta-blockers.
Endogenous hypertriglyceridemia type IV in the form of an addition to a lipid-lowering diet, provided that it is of low effectiveness.
Endogenous hypertriglyceridemia type ll b or type III in combination with statin inhibitors, if triglyceride levels are unsatisfactorily controlled by the use of statins.

Instructions for use of Omacor

The drug is intended for oral use during meals. If the indication for use is the prevention of secondary myocardial infarction, then the dosage is one capsule per day. For the treatment of hypertriglyceridemia, the initial dosage is two capsules/day. In the absence of a clinically significant effect, the dose may be increased to four capsules/day. The doctor prescribes the duration of treatment individually. For patients with impaired renal function, the dose is not adjusted.

special instructions

Patients over 70 years of age, people with impaired liver function, hemorrhagic diathesis, surgical interventions or severe injuries should take the medication with caution. Due to the effect of large doses on bleeding time, monitoring of patients diagnosed with bleeding disorders and being treated with anticoagulants is necessary. Patients receiving drugs that affect hemostasis and leukocytes require special attention.

If undesirable side effects are identified when combining the drug with anticoagulants, the dosage of the latter must be adjusted. In some cases, the use of the drug may cause an increase in the activity of aspartate aminotransferase, transaminase and alanine aminotransferase, but there are no precedents for an increased risk of taking the drug in patients with liver dysfunction. The drug can cause dizziness, so increased caution is required when driving.

During pregnancy

To date, there is no objective and authoritative data on the peculiarities of taking the drug during pregnancy. For this reason, the use of the medication is possible with caution, and only if there is an understanding that the likelihood of benefit to the mother will be greater than the possible risk to the unborn child. During lactation, taking the medication is prohibited.

In childhood

There are no clinical studies of the effect of the drug on children and adolescents under 18 years of age. It is impossible to reliably and objectively predict the consequences of taking a medicine in terms of possible effectiveness and safety. In this regard, the prescription of Omacor both in monotherapy and in combination with other drugs for these groups should be considered inappropriate.

Compatibility of Omacor and alcohol

Alcohol should not be taken during Omacor therapy. Both products are processed by the liver, increasing the load on the organ. This can lead to intoxication of the body, the development of side effects and a deterioration in the effect of the medication. After completing therapy with the drug, it is not recommended to take alcohol-containing drinks and ethanol-based medications for another couple of days.

Drug interactions

The simultaneous combination of Omacor with fibrates, oral anticoagulants and other drugs that affect hemostasis increases the risk of increased bleeding time. Warfarin (an indirect anticoagulant) in combination with the drug does not lead to complications of the hemorrhagic type, but in this case, monitoring of the international normalized ratio (INR) of the blood is necessary. The drug weakens the effect of insulin.

Side effects

When using Omacor capsules, various side effects may occur. Common conditions include:

hypersensitivity reactions;
gout, hyperglycemia, dry skin, rash on it;
dizziness, headache, increased cholesterol levels;
decreased blood pressure, nosebleeds;
bloating, abdominal pain, constipation;
flatulence, dyspepsia, belching, nausea, muscle pain;
vomiting, gastroesophageal reflux disease, gastrointestinal bleeding, liver dysfunction, gastritis, gastroenteritis;
skin rashes on the neck, urticaria, allergic reactions, erythema.

Overdose

Doctors do not mention acute cases of drug overdose. If the recommended dose of the drug is exceeded, increased development of side effects is possible. If they appear, you should immediately stop taking the medication and consult a doctor. For patients with suspected overdose, the following are indicated: symptomatic therapy, gastric lavage, and sorbents.

Contraindications

Taking Omacor has a number of contraindications due to its pharmacological action. Among them are the following factors:

children and adolescents up to 18 years of age;
old age over 70 years;
liver dysfunction;
diabetes;
combination with fibrates, oral anticoagulants;
period after surgery, severe injuries (strictly at the discretion of the doctor);
exogenous hypertriglyceridemia, hyperchylomicronemia;
breast-feeding;
hypersensitivity to components.

Terms of sale and storage

The drug can be purchased with a prescription. It should be stored out of the reach of children at temperatures up to 25 degrees. The shelf life should not exceed three years.

Analogs

Substitutes for Omacor include drugs with the same active substance in the composition or another, but which exhibit the same effect in relation to the human body. Popular analogues of the drug:

Vitrum Cardio Omega-3 is a direct analogue with the same active ingredient;
Angionorm is a herbal preparation for the treatment of conditions accompanied by vascular disorders;
Fish oil – contains omega-3 complex (can be obtained from eel, salmon).

Omacor price

The cost of the drug varies depending on the pricing policy of the pharmaceutical chain. The approximate cost of the medicine and its analogues in Moscow and St. Petersburg is indicated in the table.

Compound

Description of the dosage form

Transparent soft gelatin capsule size 20.

The contents of the capsule are a light yellow oily liquid.

pharmachologic effect

pharmachologic effect- hypolipidemic.

Pharmacodynamics

Omega-3 PUFAs - EPA and DHA - belong to essential fatty acids.

Omacor is active against plasma lipids, reduces the concentration of triglycerides as a result of a decrease in the concentration of VLDL. In addition, it affects blood pressure and hemostasis.

Omacor reduces the synthesis of triglycerides in the liver, because EPA and DHA are less active substrates for enzymes responsible for triglyceride synthesis, and they inhibit the esterification of other fatty acids. A decrease in triglyceride concentration is also facilitated by increased P-oxidation of fatty acids in liver peroxisomes, thereby reducing the amount of free fatty acids available for triglyceride synthesis. Inhibition of this synthesis reduces VLDL levels.

Omacor increases LDL-C levels in some patients with hypertriglyceridemia. The increase in HDL-C concentrations is minimal, significantly lower than after taking fibrates, and not constant. The duration of the lipid-lowering effect when taking Omacor for more than 1 year has not been studied. Otherwise, there is no convincing evidence that lowering triglyceride levels reduces the risk of developing CAD. During therapy with Omacor, a decrease in the synthesis of thromboxane A2 and a slight increase in blood clotting time were observed. No significant effects on other coagulation factors were observed. Clinical trial results GISSI-Prevenzione, obtained over 3.5 years of observation, showed a significant reduction in the relative risk of mortality from all causes, non-fatal myocardial infarction and non-fatal stroke by 15% (p = 0.0226) in patients after a recent myocardial infarction who took the drug Omacor 1 g /day Additionally, the RR for death due to cardiovascular disease, nonfatal myocardial infarction, and nonfatal stroke was reduced by 20% (p=0.0082). Results of another clinical study - GISSI-Heart Failure- in which patients with CHF received Omacor 1 g/day on average for 3.9 years, showed a reduction in the RR of all-cause mortality by 9% (p = 0.041), a decrease in the RR of all-cause mortality and hospitalization due to heart disease -vascular pathologies by 8% (p=0.009), reduction in the RR of initial hospitalization due to ventricular arrhythmias by 28% (p=0.013).

Pharmacokinetics

During and after absorption of omega-3 fatty acids (FAs) in the small intestine, there are 3 main pathways of their metabolism:

FAs are first delivered to the liver, where they are incorporated into various categories of lipoproteins and sent to peripheral lipid stores;

Phospholipids of cell membranes are replaced by phospholipids of lipoproteins, after which FAs can act as precursors of various eicosanoids;

Most of the FA is oxidized to meet energy needs. The concentration of omega-3 fatty acids, EPA and DHA in blood plasma phospholipids corresponds to the concentration of EPA and DHA included in cell membranes. Pharmacokinetic studies on animals have shown that ethyl esters of omega-3 acids undergo complete hydrolysis, after which EPA and DHA are absorbed in sufficient quantities and are included in the composition of phospholipids and cholesterol esters in the blood plasma.

Indications for the drug Omacor

hypertriglyceridemia:

Endogenous hypertriglyceridemia type IV according to the Fredrickson classification (in monotherapy) as an addition to a lipid-lowering diet when it is insufficiently effective;

Endogenous hypertriglyceridemia type IIb or III according to the Fredrickson classification in combination with HMG-CoA reductase inhibitors (statins), when the concentration of triglycerides is not sufficiently controlled by taking statins;

secondary prevention after myocardial infarction (as part of combination therapy): in combination with statins, antiplatelet agents, beta-blockers, ACE inhibitors.

Contraindications

hypersensitivity to the active substance, soy, peanuts or any of the excipients included in the drug;

exogenous hypertriglyceridemia (hyperchylomicronemia type I);

pregnancy and breastfeeding;

age under 18 years (efficacy and safety have not been established).

Carefully: established hypersensitivity or allergy to fish; age over 70 years; liver dysfunction; simultaneous use with oral anticoagulants; hemorrhagic diathesis; patients with a high risk of bleeding (due to severe trauma, surgery); secondary endogenous hypertriglyceridemia (especially with uncontrolled diabetes mellitus).

Use during pregnancy and breastfeeding

There is no reliable data on the use of Omacor during pregnancy. Animal studies have not revealed toxic effects on reproductive function. The potential risk to humans is unknown.

Omacor should be prescribed to pregnant women with caution, only after a careful assessment of the risk-benefit ratio, when the benefit to the mother outweighs the potential risk to the fetus.

There are no data on the excretion of Omacor into breast milk. Therefore, the drug should not be used during breastfeeding.

Fertility. There are no reliable data on the effect of Omacor on fertility.

Side effects

The frequency of the adverse reactions listed below was determined according to the following: very often (≥1/10); often (≥1/100,<1/10); нечасто (≥1/1000, <1/100); редко (≥1/10000, <1/1000); очень редко (<1/10000); частота неизвестна.

From the immune system: rarely - hypersensitivity.

Metabolism and nutrition: infrequently - hyperglycemia, gout.

From the nervous system: infrequently - dizziness, dysgeusia (taste perversion), headache.

From the side of blood vessels: infrequently - arterial hypotension.

From the respiratory system, chest and mediastinal organs: infrequently - epistaxis (nosebleeds).

From the gastrointestinal tract: often - gastrointestinal disorders (including bloating, abdominal pain, constipation, diarrhea, dyspepsia, flatulence, belching, GERD, nausea or vomiting); infrequently - gastrointestinal bleeding.

From the liver and biliary tract: uncommon - liver dysfunction, incl. increase in transaminase activity (ALT and AST).

For the skin and subcutaneous tissues: uncommon - skin rash; rarely - urticaria; frequency unknown - skin itching.

Interaction

When simultaneous use of the drug Omacor with oral anticoagulants or other drugs affecting the hemostatic system (for example, acetylsalicylic acid or NSAIDs), an increase in blood clotting time was observed, which may be a consequence of a possible additive effect on blood clotting time. In this case, no hemorrhagic complications were observed (see “Special Instructions”).

Acetylsalicylic acid. Patients should be informed about the possible increase in blood clotting time.

The combined use of Omacor with warfarin did not lead to any hemorrhagic complications. However, monitoring of the PT/INR ratio is necessary when using Omacor together with other drugs that affect the PT/INR ratio, or after stopping therapy with Omacor.

Directions for use and doses

Inside, regardless of food intake. To avoid the development of possible adverse events from the gastrointestinal tract, Omacor can be taken with meals.

Hypertriglyceridemia. The initial dose is 2 capsules/day. If there is no therapeutic effect, the dose may be increased to the maximum daily dose - 4 caps.

Secondary prevention of myocardial infarction. It is recommended to take 1 capsule/day.

There are no data on the use of Omacor in children and adolescents, elderly patients over 70 years of age and patients with liver failure (see “Special Instructions”). There are limited data on the use of the drug in patients with renal failure.

Overdose

No data available.

Treatment: symptomatic therapy should be carried out.

special instructions

Omacor should be used with caution in patients with known hypersensitivity or allergy to fish.

Due to a moderate increase in blood clotting time (when taken in a high dose, i.e. 4 caps./day), monitoring of patients with disorders of the blood coagulation system or receiving anticoagulant therapy or other drugs that affect the hemostatic system is required ( for example, acetylsalicylic acid or NSAIDs); if necessary, the dose of the anticoagulant should be adjusted (see “Interaction”).

It is necessary to take into account the increase in blood clotting time in patients with a high risk of bleeding (due to severe trauma, surgery, etc.). When treated with Omacor, the level of thromboxane A2 formation decreases. There was no significant effect on the levels of other coagulation factors. In clinical studies, there was no increase in the incidence of bleeding episodes.

Some patients experienced a small but significant increase in AST and ALT activity (within normal limits), while there is no data indicating an increased risk of taking Omacor in patients with impaired liver function. It is necessary to monitor the activity of AST and ALT in patients with any signs of liver dysfunction (in particular, when taken in a high dose, i.e. 4 caps./day).

There is no experience with the use of Omacor for the treatment of exogenous hypertriglyceridemia (hyperchylomicronemia type 1). Experience with the use of Omacor in secondary endogenous hypertriglyceridemia is limited (especially in uncontrolled diabetes mellitus).

Impact on the ability to drive vehicles and machinery. No studies have been conducted on the effect of the drug Omacor on the ability to drive vehicles and operate machinery. However, the drug is expected to have no or negligible effects on the ability to drive vehicles and operate machines.