Clinical and pharmacological group: & nbsp

Other lipid-lowering agents

Included in the formulation
  • Omakor
    capsules inwards 
  • АТХ:

    C.10.A.X.06   Omega-3 triglycerides, including other esters and acids

    Pharmacodynamics:

    Inhibits acyl-CoA-1,2-diacylglycerol acyltransferase, esterification of higher fatty acids. Enhances peroxisomal β-oxidation of triglycerides in the liver.

    Polyunsaturated fatty acids of the omega-3 - eicosapentaenoic acid and docosahexaenoic acid - class are essential (essential) fatty acids.

    The drug reduces the triglyceride content by decreasing the concentration very low density lipoproteins, in addition, it actively affects hemostasis, reducing the synthesis of thromboxane A2 and slightly increasing the clotting time.

    Delays the synthesis of triglycerides in the liver, as eicosapentaenoic acid and docosahexaenoic acid inhibit the esterification of other fatty acids.

    Reducing the concentration of triglycerides is facilitated by an increase in peroxisomes of beta-oxidation of fatty acids (a decrease in the amount of free fatty acids available for the synthesis of triglycerides). The inhibition of this synthesis reduces the level of very low density lipoproteins. The drug raises the level of cholesterol low density lipoprotein in some patients with hypertriglyceridemia. Increase in concentration high-density lipoproteins is minimal and significantly lower than after taking fibrates.

    Pharmacokinetics:

    It is better absorbed in persons younger than 50 years and women. Metabolized by replenishment of peripheral lipid stocks, oxidation to ensure energy needs, inclusion in the composition of cell membranes.

    During and after absorption in the small intestine of fatty acids of the omega-3 class, there are 3 main ways of their metabolism:

    - Fatty acids are first delivered to the liver, where they are included in the composition of various categories of lipoproteins and are directed to peripheral lipid stocks;

    - phospholipids 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 provide energy needs.

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

    Indications:

    Secondary prevention of myocardial infarction (in combination with other standard methods of treatment: statins, antiplatelet agents, beta-blockers, inhibitors ACE).

    Endogenous hypertriglyceridemia - as a supplement to the diet with its insufficient effectiveness:

    - type IV (as a monotherapy),

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

    IV.E70-E90.E78.1   Pure hyperglyceridemia

    IV.E70-E90.E78.2   Mixed hyperlipidemia

    IX.I20-I25.I25.2   Postponed myocardial infarction

    Contraindications:

    - exogenous hypertriglyceridemia (hyperhilomicronemia type 1);

    - hypersensitivity;

    - pregnancy and lactation.

    Carefully:

    - severe liver dysfunction;

    - age to 18 years (efficiency and safety not established);

    - age over 70 years;

    - surgical operations (due to the risk of increased bleeding time);

    - simultaneous use with fibrates or oral anticoagulants;

    - severe injuries.

    Pregnancy and lactation:

    Category FDA - C. Contraindicated in pregnancy. For the duration of treatment, breastfeeding should be discontinued.There are no adequate and well-controlled studies.

    Dosing and Administration:

    Orally with meals. 1 capsule contains omega-3-polyunsaturated fatty acids of ethyl esters of 1000 mg.

    Hypertriglyceridemia: 2 capsules per day. The maximum daily dose is 4 capsules. The duration of treatment is determined by the doctor.

    Secondary prophylaxis after myocardial infarction: 1 capsule per day. The duration of treatment is determined by the doctor.

    Side effects:

    From the gastrointestinal tract: often - dyspepsia, nausea; infrequently - abdominal pain, gastrointestinal disorders, gastritis, pain in the upper abdomen; very rarely - bleeding from the lower divisions GIT.

    From the skin: rash, rarely - acne, itchy rashes; very rarely - hives.

    From the respiratory system: epistaxis, dryness in the nose.

    From the cardiovascular system: lowering of blood pressure.

    From the immune system: allergic reactions.

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

    From the side of metabolism: gout, hyperglycemia.

    Infectious processes: infrequently - gastroenteritis.

    From the side of the liver: rarely - violations of the liver, increased activity of liver enzymes.

    Overdose:

    Increased side effects, treatment is symptomatic.

    Interaction:

    At simultaneous application with oral anticoagulants there is a risk of an increase in bleeding time. The administration of the drug together with warfarin does not lead to any hemorrhagic complications. However, with the combined administration of the drug and warfarin or discontinuation of the course of treatment with the drug, prothrombin time control is necessary.

    Drugs that aggravate hypertriglyceridemia, weaken the effect of the drug.

    Potentiating Effects simvastatin, atorvastatin at a dose of 4 grams per day.

    Special instructions:

    Due to a moderate increase in bleeding time (when used in a high dose - 4 capsules), it is necessary to monitor patients who have disorders from the blood coagulation system, as well as receiving anticoagulant therapy or drugs that affect the hemostasis systemacetylsalicylic acid as antiaggregant agent, non-steroidal anti-inflammatory drugs), and if necessary - appropriate correction of the dose of anticoagulant or agents affecting the hemostatic system.

    Some patients showed an increase in liver transaminase activity (within the normal range), while there are no data indicating an increased risk of using the drug in patients with impaired liver function. It is necessary to monitor the activity of hepatic transaminases in patients with signs of impaired liver function (especially when used in a high dose - 4 capsules).

    Impact on the ability to drive vehicles and manage mechanisms

    Studies have not been conducted. May cause dizziness, use caution.

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