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1 Omacor capsule contains 1000 mg of omega-3-acid ethyl ester, of which 46% is EPA (eicosapentaenoic acid) and 38% DHA (docosahexaenoic acid), and 4 mg α-tocopherol.Sheath: 293 mg of gelatin, 135 mg of glycerol, purified water.Form of issue
Omacor is produced in the form of capsules, No. 28 or No. 100 in polyethylene bottles placed in a cardboard box.pharmachologic effect
Omacor is a lipid-lowering medication, the active ingredients of which belong to the class of omega-3-polyunsaturated fatty acids (eicosapentaenoic and docosahexaenoic) and are essential fatty acids.The use of Omacor helps reduce triglyceride levels as a result of lower VLDL content, as well as a decrease in the synthesis of thromboxane A2 and a certain prolongation of clotting time, which is reflected in its active effect on blood pressure and hemostasis. There was no significant effect of the drug on other clotting factors.Due to the inhibition of esterification of EPA and DHA, a delay in the synthesis of hepatic triglycerides is observed, leading to a decrease in their concentration, which in turn contributes to an increase in β-oxidation of fatty acids by peroxisomes (a decrease in the number of free fatty acids suitable for the synthesis of triglycerides). The suppression of the processes of this synthesis favors the reduction of the VLDL level. In some patients suffering from hypertriglyceridemia, Omacor therapy leads to an increase in LDL cholesterol, while an increase in HDL cholesterol levels is minimal and significantly less in comparison with treatment with fibrates.The duration of lipid-lowering efficacy of the therapeutic agent Omacor over a period of more than 12 months has not been studied. The parameters of the studies do not provide convincing evidence of a reduction in the risk of IHD formation with a decrease in the concentration of triglycerides.Based on the results of clinical studies, oral daily intake of 1000 mg Omacor for 3.5 years resulted in a significant reduction in the combined negative index including stroke, myocardial infarction and total mortality of patients from all causes.In the process, as well as after absorption of omega-3 fatty acids in the small intestine, 3 main ways of their metabolic transformations were observed:    the initial delivery of fatty acids to the liver, where they are included in the composition of various groups of lipoproteins and redirection to peripheral lipid stocks    replacement of phospholipids of cell membranes with phospholipids of lipoproteins and the further functioning of fatty acids as precursors of a variety of eicosanoids    oxidation of more fatty acids to meet energy needs.The content of the class of omega-3 fatty acids (EPA and DHA) in plasma phosphoylipids corresponds to their level noted in cell membranes.
Indications for use of Omacor medicines include:    secondary prevention of diagnosed myocardial infarction (in complex treatment with other standard medications in such cases: ACE inhibitors, antiplatelet agents, statins, beta-blockers    endogenous hypertriglyceridemia, as a supplement to diet therapy in case of its low effectiveness: in monotherapy with type IV of the disease and in combination with statins in the IIb / III type of pathology (when the concentration of triglycerides is kept at a high level).
The appointment of Omacor is unacceptable when:    pregnancy    personal hypersensitivity to omega-3-triglycerides    breastfeeding    exogenous hypertriglyceridemia (type I hyperhylomicronemia).The use of Omacor with caution is allowed when:
parallel to taking oral anticoagulants and fibrates    expressed pathologies of hepatic function    surgical operations and the treatment of serious injuries (in connection with the possibility of increasing the duration of bleeding)    at the age of 18 years (due to the unexplained safety of such therapy and its effectiveness until the end), and also in the elderly (after 70 years).
In the course of Omacor therapy, with different frequency of manifestation (most often rarely), noted:    dyspeptic disorders    lowering blood pressure    nausea    development of gastroenteritis    dryness in the nose    phenomena of increased personal sensitivity    disorders of the gastrointestinal tract    hyperglycemia    itching rashes    dizziness    the appearance of blackheads    perversion of taste (dysgeusia)    soreness in the abdomen    headache    the formation of gastritis    urticaria    violations of hepatic function    bleeding from the digestive tract.During the research, very rarely observed:
increase in lactate dehydrogenase and blood leukocytes    a moderate increase in the levels of transaminases (ALT, AST).In isolated cases recorded:
increasing the patients need for insulin    increased activity of liver enzymes    skin rash phenomena    formation of rosacea    redness / erythema    occurrence of urticaria in the region of the chest, shoulders and neck    muscle pain    increase in blood levels of creatine phosphokinase    weight gain.
Instructions for use Omacor recommends oral (inward) reception of capsules of the drug in parallel with food intake.For the purpose of secondary prevention of a diagnosed myocardial infarction, a daily intake of the 1st capsule of the drug is shown during the time set by the doctor (depending on the situation).When hypertriglyceridemia is initially recommended to take 2 capsules in 24 hours, with the possibility of increasing the daily dosage of the widow (4 capsules). Duration of the drug is prescribed by the attending physician.
In the case of taking a large number of capsules, there may be side effects inherent in the preparation or aggravation of already noted negative effects.The treatment for such conditions should be consistent with the observed overdose symptoms.
Parallel reception of Omacor and fibrates is not recommended.The use of Omacor in combination with Warfarin did not lead to any hemorrhagic negative phenomena. However, in the case of a combination of these drugs or discontinuation of Omacor therapy, the prothrombin time should be monitored.Co-administration with oral anticoagulants increases the risk of bleeding and their duration.Storage conditions
The maximum temperature index of storage of capsules should not exceed 25 ° С.Shelf life - 3 years from the date of production.
Due to a moderate increase in the duration of possible bleeding in a dosage regimen of 4 Omacor capsules per day, patients who are on anticoagulant therapy should be monitored and, if necessary, corrected the dosage of anticoagulants. This recommendation does not exclude the holding of other indicators for such patients.It should be taken into account the prolongation of the time of possible bleeding in patients with a high risk of hemorrhage (including surgical operations or the presence of serious injuries).The existing research experience of endogenous secondary hypertriglyceridemia (especially with regard to uncontrolled diabetes mellitus) is extremely limited. There is no clinical practice in the use of Omacor for the treatment of hypertriglyceridemia with simultaneous administration of fibrates.When conducting treatment with Omacor, a moderate increase in the activity of liver transaminases is allowed.In the case of a diagnosed liver function disorder (especially with a 4-fold daily capsule intake), it is required to regularly monitor the liver function (control ALT and ACT levels).There is no reliable information about the effects of Omacor in childhood (up to 18 years) and elderly (after 70 years) age, and also on patients with liver pathologies.With observable renal pathologies, dosage adjustment is not required.Children
Omacor is not allowed for use by children under 18 years of age.During pregnancy (and lactation)
The appointment of Omacor to pregnant and lactating women is contraindicated.
Tracking feedback on Omacor in the forums, you can meet the completely opposite opinions of his patients, ranging from the most positive, talking about the high efficacy and safety of this drug, and ending with a purely negative, positioning this drug as useless.An objective assessment of the appropriateness of prescribing such remedies can be considered the opinion of specialists who are not interested in high sales of Omacor. Reviews of cardiologists in this case are reduced to a common denominator, in which the effectiveness of the banal remedy Fish Oil is in no way inferior to Omacor.
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