Capsules soft gelatinous, transparent; the size в„–20; the contents of the capsules are an oily liquid of light yellow color.
1 caps.
omega-3-polyunsaturated fatty acids, ethyl esters, 1000 mg,
in t.ch. ethyl eicosapentaenoic acid 46%
ethyl ester of docosahexaenoic acid 38%
Excipients:? -tocopherol - 4 mg.
The composition of the capsule shell: gelatin - 293 mg, glycerol - 135 mg, purified water - qs
28 pcs. - Polyethylene bottles (1) - cardboard boxes.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2015.
PHARMACHOLOGIC EFFECT
Lipid-lowering drug. Polyunsaturated fatty acids of the omega-3-eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) class are referred to as essential fatty acids (NEFIC).
Omacor reduces the concentration of triglycerides as a result of decreasing VLCL concentration, in addition, it actively affects blood pressure and hemostasis, reducing the synthesis of thromboxane A 2 and slightly increasing the clotting time. There was no significant effect on other coagulation factors.
Omacor delays the synthesis of triglycerides in the liver (by inhibiting the esterification of EPA and DHA). 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). Inhibition of this synthesis reduces the level of VLDL. Omacor increases LDL cholesterol in some patients with hypertriglyceridemia. The increase in the concentration of HDL is minimal and significantly lower than after taking the fibrates.
The duration of hypolipidemic action in the use of Omacor over 1 year has not been studied. Otherwise, there is no conclusive evidence that lowering triglycerides reduces the risk of developing coronary artery disease.
Clinical results of studies of Omakor in a dose of 1 g / day for 3.5 years showed a significant reduction in the combined index, including total mortality from all causes, as well as non-fatal myocardial infarction and stroke.
PHARMACOKINETICS
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 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 provide 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 the composition of cell membranes.
INDICATIONS
Hypertriglyceridemia:
- endogenous type IV hypertriglyceridemia according to Fredrickson classification (in monotherapy) as an adjunct to the hypolipidemic diet with its insufficient efficiency;
- endogenous hypertriglyceridemia of the Ili or III type according to Fredrickson classification in combination with inhibitors of HMG-CoA reductase (statins), when the concentration of triglycerides is not sufficiently controlled by the use of statins.
Secondary prophylaxis after myocardial infarction (as part of combination therapy): in combination with statins, antiplatelet agents, beta-blockers, ACE inhibitors.
DOSING MODE
The drug is taken orally, during meals to avoid the development of unwanted effects from the gastrointestinal tract.
In hypertriglyceridemia, the initial dose of Omakor is 2 caps / day. In the absence of a therapeutic effect, it is possible to increase the dose to the maximum daily dose of 4 caps. Duration of treatment and repeated courses are established on the recommendation of a doctor.
For secondary prevention of myocardial infarction, it is recommended to take 1 caps / day. Duration of treatment and repeated courses are established on the recommendation of a doctor.
SIDE EFFECT
The incidence of adverse reactions listed below was determined as follows: very often (? 1/10); often (? 1/100, <1/10); infrequently (? 1/1000, <1/100); rarely (? 1/10000, <1/1000); very rarely (<1/10000, including individual messages).
From the side of the immune system: rarely - reactions of increased sensitivity.
From the side of metabolism: infrequently - hyperglycemia, gout.
From the nervous system: infrequently - dizziness, dysgeusia (perversion of taste); rarely - a headache.
From the side of the cardiovascular system: infrequent - a pronounced decrease in blood pressure.
From the respiratory system: infrequently - epistaxis (nosebleed).
On the part of the digestive system: often - gastrointestinal disorders (including bloating, abdominal pain, constipation, diarrhea, dyspepsia, flatulence, belching, gastroesophageal reflux disease, nausea, vomiting); infrequently - gastrointestinal bleeding, violation of liver function (including increased activity of AST and ALT).
From the skin and subcutaneous tissues: infrequently - skin rash; very rarely - hives.
With prolonged use of Omacor in high doses (4 g / day), a belching with odor or taste of fish is possible.
CONTRAINDICATIONS
- exogenous hypertriglyceridemia (type I hyperchylomicronemia);
- Pregnancy;
- the period of breastfeeding;
- age under 18 years (effectiveness and safety not established);
- Hypersensitivity to the active substance, excipients, and also to soy.
Caution should be given to elderly patients (over 70 years old), with violations of liver function, simultaneous reception with oral anticoagulants, with fibrates, hemorrhagic diathesis, with severe injuries, and surgical operations (due to the risk of increased bleeding time).
Experience with secondary endogenous hypertriglyceridemia is limited (especially in uncontrolled diabetes mellitus).
PREGNANCY AND LACTATION
There are no clinical data on the use of the drug during pregnancy.
Prescribe Omakor during pregnancy should be done with caution, only after a thorough assessment of the risk-benefit relationship, when the benefit to the mother exceeds the potential risk to the fetus.
The use of Omacor is contraindicated during breastfeeding. If Omakor is needed during breastfeeding, breastfeeding should be discarded.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
With caution should prescribe the drug for violations of liver function.
In patients with impaired hepatic function (especially when taking the drug at a dose of 4 caps / day), regular monitoring of liver function is necessary (determination of ACT and ALT activity).
APPLICATION FOR CHILDREN
Contraindicated in childhood and adolescence under 18 years (efficacy and safety not established).
APPLICATION IN ELDERLY PATIENTS
With caution should prescribe the drug to elderly patients (over 70 years).
SPECIAL INSTRUCTIONS
Due to a moderate increase in bleeding time (when applied at a high dose of 4 capsules), patients who have abnormalities from the blood coagulation system and who are receiving anticoagulant therapy or drugs that affect the hemostatic system (acetylsalicylic acid as an antiplatelet agent , NSAIDs), and if necessary - appropriate correction of the dose of anticoagulant or agents that affect the hemostasis system.
In some patients, there was an increase in ACT and ALT activity (within normal limits), but there is no evidence that the risk of using Omacor in patients with impaired hepatic function is increased. It is necessary to monitor the activity of ACT and ALT in patients with signs of impaired liver function (especially when used in a high dose - 4 caps.).
Impact on the ability to drive vehicles and manage mechanisms
Studies on the effect of Omakor on the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions have not been conducted.
Nevertheless, taking Omacor may not significantly affect the risk of developing dizziness on the ability to drive vehicles and engage in other potentially hazardous activities that require an increased concentration of attention and speed of psychomotor reactions, so care should be taken.
OVERDOSE
Symptoms: There may be side effects.
Treatment: symptomatic therapy.
DRUG INTERACTION
With the simultaneous use of Omacor with oral anticoagulants and other drugs that affect the hemostasis system, the risk of increasing bleeding time increases.
There are no data on simultaneous use with fibrates in the treatment of hypertriglyceridemia.
Simultaneous use with warfarin does not lead to any hemorrhagic complications. However, with the combined use of the drug Omacor and warfarin or discontinuation of treatment with Omacor, monitoring of prothrombin time or MHO is necessary.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored in a dry place inaccessible to children at a temperature of no higher than 25 В° C. Shelf life - 3 years.
The information is provided for your information, do not self-medicate, it is dangerous for your health.
