Omakor

General characteristics. Structure:

Active agents:

Omega-3-polinenasyshchennykh fatty acids ethyl ethers — 1000 mg

(the ethyl ether an omega-3 of acids consisting of ethyl ether of eykozapentayenovy acid (EPK) — 46% and ethyl ether of dokozageksayenovy acid (DGK) — 38%).

Excipients: α-tocopherol — — 44 4 mg.

Capsule cover: gelatin — 293 mg, глицерол — 135 mg, the water purified — q.s.

Description:

Transparent soft gelatin capsule of 20 in size. Capsule contents — oily liquid of light yellow color.

Pharmacological properties:

Pharmacodynamics. Class polyunsaturated fatty acids an omega-3 — eykozapentayenovy acid (EPK) and dokozageksayenovy acid (DGK) — belong to irreplaceable (essential) fatty acids (NEZhK). Omakor reduces concentration of triglycerides as a result of reduction of concentration of lipoproteins of very low density (LPONP), besides, he actively influences a hemostasis, reducing synthesis of A2 thromboxane and slightly increasing time of coagulability of blood.

Omakor detains synthesis of triglycerides in a liver (at the expense of inhibition of etherification of EPK and DGK).

Decrease in concentration of triglycerides is promoted by increase in quantity of peroxisomas β — oxidations of fatty acids (reduction of amount of the free fatty acids available to synthesis of triglycerides).

Increase in concentration of lipoproteins of the high density (LPVP) minimum and is much lower, than after reception of fibrat.

Clinical results of researches of drug Omakor in a dose of 1 g a day within 3,5 years showed considerable reduction of the combined indicator including the general mortality from all reasons and also not fatal myocardial infarction and a stroke.

Pharmacokinetics. In time and after absorption in a small intestine of fatty acids of a class an omega-3 there are 3 highways of their metabolism:

— the fatty acids (FA) at first are delivered in a liver where are included various categories of lipoproteins and go to peripheral stocks of lipids;

— phospholipids of cellular membranes are replaced with phospholipids of lipoproteins then fatty acids can act as predecessors of various eicosanoids;

— the most part of fatty acids is oxidized for the purpose of ensuring energy needs.

Concentration of fatty acids of a class an omega-3 — EPK and DGK in phospholipids of a blood plasma corresponds to concentration of EPK and DGK included in structure of cellular membranes.

Indications to use:

Gipertriglitseridemiya:

— an endogenous gipertriglitseridemiya of the IV type on Fredrikson's classification (in monotherapy) as addition to a hypolipidemic diet at its insufficient efficiency;

— an endogenous gipertriglitseridemiya of IIb or the III type on Fredrikson's classification (in a combination with hypolipidemic means — GMG-KOA reductase inhibitors (statines)).

Secondary prevention of a myocardial infarction (as a part of a combination therapy): in combination with GMG-KOA reductase inhibitors (statines), antiagregantny means, beta adrenoblockers, inhibitors of an angiotensin-converting enzyme (APF).

Route of administration and doses:

Inside, along with meal.

Gipertriglitseridemiya

The initial dose makes 2 capsules a day. In case of lack of therapeutic effect increase in a dose up to the maximum daily dose — 4 capsules is possible.

Duration of treatment and repeated courses — according to the recommendation of the doctor.

Secondary prevention of a myocardial infarction

About 1 capsule in days is recommended to accept. Duration of treatment and repeated courses — according to the recommendation of the doctor.

Features of use:

Due to the moderate increase in a bleeding time (at reception of a high dose — 4 capsules) observation of the patients having disturbances from coagulant system of blood, and also receiving the anticoagulating therapy or drugs influencing system of a hemostasis (acetylsalicylic acid as antiagregantny means, non-steroidal anti-inflammatory drugs), and if necessary — the corresponding dose adjustment of anticoagulant or the means influencing system of a hemostasis is required.

At patients with an abnormal liver function (especially at reception of a high dose — 4 capsules) regular control of function of a liver is necessary (nuclear heating plant and ALT).

Omakor's use together with warfarin does not lead to any hemorrhagic complications. However at the combined Omakor's use and warfarin or the termination of a course of treatment by Omakor control of a prothrombin time or INR (the international normalized relation) is necessary.

Influence on ability to manage vehicles and occupations other potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.

Researches on drug influence Omakor on ability to manage vehicles and occupations by other potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions were not conducted.

During treatment by drug Omakor it is necessary to be careful at control of vehicles and occupation potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.

Side effects:

Frequency of the side reactions given below was defined according to the following: very often (> 1/10); often (> 1/100, <1/10); infrequently (> 1/1000, <1/100); seldom (> 1/10000, <1/1000); very seldom (<1/10000), including separate messages.

From immune system: infrequently — hypersensitivity reactions.

From a metabolism and food: seldom — a hyperglycemia.

From a nervous system: infrequently — dizziness, a dysgeusia (food faddism); seldom — a headache.

From cardiovascular system: very seldom — the expressed lowering of arterial pressure.

From respiratory system, bodies of a thorax and a mediastinum: very seldom — a xeromycteria.

From the digestive tract (DT): often — dyspepsia, nausea; infrequently — an abdominal pain, gastrointestinal frustration (a gastroesophageal reflux disease, an eructation, vomiting, a lock), a gastroenteritis; very seldom — bleedings from lower parts of a GIT; seldom — abnormal liver functions.

From skin and hypodermic fabrics: seldom — an acne, a skin itch, rash; very seldom — a small tortoiseshell.

Laboratory and tool data: very seldom — increase in maintenance of leukocytes in blood, increase in activity of a lactate dehydrogenase, increase in activity of "hepatic" transaminases: aspartate aminotransferases (nuclear heating plant), alaninamino-transferases (ALT).

In some cases (frequency is unknown):

From blood and lymphatic system: hemorrhagic diathesis.

At prolonged use of drug Omakor in high doses (4 g a day) the eructation with a smell or smack of fish is possible.

Interaction with other medicines:

At simultaneous use with the peroral anticoagulants and other drugs influencing system of a hemostasis the risk of increase in a bleeding time increases.

There are no data on simultaneous use from fibrata at treatment of a gipertriglitseridemiya.

Contraindications:

Hypersensitivity to active agent, excipients, and also to soy.

Age up to 18 years (efficiency and safety are not established).

Pregnancy and period of a lactation.

Omakor it is not necessary to apply at patients with an exogenous gipertriglitseridemiya (a hyper chylomicronemia of the I type).

With care

The age is more senior than 70 years, an abnormal liver function (a class A, B and C on a scale of Chayld-Pyyu), a concomitant use with peroral anticoagulants, fibrata; hemorrhagic diathesis, severe injuries, surgeries (risk of increase in a bleeding time).

Experience of use at a secondary endogenous gipertriglitseridemiya is limited.

Use at pregnancy and in the period of a lactation

There are no clinical data on use of drug during pregnancy. It is necessary to appoint Omakor pregnant with care, only after careful assessment of a ratio of risk and advantage when the advantage for mother exceeds potential risk for a fruit.

Drug use Omakor contraindicated in the period of a lactation.

If administration of drug Omakor is necessary in the period of a lactation, breastfeeding needs to be cancelled.

Overdose:

Symptoms: emergence of side effects is possible.

Treatment: symptomatic therapy.

Storage conditions:

In the dry place at a temperature not above 25 °C. To store in the place, unavailable to children! Period of validity 3 years. Not to apply after the period of validity specified on packaging.

Issue conditions:

According to the recipe

Packaging:

Capsules on 1000 mg.

On 28 or 100 gelatin capsules are packed into the bottles from polyethylene of high density of white color corked by a stopper with a detachable ring (with control of the first opening) and the screwed cover. On a bottle the self-adhesive label is pasted.

On 1 bottle together with the application instruction in a cardboard box.