Omakor
Producer: Solvay Pharmaceuticals, (Solvey Pharmasyyutikalz) GmbH Germany
Code of automatic telephone exchange: C10AX06
Release form: Firm dosage forms. Capsules.
General characteristics. Structure:
Active agents: the ethyl ether of omegas-3-acids consisting of ethyl ether of eykozapentayenovy acid (EPK) — 46% and ethyl ether of dokozageksayenovy acid (DGK) — 38% 1000 mg; alpha tocopherol of 4 mg
Structure of a cover: gelatin; глицерол; the water purified.
Pharmacological properties:
Pharmacodynamics. Omakor reduces the content of triglycerides as a result of reduction of concentration of LPONP, besides, it actively influences a hemostasis, reducing synthesis of A2 thromboxane and slightly raising time of coagulability of blood.
Synthesis of triglycerides in a liver as EPK and DGK oppress etherification of other fatty acids detains. Decrease in level of triglycerides is promoted also by reduction of amount of the free fatty acids (increase peroxisomas of beta oxidation of fatty acids) participating in synthesis of triglycerides.
Increase in LPVP is very insignificant and is not constant. It is much less, than after reception of fibrat.
Results of observations (within 3,5 years) the patients accepting 1 g of drug Omakor in days showed considerable reduction of the combined indicator including mortality from all reasons and also not fatal myocardial infarction and a stroke.
Pharmacokinetics. In time and after absorption of fatty acids an omega-3 there are 3 highways of their metabolism:
- fatty acids at first are delivered in a liver where they are included various categories of lipoproteids and go to peripheral stocks of lipids;
- phospholipids of cellular membranes are replaced with phospholipids of lipoproteids then fatty acids act as predecessors of various eicosanoids;
- the majority 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:
- secondary prevention of a myocardial infarction (in combination with other standard methods of treatment: statines, anti-aggregation means, beta adrenoblockers, APF inhibitors);
gipertriglitseridemiya: an endogenous gipertriglitseridemiya — as addition to a diet at its insufficient efficiency:
- type IV (as monotherapy),
- the IIb/III types (in a combination with statines — in case concentration of triglycerides remains high).
Route of administration and doses:
Inside, together with food. For secondary prevention of a myocardial infarction it is recommended to accept on 1 капс. in days. Treatment duration — according to the recommendation of the doctor.
Gipertriglitseridemiya: an initial dose — 2 капс. in days. In case of lack of therapeutic effect increase in a dose to 4 капс is possible. in days. Treatment duration — 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 капс.) observation of the patients undergoing anticoagulating therapy, and if necessary — the corresponding dose adjustment of anticoagulant is required. Performing this therapy does not exclude need of control, usual at treatment of such patients. It is necessary to take into consideration increase in a bleeding time at patients with the increased risk of a hemorrhage (as a result of a severe injury, surgery, etc.). The available experience of the research of a secondary endogenous gipertriglitseridemiya (which is especially not giving in to control of a diabetes mellitus) is very limited. There is no clinical experience in the relation of treatment of a gipertriglitseridemiya in combination with fibrata. At Omakor's reception perhaps moderate increase in activity of "hepatic" transaminases. At patients with an abnormal liver function (especially at reception of a high dose — 4 капс.) regular control of function of a liver is necessary (nuclear heating plant and ALT). Data on drug use Omakor at children, elderly patients are more senior than 70 years or at patients with an abnormal liver function are absent. With a renal failure of dose adjustment it is not required from patients.
Side effects:
Frequency of side effects is distributed in the following order: often (1–10%); infrequently (0,1–1%); seldom (0,01–0,1%); very seldom (<0,01%), including messages on single side effects.
Infectious processes: infrequently — a gastroenteritis.
From immune system: infrequently — hypersensitivity.
Disbolism and food: seldom — a hyperglycemia.
From a nervous system: infrequently — dizziness, a dysgeusia (food faddism); seldom — a headache.
Vascular disorders: very seldom — decrease in the ABP.
From a respiratory organs, bodies of a thorax and mediastinum: very seldom — dryness in a nose.
From a GIT: often — dyspepsia, nausea; infrequently — an abdominal pain, gastrointestinal frustration, gastritis, pain in an upper part of a stomach; very seldom — bleedings from lower parts of a GIT.
From a liver: seldom — abnormal liver functions.
From skin and a hypodermic fatty tissue: seldom — eels, pruritic rashes; very seldom — a small tortoiseshell.
During the researches: increase in number of leukocytes of blood, a blood lactate dehydrogenase was very seldom noted. At patients with a gipertriglitseridemiya it was reported about moderate increase in transaminases (nuclear heating plant, ALT).
Messages on single side effects.
Disbolism and food: increase in need for insulin (need of increase in a standard dose).
Disturbances from a liver: increase in activity of liver enzymes.
Disturbances from skin and hypodermic fabrics: pink eels, rash, a redness/erythema, a small tortoiseshell in a thorax, a neck and shoulders.
During the researches single messages on increase in level of a kreatinfosfokinaza in blood, a mialgiya, increase in nuclear heating plant, ALT, increase in body weight are noted.
Interaction with other medicines:
At simultaneous use with peroral anticoagulants — risk of increase in a bleeding time. Omakor's appointment together with warfarin does not lead to any hemorrhagic complications. However at the combined Omakor's reception and warfarin or the termination of a course of treatment by Omakor control of a prothrombin time is necessary.
Simultaneous use from fibrata is not recommended.
Contraindications:
- hypersensitivity to drug components;
- exogenous gipertriglitseridemiya (hyper chylomicronemia of type 1);
- pregnancy;
- breastfeeding period.
With care:
- age up to 18 years (efficiency and safety are not established);
- advanced age (70 years are more senior);
- the expressed abnormal liver functions;
- simultaneous use from fibrata or peroral anticoagulants;
- severe injuries;
- surgeries (in connection with risk of increase in a bleeding time).
Use at pregnancy and feeding by a breast
Contraindicated at pregnancy. For the period of treatment it is necessary to stop breastfeeding.
Overdose:
Symptoms: emergence of side effects or strengthening of their expressiveness is possible.
Treatment: symptomatic therapy.
Storage conditions:
At a temperature not above 25 °C (not to freeze).
To store in the place, unavailable to children.
Issue conditions:
According to the recipe
Packaging:
In bottles polyethylene on 28 and 100 pieces.