Omacor 1000mg 28 capsules — Made in Germany — Free Delivery

Pharmacological properties

Pharmacodynamics. Omega-3 polyunsaturated fatty acids - eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are essential fatty acids.

Omacor affects blood plasma lipids, reducing the level of TG due to a decrease in the amount of VLDL. In addition, it affects hemostasis and blood pressure.

Omacor reduces the synthesis of TG in the liver, since EPA and DHA are weak substrates for enzymes responsible for the synthesis of TG, and thus inhibit the formation of esters of other fatty acids.

An increase in β-oxidation of fatty acids in liver peroxisomes also contributes to a decrease in TG levels by decreasing the amount of free fatty acids for TG synthesis. A decrease in the synthesis of TG leads to a decrease in the level of VLDL.

In some patients with hypertriglyceridemia, Omacor increases LDL cholesterol levels. The increase in HDL cholesterol during treatment with Omakor is insignificant, much lower than after taking fibrates, and controversial.

The long-term lipid-lowering effect (over 1 year) is unknown. There is no conclusive evidence that long-term reduction in TG levels reduces the risk of coronary heart disease.

During the period of treatment with Omakor, the formation of thromboxane A2 decreases and the bleeding time slightly increases. No significant effect on other factors of blood coagulation is noted.

In a multicenter, randomized, open-label clinical trial GISSI-Prevenzione, 11 324 patients after myocardial infarction (3 months) who received standard preventive treatment and a Mediterranean diet were randomized into groups: Omacor (n = 2836), vitamin E (n = 2830), combinations of Omakor + vitamin E (n = 2830) or without taking Omakor and vitamin E (n = 2828).

The results obtained over 3.5 years showed that taking Omakor at a dose of 1 g / day significantly reduced the frequency of the combined endpoint, which included death from all causes, non-fatal myocardial infarction and non-fatal stroke (reducing the relative risk by 15% [2– 26], p = 0.0226 in patients who took only Omacor, compared with the control and by 10% [1–18], p = 0.0482 in patients who took Omacor without or with vitamin E). A decrease in the incidence of the secondary endpoint, which included cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke, was also demonstrated (a decrease in the relative risk by 20% [5–32], p = 0.0082 in patients taking Omacor alone, compared with controls and by 11% [1–20], p = 0.0526 in patients taking Omacor without or with vitamin E). Secondary analyzes of each component of the primary endpoints found a significant reduction in the incidence of death among all and separately for cardiovascular causes, but without a decrease in the number of non-fatal cardiovascular events or fatal and non-fatal stroke.

Pharmacokinetics. During and after absorption, there are three main pathways for the metabolism of omega-3 fatty acids:

- fatty acids are first transported to the liver, where they are included in various categories of lipoproteins and then transferred to peripheral lipid depots;

- phospholipids of cell membranes are replaced by lipoprotein phospholipids, and fatty acids can then act as precursors of various eicosanoids;

- Most of the fatty acids are oxidized to meet energy needs.

The concentration of omega-3 fatty acids - EPA and DHA - in plasma phospholipids corresponds to the concentration of EPA and DHA included in the composition of cell membranes.

Pharmacokinetic studies in animals have demonstrated complete hydrolysis of ethyl esters, which was accompanied by sufficient absorption and incorporation of EPA and DHA into plasma phospholipids and CS esters.

Indications

After myocardial infarction. adjuvant therapy for secondary prevention after myocardial infarction as an adjunct to standard treatments (eg statins, antiplatelet preparations, β-adrenergic receptor blockers, APF inhibitors).

Hypertriglyceridemia. With endogenous hypertriglyceridemia, Omacor is used as an adjunct to diet therapy if dietary measures are insufficient to achieve an adequate response:

• type IV - in the form of monotherapy;

• types IIb / III - in combination with statins, if the control of the level of triglycerides in the blood is insufficient.

Application

After myocardial infarction: 1 capsule per day.

Hypertriglyceridemia: initial dose - 2 capsules per day (in 1 or 2 doses). In case of insufficient effect, the dose can be increased to 4 capsules per day. The duration of treatment is determined by the doctor depending on the individual characteristics of the organism.

The capsules can be taken with food to help prevent gastrointestinal upset. Information on the use of Omakor in children and adolescents, patients over the age of 70 years and patients with hepatic insufficiency is absent (see SPECIAL INSTRUCTIONS), and for use in patients with renal insufficiency, it is limited.

Contraindications

Hypersensitivity to the active substance, soy or any other components of the preparation.

Side effects

The frequency of side effects according to studies is distributed as follows: very often (≥10); often (≥1 / 100, 1/10); infrequently (≥1 / 1000, 1/100); rarely (≥1 / 10,000, 1/1000); very rare (1/10 000).

From the immune system: rarely - hypersensitivity.

From the side of metabolism and nutrition: infrequently - hyperglycemia, gout.

From the nervous system: infrequently - dizziness, dysgeusia, headache.

From the side of the vessels: infrequently - hypotension.

From the respiratory system, chest and mediastinal organs: infrequently - epistaxis.

From the gastrointestinal tract: often - gastrointestinal disorders (including bloating, abdominal pain, constipation, diarrhea, dyspepsia, flatulence, belching, gastroesophageal reflux, nausea or vomiting); infrequently - gastrointestinal bleeding.

On the part of the hepatobiliary system: infrequently - liver disorders, including an increase in the level of transaminases (ALT and AST).

Skin and subcutaneous tissue disorders: infrequently - rash, itching; rarely - urticaria.

Special instructions

Due to a moderate increase in bleeding time (when using high doses, that is, 4 capsules per day), it is necessary to monitor the condition of patients with blood coagulation disorders, as well as patients receiving anticoagulant therapy or other preparations that can affect coagulation (for example, acetylsalicylic acid or NSAIDs) ), and appropriate dose adjustment of the anticoagulant if necessary (see interactions).

In some patients, a small but significant increase (within the normal range) in AST and ALT was noted, but at the same time there are no data that would indicate an increased risk for patients with hepatic insufficiency. Patients with any manifestations of liver dysfunction (especially when taking a high dose, that is, 4 capsules per day) need to control the level of ALT and AST.

Omacor is not indicated for the treatment of exogenous hypertriglyceridemia (type 1 hyperchylomicronemia). Experience with secondary endogenous hypertriglyceridemia (especially with decompensated diabetes) is limited.

During pregnancy and breastfeeding

Pregnancy. There is no experience of using Omakor during pregnancy. The potential risk to humans is unknown, therefore, it is possible to prescribe Omacor during pregnancy only if the benefits to the mother outweigh the risk to the fetus.

Lactation. There are no data on the excretion of Omacor into breast milk, so the preparation is not recommended to be taken during breastfeeding.

Children. Due to the lack of data on the effectiveness and safety of the use of Omakor in children, its appointment to children is not recommended.

The ability to influence the reaction rate when driving and working with other mechanisms. The effect of the preparation on the ability to drive a car or operate machinery has not been studied. However, it is expected that Omakor does not or does not significantly affect the ability to drive vehicles or other mechanisms.

Interactions

See special instructions for oral anticoagulants or other preparations that affect coagulation (eg acetylsalicylic acid or NSAIDs).

The appointment of Omakor together with warfarin did not lead to any hemorrhagic complications. However, in the case of the combined use of Omakor and preparations that affect the prothrombin time / international normalized ratio (PT / INR), or in case of discontinuation of Omakor treatment, PT / INR control is necessary.

Overdose

Due to the lack of data, there are no specific recommendations. treatment should be symptomatic.

Storage conditions

In its original packaging at a temperature not exceeding 25 ° c. do not freeze. Keep out of the reach of children.