Omacor 1g capsules, 28pcs (epa/dha=12/1 – 90%)

Composition

Each capsule contains: Active ingredients: omega-3 polyunsaturated fatty acids ethyl esters 1000 mg, including eicosapentaenoic acid ethyl ester 46%, docosahexaenoic acid ethyl ester 38%, Capsule shell composition: gelatin-293 mg, glycerol-135 mg, purified water-q. s.

Pharmacological action

Omacor reduces the content of triglycerides as a result of a decrease in the concentration of VLDL, in addition, it actively affects hemostasis, reducing the synthesis of thromboxane a2 and slightly increasing blood clotting time.

It delays the synthesis of triglycerides in the liver, since EPA and DHA inhibit the esterification of other fatty acids. Reducing the level of triglycerides also contributes to a decrease in the amount of free fatty acids (increasing the peroxisomes of beta-oxidation of fatty acids) involved in the synthesis of triglycerides.

The increase in HDL is very small and not permanent. It is significantly less than after taking fibrates.

The results of observation (for 3.5 years) of patients taking 1 g of Omacor per day showed a significant reduction in the combined indicator, including all-cause mortality, as well as non-fatal myocardial infarction and stroke.

Pharmacokinetics

During and after the absorption of omega-3 fatty acids, there are 3 main ways of their metabolism:

– fatty acids are first delivered to the liver, where they are incorporated into various categories of lipoproteins and sent to peripheral lipid stores;

– phospholipids of cell membranes are replaced by phospholipids of lipoproteins, after which fatty acids act as precursors of various eicosanoids;

– most fatty acids are oxidized to meet energy requirements.

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

Indications

• Hypertriglyceridemia: endogenous hypertriglyceridemia of type IV according to the Frederickson classification (in monotherapy) as an adjunct to a hypolipidemic diet if it is not effective enough;
• endogenous hypertriglyceridemia of type IIb or III according to the Frederickson classification in combination with HMG-CoA reductase inhibitors (statins), when the concentration of triglycerides is insufficiently controlled by statins.
• Secondary prevention after myocardial infarction (as part of combination therapy): in combination with statins, antiplatelet agents, beta-blockers, angiotensin-converting enzyme (ACE) inhibitors.

Use during pregnancy and lactation

Prescribe Omacor to pregnant women with caution, only after careful assessment of the risk-benefit ratio, when the benefit to the mother exceeds the potential risk to the fetus. The drug should not be used during breastfeeding.

Contraindications

• hypersensitivity to the components of the drug;
• exogenous hypertriglyceridemia (hyperhilomicronemia type 1);
• pregnancy;
• breast-feeding period.

With caution:

• age up to 18 years (efficacy and safety have not been established);
• elderly (over 70 years);
• severe liver function disorders;
• concomitant use with fibrates or oral anticoagulants;
• severe injuries;
• surgical operations (due to the risk of increased bleeding time).

Side effects

Infectious processes:  infrequently-gastroenteritis.

From the immune system:  infrequently — hypersensitivity.

Metabolic and nutritional disorders:  rarely-hyperglycemia.

Nervous system disorders:  infrequently — dizziness, dysgeusia (perversion of taste); rarely-headache.

Vascular disorders:  very rarely — a decrease in blood pressure.

Respiratory, thoracic and mediastinal disorders:  very rarely-dryness in the nose.

From the gastrointestinal tract:  often-dyspepsia, nausea; infrequently-abdominal pain, gastrointestinal disorders, gastritis, pain in the upper abdomen; very rarely-bleeding from the lower gastrointestinal tract.

From the liver:  rarely-liver function disorders.

Skin and subcutaneous fat disorders:  rarely-acne, itchy rashes; very rarely-urticaria.

In the course of studies: very rarely there was an increase in the number of white blood cells, blood lactate dehydrogenase. Moderate increases in transaminases (AST, ALT) have been reported in patients with hypertriglyceridemia.

Reports of isolated side effects.

Metabolic and nutritional disorders:  increased need for insulin (the need to increase the standard dose).

Liver disorders:  increased activity of liver enzymes.

Skin and subcutaneous tissue disorders:  rosacea, rash, redness/erythema, urticaria in the chest, neck and shoulders.

Interaction

When used concomitantly with oral anticoagulants, there is a risk of increased bleeding time. The use of Omacor together with warfarin does not lead to any hemorrhagic complications.

However, when taking Omacor and warfarin in combination or stopping the course of treatment with Omacor, monitoring of prothrombin time is necessary.

Concomitant use with fibrates is not recommended.

How to take, course of use and dosage

Inside, along with food. For secondary prevention of myocardial infarction, it is recommended to take 1 capsule per day.

Duration of treatment — according to the doctor’s recommendation.

Hypertriglyceridemia: the initial dose is 2 capsules per day.

In the absence of a therapeutic effect, it is possible to increase the dose to 4 capsules per day.

Duration of treatment — according to the doctor’s recommendation.

Overdose

Symptoms:  side effects may occur or increase their severity.

Treatment:  symptomatic therapy.

Special instructions

Due to a moderate increase in bleeding time (when taking a high dose — 4 capsules), monitoring of patients undergoing anticoagulant therapy is required, and if necessary, appropriate dose adjustment of the anticoagulant. This therapy does not exclude the need for routine monitoring in the treatment of such patients.

It is necessary to take into account the increased bleeding time in patients with an increased risk of hemorrhage (as a result of severe trauma, surgery, etc. ). The available experience in the study of secondary endogenous hypertriglyceridemia (especially uncontrolled diabetes mellitus) is very limited.

There is no clinical experience regarding the treatment of hypertriglyceridemia in combination with fibrates. When taking Omacor, a moderate increase in the activity of “hepatic” transaminases is possible.

In patients with impaired liver function (especially when taking a high dose of 4 capsules), regular monitoring of liver function (AST and ALT) is necessary. There are no data on the use of Omacor in children, elderly patients over 70 years of age, or in patients with impaired liver function. No dose adjustment is required in patients with impaired renal function.

Form of production

Capsules

Storage conditions

At a temperature not exceeding 25 °C (do not freeze).

Shelf life

1 year

Active ingredient

Omega-3 Triglycerides [EPA/DHA=1.2/1 – 90%]

Conditions of release from pharmacies

By prescription

Dosage form

Capsules

Description

For adults

Indications

Prevention of heart attacks and strokes, Atherosclerosis