Description
packing 28 pcs
Pharmacological action
OMACOR – lipid-lowering drug. Contains polyunsaturated essential fatty acids of the omega-3 class – eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) – are essential (essential) fatty acids (NEFA).
Omacor reduces triglycerides by reducing the concentration of very low density lipoproteins (VLDL), in addition, it actively affects hemostasis, reducing the synthesis of thromboxane A2 and slightly increasing the coagulation time.
Delays the synthesis of triglycerides in the liver (by inhibiting the esterification of EPA and DHA).
A decrease in triglyceride levels is facilitated by an increase in the peroxisome of beta oxidation of fatty acids (a decrease in the amount of free fatty acids available for triglyceride synthesis).
The increase in high density lipoproteins (HDL) is very slight and not constant. It is significantly less than after taking fibrates.
The results of observations (over 3.5 years) of patients taking Omacor at a dose of 1 g / day showed a significant reduction in the combined indicator, including mortality from all causes, as well as non-fatal myocardial infarction and stroke.
Indications
secondary prophylaxis of myocardial infarction (in combination with other standard methods of treatment: statins, antiaggregatory agents, beta-blockers, ACE inhibitors)
hypertriglyceridemia: endogenous hypertriglyceridemia in type IV as monotherapy), types IIb / III (in combination with statins – in the case when the concentration of triglycerides remains high).
Contraindications
exogenous hypertriglyceridemia (hyperchilomicronemia) (type I according to the Fredrickson classification)
pregnancy
lactation (breastfeeding)
hypersensitivity to the components of the drug.
With caution, the drug should be prescribed for severe impaired liver function, with simultaneous use with fibrates, with oral anticoagulants, with severe injuries, surgical operations (due to the risk of an increase in bleeding time), elderly patients (over 70 years old), as well as children and adolescents under the age of 18 (efficacy and safety have not been established).
Use during pregnancy and lactation
The drug is contraindicated in pregnancy and lactation (breastfeeding).
Composition
Each capsule contains:
Active ingredients:
Omega-3-acids ethyl esters 1000 mg (omega-3 acids ethyl ester, consisting of eicosapentaenoic acid ethyl ester (EPA) -46% and docosahexaenoic acid ethyl ester (Dose) – 38%)
alpha-tocopherol 4 mg.
Capsule shell composition:
gelatin,
glycerol,
purified water.
Dosage and administration of
The drug is taken orally during meals.
For secondary prevention of myocardial infarction, it is recommended to take 1 capsule per day.
In the treatment of hypertriglyceridemia, the initial dose of Omacor is 2 capsules per day. In the absence of a therapeutic effect, it is possible to increase the dose to 4 capsules per day.
The duration of treatment is set individually.
Dose adjustment is not required in patients with impaired renal function.
Side effects
Infectious processes: infrequently – gastroenteritis.
On the part of the immune system: infrequently – increased sensitivity.
Metabolic and nutritional disorders: rarely – hyperglycemia.
From the nervous system: infrequently – dizziness, dysgeusia (perversion of taste) rarely – headache.
Vascular disorders: very rarely – lowering blood pressure.
On the part of the respiratory system, chest and mediastinal organs: very rarely – dry nose.
From the gastrointestinal tract: often – dyspepsia, nausea infrequently – abdominal pain, gastrointestinal upsets, gastritis, pain in the upper abdomen is very rare – bleeding from the lower gastrointestinal tract.
From the liver: rarely – impaired liver function.
From the skin and subcutaneous fat: rarely – acne, itchy rashes very rarely – urticaria.
In the course of research: an increase in the number of blood leukocytes and blood lactate dehydrogenase was very rarely observed. In patients with hypertriglyceridemia, a moderate increase in transaminases (AST, ALT) has been reported.
Reports of single side effects.
Metabolism and nutritional disorders: increased need for insulin (the need to increase the standard dose).
Disorders from the liver: increased activity of liver enzymes.
Disorders of the skin and subcutaneous tissue: rosacea, rash, redness / erythema, urticaria in the chest, neck and shoulders.
Drug Interaction
When Omakor is taken with oral anticoagulants, there is a risk of increased bleeding time.
Omakor’s administration with warfarin does not lead to any hemorrhagic complications.
However, combined administration of Omacor and warfarin or discontinuation of Omacor requires prothrombin time control.
Overdose
Symptoms: side effects may occur and their severity may increase.
Treatment: carry out symptomatic therapy.
Storage conditions
The drug should be stored in a dry place inaccessible to children at a temperature not exceeding 25 ° C.
Expiration
3 Year
2/1 – 90%]
pharmacy prescription
Dosage form
dosage form
capsules
