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Home » Products » Omacor
Eicosapentaenoic acid + Docosahexaenoic acid
Omacor®
FORMULATION:
Each 1000mg capsule contains 90% omega - 3 acid ethyl esters predominantly a combination of :
Eicosapentaenoic acid (EPA) ethyl esters ............................. 465mg
Docosahexaenoic acid (DHA) ethyl esters ............................. 375mg
INDICATIONS:
For isolated or predominant endogenous hypertriglyceridaemia in patients at risk of ischaemic heart disease and/or pancreatitis; as a supplement to diet when appropriate and assiduous dietary measures alone are insufficient to produce an adequate response
PHARMACOKINETIC PROPERTIES:
During and after absorption, there are three main pathways for the metabolism of the omega-3 fatty acids:
- the fatty acids are first transported to the liver where they are incorporated into various categories of lipoproteins and then channelled to the peripheral lipid stores:
- the cell membrane phospholipids are replaced by lipoprotein phospholipids and the fatty acids can then act as precursors for various eicosanoids;
- the majority are oxidized to meet energy requirements.
The concentration of omega-3 fatty acids, EPA and DHA, in the plasma phospholipids corresponds to the EPA and DHA incorporated into the cell membranes.
Animal pharmacokinetics studies have shown that there is complete hydrolysis of the ethyl ester, accompanied by satisfactory absorption and incorporation of EPA and DHA into the plasma phospholipids and cholesterol esters.
There is no information concerning the pharmacokinetics of Omacor in children, in elderly patients over 70 years of age, or in patients with renal or hepatic impairment.
CONTRAlNDICATlONS:
Allergy to any of the ingredients.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
WARNINGS:
Risk of hemorrhage:
Because of the moderate increase in bleeding time, patients receiving anticoagulant therapy must be monitored and the dosage of anticoagulant adjusted if necessary (see drug interactions). Use of this medication does not eliminate the need for surveillance usually required for patients of this type.
Make allowance for the increased bleeding time In patients at high risk of hemorrhage (because of severe trauma. surgery, etc.).
- In the absence of efficacy and safety data, use of the medication in children is not recommended.
- Ornacor is not indicated in exogenous hypertriglyceridemia (type I hyperchylomicronemia).
- There is only limited experience in secondary endogenous hypertriglycerldemia (especially uncontrolled diabetes).
- There is no experience in combination with other lipid-lowering agents.
SPECIAL PRECAUTION:
Regular monitoring of hepatic function (ASAT and ALAT) is required in patients with hepatic impairment.
INTERACTIONS:
- Oral anticoagulants; see special warning.
Omacor has been given in conjunction with warfarin without hemorrhagic complications. However, the prothrombin time must be checked when Omacor is combined with warfarin or when treatment with Omacor is stopped.
PREGNANCY AND LACTATION:
No teratogenic effect has been observed in animal studies.
As there is no information on its effects on human pregnancy, however, Omacor should not be used during pregnancy or lactation unless absolutely necessary.
UNDESIRABLE EFFECTS:
The most frequently reported undesirable clinical effects are gastrointestinal disturbances such as reflux or eructation with an odor or taste of fish, nausea, vomiting, distension, diarrhea, or constipation.
There have also been rare reports of eczema and acne.
Moderate elevation of the hepatic transaminases (ASAT and ALAT) has been reported.
DOSAGE AND METHOD OF ADMINISTRATION:
The recommended daily dosage is four capsules. This may be administered in two doses a day. The capsules should be taken with meals to avoid gastrotintestinal disturbances.
CAUTION:
Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription.
AVAILABILITY:
Bottle by 28's
STORE BELOW 25 0C
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