OMG-3 1000 mg Capsule

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Indications of OMG-3 1000 mg

OMG-3 1000 mg is indicated as an adjunct to diet to reduce very high (>500mg/dl) triglyceride (TG) levels in adult patients and as an adjunct in secondary prevention in those who have had a myocardial infarction in the preceding 3 months. It is also indicated to help reduce the joint ... Read moreOMG-3 1000 mg is indicated as an adjunct to diet to reduce very high (>500mg/dl) triglyceride (TG) levels in adult patients and as an adjunct in secondary prevention in those who have had a myocardial infarction in the preceding 3 months. It is also indicated to help reduce the joint inflammation associated with mild arthritis, mood disorders & impulse control, age-related macular degeneration.

Composition

Each Soft Gelatin Capsule Contains Omega-3-Acid Ethyl Esters BP 1000 mg. A combination of- Eicosapentaenoic Acid BP 80 mg Docosahexaenoic Acid BP 120 mg

Theropeutic Class

Other lipid regulating drugs

Pharmacology

The omega-3 fatty acids eicosapentaenoic acid and docosahexaenoic acid are long-chain n-3 polyunsaturated fatty acids, which compete with arachidonic acid for inclusion in cyclo-oxygenase and lipoxygenase pathways. Their actions include hypolipidaemic action (especially a reduction in plasma triglycerides) by reducing very-low-density lipoproteins; anti-inflammatory action, attributed to effects on leukotriene synthesis; and antiplatelet effect, attributed to effects on prostanoid synthesis, which promote vasodilatation, reduction in platelet aggregation, increased bleeding time and decreased platelet counts.

Dosage & Administration of OMG-3 1000 mg

Post Myocardial Infarction: One capsule daily.Hypertriglyceridaemia: Initial treatment two capsules daily. If adequate response is not obtained, the dose may be increased to four capsules daily. The capsules may be taken with food to avoid gastrointestinal disturbances.There is limited clinical data regarding the use of Omega-3-acid ethyl esters in elderly patients over 70 years of age and patients with renal impairment.There is no information regarding the use of Omega-3-acid ethyl esters in children and adolescents or in patients with hepatic impairment.

Dosage of OMG-3 1000 mg

In hypertriglyceridaemia: it can be taken as a single dose of 4 capsules (4 gm) or 2 capsules (2 gm) twice daily.In previously myocardial infarction patients: It can be taken 1 capsule (1 gm ) daily with food. Patients should be placed on an appropriate lipid lowering diet before receiving OMG-3 1000 mg and should continue this diet during treatment.In joint inflammation associated with mild arthritis: The dose is 2.7 gm daily.In mood disorders & impulse control and age-related macular degeneration: The dose is 1 capsule (1 gm) per day. Or, as directed by the registered physician.

Interaction of OMG-3 1000 mg

Patients receiving treatment with both Omega-3-acid ethyl esters and anticoagulants should be monitored periodically.

Contraindications

It is contraindicated in patients who exhibit hypersensitivity to any component of this medication.

Side Effects of OMG-3 1000 mg

Adverse events are rarely reported such as dyspepsia, nausea, constipation, gastritis, dizziness etc.

Pregnancy & Lactation

Research has confirmed that adding EPA and DHA to the diet of pregnant women has a positive effect on visual and cognitive development of the baby. Omega-3s are also used after birth to make breast milk. Studies have also shown that higher consumption of omega-3s may reduce the risk of allergies in infants.

Precautions & Warnings

During therapy with omega-3-acid ethyl esters, LDL-C levels should be monitored and laboratory studies should be performed periodically to measure the patient's TG levels.

Overdose Effects of OMG-3 1000 mg

There are no special recommendations. Treatment should be symptomatic.

Storage Conditions

Store below 25°C in a dry & cool place.

Use In Special Populations

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.Geriatric Use: A limited number of subjects older than 65 years were enrolled in the clinical trials of Omega-3-Acid Ethyl Esters. Safety and efficacy findings in subjects older than 60 years did not appear to differ from those of subjects younger than 60 years.

Drug Classes

Other lipid regulating drugs

Mode Of Action

Omega-3-acid ethyl esters reduce triglyceride production by the liver but this mechanism is not well understood. Omega-3-acid ethyl esters inhibit acyl-CoA: 1,2-diacylglycerol acyltransferase, reducing triglyceride synthesis and increasing paroxysmal beta-oxidation, which increases fatty aside metabolism. Omega-3-acid ethyl esters also inhibit the release of fatty acids by competing for enzymes involved in the synthesis of triglycerides, increase triglyceride clearance by increasing the activity of lipoprotein lipase, and decrease production of VLDL-C.

Pregnancy

Omega-3-acid ethyl esters should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether it is excreted in human milk. Caution should be exercised when Omega-3-acid ethyl esters are administered to a lactating mother.
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