Omega -3 Ethyl Esters- (FDC- List )
Drug Name:
Omega -3 Ethyl Esters- (FDC- List )
List Of Brands:
Indication Type Description:
Pharmacology/ Pharmacokinetics
Indication:
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Each 1000ml of emulsion contains 14-05-2009
Medium chain Triglycerides 100gm
+Soya oil 80gm
+ Omega 3 Triglycerides 20gm
+ Egg lecithin 12gm
+ Glyceryl 25gm
+ Sodium Oleate 0.30gm
+ Alpha Tocopherol 0.20gm
+ Ascobypalmitate 0.30gm
+ Sodium Hydroxide Max 0.06gm
+ Water for Injection 784gm
Emulsion for Infusion
For the supply of fats,including essential 6 fatty acids,and Omega -3 Fatty
acids as a part of Parenteral Nutrition Regimen in Adults, if Oral or Enteral
Nutrition is impossible inadequate or contraindicated
Hypertriglyceridemia
Adverse Reaction:
Constipation, eructation, dyspepsia, taste perversion, and vomiting
Contra-Indications:
Hypersensitivity to the drug or other ingredients in the formulation
Dosages/ Overdosage Etc:
Indication-
Hypertriglyceridemia
Dosage-
Adult- 1 capsule a day or as prescribed by the physician
Pharmacology/ Pharmacokinetics:
Pharmacology-
Omega 3 acid ethyl ester is a long term polysaturated ethyl ester of
eicosapentaenoic acid ( EPA ) and docsahaexaenoic acid DHA . The esters of
omega-3 fatty acids are rapidly hydrolysed to free acid which are rapidly
which are rapidly incorporated into phospholipids, cholestrol esters and triglycerides.
EPA and DHA with their ethyl esters reduce plasma triglycerides and cholesterol
Combination with Atorvastatin-
Co-administration of omega-3 acid ethyl ester with atorvastatin was well tolerated at all
atorvastatin doses and this might be a rational treatment approach for improving
non-HDL -C levels and other lipid parameters in patients with elevated non-HDL -C
and triglyceride levels