Omacor

Omacor

omega-3 triglycerides

Manufacturer:

Pronova BioPharma

Distributor:

Lee's Pharm

Marketer:

Ferrer
Concise Prescribing Info
Contents
Omega-3-acid ethyl esters 90 (EPA ethyl ester 460 mg, DHA ethyl ester 380 mg)
Indications/Uses
Supplement to diet in endogenous hypertriglyceridaemia when dietary measures alone are insufficient to produce an adequate response: type IV in monotherapy; type IIb/III in combination w/ statins, when triglyceride control is insufficient.
Dosage/Direction for Use
Initially 2 cap daily, may be increased to 4 cap daily if adequate response is not obtained.
Administration
Should be taken with food.
Contraindications
Hypersensitivity to omega-3-acid ethyl esters 90 or soya.
Special Precautions
Patients at high risk of haemorrhage. Monitor patients receiving anticoagulant therapy & adjust anticoagulant dose, if necessary, due to moderate increase in bleeding time. ALT & AST levels should be monitored in patients w/ any signs of liver damage. Not indicated in exogenous hypertriglyceridaemia (type 1 hyperchylomicronaemia). Limited experience in secondary endogenous hypertriglyceridaemia (especially uncontrolled diabetes); elderly >70 yr; patient w/ renal impairment. No information regarding use in patients w/ hepatic impairment; hypertriglyceridaemia in combination w/ fibrates. Should not be used during pregnancy unless clearly necessary. Should not be used during lactation. Not recommended in childn due to the absence of efficacy & safety data.
Adverse Reactions
GI disorders (including abdominal distension &/or pain, constipation, diarrhoea, dyspepsia, flatulence, eructation, GERD, nausea or vomiting).
Drug Interactions
Check prothrombin time when combined w/ warfarin or when treatment w/ Omacor is stopped.
MIMS Class
Dyslipidaemic Agents
ATC Classification
C10AX06 - omega-3-triglycerides incl. other esters and acids ; Belongs to the class of other lipid modifying agents.
Presentation/Packing
Form
Omacor soft gel cap 1,000 mg
Packing/Price
28's
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