Omacor

Omacor

Manufacturer:

BASF AS

Distributor:

Patriot
Concise Prescribing Info
Contents
EPA ethyl ester 460 mg, DHA ethyl ester 380 mg
Indications/Uses
Supplement to diet when appropriate & assiduous dietary measures alone are insufficient to produce an adequate response in isolated or predominant endogenous hypertriglyceridaemia in patient at risk of ischaemic heart disease &/or pancreatitis.
Dosage/Direction for Use
Hypertriglyceridaemia Initially 2 cap daily. May be increased to 4 cap daily if adequate response is not obtained.
Administration
Should be taken with food: Take w/ food to avoid GI disturbances.
Contraindications
Hypersensitivity to EPA ethyl ester, DHA ethyl ester, soya (including soya milk or beans) or peanut.
Special Precautions
Caution in patients w/ known sensitivity or allergy to fish. Dose-dependent increased risk of atrial fibrillation in patients w/ established CV disease or CV risk factors treated w/ omega-3-acid ethyl esters. Permanently discontinue treatment if atrial fibrillation develops. Thromboxane A2 production may fall during treatment. Periodically monitor patients receiving concomitant anticoagulant or other drugs affecting coagulation (eg, ASA, warfarin & coumarin). Routine monitoring of the entire lipid profile is recommended. Regularly monitor LDL-C especially in patients w/ type IV & V dyslipidaemia. Not recommended as monotherapy in type IIb dyslipidaemia. Regularly monitor hepatic function (especially ALT) in patients w/ hepatic impairment. Should not be used during pregnancy unless clearly necessary. Exercise caution when administered to woman who is breastfeeding. Limited information regarding use in patients w/ renal impairment. No information regarding use in childn & adolescents, in elderly >70 yr or in patients w/ hepatic impairment. Not recommended in childn.
Adverse Reactions
Eructation, taste perversion. Atrial fibrillation; GI disorders (including abdominal distension/pain, constipation, diarrhoea, dyspepsia, flatulence, GERD, nausea or vomiting).
Drug Interactions
Increased bleeding time w/o haemorrhagic complications w/ ASA & warfarin.
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 softgel cap
Packing/Price
28's (P766.55/box)