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BASF AS
[Patriot]
Regulatory Class: Rx
C: EPA 460 mg, DHA 380 mg
I: Isolated or predominant endogenous hypertriglyceridemia in patient at risk of ischemic heart disease &/or pancreatitis. Supplement to diet when appropriate & assiduous dietary measures alone are insufficient to produce an adequate response. Secondary prevention after MI.
D: Post MI 1 cap daily. Hypertriglyceridemia Initially 2 cap daily may be increased to 4 cap daily.
A: Take w/ food to avoid GI disturbances.
CI: Hypersensitivity to EPA or DHA, soya (soya milk, soya beans).
SP: Thromboxane A2 production may fall during treatment. Monitor patients receiving anticoagulant or other drugs affecting coagulation (eg, ASA, warfarin & coumarin). Routine monitoring of the entire lipid profile; LDL-C especially in patients w/ type IV & V dyslipidemia. Not recommended as monotherapy in type IIb dyslipidemia. Regular monitoring of hepatic function (especially ALT) in patients w/ hepatic impairment. Pregnancy & lactation. Not recommended in childn.
AR: Dyspepsia, nausea. Post MI: GI disturbances. Hypertriglyceridemia: Eructation taste perversion.
INT: Increased bleeding time w/ acetylsalicylic acid; warfarin & coumarin.