Finora

Adjunctive therapy to diet for the reduction of LDL-C, total-C, triglycerides & Apo B in adults w/ primary hypercholesterolemia or mixed dyslipidemia (Fredrickson types IIa & IIb). Adjunctive therapy to diet for treatment of adults w/ hypertriglyceridemia (Fredrickson types IV & V hyperlipidemia).

Adult 200 mg daily. Dose can be titrated up to 267 mg daily, if required (max dose is not recommended in addition to a statin). Patient w/ renal impairment eGFR 30-59 mL/min/1.73 m² Dose should not exceed 100 mg once daily.

Should be taken with food: Swallow cap whole during a meal.

Hypersensitivity. Pre-existing gall bladder disease. Hepatic or severe renal dysfunction, including primary biliary cirrhosis. Unexplained persistent liver function abnormality.

Not indicated for patients w/ type I hyperlipoproteinemia, who have elevations of chylomicrons & plasma triglycerides, but who have normal levels of VLDL. Reports of pancreatitis; increases in transaminase levels; muscle toxicity, including rare cases of rhabdomyolysis, w/ or w/o renal failure. Monitor transaminase levels every 3 mth during the 1st 12 mth of treatment & thereafter periodically. Discontinue therapy if AST (SGOT) & ALT (SGPT) levels increase to >3 times ULN or symptoms indicative of hepatitis occur (eg, jaundice, pruritus), & diagnosis is confirmed by lab testing; muscle toxicity is suspected. Treat secondary causes of hyperlipidemia (eg, uncontrolled type 2 DM, hypothyroidism, nephrotic syndrome, dysproteinemia, obstructive liver disease, pharmacological treatment, alcoholism) before considering drug therapy. Caution in patients w/ mild to moderate renal insufficiency. Measure creatinine during the 1st 3 mth after initiation of treatment & periodically thereafter. Not recommended in patients w/ hepatic impairment. Should only be used during pregnancy after careful benefit/risk assessment. Should not be used during breast-feeding. Not recommended in ped <18 yr.

GI signs & symptoms (abdominal pain, nausea, vomiting, diarrhea, flatulence); increased transaminases; increased blood homocysteine level.

Enhanced oral anti-coagulant effect & may increase risk of bleeding. Reports of severe cases of reversible renal function impairment w/ ciclosporin. Increased risk of serious muscle toxicity w/ HMG-CoA reductase inhibitors or other fibrates. Reports of cases of reversible paradoxical reduction of HDL-C w/ glitazones. Carefully monitor patients co-administered w/ CYP2C19, CYP2A6, & especially CYP2C9 metabolized drugs w/ narrow therapeutic index. May interact w/ drugs metabolized by microsomal mixed-function oxidases.

Dyslipidaemic Agents

C10AB05 - fenofibrate ; Belongs to the class of fibrates. Used in the treatment of hyperlipidemia.

Rx