Lipanthyl Penta/Lipanthyl Supra

Fenofibrate

Hypercholesterolaemia & hypertriglyceridaemia alone or combined (types IIa, IIb, III, IV & V dyslipidaemias) in patients unresponsive to dietary & other non-drug therapeutic measures (eg, wt reduction or increased physical activity) particularly when there is evidence of associated risk factors (eg, HTN & smoking). Secondary hyperlipoproteinaemia despite effective treatment of underlying disease (eg, dyslipidaemia in DM). Lipanthyl Penta Reduction in the progression of diabetic retinopathy in patients w/ type 2 diabetes & existing diabetic retinopathy.

Adult & elderly Lipanthyl Penta 145 mg once daily. Lipanthyl Supra 160 mg once daily. Renal impairment Dosage reduction is required. Moderate CKD (CrCl 30-59 mL/min) If low dose is available, start w/ 1 cap of 100 mg standard or 67 mg micronized once daily.

Lipanthyl Penta: May be taken with or without food: Swallow whole w/ a glass of water. Lipanthyl Supra: Should be taken with food: Swallow whole.

Hypersensitivity. Known photoallergy or phototoxic reaction during treatment w/ fibrates or ketoprofen. Not to be taken by patients allergic to peanut, arachis oil, soybean lecithin or related products. Known gallbladder disease. Chronic or acute pancreatitis w/ exception of acute pancreatitis due to severe hypertriglyceridemia. Hepatic insufficiency (including biliary cirrhosis & unexplained persistent liver function abnormality). Severe CKD.

Adequately treat secondary cause of hyperlipidemia (eg, uncontrolled type 2 DM, hypothyroidism, nephrotic syndrome, dysproteinemia, obstructive liver disease, pharmacological treatment, alcoholism) prior to therapy. Possible elevated lipid values by oral oestrogen. Monitor transaminase levels every 3 mth during the 1st 12 mth of treatment & thereafter periodically. Discontinue use if AST & ALT levels increase to >3x ULN & if symptoms of hepatitis occur (eg, jaundice, pruritus). Pancreatitis. Muscle toxicity. Increased risk of rhabdomyolysis in patient w/ pre-disposing factors including >70 yr, personal/familial history of hereditary muscular disorders, renal impairment, hypothyroidism & high alcohol intake. Closely monitor for signs of muscle toxicity when co-administered w/ another fibrate or HMG-CoA reductase inhibitor (statins) especially in cases of pre-existing muscular disease. Interrupt treatment in case of an increase creatinine levels >50% & ULN. Measure creatinine during the 1st 3 mth after initiation of treatment & thereafter periodically. Contains lactose; not to be taken by patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Not recommended for use in patients w/ hepatic impairment. Pregnancy. Not to be used during breast-feeding. Not recommended in adolescents & childn <18 yr. Lipanthyl Penta Risk of hypersensitivity reactions in patient allergic to soybean lecithin or related products. Contains sucrose; not to be taken by patients w/ rare hereditary problems of fructose intolerance or sucrase-isomaltase insufficiency.

Increased blood homocysteine level. GI signs & symptoms (abdominal pain, nausea, vomiting, diarrhoea, flatulence); increased transaminases. Rarely, ILD, rhabdomyolysis, jaundice, cholelithiasis complications (eg, cholecystitis, cholangitis, biliary colic), severe cutaneous reactions (eg, erythema multiforme, SJS, TEN), fatigue.

Enhanced oral anticoagulant effect & may increase risk of bleeding. Severe cases of reversible renal function impairment w/ cyclosporin. Increased risk of serious muscle toxicity w/ HMG-CoA reductase inhibitors & other fibrates. Reversible paradoxical reduction of HDL-C w/ glitazones. Co-administration w/ weak inhibitors of CYP2C19 & CYP2A6 & mild to moderate inhibitors of CYP2C9.

Dyslipidaemic Agents

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

POM