|Composition||Atorvastatin 10mg and fenofibrate 160mg Tablets.|
|Mechanism of Action||
Atorvastatin competitively inhibits HMG-CoA reductase, the enzyme that catalyses the conversion of HMG-CoA to mevalonic acid. HMG-CoA reductase inhibitors increase HDL-C and decrease LDL-C, VLDL-C and plasma triglycerides. Fenofibric acid, active metabolite of fenofibrate, lowers plasma triglycerides by inhibiting TG synthesis, resulting in the reduction of VLDL-C. Also, it stimulates the catabolism of VLDL-C. It reduces serum uric acid levels by increasing the urinary excretion of uric acid.
Absorption: Atorvastatin: Rapid absorption after oral admin. Absolute bioavailability: 14%. Fenofibrate: Well absorbed after oral admin.
Distribution: Atorvastatin: >98% bound to plasma proteins. Fenofibrate: About 99% bound to plasma proteins.
Metabolism: Atorvastatin: Extensively metabolised. Fenofibrate: Rapidly hydrolysed by esterases to the active metabolite, fenofibric acid.
Excretion: Atorvastatin and its metabolites: Removed mainly in the bile. Mean elimination half-life: About 14 hr. Fenofibrate: Mainly removed in the urine as metabolites; fenofibric acid has an elimination half-life of about 16 hr.
Abnormal LFTs, gastritis, abdominal pain, back pain, leg pain, joint pain, burning feet, body ache, numbness in legs, resp disorder, rhinitis. Constipation, flatulence, dyspepsia, headache, nausea, myalgia, asthenia, diarrhoea, insomnia.
Potentially Fatal: Pancreatitis, cholelithiasis, hepatitis, cholecystitis, hepatomegaly, rhabdomyolysis; hypersensitivity
|Drug drug interaction||
Concurrent administration with colestipol may reduce the serum levels of atorvastatin by about 25%. Concurrent administration with digoxin may increase steady-state plasma digoxin levels by about 20%. Increased risk of myopathy when used with erythromycin. Concurrent use of atorvastatin with oral contraceptives containing norethindrone and ethinylestradiol may increase plasma levels of norethindrone and ethinylestradiol. Monitor prothrombin time/INR when used with oral anticoagulants. Increased risk of myopathy when used with ciclosporin or azole antifungals/niacin.
Potentially Fatal: Co-administration with antacids susp decreased atorvastatin levels. Plasma levels of atorvastatin decreased with co-administration of colestipol. Decrease in antihyperlipidaemic activity may occur with propranolol. Fenofibrate increases the clotting time and causes bleeding complications when co-administered with oral anticoagulants.
Uncomplicated myalgia, patients who consume substantial quantities of alcohol and have a history of liver disease. Monitor LFTs before starting therapy and at 12 wk after starting and periodically thereafter. Treatment should be temporarily discontinued in patients with acute, serious condition suggestive of myopathy or having risk factor predisposing to the development of renal failure secondary to rhabdomyolysis. Fenofibrate may increase risk of cholelithiasis; discontinue if gallbladder stones are found. Fenofibrate may increased risk of pancreatitis. Renal impairment. Safety and efficacy have not been established in paediatrics.
Adult: Per tablet contains atorvastatin 10 mg and fenofibrate (micronised) 160 mg: 1 tab once daily.