Atorvastatin + fenofibrate

Full Generic Medicine Info
Dosage/Direction for Use

Mixed dyslipidaemia
Adult: Per tablet contains atorvastatin 10 mg and fenofibrate (micronised) 160 mg: 1 tab once daily.
Hypersensitivity, hepatic or severe renal dysfunction, unexplained persistent liver function abnormality, unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal. Preexisting gallbladder disease. Pregnancy and lactation.
Special Precautions
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.
Adverse Reactions
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.
Monitor LFTs and serum CPK levels. Unabsorbed drug may be removed by gastric lavage or emesis. General supportive care.
Drug Interactions
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 ethinyl estradiol may increase plasma levels of norethindrone and ethinyl estradiol. 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.
Lab Interference
Fenofibrate increases AST, ALT, creatinine, blood urea levels; decreased haemoglobin, haematocrit, uric acid.
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.
ATC Classification
C10AA05 - atorvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
C10AB05 - fenofibrate ; Belongs to the class of fibrates. Used in the treatment of hyperlipidemia.
Disclaimer: This information is independently developed by CIMS based on atorvastatin + fenofibrate from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 CIMS. All rights reserved. Powered by
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