Contraindications
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.
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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.
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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. |
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.
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CIMS Class
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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. |