Atorsam-F

Adjunct to diet to reduce elevated total-C, LDL-C, Apo B & triglyceride levels & to increase HDL-C in patients w/ mixed hyperlipidemia.

Adult & elderly Initially atorvastatin 10 mg + fenofibrate 160 mg once daily.

Should be taken with food.

Hypersensitivity. Patients w/ unexplained persistent liver function abnormality & elevations of serum transaminases exceeding 3 times ULN; pre-existing gallbladder disease. Severe hepatic or renal dysfunction including primary biliary cirrhosis. Pregnancy & lactation.

Associated w/ biochemical abnormalities of liver function. Perform LFTs prior to & at 12 wk following initiation of therapy & periodically thereafter (eg, semiannually). May occasionally be associated w/ myopathy. Temporarily w/hold or discontinue use in any patient w/ acute, serious condition suggestive of myopathy or risk factors predisposing to development of renal failure secondary to rhabdomyolysis (eg, severe acute infection, hypotension, major surgery, trauma, severe metabolic, endocrine & electrolyte disorders, & uncontrolled seizures). Concomitant use of drugs that may decrease levels or activity of endogenous steroid hormones eg, ketoconazole, spironolactone, & cimetidine. Not recommended in childn & adolescents <18 yr. Fenofibrate: Very rare reports of acute hypersensitivity reactions. May increase cholesterol excretion into the bile, leading to cholelithiasis. Discontinue use if gallstones are found. Reports of pancreatitis. Mild to moderate Hb, hematocrit, & WBC decreases have been observed following initiation of therapy. Perform periodic blood counts during 1st 12 mth of administration.

Headache; abdominal pain, nausea, constipation, diarrhea; asthenia, back pain; elevated serum ALT/creatine phosphokinase. Atorvastatin: Insomnia; dizziness, paraesthesia, hypoesthesia; dyspepsia, flatulence; myalgia, arthralgia; chest pain, fatigue; allergic reactions (including anaphylaxis); skin rash, pruritus. Fenofibrate: Flu syndrome; abnormal LFTs; increased SGOT; resp disorder, rhinitis.

Prolonged prothrombin time/INR w/ oral anticoagulants. Absorption may be impeded w/ bile acid sequestrants. Atorvastatin: Decreased plasma conc w/ colestipol. Increased steady-state plasma conc of digoxin. Increased plasma conc w/ erythromycin (CYP3A4 inhibitor). Increased plasma conc of norethindrone & ethinyl estradiol. Risk of renal deterioration w/ cyclosporine/immunosuppressants & other potentially nephrotoxic agents. Risk of myopathy w/ cyclosporine; azole antifungals/niacin. Fenofibrate: Increased mean AUC of glimepiride. Increased AUC, C_max & C_min of ezetimibe & ezetimibe glucuronide.

Dyslipidaemic Agents

C10AB05 - fenofibrate ; Belongs to the class of fibrates. Used in the treatment of hyperlipidemia.
C10AA05 - atorvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.

Rx