Atorsam-F

Atorvastatin Ca 10 mg, fenofibrate 160 mg

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 (or atorvastatin 10 mg + fenofibrate 200 mg) once daily, can be titrated upwards to max: atorvastatin 40 mg + fenofibrate 160 mg (or atorvastatin 40 mg + fenofibrate 200 mg).

Should be taken with food.

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

Hypersensitivity. Temporarily w/hold or discontinue use in any patient w/ acute, serious condition suggestive of myopathy or having risk factor predisposing to development of renal failure secondary to rhabdomyolysis (eg, severe acute infection, hypotension, major surgery, trauma, severe metabolic, endocrine & electrolyte disorders, & uncontrolled seizures). Discontinue use if gallstones are found. Pancreatitis. Patients who consume substantial quantities of alcohol &/or have a past history of liver disease. Perform LFTs prior to & at 12 wk following initiation of therapy & periodically thereafter (eg, semiannually); periodic blood counts during 1st 12 mth of treatment. Concomitant use w/ drugs that may decrease levels or activity of endogenous steroid hormones eg, ketoconazole, spironolactone & cimetidine. Not recommended in childn & adolescents <18 yr.

Abdominal pain, constipation, nausea, diarrhea; headache; asthenia, back pain. Atorvastatin: Flatulence, dyspepsia; allergic reactions (including anaphylaxis); insomnia; dizziness, paraesthesia, hypoesthesia; skin rash, pruritus; myalgia, arthralgia; chest pain, fatigue. Fenofibrate: Flu syndrome; abnormal LFTs; increased SGPT, creatine phosphokinase, 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. Increased plasma conc of norethindrone & ethinyl estradiol. Risk of renal deterioration w/ cyclosporine. Concomitant use w/ immunosuppressants & other potentially nephrotoxic agents. Increased risk of myopathy w/ azole antifungals/niacin. Fenofibrate: Increased mean AUC of glimepiride. Increased total AUC, C_max & C_min of ezetimibe.

Dyslipidaemic Agents

C10BA - Combinations of various lipid modifying agents ; Used in the treatment of hyperlipidemia.

Rx