Lipostat

Atorvastatin Ca trihydrate

Adjunct to diet for the treatment of patients w/ elevated total cholesterol, LDL-C, Apo B & triglyceride & to increase HDL-C in patients w/ primary hypercholesterolemia (heterozygous familial & non-familial hypercholesterolemia), combined (mixed) hyperlipidemia (Fredrickson Type IIa & IIb), elevated serum triglyceride levels (Fredrickson Type IV) & for patients w/ dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet. Reduction of total cholesterol & LDL-C in patients w/ homozygous familial hypercholesterolemia. Patients w/o clinically evident CV disease, & w/ or w/o dyslipidemia, but w/ multiple risk factors for CHD eg, smoking, HTN, low HDL-C, family history of early CHD or diabetes. Reduce the risk of fatal CHD, non-fatal MI, fatal & non-fatal stroke, revascularization procedures, angina pectoris & hospitalization for CHF in patients w/ clinically evident CHD. Reduce the risk for CV disease in patients w/ diabetes w/ moderately decreased estimated glomerular filtration rate (estimated GFR). Reduce the risk of major CV events including stroke in patients w/ clinically evident CHD & CKD not requiring dialysis. Reduce the rate of GFR decline & progression of chronic kidney disease in patients w/ clinically evident CHD &/or diabetes w/ microalbuminuria. Adjunct to diet to reduce total cholesterol, LDL-C & Apo B levels in boys & post-menarchal girls 10-17 yr w/ heterozygous familial hypercholesterolemia.

Individualized starting & maintenance dosage according to baseline LDL-C levels, goal therapy & patient response. Dosing range: 10-80 mg once daily. Primary hypercholesterolemia & combined (mixed) hyperlipidemia 10 mg once daily. Homozygous familial hypercholesterolemia 10-80 mg once daily. Heterozygous familial hypercholesterolemia Ped 10-17 yr Initially 10 mg once daily. Max: 20 mg once daily. In combination w/ cyclosporine, telaprevir, or tipranavir/ritonavir Max: 10 mg.

May be taken with or without food: Avoid excessive consumption (>1 L/day) of grapefruit juice.

Hypersensitivity. Active liver disease or unexplained persistent elevations of serum transaminases >3x ULN. Women of childbearing potential who are not using adequate contraceptive measures. Pregnancy & lactation.

Perform liver tests before & at 6, 12 wk following initiation of therapy; every 6 mth in patients w/ long-term use. Monitor patients who develop increased transaminase levels & discontinue if >3x ULN; skeletal muscle effects. History of liver disease & renal impairment. Increased risk of myopathy or rhabdomyolysis in hepatic or renal dysfunction, patients w/ hypothyroidism; chronic alcoholic patients. Hemorrhagic stroke; hyperglycemia. Increase in HbA1c may occur. Discontinue use if sign of myalgia or back pain occur. Concomitant use w/ warfarin or digoxin; azole antifungals (eg, ketoconazole, itraconazole), macrolides (eg, erythromycin, clarithromycin), HIV PIs (eg, indinavir, ritonavir, nelfinavir, saquinavir), verapamil, diltiazem, gemfibrozil, nicotinic acid, cyclosporine, amiodarone; colchicine. Elderly ≥65 yr.

Nasopharyngitis; hyperglycemia; pharyngolaryngeal pain, epistaxis; diarrhea, dyspepsia, nausea, flatulence, abdominal discomfort, eructation; myalgia, joint swelling, muscle fatigue, neck pain; nightmare; blurred vision; tinnitus; hepatitis, cholestasis; urticaria; malaise, pyrexia.

Increased plasma conc w/ CYP 3A4 inhibitors eg, PIs, grapefruit juice (>1.2 L/day), diltiazem. Increased bioavailability w/ OATP1B1 eg, cyclosporine. Increased risk of myopathy or rhabdomyolysis & higher plasma conc w/ macrolides eg, erythromycin, clarithromycin. Increased peak plasma conc & AUC w/ azole antifungals eg, itraconazole, lomitapide. Increased risk of myopathy w/ niacin antilipemic dosages (≥1 g daily), fibric acid derivatives eg, gemfibrozil, fenofibrate; colchicine. Reduced plasma conc w/ CYP3A4 inducers eg, efavirenz, rifampin; antacid containing Mg- & Al hydroxide; bile sequestrants eg, colestipol. Increase conc of digoxin. Increase AUC of OCs containing norethindrone & ethinyl estradiol. Occurrence of rhabdomyolysis w/ fusidic acid.

Dyslipidaemic Agents

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

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