Synerrv Atorvastatin

Atorvastatin Ca

Adjunct to diet for patients w/ elevated total cholesterol (total-C), LDL-C, Apo B & triglycerides (TG) & to increase HDL-C in patients w/ primary hypercholesterolemia (heterozygous familial & non-familial), combined (mixed) hyperlipidemia (Fredrickson types IIa & IIb), elevated serum TG levels (Fredrickson type IV) & for patients w/ dysbetalipoproteinemia (Fredrickson type III) who inadequately respond to diet. Reduction of total-C & LDL-C in patients w/ HoFH. Prevention of CV disease w/o clinically evident CHD but w/ multiple risk factors eg, age, smoking, HTN, low HDL-C, or family history of early CHD to reduce risk of MI, stroke, revascularization procedures & angina. Type 2 diabetes w/o clinically evident CHD but w/ multiple risk factors eg, retinopathy, albuminuria, smoking or HTN to reduce risk of MI & stroke. Patients w/ clinically evident CHD to reduce risk of non-fatal MI, fatal & non-fatal stroke, revascularization procedures, hospitalization for CHF & angina. Adjunct to diet to reduce total-C, LDL-C & Apo B levels in boys & postmenarchal girls 10-17 yr w/ heterozygous familial hypercholesterolemia if after adequate diet therapy LDL-C remains ≥190 mg/dL or ≥160 mg/dL & there is +ve family history of premature CV disease or ≥2 other CV disease risk factors.

Dose range: 10-80 mg once daily. Primary hypercholesterolemia & combined (mixed) hyperlipidemia 10 mg once daily. HoFH Most patient responded to 80 mg once daily. Heterozygous familial hypercholesterolemia in ped patient 10-17 yr Initially 10 mg daily, dose adjustments made at ≥4 wk intervals. Max: 20 mg daily. Childn HoFH Up to 80 mg daily.

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

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

Discontinue use if clinically significant elevation of creatine kinase levels (>10 x ULN) occurs; ILD develops. Patients w/ prior hemorrhagic stroke or lacunar infarct; predisposing factors for rhabdomyolysis; DM; immune-mediated necrotizing myopathy. Substantial alcohol consumption &/or history of liver disease. Perform LFTs prior to & periodically thereafter. Not to be co-administered w/ fusidic acid or w/in 7 days of discontinuation. Concomitant use w/ fibrates, erythromycin, immunosuppressive drugs, azole antifungals, niacin ≥1 g daily; potent CYP3A4 inhibitors. Renal impairment. Women of childbearing potential should use effective contraception. Not to be used during pregnancy & lactation. Elderly >70 yr.

Nasopharyngitis; allergic reactions; hyperglycemia; headache; pharyngolaryngeal pain, epistaxis; constipation, flatulence, dyspepsia, nausea, diarrhoea; myalgia, arthralgia, pain in extremity, muscle spasms, joint swelling, back pain.

Increased plasma conc by CYP3A4 inhibitors, HIV PIs, fibric acid derivatives, ezetimibe. Increased exposure w/ amiodarone, verapamil, transport protein inhibitors. Reduced plasma conc by CYP3A4 inducers, colestipol. Severe myositis & myoglobinuria w/ fibrates. Increased muscle-related events w/ ezetimibe. Increased risk of rhabdomyolysis w/ fusidic acid. Cases of myopathy w/ colchicine. Increased digoxin conc. Increased plasma conc of norethindrone & ethinyl estradiol. Monitor prothrombin time w/ warfarin & other coumarin anticoagulants.

Dyslipidaemic Agents

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

B