Zuellig Pharma
Concise Prescribing Info
Atorvastatin Ca
Adjunct to diet for patients w/ elevated total cholesterol (total-C) & LDL-cholesterol (LDL-C), apolipoprotein B (apo B) & triglycerides (TG) & to increase HDL-cholesterol (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 do not respond adequately to diet. Reduction of total-C & LDL-C in patients w/ homozygous familial hypercholesterolaemia. Reduction of total-C & LDL-C & apo B levels in boys & postmenarchal girls 10-17 yr w/ heterozygous familial hypercholesterolemia when 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. Prevention of CV disease w/o clinically evident CV disease but w/ multiple risk factors eg, age, smoking, HTN, low HDL-C, or family history of early CHD to reduce risk of MI, stroke & revascularisation 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, revascularisation procedures, hospitalisation for CHF & angina.
Dosage/Direction for Use
Dose range: 10-80 mg once daily. Primary hypercholesterolemia & combined (mixed) hyperlipidemia 10 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. Severe dyslipidemia in ped patient (≥10 yr) Initially 10 mg daily, may be increased to 80 mg daily. Dose adjustments made at ≥4 wk intervals. Childn Homozygous familial hypercholesterolemia Up to 80 mg daily.
May be taken with or without food.
Hypersensitivity. Active liver disease or unexplained persistent elevated serum transaminases >3 times upper limit of normal. Women of childbearing potential who are not using adequate contraceptive measures. Pregnancy & lactation.
Special Precautions
Discontinue use if markedly elevated creatine phosphokinase levels occur; myopathy is diagnosed or suspected; acute, serious condition suggestive of myopathy or risk factor predisposing to renal failure secondary to rhabdomyolysis development. Increased risk for recurrent hemorrhagic stroke; increased HbA1c & fasting serum glucose levels; immune-mediated necrotizing myopathy. Substantial alcohol consumption &/or history of liver disease. Perform liver function tests prior to initiation & periodically thereafter. Reduce dose or discontinue use if increased ALT or AST of >3 times upper limit of normal persist. Concurrent use w/ cyclosporine, fibric acid derivatives, erythromycin, niacin, azole antifungals, colchicine, telaprevir, boceprevir, tipranavir/ritonavir, immunosuppressives. Women of childbearing potential should use effective contraception.
Adverse Reactions
Nasopharyngitis; hyperglycemia; pharyngolaryngeal pain, epistaxis; diarrhoea, dyspepsia, nausea, flatulence; arthralgia, pain in extremity, musculoskeletal pain, muscle spasms, myalgia, joint swelling; abnormal liver function test, increased blood creatine phosphokinase.
Drug Interactions
Increased risk of myopathy w/ cyclosporine, fibric acid derivatives, niacin, erythromycin, azole antifungals. Increased plasma conc by CYP3A4 inhibitors, erythromycin/clarithromycin, PIs, diltiazem, grapefruit juice. Increased exposure w/ OATP1B1 inhibitors. Increased AUC w/ itraconazole. Reduced plasma conc by CYP3A4 inducers, Mg- & Al hydroxide-containing antacids, colestipol. Increased digoxin conc. Increased AUC values for norethindrone & ethinyl estradiol. Cases of myopathy w/ colchicine. Increased risk of rhabdomyolysis w/ fusidic acid. Severe myositis & myoglobinuria w/ fibrates.
MIMS Class
Dyslipidaemic Agents
ATC Classification
C10AA05 - atorvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
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