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 a +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 for reduction of the risk of MI, stroke & revascularisation procedures & angina. In type 2 diabetes w/o clinically evident CHD but w/ multiple risk factors eg, retinopathy, albuminuria, smoking or HTN for reduction of the risk of MI & stroke. In patients w/ clinically evident CHD for reduction of the 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 the 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 or myopathy is diagnosed or suspected. Temporarily withheld or discontinue in acute, serious condition suggestive of myopathy or risk factor predisposing to renal failure secondary to rhabdomyolysis development. Promptly report unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever. Perform liver function tests before initiation of treatment & periodically thereafter; should an increase in ALT or AST of >3 times the upper limit of normal persist, reduce dose or discontinue use. Increased risk for recurrent hemorrhagic stroke. Increased HbA1c & fasting serum glucose levels. Immune-mediated necrotizing myopathy. Substantial alcohol consumption &/or history of liver disease. Not recommended concurrently w/ fusidic acid. Concurrent use w/ cyclosporine, fibric acid derivatives, clarithromycin, erythromycin, niacin, azole antifungals, colchicine, telaprevir, boceprevir or combination of tipranavir/ritonavir. Women of childbearing potential should use effective contraception.
Adverse Reactions
Nasopharyngitis; hyperglycaemia; 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 bioavailability 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.
ATC Classification
C10AA05 - atorvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
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