Lipitor

Crystalline atorvastatin

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 do not respond adequately to diet. Reduction of total-C & LDL-C in patients w/ HoFH. 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.

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 HoFH Up to 80 mg daily.

May be taken with or without food.

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

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 LFTs prior to initiation & periodically thereafter. Reduce dose or discontinue use if increased ALT or AST of >3 times ULN persist. Not recommended to be used concurrently w/ fusidic acid. Avoid use w/ cyclosporine, HIV PIs, hepatitis C PIs. Concurrent use w/ fibric acid derivatives, erythromycin, immunosuppressives, azole antifungals, HCV NS5A/NS5B inhibitors, letermovir, niacin ≥1 g daily. Women of childbearing potential should use effective contraception.

Nasopharyngitis; hyperglycemia; pharyngolaryngeal pain, epistaxis; diarrhoea, dyspepsia, nausea, flatulence; arthralgia, pain in extremity, musculoskeletal pain, muscle spasms, myalgia, joint swelling; abnormal LFT, increased blood creatine phosphokinase.

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.

Dyslipidaemic Agents

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