Lipitor

Adjunct to diet for the treatment of patients w/ elevated total cholesterol (total-C), LDL-C, Apo B, & triglycerides (TG) & to increase HDL-C in patients w/ primary hypercholesterolemia (heterozygous familial & nonfamilial hypercholesterolemia), 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. Reduces the risk of fatal CHD & non-fatal MI, stroke, & revascularization procedures & angina pectoris in patients w/o clinically evident CV disease (CVD), & w/ or w/o dyslipidemia, but w/ multiple risk factors for CHD (eg, smoking, HTN, diabetes, low HDL-C, or a family history of early CHD). Reduces the risk of non-fatal MI, fatal & non-fatal stroke, revascularization procedures, hospitalization for CHF, & angina in patients w/ clinically evident CHD. Adjunct to lifestyle changes (eg, proper diet & exercise) to halt the progression of atherosclerosis (total atheroma or plaque vol) in patients w/ CAD & other individuals who are at high risk for CVD. Reduces the risk for CVD in patients w/ diabetes w/ moderately decreased eGFR. Reduces the risk of major CV events including stroke in patients w/ clinically evident CHD & CKD not requiring dialysis. Reduces the rate of GFR decline & progression of CKD in patients w/ clinically evident CHD &/or diabetes w/ microalbuminuria. Adjunct to diet to reduce total-C, LDL-C, & Apo B levels in boys & post-menarchal girls 10-17 yr w/ heterozygous familial hypercholesterolemia if, after an adequate trial of diet therapy, LDL-C remains ≥190 mg/dL or, LDL-C remains ≥160 mg/dL & there is a +ve family history of premature CVD or ≥2 other CVD risk factors are present.

Individualized starting & maintenance dose according to baseline LDL-C levels, goal of therapy, & patient response. Dose range: 10-80 mg once daily. Primary hypercholesterolemia & combined (mixed) hyperlipidemia 10 mg once daily. HoFH 80 mg. Severe dyslipidemia Childn ≥10 yr Initially 10 mg once daily, may be increased to 80 mg daily according to response & tolerability. Adjustments should be made at ≥4 wk intervals.

May be taken with or without food.

Hypersensitivity. Active liver disease or unexplained persistent elevations of serum transaminases exceeding 3 times ULN. Pregnant, breast-feeding, or women of childbearing potential who are not using adequate contraception.

Perform LFTs before initiation of treatment & periodically thereafter, & in patients who develop any signs or symptoms suggesting liver injury. Dose reduction or w/drawal is recommended should an increase in ALT or AST of >3 times ULN persist. Caution in patients who consume substantial quantities of alcohol &/or have history of liver disease. Discontinue therapy if markedly elevated CPK levels occur or if myopathy is diagnosed or suspected. Temporarily w/hold or discontinue therapy in patients w/ acute, serious condition suggestive of myopathy or w/ risk factor predisposing to the development of renal failure secondary to rhabdomyolysis (eg, severe acute infection, hypotension, major surgery, trauma; severe metabolic, endocrine & electrolyte disorders, & uncontrolled seizures). Increased incidence of recurrent hemorrhagic stroke in patients w/o CHD who had a stroke or transient ischemic attack w/in the preceding 6 mth & were initiated on atorvastatin 80 mg. Increased HbA1c & fasting serum glucose levels. Caution when considering combined therapy w/ fibric acid derivatives, erythromycin, immunosuppressive drugs, azole antifungals, HIV/HCV PIs, HCV NS5A/NS5B inhibitors, letermovir, or lipid-modifying doses of niacin. Not recommended in concurrent use w/ fusidic acid. Women of childbearing potential should use adequate contraception.

Nasopharyngitis; hyperglycemia; pharyngolaryngeal pain, epistaxis; diarrhea, dyspepsia, nausea, flatulence; arthralgia, pain in extremity, musculoskeletal pain, muscle spasms, myalgia, joint swelling; abnormal LFT, increased blood creatine phosphokinase. Nightmare; blurred vision; tinnitus; abdominal discomfort, eructation; hepatitis, cholestasis; urticaria; muscle fatigue, neck pain; malaise, pyrexia; WBC urine +ve.

Increased risk of myopathy w/ cyclosporine, fibric acid derivatives, lipid-modifying doses of niacin or CYP3A4/transporter inhibitors (eg, erythromycin & azole antifungals). Increased plasma conc w/ CYP3A4 inhibitors eg, erythromycin, clarithromycin, PIs, diltiazem HCl, grapefruit juice (>1.2 L/day). Increased AUC w/ itraconazole. Increased exposure to atorvastatin w/ transporter inhibitors eg, cyclosporine, glecaprevir, pibrentasvir, letermovir, elbasvir, grazoprevir. Reduced plasma conc w/ CYP3A4 inducers (eg, efavirenz, rifampin), oral antacid susp containing Mg & Al hydroxides, colestipol. Increased digoxin conc. Increased AUC of OCs containing norethindrone & ethinyl estradiol. Reports of myopathy w/ colchicine. Increased risk 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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