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. Reduce the risk of fatal CHD & non-fatal MI, stroke, revascularization procedures & angina pectoris in patients w/o clinically evident CV disease, & 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). Reduce 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 CV disease. Reduce the risk for CV disease in patients w/ diabetes w/ moderately decreased eGFR. Reduce the risk of major CV events including stroke in patients w/ clinically evident CHD & CKD not requiring dialysis. Reduce 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 the 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. Dose range: 10-80 mg once daily. Primary hypercholesterolemia & combined (mixed) hyperlipidemia 10 mg once daily. HoFH 80 mg. Co-administration w/ cyclosporine, telaprevir, tipranavir/ritonavir, or glecaprevir/pibrentasvir Max: 10 mg. Severe dyslipidemia Childn ≥10 yr 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 3x the ULN. Women of childbearing potential who are not using adequate contraceptive measures. Pregnancy & lactation.

Patients who consume substantial quantities of alcohol &/or have history of liver disease. Dose reduction or w/drawal is recommended if increase in ALT or AST of >3 x ULN persist. Discontinue therapy if markedly elevated CPK levels occur or if myopathy is diagnosed or suspected. Temporarily w/held or discontinue in patients w/ an 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 risk for recurrent hemorrhagic stroke. Increased HbA1c & fasting serum glucose levels. Perform LFTs before the initiation of treatment & periodically thereafter, & in patients who develop any signs or symptoms suggesting liver injury. Combination 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 w/ concurrent use of fusidic acid.

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 CYP 3A4/transporter inhibitors (eg, erythromycin & azole antifungals). Increased plasma conc w/ CYP 3A4 inhibitors eg, erythromycin, clarithromycin, PIs, diltiazem HCl, grapefruit juice (>1.2 L/day). Increased AUC w/ itraconazole. Increased exposure w/ cyclosporine, glecaprevir, pibrentasvir, letermovir, elbasvir, grazoprevir. Reduced plasma conc w/ CYP 3A4 inducers (eg, efavirenz, rifampin), oral antacid susp containing Mg & Al hydroxides, colestipol. Increased digoxin conc. Increased AUC of OCs containing norethindrone & ethinyl estradiol. 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.

Rx