Lipitor

Adjunct to diet for patients w/ elevated total-cholesterol, LDL-C, Apo B & triglycerides & to increase HDL-C in patients w/ primary hypercholesterolemia (heterozygous familial & non-familial hypercholesterolemia), combined (mixed) hyperlipidemia (Fredrickson types IIa & IIb), elevated serum triglyceride levels (Fredrickson type IV) & for patients w/ dysbetalipoproteinemia (Fredrickson type III) who do not respond adequately to diet. Reduction of total-cholesterol & LDL-C in patients w/ HoFH. Reduce risk of fatal & 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. Reduce risk of non-fatal MI; fatal & non-fatal stroke; revascularization procedures; hospitalization for CHF; angina in patients w/ clinically evident CHD. Reduce risk for CV disease in patients w/ diabetes w/ moderately decreased estimated GFR; risk of major CV events including stroke in patients w/ clinically evident CHD & CKD not requiring dialysis; rate of GFR decline & progression of CKD in patients w/ clinically evident CHD &/or diabetes w/ microalbuminuria. Adjunct to diet to reduce total-cholesterol, LDL-C & apo-B levels in boys & post-menarchal girls 10-17 yr w/ heterozygous familial hypercholesterolemia if after adequate trial of diet therapy LDL-C remains ≥190 mg/dL or LDL-C remains ≥160 mg/dL & there is +ve family history of premature CV disease or ≥2 other CV disease risk factors are present in ped patient.

10-80 mg once daily. Dose adjustment according to lipid levels analyzed w/in 2-4 wk after initiation &/or upon titration. Primary hypercholesterolemia & combined (mixed) hyperlipidemia 10 mg once daily. HoFH 80 mg once daily. Heterozygous familial hypercholesterolemia Ped patients 10-17 yr Initially 10 mg daily. Max: 20 mg daily. Dose adjustments at ≥4 wk intervals. In combination w/ cyclosporine, telaprevir, tipranavir/ritonavir, or glecaprevir/pibrentasvir Max: 10 mg once daily.

May be taken with or without food.

Hypersensitivity. Active liver disease or unexplained persistent elevations of serum transaminases >3x ULN. Women of childbearing potential not using adequate contraception. Pregnancy & lactation.

Discontinue treatment if markedly elevated creatine phosphokinase (CPK) levels occur or if myopathy is diagnosed or suspected; there is myalgia at calf, back or whole body. Temporarily withhold or discontinue in any patient w/ acute, serious condition suggestive of myopathy or w/ risk factor predisposing to development of renal failure secondary to rhabdomyolysis (eg, severe acute infection, hypotension, major surgery, trauma, severe metabolic, endocrine, electrolyte disorders & uncontrolled seizures). Reduce dose or w/draw treatment if increase in ALT or AST of >3x ULN persist. Increased risk of hemorrhagic stroke in patients w/ pre-existing condition. Moderate (>3x ULN) serum transaminase elevations; myalgia; immune-mediated necrotizing myopathy; rhabdomyolysis w/ acute renal failure secondary to myoglobinuria; increased HbA1c & fasting serum glucose levels. Patients consuming substantial quantities of alcohol or w/ history of liver disease; w/ diffuse myalgias, muscle tenderness or weakness &/or marked elevated CPK. Hypothyroidism. Perform LFTs before initiating treatment & periodically thereafter; in patients developing signs & symptoms of liver injury. Monitor patients who develop increased transaminase levels until it resolves; skeletal muscle effects in patients w/ history of renal impairment. Not recommended to use concomitantly w/ fusidic acid (suspend atorvastatin temporarily); in patients taking letermovir co-administered w/ cyclosporine. Increased risk of myopathy or rhabdomyolysis w/ azole antifungals (eg, ketoconazole, itraconazole), macrolides (eg, erythromycin, clarithromycin), HIV PIs (eg, indinavir, ritonavir, nelfinavir, saquinavir), verapamil, diltiazem, gemfibrozil, nicotinic acid, cyclosporine, amiodarone. Concomitant treatment w/ fibric acid derivatives, erythromycin, immunosuppressives, azole antifungals, HIV/HCV PIs, HCV NS5A/NS5B inhibitors, letermovir or lipid-modifying doses of niacin; digoxin, warfarin; colchicine. Hepatic or renal insufficiency. Elderly.

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

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, itraconazole, grapefruit juice). Increased exposure w/ cyclosporine, glecaprevir & pibrentasvir, letermovir, elbasvir & grazoprevir; amlodipine. Reduced plasma conc w/ CYP 3A4 inducers (eg, efavirenz, rifampin); antacids; colestipol. Increased digoxin conc. Increased AUC of OCs containing norethindrone & ethinyl estradiol. Concomitant use 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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