Xarator

Adjunct to diet in patients w/ elevated total cholesterol (total-C), 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-C & LDL-C in patients w/ HoFH. Reduce 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; non-fatal MI, fatal & non-fatal stroke, revascularization procedures, hospitalization for CHF & angina in patients w/ clinically evident CHD; CV disease in patients w/ diabetes w/ moderately decreased estimated GFR; major CV events including stroke in patients w/ clinically evident CHD & CKD not requiring dialysis. Reduce 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 LDL-C remains ≥190 mg/dL or ≥160 mg/dL & +ve family history of premature CV disease or ≥2 other CV disease risk factors present in ped patient after adequate trial of diet therapy.

Individualized dosage. Dose range: 10-80 mg once daily. Primary hypercholesterolemia & combined (mixed) hyperlipidemia 10 mg once daily. HoFH 80 mg. Heterozygous familial hypercholesterolemia Ped patient 10-17 yr Initially 10 mg daily. Max: 20 mg daily. Combination w/ cyclosporine, telaprevir, tipranavir/ritonavir, or glecaprevir/pibrentasvir Max: 10 mg.

May be taken with or without food.

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

Discontinue treatment if markedly elevated creatine phosphokinase levels occur or if myopathy is diagnosed or suspected. Temporarily withhold or discontinue therapy in any patient w/ acute, serious condition suggestive of myopathy or 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). Dose reduction or w/drawal of treatment if increase in ALT or AST of >3x ULN persist. Moderate (>3x ULN) elevations of serum transaminases. Unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever. Increased risk of myopathy w/ concurrent administration of drugs increasing atorvastatin systemic conc (eg, CYP 3A4 inhibitors); recurrent hemorrhagic stroke in patients w/ hemorrhagic stroke. Immune-mediated necrotizing myopathy. Rhabdomyolysis w/ acute renal failure secondary to myoglobinuria. Increased HbA1c & fasting serum glucose levels. Patient consuming substantial quantities of alcohol &/or w/ history of liver disease. Not recommended in patients taking letermovir co-administered w/ cyclosporine. Perform LFTs before treatment initiation & periodically thereafter & in patients developing signs & symptoms of liver injury. Monitor patients who develop increased transaminase levels until it resolves; for skeletal muscle effects w/ history of renal impairment. Not recommended in concurrent use w/ fusidic acid (temporary suspension of atorvastatin). Concomitant treatment w/ fibric acid derivatives, erythromycin, immunosuppressives, azole antifungals, HIV/HCV PIs, HCV NS5A/NS5B inhibitors, letermovir, or lipid-modifying doses of niacin. 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. Thrombocytopenia; allergic reactions (including anaphylaxis); tendon rupture; wt gain; hypoesthesia, amnesia, dizziness, dysgeusia; pancreatitis; SJS, TEN, angioedema, erythema multiforme, bullous rashes; rhabdomyolysis, immune-mediated necrotizing myopathy, myositis, back pain; chest pain, peripheral edema, fatigue.

Increased risk of myopathy w/ concurrent administration of cyclosporine, fibric acid derivatives, lipid-modifying doses of niacin or CYP 3A4/transporter inhibitors (eg, erythromycin & azole antifungals); colchicine. Increased plasma conc w/ CYP 3A4 inhibitors (eg, erythromycin, clarithromycin, PIs), diltiazem HCl, grapefruit juice. Increased AUC w/ itraconazole. Increased exposure w/ cyclosporine, glecaprevir & pibrentasvir, letermovir, elbasvir & grazoprevir. Reduced plasma conc w/ CYP 3A4 inducers (eg, efavirenz, rifampin); Mg- & Al hydroxide containing antacids; colestipol. Increased conc of digoxin. Increased AUC of OC containing norethindrone & ethinyl estradiol. 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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