Atorvin

Atorvastatin Ca

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 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 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 after adequate trial of diet therapy LDL-C remains ≥190 mg/dL or ≥160 mg/dL & w/ +ve family history of premature CV disease or ≥2 other CV disease risk factors are present in ped patient.

Adult & geriatric Primary prevention Individualized dose. Dose adjustment at 2-4 wk intervals (4 wk in ped). Hypercholesterolemia (heterozygous familial & non-familial) & mixed hyperlipidemia (Fredrickson types IIa & IIb) Initially 10-20 mg once daily. Patient requiring >45% reduction in LDL-C Initially at 40 mg once daily. Dose range: 10-80 mg once daily. HoFH 10-80 mg once daily. Primary prevention Adult ≥21 yr w/ LDL-C ≥190 mg/dL High intensity therapy: 80 mg once daily. May reduce to 40 mg once daily, if unable to tolerate. Adult 40-75 yr Patient w/ estimated 10-yr ASCVD risk ≥7.5% Moderate to high intensity therapy: 10-80 mg once daily, type 1 or 2 diabetes Moderate intensity therapy: 10-20 mg once daily, type 1 or 2 diabetes & estimated 10-yr ASCVD risk ≥7.5% High-intensity therapy: 80 mg once daily. Secondary prevention Patient w/ ASCVD (eg, CHD, stroke/transient ischemic attack (TIA) or peripheral arterial disease) & >75 yr or not candidate for high intensity therapy Moderate intensity therapy: 10-20 mg once daily, ≤75 yr High-intensity therapy: 80 mg once daily. May reduce to 40 mg once daily, if unable to tolerate. Heterozygous familial hypercholesterolemia Childn 10-17 yr (female post menarche) Initially 10 mg once daily. Max: 20 mg once daily. Concomitant use w/ boceprevir & nelfinavir Max: 40 mg daily. Concomitant use w/ clarithromycin, itraconazole, fosamprenavir, ritonavir (+ darunavir, fosamprenavir or saquinavir) Max: 20 mg daily.

May be taken with or without food. Avoid intake of large quantities of grapefruit juice (>1 quart daily).

Hypersensitivity. Active liver disease. Unexplained persistent elevations of serum transaminases. Pregnancy & lactation.

Discontinue treatment if myalgia at calf, back or whole body; if transaminase level >3x ULN occurs; in markedly elevated creatine phosphokinase levels (≥10x ULN) or if myopathy is suspected/diagnosed; for elective major surgery experiencing acute or serious condition predisposing to renal failure (eg, sepsis, hypotension, trauma, uncontrolled seizures). Rule out secondary cause of hyperlipidemia prior therapy that has not been studied when primary lipid abnormality is chylomicron elevation (Fredrickson types I & V). Increased risk of hemorrhagic stroke in patients w/ prior stroke or TIA in long-term high dose (80 mg daily); rhabdomyolysis w/ acute renal failure secondary to myoglobinuria &/or myopathy w/ concurrent lipid lowering agent (fibric acid derivatives or niacin ≥1 g daily) or strong CYP3A4 inhibitors (eg, clarithromycin, itraconazole & PI), cyclosporine, & use at high dose; increasing blood sugar level. Patients w/ hypothyroidism; who consume large amounts of ethanol or w/ history of liver disease. Obtain liver enzyme tests at baseline & if signs/symptoms of liver injury occur. Perform LFTs before & 6 & 12 wk after treatment; every 6 mth in patients w/ routine use. Not to be used w/ cyclosporine, gemfibrozil, tipranavir + ritonavir & glecaprevir/pibrentasvir. Concomitant use w/ digoxin, warfarin; azole antifungal (eg, ketoconazole, itraconazole), macrolides (eg, erythromycin, clarithromycin), HIV PIs (eg, indinavir, ritonavir, nelfinavir, saquinavir), verapamil, diltiazem, gemfibrozil, nicotinic acid, cyclosporine, amiodarone; colchicine. Hepatic or renal insufficiency. Elderly ≥65 yr (predisposed to myopathy).

Hemorrhagic stroke; insomnia; DM; diarrhea, dyspepsia, nausea; cystitis, UTI; increased serum transaminases; arthralgia, limb & musculoskeletal pain, myalgia, muscle spasm; nasopharyngitis, pharyngolaryngeal pain. SJS, TEN.

Avoid concomitant use w/ conivaptan, systemic cyclosporine & fusidic acid, gemfibrozil, idelalisib, pazopanib, posaconazole, red rice yeast, telaprevir, tipranavir. May increase levels/effects of aliskiren, aripiprazole, cimetidine, daptomycin, digoxin, diltiazem, dofetilide, flibanserin, hydrocodone, systemic ketoconazole, lomitapide, midazolam, nimodipine, pazopanib, pimozide, repaglinide, spironolactone, trabectedin, verapamil. Increased levels/effects w/ acipimox, amiodarone, aprepitant, asunaprevir, systemic azithromycin, cyclosporine, erythromycin, fusidic acid & ketoconazole, bezafibrate, boceprevir, ciprofibrate, clarithromycin, cobicistat, colchicine, conivaptan, moderate/strong CYP3A4 inhibitors, cyproterone, danazol, dasatinib, diltiazem, dronedarone, elbasvir, eltrombopag, fenofibrate & derivatives, fluconazole, fosaprepitant, gemfibrozil, grapefruit juice, idelalisib, itraconazole, ivacaftor, mifepristone, netupitant, niacin, niacinamide, ombitasvir, paritaprevir, ritonavir, dasabuvir, palbociclib, P-gp/ABCB 1 inhibitors, posaconazole, PIs, quinine, raltegravir, ranolazine, red yeast rice, rupatadine, simeprevir, stiripentol, telaprevir, telithromycin, teriflunomide, tipranavir, verapamil, voriconazole. May decrease levels/effects of dabigatran etexilate, lanthanum. Decreased levels/effects w/ antacid, systemic bexarotene, bile acid sequestrants, bosentan, moderate/strong CYP3A4 inducers, dabrafenib, deferasirox, efavirenz, etravirine, fosphenytoin, mitotane, phenytoin, rifamycin derivatives, siltuximab, St. John's wort, tocilizumab. Increased serum conc w/ grapefruit juice.

Dyslipidaemic Agents

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

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