Concise Prescribing Info
Atorvastatin Ca
Adjunct to diet for the treatment of patients w/ elevated total cholesterol (total-C), low density lipoprotein cholesterol (LDL-C), apolipoprotein B (apo-B), triglycerides (TG) & to increase high density lipoprotein cholesterol (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/ homozygous familial hypercholesterolemia. 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. 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, intensive treatment has been shown 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.
Dosage/Direction for Use
10-80 mg once daily. Primary hypercholesterolemia & combined (mixed) hyperlipidemia 10 mg once daily. Homozygous familial hypercholesterolemia 80 mg. Combination w/ other medicinal compd Max: 10 mg. Childn ≥10 yr Severe dyslipidemia 10 mg once daily, may be increased to 80 mg daily.
May be taken with or without food.
Hypersensitivity. Active liver disease or unexplained persistent elevations of serum transaminases exceeding 3x the upper limit of normal. Women of childbearing potential not using adequate contraceptive measures. Pregnancy & lactation.
Special Precautions
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 withheld or discontinue in any patient with an acute, serious condition suggestive of myopathy or w/ a risk factor predisposing to the development of renal failure secondary to rhabdomyolysis. Increased risk for recurrent hemorrhagic stroke. Increased HbA1c & fasting serum glucose levels. Concomitant use w/ fibric acid derivatives, erythromycin, immunosuppressive drugs, azole antifungals, HIV/HCV PIs, letermovir or lipid-modifying doses of niacin. Not recommended w/ concomitant use w/ fusidic acid. Perform liver function tests before the initiation of treatment & periodically thereafter.
Adverse Reactions
Nasopharyngitis; hyperglycemia; pharyngolaryngeal pain, epistaxis; diarrhea, dyspepsia, nausea, flatulence; arthralgia, pain in extremity, musculoskeletal pain, muscle spasms, myalgia, joint swelling; abnormal liver function test, increased blood creatine phosphokinase.
Drug Interactions
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/ erythromycin/clarithromycin, PIs, diltiazem HCl & grapefruit juice. Increased AUC w/ itraconazole, OCs containing norethindrone & ethinyl estradiol. Increased exposure w/ cyclosporine, glecaprevir, pibrentasvir, letermovir, elbasvir, grazoprevir, amlodipine. Reduced plasma conc w/ CYP3A4 inducers (eg, efavirenz, rifampin), oral antacid susp containing Mg & Al, colestipol. Increased digoxin conc. Myopathy w/ colchicine. Increased risk of rhabdomyolysis w/ fusidic acid.
ATC Classification
C10AA05 - atorvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
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