HMG-CoA reductase inhibitor (statin)
Each tablet contains:
Atorvastatin (as calcium trihydrate) 10mg, 20mg or 40mg
Adjunct to diet to decrease total cholesterol, LDL, apolipoprotein B, and TG levels, and to increase HDL levels in primary hypercholesterolemia and mixed dyslipidemia, hypertriglyceridemia, primary dysbetalipoproteinemia, homozygous familial hypercholesterolemia, heterozygous familial hypercholesterolemia (boys and postmenarchal girls 10-17 yrs of age), and in prevention of cardiovascular disease.
Active liver disease, which may include unexplained persistent elevations in hepatic transaminases,
women who are pregnant or may become pregnant.
Precaution & warnings:
Has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V).
Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria reported.
Increased risk of rhabdomyolysis with history of renal impairment; closely monitor for skeletal muscle effects.
May cause myopathy (including immune-mediated necrotizing myopathy [IMNM]); discontinue if markedly elevated CPK levels occur or if myopathy is diagnosed or suspected.
Temporarily withhold or discontinue if acute, serious condition suggestive of myopathy occurs or if with risk factor predisposing to development of renal failure secondary to rhabdomyolysis.
Persistent increases in serum transaminases reported; obtain liver enzyme tests prior to initiation and repeat as clinically indicated.
Fatal and nonfatal hepatic failure reported (rare); promptly interrupt therapy if serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs and do not restart if no alternate etiology found.
Caution in patients who consume substantial quantities of alcohol and/or have history of liver disease.
Increases in HbA1c and FPG levels reported.
May blunt adrenal and/or gonadal steroid production.
Increased risk of hemorrhagic stroke in patients with recent stroke or transient ischemic attack (TIA).
Caution in elderly.
Pregnancy & Breastfeeding:
Category X, not for use in nursing.
Dosage and administration:
Initial: 10mg or 20mg qd (or 40mg qd for LDL reduction >45%)
Titrate: Adjust dose accordingly at 2- to 4-week intervals
Range: 10-80mg qd
Homozygous Familial Hypercholesterolemia
Prevention of Cardiovascular Disease
Dose based on current clinical practice
Heterozygous Familial Hypercholesterolemia
10-17 Years (Boys and Postmenarchal Girls):
Titrate: Adjust dose at intervals of ≥4 weeks
Nasopharyngitis, arthralgia, diarrhea, diabetes, pain in extremity, UTI, dyspepsia, nausea, musculoskeletal pain, muscle spasms, myalgia, insomnia.
Avoid with cyclosporine, telaprevir, gemfibrozil, or combination of tipranavir plus ritonavir.
Caution with fibrates and drugs that decrease levels or activity of endogenous steroid hormones (eg, ketoconazole, spironolactone, cimetidine).
Increased risk of myopathy with fibric acid derivatives, erythromycin, lipid-modifying doses of niacin, strong CYP3A4 inhibitors (eg, clarithromycin, HIV protease inhibitors), and azole antifungals; consider lower initial and maintenance doses.
Strong CYP3A4 inhibitors (eg, clarithromycin, several combinations of HIV protease inhibitors, telaprevir, itraconazole) and grapefruit juice may increase levels.
CYP3A4 inducers (eg, efavirenz, rifampin) may decrease levels; simultaneous coadministration with rifampin recommended.
May increase digoxin levels; monitor appropriately.
May increase area under the curve of norethindrone and ethinyl estradiol.
Myopathy, including rhabdomyolysis, reported with colchicine; use with caution.
OATP1B1 inhibitors (eg, cyclosporine) may increase bioavailability.
Store below 30°C.
Keep out of reach of children.