Generic Name and Formulations:
Atorvastatin (as calcium) 10mg, 20mg, 40mg, 80mg; tabs.

Company:
Pfizer Inc.

Indications for LIPITOR:
Adjunct to diet in primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Types IIa and IIb) to reduce total-C, LDL-C, apo B and TG, and to increase HDL-C. Adjunct to diet in treating elevated serum TG (Type IV). Treatment of primary dysbetalipoproteinemia (Type III) not adequately responsive to diet. Adjunct to other lipid-lowering treatments (or when these are unavailable), in homozygous familial hypercholesterolemia to reduce total-C and LDL-C. Adjunct to diet to reduce total-C, LDL-C and apo B in patients 10–17 years of age (≥1 year post-menarche) with heterozygous familial hypercholesterolemia if LDL-C remains ≥190mg/dL, or if LDL-C remains ≥160mg/dL with either family history of premature cardiovascular disease (CVD) or if patient has at least 2 other CVD risk factors. To reduce risk of MI, stroke, and risk of revascularization procedures in adults at risk (see full labeling). To reduce risk of MI and stroke in patients with type 2 diabetes and at risk (see full labeling). To reduce the risk of non-fatal MI, fatal and non-fatal stroke, revascularization, hospitalization for CHF, and angina in patients with clinically evident coronary heart disease. Limitations of use: not studied where major abnormality is elevation of chylomicrons (Fredrickson Types I and V).

Adult Dose for LIPITOR:
≥17yrs: Heterozygous and Types IIa and IIb: initially 10 or 20mg once daily; if more than a 45% reduction in LDL-C is needed, may start at 40mg once daily; range 10–80mg once daily. Homozygous: 10–80mg daily. Concomitant clarithromycin, itraconazole, saquinavir + ritonavir, darunavir + ritonavir, fosamprenavir or fosamprenavir + ritonavir: max 20mg/day. Concomitant nelfinavir or boceprevir: max 40mg/day.

Children's Dose for LIPITOR:
Heterozygous: <10yrs: not recommended. 10–17yrs: initially 10mg/day, may increase to 20mg/day after at least 4 weeks. Homozygous: 80mg/day has been used; see literature.

Pharmacological Class:
HMG-CoA reductase inhibitor.

Contraindications:
Active liver disease. Unexplained persistent elevated serum transaminases. Pregnancy (Cat.X). Nursing mothers.

Warnings/Precautions:
Discontinue if myopathy, elevated CPK levels occur; suspend if a predisposition to development of renal failure secondary to rhabdomyolysis develops. Monitor liver function before starting therapy and repeat as clinically indicated. History of liver disease. Substantial alcohol ingestion. Hemorrhagic stroke. Elderly.

Interactions:
See Adult dose. Avoid with concomitant cyclosporine, gemfibrozil, tipranavir + ritonavir, telaprevir. Potentiated by strong CYP3A4 inhibitors, grapefruit juice (>1.2L/day). Caution with lopinavir + ritonavir, other fibrates, niacin (≥1g/day), colchicine; consider dose reduction of atorvastatin. May increase serum levels of digoxin, oral contraceptives (norethindrone, ethinyl estradiol); monitor digoxin. Caution with drugs that decrease levels or activity of steroid hormones (eg, ketoconazole, spironolactone, cimetidine).

Adverse Reactions:
GI upset, headache, myalgia, arthralgia, rash, elevated serum transaminases, myopathy, rhabdomyolysis with renal dysfunction; increased HbA1c and fasting serum glucose, cognitive impairment; rare: immune-mediated necrotizing myopathy.

How Supplied:
Tabs 10mg, 20mg—90, 5000; 40mg, 80mg—90, 500, 2500