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Lipitor (atorvastatin calcium)

THERAPEUTIC CLASS

HMG-CoA reductase inhibitor (statin)

DEA CLASS

RX

INDICATIONS

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.

ADULT DOSAGE

Hyperlipidemia/Mixed Dyslipidemia

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

10-80mg qd

Prevention of Cardiovascular Disease

Dose based on current clinical practice

PEDIATRIC DOSAGE

Heterozygous Familial Hypercholesterolemia

10-17 Years (Boys and Postmenarchal Girls):
Initial: 10mg/day
Titrate: Adjust dose at intervals of ≥4 weeks
Max: 20mg/day

DOSING CONSIDERATIONS

Concomitant Medications
Lopinavir plus Ritonavir:
Use lowest dose necessary

Clarithromycin/Itraconazole/Fosamprenavir/Ritonavir plus Saquinavir, Darunavir, or Fosamprenavir:
Limit to 20mg/day; use lowest dose necessary

Nelfinavir or Boceprevir:
Limit to 40mg/day; use lowest dose necessary

ADMINISTRATION

Oral route

Take PO as a single dose at any time of the day, w/ or w/o food

HOW SUPPLIED

Tab: 10mg, 20mg, 40mg, 80mg

CONTRAINDICATIONS

Active liver disease, which may include unexplained persistent elevations in hepatic transaminases, women who are pregnant or may become pregnant, nursing mothers.

WARNINGS/PRECAUTIONS

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]); d/c if markedly elevated CPK levels occur or if myopathy is diagnosed or suspected. Temporarily withhold or d/c 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.

ADVERSE REACTIONS

Nasopharyngitis, arthralgia, diarrhea, diabetes, pain in extremity, UTI, dyspepsia, nausea, musculoskeletal pain, muscle spasms, myalgia, insomnia.

DRUG INTERACTIONS

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.

PREGNANCY AND LACTATION

Category X, not for use in nursing.

MECHANISM OF ACTION

HMG-CoA reductase inhibitor; inhibits conversion of HMG-CoA to mevalonate (precursor of sterols, including cholesterol).

PHARMACOKINETICS

Absorption: Rapid; absolute bioavailability (14%); Tmax=1-2 hrs. Distribution: Vd=381L; plasma protein binding (≥98%). Metabolism: CYP3A4 (extensive); ortho- and parahydroxylated derivatives (active metabolites). Elimination: Bile (major), urine (<2%); T1/2=14 hrs.

ASSESSMENT

Assess for active or history of liver disease, unexplained and persistent elevations in serum transaminase levels, pregnancy/nursing status, history of renal impairment, risk factors predisposing to the development of renal failure secondary to rhabdomyolysis, alcohol intake, recent stroke or TIA, hypersensitivity to the drug, and possible drug interactions. Obtain baseline LFTs.

MONITORING

Monitor for signs/symptoms of rhabdomyolysis and myopathy (including IMNM). Monitor lipid profile and CPK levels. Perform LFTs as clinically indicated.

PATIENT COUNSELING

Advise to adhere to the National Cholesterol Education Program-recommended diet, a regular exercise program, and periodic testing of a fasting lipid panel. Inform of the substances that should not be taken concomitantly with the drug. Advise to inform other healthcare professionals that they are taking the drug. Inform of the risk of myopathy; instruct to report promptly any unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever or if these muscle signs or symptoms persist after discontinuation. Inform that liver function will be checked prior to initiation and if signs or symptoms of liver injury occur; instruct to report promptly any symptoms that may indicate liver injury. Instruct women of childbearing age to use effective method of birth control to prevent pregnancy. Advise to d/c therapy and contact physician if pregnancy occurs. Instruct not to use the drug if breastfeeding.

STORAGE

20-25°C (68-77°F).

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