atorvastatin calcium
(ah tor' va stah tin)
Lipitor

Pregnancy Category X

Drug classes
Antihyperlipidemic
HMG CoA inhibitor

Therapeutic actions
Inhibits HMG co-enzyme A, the enzyme that catalyzes the first step in the cholesterol synthesis pathway, resulting in a decrease in serum cholesterol, serum LDLs (associated with increased risk of CAD), and increases serum HDLs (associated with decreased risk of CAD); increases hepatic LDL recapture sites, enhances reuptake and catabolism of LDL; lowers triglyceride levels.

Indications
· Adjunct to diet in treatment of elevated total cholesterol, serum triglycerides, and LDL cholesterol in patients with primary hypercholesterolemia (types IIa and IIb) and mixed dyslipidemia, primary dysbetalipoproteinemia, and homozygous familial hypercholesterolemia whose response to dietary restriction of saturated fat and cholesterol and other nonpharmacologic measures has not been adequate
· To increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia
· Adjunct to diet in treatment of boys and postmenarchal girls 10–17 yr, with heterozygous familial cholesterolemia if diet alone is not adequate to control lipid levels and LDL-C levels are > 190 mg/dL or if LDL-C level is > 160 mg/dL and there is a family history of premature cardiovascular disease or the child has two or more risk factors for the development of coronary disease

Contraindications and cautions
· Contraindicated with allergy to atorvastatin, fungal byproducts, active liver disease or unexplained and persistent elevations of transaminase levels, pregnancy, lactation.
· Use cautiously with impaired endocrine function.

Available forms
Tablets--10, 20, 40, 80 mg

Dosages
ADULTS
Initial: 10 mg PO once daily without regard to meals; maintenance: 10–80 mg PO daily. May be combined with bile acid binding resin.
PEDIATRIC PATIENTS 10–17 YR
Starting dose: 10 mg PO daily. Maximum dosage: 10 mg/day.

Pharmacokinetics
Route
Onset
Peak
Oral
Slow
1–2 hr

Metabolism: Hepatic and cellular; T1/2: 14 hr
Distribution: Crosses placenta; passes into breast milk
Excretion: Bile

Adverse effects
· CNS: Headache, asthenia
· GI: Flatulence, abdominal pain, cramps, constipation, nausea, dyspepsia, heartburn, liver failure
· Respiratory: Sinusitis, pharyngitis
· Other: Rhabdomyolysis with acute renal failure, arthralgia, myalgia

Interactions
Drug-drug
· Possible severe myopathy or rhabdomyolysis with erythromycin, cyclosporine, niacin, antifungals, other HMG-CoA reductase inhibitors
· Increased digoxin levels with possible toxicity if taken together; monitor digoxin levels
· Increased estrogen levels with oral contraceptives; monitor patients on this combination
Drug-food
· Decreased metabolism and risk of toxic effects if combined with grapefruit juice; avoid this combination.

Nursing considerations
Assessment
· History: Allergy to atorvastatin, fungal byproducts; active hepatic disease; acute serious illness; pregnancy, lactation
· Physical: Orientation, affect, muscle strength; liver evaluation, abdominal exam; lipid studies, liver and renal function tests

Interventions
· Obtain liver function tests as a baseline and periodically during therapy; discontinue drug if AST or ALT levels increase to 3 times normal levels.
· Withhold atorvastatin in any acute, serious condition (severe infection, hypotension, major surgery, trauma, severe metabolic or endocrine disorder, seizures) that may suggest myopathy or serve as risk factor for development of renal failure.
· Ensure that patient has tried cholesterol-lowering diet regimen for 3–6 mo before beginning therapy.
· Administer drug without regard to food, but at same time each day.
· Atorvastatin may be combined with a bile acid binding agent. Do not combine with other HMG-CoA reductase inhibitors or fibrates.
· Consult dietitian regarding low-cholesterol diets.
· Ensure that patient is not pregnant and has appropriate contraceptives available during therapy; serious fetal damage has been associated with this drug.

Teaching points
· Take this drug once a day, at about the same time each day; may be taken with food. Do not drink grapefruit juice while on this drug.
· Institute appropriate dietary changes that need to be made.
· These side effects may occur: nausea (eat small, frequent meals); headache, muscle and joint aches and pains (may lessen over time).
· Arrange to have periodic blood tests while you are on this drug.
· Alert any health care provider that you are on this drug; it will need to be discontinued if acute injury or illness occurs.
· Do not become pregnant while you are on this drug; use barrier contraceptives. If you wish to become pregnant or think you are pregnant, consult your health care provider.
· Report muscle pain, weakness, tenderness; malaise; fever; changes in color of urine or stool; swelling.

Adverse effects in Italic are most common; those in Bold are life-threatening.