Atorvastatin: Uses, Indications, Dosages, Precautions, Contraindications, Side Effects & Interactions

Atorvastatin

(a-tor-va-sta-tin)
Classification 
Pharmacotherapeutic: Hydroxymethylglutaryl CoA (HMG-CoA)

reductase inhibitor

Clinical: Antihyperlipidemic

Apo-Atorvastatin

Lipitor

Novo-Atorvastatin

CATEGORY AND SCHEDULE

Pregnancy Risk Category: X

Do not confuse:

Lipitor/Levatol

General Information

Atorvastatin is a member of the statin group of lipid-lowering drugs. It is used to treat hypercholesterolemia (high blood cholesterol levels) in patients who have not responded to other treatments, such as a special diet or lifestyle changes, and who have or are at risk of developing heart disease. Atorvastatin is also used in diabetic patients at high risk of heart attack or stroke. It blocks the action, in the liver, of an enzyme necessary for the production of cholesterol. As a result, blood cholesterol levels are reduced, which can help prevent coronary heart disease. Rarely, atorvastatin can cause muscle pain, swelling, and muscle damage

Atorvastatin can cause severe reactions, such as: Cataracts can develop and photosensitivity can occur. Hepatotoxicity or rhabdomyolysis occurs rarely and hypersensitivity such as bullous rash or anaphylaxis is rarely reported

Action

An antihyperlipidemic inhibits the enzyme HMG-CoA reductase, which reduces the synthesis of cholesterol, high doses lead to plaque regression

Therapeutic Effect

Lowers plasma triglyceride, LDL and VLDL levels; increases the concentration of HDL

Availability (Rx)

Tablets: 10 mg, 20 mg, 40 mg, 80 mg

Uses

Primary prevention of cardiovascular disease in high-risk pts. Reduces risk of

stroke and heart attack in pts with type 2 diabetes with or without evidence of

heart disease. Reduces risk of stroke in pts with or without evidence of heart

disease with multiple risk factors other than diabetes. Adjunct to diet therapy in

management of hyperlipidemias (reduces elevations in total cholesterol, LDL-C, apolipoprotein B, triglycerides in pts with primary hypercholesterolemia), homozygous familial hypercholesterolemia, heterozygous familial hypercholesterolemia in pts 10–17 yrs of age, females more than 1 yr postmenarche

Unlabeled uses: Secondary prevention in pts who have experienced a noncardioembolic stroke/TIA or following an acute coronary syndrome (ACS) event

Precautions

Pregnancy (X), breastfeeding, Past liver disease, alcoholism, severe acute infections, trauma, severe metabolic disorders, electrolyte imbalance

Make sure to tell your doctor if:

• You have had liver problems

• You have kidney problems

• You are a heavy drinker

• You have an underactive thyroid

• You or a family member have a muscle disorder

• You have had muscle problems or other reactions with other lipid lowering drugs

• You are taking other medicines

Indications and Dosages

‣ To Treat Hyperlipidemia, reduction of risk of myocardial infarction (MI), angina revascularization procedures, or stroke in patients with certain risk factors

PO

• Adults, Elderly: Initially, 10-40 mg a day given as a single dose. Dose range:

10-80 mg/day. Increase at 2- to 4-wk intervals to maximum of 80 mg/day

• Children 10-17 yr: Initially, 10 mg/ day, may increase to 20 mg/day

‣ To Treat Dyslipidemias

PO

• Adults, Elderly: Initially, 10–20 mg/day (40 mg in pts requiring greater than 45% reduction in LDL-C). Range: 10–80 mg/day

‣ To Treat Heterozygous Hypercholesterolemia

PO

• Children 10–17 YRS: Initially, 10 mg/day. Maximum: 20 mg/day

‣ Dosage in Renal Impairment

• No dose adjustment

‣ Dosage in Hepatic Impairment

• See contraindications

Pharmacokinetics

Poorly absorbed from the GI tract. Protein binding is > 98%. Metabolized in the liver. Minimally eliminated in urine. Plasma levels are markedly increased in chronic alcoholic hepatic disease but are unaffected by renal disease. Half-life: 14 h

Implementation

PO route

• Administer total daily dose at any time of day

• Store in cool environment in airtight, lightresistant container

• Give without regard to food or time of day

• Do not break, crush, dissolve, or divide film-coated tablets

Contraindications

Active hepatic disease, lactation, pregnancy, unexplained elevated liver function test results, rhabdomyolysis, hypersensitivity

Cautions: Anticoagulant therapy; history of hepatic disease; substantial alcohol

consumption; pts with prior stroke/TIA; concomitant use of potent CYP3A4

inhibitors; elderly (predisposed to myopathy)

Interactions

Individual drugs

• Clofibrate, cycloSPORINE, erythromycin, gemfibrozil, niacin: increased risk of

rhabdomyolysis

• Clarithromycin, protease inhibitors, itraconazole (strong CYP3A4 inhibitors): increased concentration, risk of rhabdomyolysis

• Colestipol: decreased action of atorvastatin

• Digoxin: increased action of digoxin

• Erythromycin: increased levels of atorvastatin

• Warfarin: increased action of warfarin

Drug classifications

• Antifungals (azole): possible rhabdomyolysis

• Contraceptives (oral): increased levels

Drug/laboratory tests

• Increased: bilirubin, alkaline phosphatase, ALT, AST, CK

• Interference: thyroid function tests

Drugs/food

• Grapefruit products may increase serum concentrations 

• Red yeast rice may increase serum levels (2.4 mg lovastatin per 600 mg rice)

Herbal

• None significant

Side effects

• CNS: Abnormal dreams, amnesia, asthenia, emotional lability, facial paralysis, fever, headache, hyperkinesia, lack of coordination, malaise, paresthesia, peripheral neuropathy, somnolence, syncope, weakness

• CV: Arrhythmias, elevated serum CK level, orthostatic hypotension, palpitations, phlebitis, vasodilation

• EENT: Amblyopia, altered refraction, dry eyes, dry mouth, epistaxis, eye hemorrhage, gingival hemorrhage, glaucoma, glossitis, hearing loss, lip swelling, loss of taste, pharyngitis, sinusitis, stomatitis, taste perversion, tinnitus

• ENDO: Hyperglycemia or hypoglycemia

• GI: Abdominal or biliary pain, anorexia, colitis, constipation, diarrhea, duodenal or stomach ulcers, dysphagia, eructation, esophagitis, flatulence, gastroenteritis, hepatic failure, hepatitis, increased appetite, indigestion, melena, pancreatitis, rectal hemorrhage, tenesmus, vomiting

• GU: Abnormal ejaculation; cystitis; decreased libido; dysuria; epididymitis; hematuria; impotence; nephritis; nocturia; renal calculi; urinary frequency, incontinence, or urgency; urine retention; vaginal hemorrhage

• HEME: Anemia, thrombocytopenia

• MS: Arthralgia, back pain, bursitis, gout, leg cramps, myalgia, myasthenia gravis, myositis, neck rigidity, tendon contracture, tenosynovitis, torticollis

• RESP: Dyspnea, pneumonia

• SKIN: Acne, alopecia, contact dermatitis, diaphoresis, dry skin, ecchymosis, eczema, jaundice, petechiae, photosensitivity, pruritus, rash, seborrhea, ulceration, urticaria

• Other: Allergic reaction, facial or generalized edema, flulike symptoms, infection, lymphadenopathy, weight gain

 

Nursing considerations

Baseline assessment

• Obtain baseline cholesterol, triglycerides, LFT

• Question for possibility of pregnancy before initiating therapy

• Obtain dietary history

Intervention/evaluation

• Monitor for headache

• Assess for rash, pruritus, malaise

• Monitor cholesterol, triglyceride lab values for therapeutic response

• Monitor LFTs, CPK

Equipment must be available for anaphylaxis

• Hypercholesterolemia: assess nutrition: fat, protein, carbohydrates; nutritional analysis should be completed by dietitian before treatment; assess for muscle pain, tenderness; obtain CPK if these occur, product may need to be discontinued; monitor triglycerides, cholesterol at baseline and throughout treatment; LDL and VLDL should be watched closely; if increased, product should be discontinued

• Monitor bowel pattern daily; diarrhea may be a problem

• Monitor liver function studies q1-2mo during the first 1½ yr of treatment; AST, ALT, liver function tests may be increased

• Monitor renal studies in patients with compromised renal system: BUN, I&O ratio, creatinine

• Assess eyes via ophthalmic exam 1 mo after treatment begins, annually

Evaluation

Positive therapeutic result

• Decreased cholesterol levels, serum triglyceride

• Improved HDL: LDL ratio

Patient/family teaching

• Inform patient that compliance is needed for positive results to occur, not to double doses

• Teach patient that risk factors should be decreased: high-fat diet, smoking, alcohol consumption, absence of exercise

• Advise patient to notify prescriber if the GI symptoms of diarrhea, abdominal or epigastric pain, nausea, vomiting; chills, fever, sore throat; muscle pain, weakness occur

• Inform patient to report dark urine, muscle fatigue, bone pain

• Inform patient to periodic lab tests are essential part of therapy

• Tell patient to Do not take other medications without consulting physician

• Tell patient to Do not chew, crush, dissolve, or divide tablets

• Advise not to take if pregnant (pregnancy X) or breastfeeding

• Advise patient to stay out of the sun, use protective clothing, or use sunscreen to prevent photosensitivity (rare)

• Advise patient to avoid excessive alcohol intake, large quantities of grapefruit products