Atorvastatin Calcium

Class: HMG-CoA Reductase Inhibitors
VA Class: CV350
Molecular Formula: (C₃₃H₃₄FN₂O₅)2Ca•3H₂O
CAS Number: 134523-03-08
Brands: Caduet , Lipitor

Special Alerts:

[Posted 09/30/2008] An FDA analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease often referred to as “Lou Gehrig's Disease.” The FDA analysis, undertaken after the agency received a higher than expected number of reports of ALS in patients on statins, is based on data from 41 long-term controlled clinical trials. The results showed no increased incidence of the disease in patients treated with a statin compared with placebo.

The FDA is anticipating the completion of a case-control or epidemiological study of ALS and statin use. Results from this study should be available within 6-9 months. FDA is also examining the feasibility of conducting additional epidemiologic studies to examine the incidence and clinical course of ALS in patients taking statins.

Based on currently available information, health care professionals should not change their prescribing practices for statins and patients should not change their use of statins. For more information visit the FDA website at: .

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Introduction

Atorvastatin is an antilipemic agent; hydroxymethylglutaryl-CoA (HMG-CoA) reductase inhibitor (i.e., statin).^{1 18}

Uses for Atorvastatin Calcium

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Prevention of Cardiovascular Events

Atorvastatin is used to reduce the risk of MI, stroke, or angina and the risk of undergoing revascularization procedures in patients without clinical evidence of CHD who have multiple risk factors (e.g., age, smoking, hypertension, low HDL-cholesterol concentrations, family history of early CHD).^{1 65}

Atorvastatin is used to reduce the risk of MI or stroke in patients without clinical evidence of CHD who have type 2 diabetes mellitus and other risk factors (e.g., smoking, hypertension, retinopathy, microalbuminuria, macroalbuminuria).^{1 65}

Atorvastatin is used to reduce the risk of nonfatal MI, fatal and nonfatal stroke, angina, or hospitalization for CHF, and the risk of undergoing revascularization procedures in patients with clinical evidence of CHD.^{1 65}

Atorvastatin has been used to slow the progression of coronary atherosclerosis† in patients with CHD.⁶⁷

Intensive antilipemic therapy (atorvastatin 80 mg daily) shown to be more effective than moderate antilipemic therapy (pravastatin 40 mg daily) in reducing the risk of cardiovascular events in patients hospitalized for acute coronary syndrome† (16% reduction in composite risk of death or major cardiovascular events for atorvastatin compared with pravastatin regimen).⁶⁶ Intensive antilipemic therapy also more effective in slowing progression of coronary atherosclerosis† in patients with CHD.⁶⁷

May use atorvastatin/amlodipine fixed-combination preparation when treatment with both atorvastatin (for prevention of cardiovascular events) and amlodipine (for hypertension and/or CAD) is appropriate.⁶⁵

Dyslipidemias

Atorvastatin is used as an adjunct to dietary therapy in adults to decrease elevated serum total cholesterol, LDL-cholesterol, apolipoprotein B (apo B), and triglyceride concentrations, and to increase HDL-cholesterol concentrations in the management of primary hypercholesterolemia and mixed dyslipidemia, including heterozygous familial hypercholesterolemia and other causes of hypercholesterolemia (e.g., polygenic hypercholesterolemia).¹ May be used in combination with ezetimibe for additive antilipemic effects.⁶⁴

Atorvastatin is used as an adjunct to dietary therapy to decrease elevated serum total cholesterol, LDL-cholesterol, and apo B concentrations in the management of heterozygous familial hypercholesterolemia in boys and postmenarchal girls ≥10 years of age who have a serum LDL-cholesterol concentration of ≥190 mg/dL and in those who have a serum LDL-cholesterol concentration of ≥160 mg/dL and either a family history of premature cardiovascular disease or multiple cardiovascular risk factors despite an adequate trial of dietary management.¹

Atorvastatin is used to reduce elevated serum total and LDL-cholesterol concentrations in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering therapies (e.g., plasma LDL-apheresis) or when such therapies are not available.¹ May be used in combination with ezetimibe for additive antilipemic effects.⁶⁴

Atorvastatin is used as an adjunct to dietary therapy for the treatment of primary dysbetalipoproteinemia.¹

Atorvastatin is used as an adjunct to dietary therapy in the management of elevated serum triglyceride concentrations.¹

Atorvastatin has reduced total and LDL-cholesterol concentrations in patients with hypercholesterolemia associated with or exacerbated by renal transplantation† ^{8 38 39} or use of protease inhibitors†.^{21 37}

Atorvastatin has reduced total and LDL-cholesterol concentrations in hypercholesterolemic patients on peritoneal dialysis†.³⁴

May use atorvastatin/amlodipine fixed-combination preparation when treatment with both atorvastatin (for dyslipidemias) and amlodipine (for hypertension and/or CAD) is appropriate.⁶⁵

Atorvastatin Calcium Dosage and Administration

General

• 
  

  Patients should be placed on a standard lipid-lowering diet before initiation of atorvastatin therapy and should remain on this diet during treatment with the drug.^{1 60 63}

  
  

Monitoring during Antilipemic Therapy

• 
  

  Monitor lipoprotein concentrations periodically to ensure that target LDL-cholesterol goals are achieved and maintained at <100 mg/dL (optional goal: <70 mg/dL) for patients with CHD or CHD risk equivalents; <130 mg/dL (optional goal: <100 mg/dL) for patients with ≥2 risk factors and 10-year risk of 10–20%; <130 mg/dL for patients with ≥2 risk factors and 10-year risk <10%; or <160 mg/dL for patients with 0–1 risk factor.

  
  

Administration

Oral Administration

Administer atorvastatin orally at any time of day without regard to meals.^{1 7}

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Atorvastatin is available as atorvastatin calcium; dosage expressed in terms of atorvastatin.^{1 65}

Pediatric Patients

Dyslipidemias

Atorvastatin Therapy for Heterozygous Familial Hypercholesterolemia

Oral

Children ≥10 years of age: Initially, atorvastatin 10 mg once daily.¹

Adjust atorvastatin dosage at intervals ≥4 weeks until the desired effect on lipoprotein concentrations is observed or a daily dosage of 20 mg is reached.¹

Adults

Dyslipidemias and Prevention of Cardiovascular Events

Atorvastatin Therapy for Primary Hypercholesterolemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia

Oral

Initially, atorvastatin 10 or 20 mg once daily; patients who require a large reduction in LDL-cholesterol concentration (>45%) may receive 40 mg once daily.¹ Determine serum lipoprotein concentrations within 2–4 weeks after initiating and/or titrating therapy and adjust dosage accordingly.¹ Usual maintenance dosage of atorvastatin is 10–80 mg once daily.¹

Atorvastatin Therapy for Homozygous Familial Hypercholesterolemia

Oral

Atorvastatin 10–80 mg once daily.¹

Atorvastatin/Amlodipine Fixed-combination Therapy for Dyslipidemias and Prevention of Cardiovascular Events (Atorvastatin) and for Hypertension and/or CAD (Amlodipine)

Oral

Use the fixed combination as a substitute for the individually titrated drugs.⁶⁵ Can switch to the fixed-combination preparation containing the corresponding individual doses of atorvastatin and amlodipine; alternatively, can increase the dosage of one or both components for additional antihypertensive, antianginal, and/or antilipemic effects.⁶⁵

Use the fixed combination to provide additional therapy for patients currently receiving one component of the preparation.⁶⁵ Select initial dosage of the fixed combination based on the current dosage of the component being used and the recommended initial dosage for the added monotherapy.⁶⁵

Use the fixed combination to initiate treatment in patients requiring therapy for dyslipidemias and hypertension and/or angina.⁶⁵ Select initial dosage of the fixed combination based on recommended dosages of the individual components.⁶⁵

Prescribing Limits

Pediatric Patients

Dyslipidemias

Oral

Children ≥10 years of age: Maximum 20 mg of atorvastatin daily.¹

Special Populations

The following information addresses dosage of atorvastatin in special populations. Dosages of drugs administered in fixed combination with atorvastatin also may require adjustment in certain patient populations; the need for such dosage adjustments must be considered in the context of cautions, precautions, and contraindications specific to that population and drug.⁶⁵

Hepatic Impairment

No specific atorvastatin dosage recommendations for hepatic impairment.¹ (See Hepatic Impairment under Cautions and see Special Populations under Pharmacokinetics.)

Renal Impairment

Atorvastatin dosage modification not required.¹

Geriatric Patients

No specific atorvastatin dosage recommendations for geriatric patients.¹ (See Geriatric Use under Cautions.)

Cautions for Atorvastatin Calcium

Contraindications

• 
  

  Active liver disease or unexplained, persistent elevations of serum aminotransferases.¹

  
  


• 
  

  Pregnancy or lactation.¹ Administer atorvastatin to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards.¹

  
  


• 
  

  Known hypersensitivity to atorvastatin or any ingredient in the formulation.¹

  
  


• 
  

  When atorvastatin is used in fixed combination with amlodipine, consider contraindications associated with amlodipine.⁶⁵

  
  

Warnings/Precautions

Warnings

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Fetal/Neonatal Morbidity and Mortality

Suppression of cholesterol biosynthesis could cause fetal harm.¹ Congenital anomalies following intrauterine exposure to statins reported rarely.¹

Administer atorvastatin to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards.¹ If the patient becomes pregnant while taking the drug, discontinue therapy and apprise the patient of the potential hazard to the fetus.¹

Hepatic Effects

Atorvastatin is associated with increases in serum aminotransferase (AST, ALT) concentrations.¹

Possible pancreatitis,¹ hepatitis,¹ cholestatic jaundice,¹ and biliary pain.¹ Fatty change in liver, increased serum alkaline phosphatase concentrations, increased serum γ-glutamyl transpeptidase concentrations, increased bilirubin concentrations, and, rarely, cirrhosis, fulminant hepatic necrosis, and hepatoma have been reported with other statins.

Perform liver function tests before and at 12 weeks after initiation of atorvastatin therapy or any increase in dosage and periodically (e.g., semiannually) thereafter.¹

Patients who develop increased serum AST/ALT concentrations or manifestations of liver disease should receive frequent liver function tests thereafter until the abnormalities return to normal.¹ If increases in AST or ALT concentrations of >3 times the upper limit of normal (ULN) persist, reduce atorvastatin dosage or discontinue therapy.¹

The National Lipid Association (NLA) statin safety assessment task force recommends that clinicians be alert to signs and symptoms of hepatotoxicity (e.g., jaundice, malaise, fatigue, lethargy, hepatomegaly, increased indirect bilirubin concentrations, elevated PT). If substantial hepatotoxicity is suspected, discontinue statin therapy, determine etiology, and refer patient to a gastroenterologist or hepatologist if indicated.

Musculoskeletal Effects

Myopathy (manifested as muscle pain, tenderness, or weakness and CK [CPK] concentration increases >10 times the ULN) has been reported with atorvastatin.¹

Rhabdomyolysis (characterized by muscle pain or weakness with marked increases [>10 times the ULN] in serum CK concentrations and increases in S_cr [usually accompanied by brown urine and urinary myoglobinuria]) with acute renal failure secondary to myoglobinuria has been reported with atorvastatin.¹

Risk of myopathy increased in patients receiving higher doses of statins; in patients with multisystem disease (e.g., renal or hepatic impairment); in patients with concurrent serious infections or hypothyroidism; in patients (particularly women) of advanced age (especially >80 years of age); in patients with small body frame and frailty; and in patients undergoing surgery (i.e., during perioperative periods). Risk also may be increased by concomitant administration of cyclosporine, niacin, fibric acid derivatives, macrolide antibiotics (e.g., clarithromycin, erythromycin), certain azole antifungals, HIV protease inhibitors (e.g., ritonavir plus saquinavir, lopinavir plus ritonavir), alcohol, and large quantities (>1 quart daily) of grapefruit juice.¹ (See Interactions.)

Measure baseline serum CK concentrations prior to initiation of therapy, particularly in patients at high risk of developing musculoskeletal toxicity (e.g., geriatric patients, black men, patients receiving concomitant therapy with myotoxic drugs).

Obtain serum CK concentrations and compare with baseline concentrations in patients presenting with musculoskeletal symptoms suggestive of myopathy; because hypothyroidism may be a predisposing factor, TSH concentrations also should be obtained in such patients.

Discontinue atorvastatin if serum CK concentrations become markedly elevated or if myopathy is diagnosed or suspected.¹

Monitor patients weekly if myalgia (muscle pain, tenderness) is present with either no CK elevation or a moderate elevation (3–10 times the ULN) until manifestations improve; discontinue statin therapy if manifestations worsen.

Dosage reduction or temporary discontinuance of statin therapy may be prudent in patients with muscle discomfort and/or weakness in the presence of progressive elevation of CK concentrations on serial measurements.

Temporarily withhold or discontinue atorvastatin therapy in any patient experiencing an acute or serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (e.g., severe acute infection; hypotension; major surgery; trauma; severe metabolic, endocrine, or electrolyte disorders; uncontrolled seizures).¹ Initiate IV hydration therapy (in a hospital setting) in patients experiencing rhabdomyolysis as needed.

General Precautions

Role as Adjunct Therapy

Prior to institution of antilipemic therapy, vigorously attempt to control serum cholesterol by appropriate dietary regimens, weight reduction, exercise, and treatment of any underlying disorder that might be the cause of lipid abnormality.¹

Renal Effects

NLA recommends performing renal function tests prior to initiating statin therapy; routine monitoring of S_cr and proteinuria is not necessary. If S_cr is elevated in the absence of rhabdomyolysis, may continue statin therapy but dosage adjustment may be necessary per labeling recommendations. If unexpected proteinuria develops, determine etiology; may continue therapy but dosage adjustment may be necessary per labeling recommendations.

Peripheral Neuropathy

If manifestations of peripheral neuropathy occur, NLA recommends evaluating patient to rule out secondary causes (e.g., diabetes mellitus, renal impairment, alcohol abuse, vitamin B₁₂ deficiency, cancer, hypothyroidism, acquired immunodeficiency syndrome [AIDS], Lyme disease, heavy metal intoxication). If a secondary cause is not identified, discontinue statin therapy for 3–6 months.

If neurologic manifestations improve over this period, a presumptive diagnosis of statin-induced peripheral neuropathy may be made; however, consider reinitiating therapy with a different statin and dosage.

If neurologic manifestations do not improve during period of discontinuance, reinitiate statin therapy, taking into consideration the risks and benefits of such therapy.

CNS Effects

CNS vascular lesions, characterized by perivascular hemorrhages, edema, and mononuclear cell infiltration of perivascular spaces, have been observed in animals with other statins.¹

If manifestations of impaired cognition occur, NLA recommends evaluating patient to rule out secondary causes. If a secondary cause is not identified, discontinue statin therapy for 1–3 months. If no improvement, reinitiate statin therapy, taking into consideration the risks and benefits of such therapy.

Ocular Effects

Optic nerve degeneration observed in animals with other statins.¹

Use of Fixed Combinations

When atorvastatin is used in fixed combination with amlodipine, consider cautions, precautions, contraindications, and interactions associated with amlodipine.⁶⁵ Consider cautionary information applicable to specific populations (e.g., pregnant or nursing women, individuals with hepatic or renal impairment, geriatric patients) for each drug in the fixed combination.⁶⁵

Specific Populations

Pregnancy

Category X.^{1 65} (See Contraindications and also see Fetal/Neonatal Morbidity and Mortality, under Cautions.)

Lactation

Atorvastatin is distributed into milk in animals; may distribute into milk in humans.¹ Use not recommended.¹

Pediatric Use

Safety and efficacy of atorvastatin not established in prepubertal children or in children <10 years of age.¹ Advise adolescent girls to use effective and appropriate contraceptive methods during therapy to reduce the likelihood of unintended pregnancy.¹

Safety and efficacy of atorvastatin in fixed combination with amlodipine not established in children.⁶⁵

Geriatric Use

Mean reductions in LDL-cholesterol concentrations with atorvastatin therapy were slightly higher in patients ≥65 years of age compared to younger adults.¹ However, no clinically relevant differences in laboratory abnormalities or rates of discontinuance were reported.¹ Caution in patients (particularly women) of advanced age (especially >80 years of age) and in those with small body frame and frailty.

Safety and efficacy of atorvastatin in fixed combination with amlodipine not established in geriatric patients.⁶⁵

Hepatic Impairment

Use atorvastatin with caution in patients who consume substantial amounts of alcohol and/or have a history of liver disease.¹

Atorvastatin is contraindicated in patients with active liver disease or unexplained, persistent increases in liver function test results.¹

Renal Impairment

Atorvastatin dosage modification is not necessary in patients with renal impairment.¹

Atorvastatin not studied in patients with end-stage renal disease; hemodialysis not expected to substantially enhance clearance of the drug.¹

Common Adverse Effects

Atorvastatin: GI disturbances (e.g., constipation, flatulence, dyspepsia, abdominal pain, diarrhea), headache, infection, sinusitis, myalgia, arthralgia, accidental injury, back pain, flu syndrome, asthenia, allergic reaction (e.g., rash), pharyngitis.¹

Interactions for Atorvastatin Calcium

The following information addresses potential interactions with atorvastatin. When atorvastatin is used in fixed combination with amlodipine, consider interactions associated with amlodipine.⁶⁵

Atorvastatin is metabolized by CYP3A4 but has no CYP3A4 inhibitory activity.¹

Drugs Affecting Hepatic Microsomal Enzymes

Inhibitors of CYP3A4: Potential pharmacokinetic interaction (variable increases in plasma atorvastatin concentrations); increased risk of myopathy.¹ Carefully monitor patients for manifestations of unexplained muscle pain, tenderness, or weakness, particularly following initiation of atorvastatin therapy or an increase in dosage of either drug.¹ (See Specific Drugs under Interactions.)

Inducers of CYP3A4: Potential pharmacokinetic interaction (variable reductions in plasma atorvastatin concentrations).¹ (See Specific Drugs under Interactions.)

Specific Drugs

Drug	Interaction	Comments
Amlodipine	Modest increase in atorvastatin exposure1	Not clinically relevant1
Antacids	Decreased plasma atorvastatin concentrations1
Anticoagulants, oral (e.g., warfarin)	Pharmacologic interaction (e.g., increased PT) unlikely1
Azole antifungals	Itraconazole: 2.5 to threefold increase in atorvastatin AUC1 Increased risk of myopathy1	Consider using lower initial and maintenance dosages of atorvastatin1
Bile acid sequestrants	Decreased plasma atorvastatin concentrations1	Administer statins ≥1 hour before or at least 2–4 hours after the resin
Cyclosporine	8.7-fold increase in atorvastatin AUC; increased risk of myopathy and/or rhabdomyolysis1	Carefully monitor patients for manifestations of unexplained muscle pain, tenderness, or weakness, particularly following initiation of atorvastatin therapy or an increase in dosage1 Atorvastatin dosage should not exceed 10 mg daily1
Digoxin	Increased plasma digoxin concentrations1	Monitor appropriately1
Diltiazem	Increased plasma atorvastatin concentrations1
Efavirenz	Possible variable reductions in plasma atorvastatin concentrations1
Fibric acid derivatives	Increased risk of myopathy1 Fenofibrate: Decreased or increased AUC of atorvastatin reported72	Concomitant use generally should be avoided;1 if used concomitantly, initiate atorvastatin at low or moderate dosages and consider using lower maintenance dosages of atorvastatin1
Grapefruit juice (particularly >1.2 L daily)1	Increased bioavailability of atorvastatin
HIV protease inhibitors (combination of ritonavir plus saquinavir, combination of lopinavir plus ritonavir)	Combination of ritonavir plus saquinavir: Threefold increase in atorvastatin AUC and increased risk of myopathy1 Combination of lopinavir plus ritonavir: 5.9-fold increase in atorvastatin AUC and increased risk of myopathy1	Carefully monitor patients for manifestations of unexplained muscle pain, tenderness, or weakness, particularly following initiation of atorvastatin therapy or an increase in dosage of either drug1 Consider using lower initial and maintenance dosages of atorvastatin1 In patients receiving the combination of ritonavir and saquinavir, or the combination of lopinavir and ritonavir, use of atorvastatin dosages >20 mg daily requires appropriate clinical assessment to ensure that the lowest effective dosage is employed1
Macrolide antibiotics (i.e., clarithromycin, erythromycin)	Clarithromycin: 4.4-fold increase in atorvastatin AUC and increased risk of myopathy1 Erythromycin: Increased plasma atorvastatin concentrations and increased risk of myopathy1	Carefully monitor patients for manifestations of unexplained muscle pain, tenderness, or weakness, particularly following initiation of atorvastatin therapy and an increase in dosage of either drug1 Consider using lower initial and maintenance dosages of atorvastatin1 In patients receiving clarithromycin, use of atorvastatin dosages >20 mg daily requires appropriate clinical assessment to ensure that the lowest effective dosage is employed1
Niacin (antilipemic dosages)	Increased risk of myopathy1	Use low dosages of niacin and carefully monitor patients for manifestations of unexplained muscle pain, tenderness, or weakness, particularly following initiation of atorvastatin therapy or an increase in dosage of either drug1 Consider using lower initial and maintenance dosages of atorvastatin1
Oral contraceptives	Increased bioavailability of norethindrone and ethinyl estradiol1	Caution when selecting an oral contraceptive1
Rifampin	Possible variable reductions in plasma atorvastatin concentrations1 2	Administer simultaneously, because delayed administration of atorvastatin following administration of rifampin associated with substantial reductions in plasma atorvastatin concentrations1

Atorvastatin Calcium Pharmacokinetics

Absorption

Bioavailability

Atorvastatin is rapidly absorbed following oral administration; undergoes extensive first-pass metabolism in the liver.¹

Peak plasma atorvastatin concentrations are attained at 1–2 hours.¹

Absolute bioavailability of atorvastatin is 14%.¹

Evening administration of atorvastatin is associated with a decrease in the extent of absorption;¹ however, antilipemic activity remains unchanged.¹

Onset

A therapeutic response to atorvastatin usually is apparent within 2 weeks; maximal response occurs within 4 weeks.¹

Food

Food decreases rate and extent of absorption of atorvastatin but does not alter antilipemic effects.¹

Distribution

Extent

Statins are distributed mainly to the liver.

Atorvastatin distributes into milk in animals; may distribute into human milk.¹

Plasma Protein Binding

Atorvastatin: About 98% (principally albumin).¹

Elimination

Metabolism

Atorvastatin is extensively metabolized in the liver,¹ mainly by CYP3A4,¹ to active metabolites.¹

Elimination Route

Atorvastatin is excreted principally in feces; <2% of a dose excreted in urine.¹

Half-life

Atorvastatin: 14 hours.¹

Special Populations

Increased plasma atorvastatin concentrations in patients with hepatic impairment (Child-Pugh class A and B).¹

Stability

Storage

Oral

Tablets

Atorvastatin: 20–25°C.¹

Atorvastatin/amlodipine fixed combination: 25°C (may be exposed to 15–30°C).⁶⁵

ActionsActions

• 
  

  Atorvastatin inhibits HMG-CoA reductase, causing subsequent reduction in hepatic cholesterol synthesis.¹ Reduces serum concentrations of total cholesterol, LDL-cholesterol, VLDL-cholesterol, apo B, and triglycerides.¹

  
  


• 
  

  Statins may slow progression of and/or induce regression of atherosclerosis in coronary and/or carotid arteries; modulate BP in hypercholesterolemic patients with hypertension; and possess anti-inflammatory activity.

  
  

Advice to Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

• 
  

  When atorvastatin is used in fixed combination with amlodipine, importance of informing patients of important cautionary information about amlodipine.⁶⁵

  
  


• 
  

  Importance of informing patients about risks, especially rhabdomyolysis, associated with statins alone or combined with other drugs.¹ Importance of patients promptly reporting muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever;¹ brown urine; and flu-like symptoms.

  
  


• 
  

  Importance of adhering to nondrug therapies and measures, including dietary management, weight control, physical activity, and management of potentially contributory disease (e.g., diabetes mellitus).

  
  


• 
  

  Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.¹ Necessity for clinicians to advise women and adolescent girls to avoid pregnancy (i.e., using effective and appropriate contraceptive methods) during therapy and to advise pregnant women of risk to fetus.¹

  
  


• 
  

  Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.¹

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Atorvastatin Calcium

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	10 mg (of atorvastatin)	Lipitor	Pfizer
		20 mg (of atorvastatin)	Lipitor	Pfizer
		40 mg (of atorvastatin)	Lipitor	Pfizer
		80 mg (of atorvastatin)	Lipitor	Pfizer

Atorvastatin Calcium Combinations

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	10 mg (of atorvastatin) with Amlodipine Besylate 2.5 mg (of amlodipine)	Caduet	Pfizer
		10 mg (of atorvastatin) with Amlodipine Besylate 5 mg (of amlodipine)	Caduet	Pfizer
		10 mg (of atorvastatin) with Amlodipine Besylate 10 mg (of amlodipine)	Caduet	Pfizer
		20 mg (of atorvastatin) with Amlodipine Besylate 2.5 mg (of amlodipine)	Caduet	Pfizer
		20 mg (of atorvastatin) with Amlodipine Besylate 5 mg (of amlodipine)	Caduet	Pfizer
		20 mg (of atorvastatin) with Amlodipine Besylate 10 mg (of amlodipine)	Caduet	Pfizer
		40 mg (of atorvastatin) with Amlodipine Besylate 2.5 mg (of amlodipine)	Caduet	Pfizer
		40 mg (of atorvastatin) with Amlodipine Besylate 5 mg (of amlodipine)	Caduet	Pfizer
		40 mg (of atorvastatin) with Amlodipine Besylate 10 mg (of amlodipine)	Caduet	Pfizer
		80 mg (of atorvastatin) with Amlodipine Besylate 5 mg (of amlodipine)	Caduet	Pfizer
		80 mg (of atorvastatin) with Amlodipine Besylate 10 mg (of amlodipine)	Caduet	Pfizer

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Caduet 10-10MG Tablets (PFIZER U.S.): 30/$150.98 or 90/$425.98

Caduet 10-20MG Tablets (PFIZER U.S.): 30/$203.99 or 90/$587.94

Caduet 10-40MG Tablets (PFIZER U.S.): 30/$204.98 or 90/$584.95

Caduet 10-80MG Tablets (PFIZER U.S.): 30/$214.99 or 90/$584.95

Caduet 2.5-10MG Tablets (PFIZER U.S.): 30/$153.25 or 90/$443.91

Caduet 2.5-20MG Tablets (PFIZER U.S.): 30/$205.98 or 90/$589.96

Caduet 2.5-40MG Tablets (PFIZER U.S.): 30/$186 or 90/$532.75

Caduet 5-10MG Tablets (PFIZER U.S.): 30/$155 or 90/$434.97

Caduet 5-20MG Tablets (PFIZER U.S.): 30/$205.98 or 90/$584.95

Caduet 5-40MG Tablets (PFIZER U.S.): 30/$204.98 or 90/$584.95

Caduet 5-80MG Tablets (PFIZER U.S.): 30/$204.98 or 90/$584.95

Lipitor 10MG Tablets (PFIZER U.S.): 30/$109.99 or 90/$309.97

Lipitor 20MG Tablets (PFIZER U.S.): 30/$149.99 or 90/$435.97

Lipitor 40MG Tablets (PFIZER U.S.): 30/$149.99 or 90/$435.97

Lipitor 80MG Tablets (PFIZER U.S.): 30/$149.99 or 90/$435.97

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions January 2010. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Parke-Davis. Lipitor (atorvastatin calcium) tablets prescribing information. New York, NY; 2007 Nov.

2. Parke-Davis. Lipitor formulary information. Morris Plains, NJ; 1997 Feb.

3. Blum C. Comparison of properties of four inhibitors of 3-hydroxy-3-methylglutaryl coenzyme A reductase. Am J Cardiol. 1994;73:3D-11D.

4. Malinowski J. Atorvastatin: A hydroxymethylglutaryl-coenzyme A reductase inhibitor. Am J Health-Syst Pharm. 1998;55(1):2253-2267.

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