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Questions & Answers

Side Effects & Adverse Reactions

Liver Dysfunction

HMG-CoA reductase inhibitors, like some other lipid-lowering therapies, have been associated with biochemical abnormalities of liver function. Persistent elevations (>3 times the upper limit of normal [ULN] occurring on 2 or more occasions) in serum transaminases occurred in 0.7% of patients who received atorvastatin in clinical trials. The incidence of these abnormalities was 0.2%, 0.2%, 0.6%, and 2.3% for 10, 20, 40, and 80 mg, respectively.

One patient in clinical trials developed jaundice. Increases in liver function tests (LFT) in other patients were not associated with jaundice or other clinical signs or symptoms. Upon dose reduction, drug interruption, or discontinuation, transaminase levels returned to or near pretreatment levels without sequelae. Eighteen of 30 patients with persistent LFT elevations continued treatment with a reduced dose of atorvastatin.

It is recommended that liver function tests be performed prior to and at 12 weeks following both the initiation of therapy and any elevation of dose, and periodically (e.g., semiannually) thereafter. Liver enzyme changes generally occur in the first 3 months of treatment with atorvastatin. Patients who develop increased transaminase levels should be monitored until the abnormalities resolve. Should an increase in ALT or AST of >3 times ULN persist, reduction of dose or withdrawal of atorvastatin is recommended.

Atorvastatin should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of liver disease. Active liver disease or unexplained persistent transaminase elevations are contraindications to the use of atorvastatin (see CONTRAINDICATIONS).

Skeletal Muscle

Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with atorvastatin and with other drugs in this class.

Uncomplicated myalgia has been reported in atorvastatin-treated patients (see ADVERSE REACTIONS). Myopathy, defined as muscle aches or muscle weakness in conjunction with increases in creatine phosphokinase (CPK) values >10 times ULN, should be considered in any patient with diffuse myalgias, muscle tenderness or weakness, and/or marked elevation of CPK. Patients should be advised to report promptly unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever. Atorvastatin therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected.

The risk of myopathy during treatment with drugs in this class is increased with concurrent administration of cyclosporine, fibric acid derivatives, erythromycin, clarithromycin, combination of ritonavir plus saquinavir or lopinavir plus ritonavir, niacin, or azole antifungals. Physicians considering combined therapy with atorvastatin and fibric acid derivatives, erythromycin, clarithromycin, a combination of ritonavir plus saquinavir or lopinavir plus ritonavir, immunosuppressive drugs, azole antifungals, or lipid-modifying doses of niacin should carefully weigh the potential benefits and risks and should carefully monitor patients for any signs or symptoms of muscle pain, tenderness, or weakness, particularly during the initial months of therapy and during any periods of upward dosage titration of either drug. Lower starting and maintenance doses of atorvastatin should be considered when taken concomitantly with the aforementioned drugs (See DRUG INTERACTIONS). Periodic creatine phosphokinase (CPK) determinations may be considered in such situations, but there is no assurance that such monitoring will prevent the occurrence of severe myopathy.

Atorvastatin therapy should be temporarily withheld or discontinued in any patient with an acute, serious condition suggestive of a myopathy or having a risk factor predisposing to the development of renal failure secondary to rhabdomyolysis (e.g., severe acute infection, hypotension, major surgery, trauma, severe metabolic, endocrine and electrolyte disorders, and uncontrolled seizures).

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Prevention of Cardiovascular Disease

In adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low HDL-C, or a family history of early coronary heart disease, LIPITOR is indicated to:

  • Reduce the risk of myocardial infarction
  • Reduce the risk of stroke
  • Reduce the risk for revascularization procedures and angina

In patients with type 2 diabetes, and without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as retinopathy, albuminuria, smoking, or hypertension, LIPITOR is indicated to:

  • Reduce the risk of myocardial infarction
  • Reduce the risk of stroke

In patients with clinically evident coronary heart disease, LIPITOR is indicated to:

  • Reduce the risk of non-fatal myocardial infarction
  • Reduce the risk of fatal and non-fatal stroke
  • Reduce the risk for revascularization procedures
  • Reduce the risk of hospitalization for CHF
  • Reduce the risk of angina
Hypercholesterolemia

LIPITOR is indicated:

  • as an adjunct to diet to reduce elevated total-C, LDL-C, apo B, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson Types IIa and IIb);
  • as an adjunct to diet for the treatment of patients with elevated serum TG levels(Fredrickson Type IV);
  • for the treatment of patients with primary dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet;
  • to reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (eg, LDL apheresis) or if such treatments are unavailable;
  • as an adjunct to diet to reduce total-C, LDL-C, and apo B levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present:
    • a.LDL-C remains ≥ 190 mg/dL or
    • b.LDL-C remains ≥ 160 mg/dL and:
      • there is a positive family history of premature cardiovascular disease or
      • two or more other CVD risk factors are present in the pediatric patient

Therapy with lipid-altering agents should be a component of multiple-risk-factor intervention in individuals at increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol only when the response to diet and other nonpharmacological measures has been inadequate (see National Cholesterol Education Program (NCEP) Guidelines, summarized in Table 7).

TABLE 7. NCEP Treatment Guidelines: LDL-C Goals and Cutpoints for Therapeutic Lifestyle Changes and Drug Therapy in Different Risk Categories
Risk Category LDL-C Goal
(mg/dL)
LDL Level at Which to Initiate Therapeutic Lifestyle Changes (mg/dL) LDL Level at Which to Consider Drug Therapy (mg/dL)
*
CHD, coronary heart disease
Some authorities recommend use of LDL-lowering drugs in this category if an LDL-C level of < 100 mg/dL cannot be achieved by therapeutic lifestyle changes. Others prefer use of drugs that primarily modify triglycerides and HDL-C, e.g., nicotinic acid or fibrate. Clinical judgement also may call for deferring drug therapy in this subcategory.
Almost all people with 0–1 risk factor have 10-year risk <10%; thus, 10-year risk assessment in people with 0–1 risk factor is not necessary.
 CHD * or CHD risk equivalents
(10-year risk >20%)
 <100 ≥100 ≥130
(100–129: drug optional) †
 2+ Risk Factors
(10-year risk ≤20%)
 <130 ≥130 10-year risk 10%–20%: ≥130
10-year risk <10%: ≥ 160
 0–1 Risk factor ‡ <160 ≥160 ≥190
(160–189: LDL-lowering drug optional)

After the LDL-C goal has been achieved, if the TG is still ≥200 mg/dL, non-HDL-C (total-C minus HDL-C) becomes a secondary target of therapy. Non-HDL-C goals are set 30 mg/dL higher than LDL-C goals for each risk category.

Prior to initiating therapy with LIPITOR, secondary causes for hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, and alcoholism) should be excluded, and a lipid profile performed to measure total-C, LDL-C, HDL-C, and TG. For patients with TG <400 mg/dL (<4.5 mmol/L), LDL-C can be estimated using the following equation: LDL-C = total-C - (0.20 × [TG] + HDL-C). For TG levels >400 mg/dL (>4.5 mmol/L), this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation.

LIPITOR has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V).

The NCEP classification of cholesterol levels in pediatric patients with a familial history of hypercholesterolemia or premature cardiovascular disease is summarized below:

Category Total-C (mg/dL) LDL-C (mg/dL)
 Acceptable <170 <110
 Borderline 170–199 110–129
 High ≥200 ≥130

History

There is currently no drug history available for this drug.

Other Information

LIPITOR® (atorvastatin calcium) is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.

Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-β, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C33H34FN2O5)2Ca•3H2O and its molecular weight is 1209.42. Its structural formula is:

Chemical Structure

Atorvastatin calcium is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile, slightly soluble in ethanol, and freely soluble in methanol.

LIPITOR tablets for oral administration contain 10, 20, 40 or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate, USP; candelilla wax, FCC; croscarmellose sodium, NF; hydroxypropyl cellulose, NF; lactose monohydrate, NF; magnesium stearate, NF; microcrystalline cellulose, NF; Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide); polysorbate 80, NF; simethicone emulsion.

Lipitor Manufacturers


  • A-s Medication Solutions Llc
    Lipitor (Atorvastatin Calcium) Tablet, Film Coated [A-s Medication Solutions Llc]
  • Pharmakon, Llc
    Lipitor (Atorvastatin Calcium) Tablet, Film Coated [Pharmakon, Llc]
  • Rebel Distributors Corp
    Lipitor (Atorvastatin Calcium) Tablet, Film Coated [Rebel Distributors Corp]
  • Physicians Total Care, Inc
    Lipitor (Atorvastatin Calcium) Tablet, Film Coated [Physicians Total Care, Inc]
  • Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
    Lipitor (Atorvastatin Calcium) Tablet, Film Coated [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]
  • Pd-rx Pharmaceuticals, Inc.
    Lipitor (Atorvastatin Calcium Trihydrate) Tablet, Film Coated [Pd-rx Pharmaceuticals, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Lipitor (Atorvastatin Calcium Trihydrate) Tablet, Film Coated [Pd-rx Pharmaceuticals, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Lipitor (Atorvastatin Calcium Trihydrate) Tablet, Film Coated [Pd-rx Pharmaceuticals, Inc.]
  • Bryant Ranch Prepack
    Lipitor (Atorvastatin Calcium) Tablet, Film Coated [Bryant Ranch Prepack]
  • Bryant Ranch Prepack
    Lipitor (Atorvastatin Calcium) Tablet, Film Coated [Bryant Ranch Prepack]
  • Bryant Ranch Prepack
    Lipitor (Atorvastatin Calcium) Tablet, Film Coated [Bryant Ranch Prepack]
  • Bryant Ranch Prepack
    Lipitor (Atorvastatin Calcium) Tablet, Film Coated [Bryant Ranch Prepack]
  • Aphena Pharma Solutions – Tennessee, Llc
    Lipitor (Atorvastatin Calcium) Tablet, Film Coated [Aphena Pharma Solutions – Tennessee, Llc]
  • Remedyrepack Inc.
    Lipitor (Atorvastatin Calcium) Tablet, Film Coated [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Lipitor (Atorvastatin Calcium) Tablet, Film Coated [Remedyrepack Inc. ]
  • Cardinal Health
    Lipitor (Atorvastatin Calcium) Tablet, Film Coated [Cardinal Health]
  • Parke-davis Div Of Pfizer Inc
    Lipitor (Atorvastatin Calcium) Tablet, Film Coated [Parke-davis Div Of Pfizer Inc]

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