Lipitor blog at BlogSpot

Saturday, December 30, 2006

Where I can buy Lipitor?

Where can I get more information about Lipitor?

Your pharmacist has additional information about Lipitor written for health professionals that you may read.

What other drugs will affect Lipitor?

• Do not take Lipitor without first talking to your doctor if you are taking any of the following medicines:
· cyclosporine (Sandimmune, Neoral);
· gemfibrozil (Lopid), clofibrate (Atromid-S), or fenofibrate (Tricor);
· niacin (Nicolar, Nicobid, Slo-Niacin, others);
· erythromycin (E-Mycin, E.E.S., Ery-Tab, others) or clarithromycin (Biaxin);
· cholestyramine (Questran) or colestipol (Colestid);
· hormonal birth control (pills, patches, or implants); or
· an antifungal medication such as itraconazole (Sporanox), fluconazole (Diflucan), or ketoconazole (Nizoral).
• You may not be able to take Lipitor, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.
• Drugs other than those listed here may also interact with Lipitor. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

What are the possible side effects of Lipitor?

• Rare cases of muscle problems and liver problems have been associated with the use of Lipitor and other similar medicines. Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness, especially if accompanied by a fever or flulike symptoms or yellowing of the skin or eyes, abdominal pain, unexplained fatigue, dark colored urine or pale colored stools. These may be early symptoms of muscle or liver problems.
• If you experience any of the following serious side effects, stop taking Lipitor and seek emergency medical attention or contact your doctor immediately:
· an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
· decreased urine or rust-colored urine; or
· blurred vision.
• Other, less serious side effects may be more likely to occur. Continue to take Lipitor and talk to your doctor if you experience
· headache;
· upset stomach or flatulence; or
· a rash.
• Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What should I avoid while taking Lipitor?

• Alcohol and Lipitor can both be damaging to the liver. Alcohol should be used only in moderation. Discuss the use of alcohol with your doctor so that the potential for liver problems can be determined.
• Grapefruit and grapefruit juice may interact with Lipitor. The interaction could lead to potentially dangerous effects. Discuss the use of grapefruit and grapefruit juice with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.

What happens if I overdose?

• Seek emergency medical attention if an overdose is suspected.
• The symptoms of an Lipitor overdose are not known.

Studies Question Need for Some Users

Do you really need to take a cholesterol-lowering medication to prevent heart disease?

If you listen to what Pfizer — the world's largest drug company and manufacturer of Lipitor, the most common treatment for elevated cholesterol, the answer is YES.

But if you listen to researchers including a highly respected Harvard physician, the answer may be NO.

According to a national class-action lawsuit filed by a group of consumers, Pfizer misled consumers into using its anti-cholesterol drug Lipitor. The suit seeks to reimburse consumers for what it claims are the unnecessary costs consumers paid for the medication.

According to the lawsuit, Pfizer engaged in a massive advertising and promotional campaign to convince both doctors and patients that Lipitor is a beneficial treatment for nearly everyone with elevated cholesterol.

With sales skyrocketing to $10 billion in 2004 and an estimated 74% of sales coming from those for whom there is no evidence the drug is needed, the campaign worked.

Recently, a group of consumers filed the first-of-its-kind nationwide class-action lawsuit against Pfizer for misleading consumers into using its anti-cholesterol drug Lipitor.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

Pfizer may lose billions in Lipitor sales

Patent on world's top-selling drug cut short by 15 months in judge's ruling.

NEW YORK (CNNMoney.com) - Pfizer's basic patent on its top-selling drug Lipitor was upheld in federal court Wednesday, but a second, longer-running patent was ruled invalid, possibly eliminating billions of dollars in potential sales.

Pfizer, the world's biggest drugmaker, said the federal Court of Appeals ruled that the basic patent on Lipitor, the world's top-selling drug, is valid. This means that Pfizer has patent protection on the cholesterol-cutting drug until March of 2010.

But the court also ruled that Pfizer's second patent on Lipitor, which would have protected the drug until June of 2011, is invalid. This chops 15 months off the Pfizer patent, which is critical, considering that Lipitor sales totaled $12.2 billion in 2005. If Pfizer can't find a way to reverse the decision, the New York-based company could miss out on billions of dollars in potential sales.

Pfizer (Charts) stock fell about 1.5 percent in heavy New York Stock Exchange trading after the ruling.

Pfizer spokesman Bryant Haskins said his company has a "good case to make" in trying to reverse the decision.

"It was a highly technical conclusion that [focused on] the issue of how you draft a patent," said Haskins. He added that Pfizer would try to "correct some technicalities in the patent" with the patent office and, if that doesn't work, will seek a review in the Court of Appeals.

The ruling is the result of a patent infringement suit from Pfizer against Ranbaxy Laboratories Ltd., the Indian maker of generic drugs that filed an application with the Food and Drug Administration to produce a generic version of Lipitor. It's common for generic drugmakers like Ranbaxy to challenge the patents on blockbuster drugs to try and win the right to produce nonbranded versions.

When a drug company loses patent protection on a brand-name drug, the price plunges in the face of generic competition, and sales typically sink to a fraction of the original level.

"Effectively, this translates to generic competition from Ranbaxy 15 months earlier than was expected based upon the initial court decision, which we believes translates into a $1 hit to Pfizer's" stock, Barbara Ryan, analyst for Deutsche Bank North America, wrote in a note to clients after the ruling.

Les Funtleyder, analyst for Miller Tabak, said the problem is not an immediate one for Pfizer, which has nearly four years to address the issue before the patent that was upheld expires.

"It's a longer term potential negative; in the short term it probably won't change anything," said Funtleyder. "There are so many things that can happen between now and then for everybody in pharma. Pfizer could discover a cure for cancer. Anything could happen."

The analysts both said the timing of an experimental Pfizer drug combo that includes Lipitor is crucial to whether the patent ruling will affect future sales.

Pfizer is experimenting with a Lipitor combination drug that could potentially increase annual sales by billions of dollars. Pfizer wants to add Lipitor, which lowers LDL or "bad" cholesterol, with the experimental drug torcetrapib, which could raise HDL, or "good" cholesterol.

The timing of torcetrapib's potential release into the market is essential. If Pfizer can get the drug combo on the market before the Lipitor patent expires in 2010, that means it has a better chance of switching Lipitor users over to the new combination drug.

Pfizer believes the Lipitor-torcetrapib combo could be lucrative for the company.

The analysts interviewed for this story do not own Pfizer stock, but Deutsche Bank does.

How should I take Lipitor?

• Take Lipitor exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
• Take each dose with a full glass of water.
• Lipitor can be taken with or without food.
• Lipitor is usually taken once a day. Try to take your dose at the same time each day. Follow your doctor's instructions.
• Your doctor may want to monitor your liver function with blood tests before starting treatment with Lipitor, at twelve weeks after both the start of your treatment and any increase in dose, and periodically (every 6 months) thereafter. Depending on the results of these tests, your doctor can determine how much monitoring you will require.
• Grapefruit and grapefruit juice may interact with Lipitor. The interaction could lead to potentially dangerous effects. Discuss the use of grapefruit and grapefruit juice with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.
• Eat a low-fat, low-cholesterol diet. To realize beneficial effects from Lipitor, avoid fatty, high-cholesterol foods.
• It is important to take Lipitor regularly to get the most benefit.
• Do not stop taking Lipitor without first talking to your doctor. Lipitor may need to be taken on a long-term basis for the treatment of high cholesterol.
• Your doctor may want you to have blood tests or other medical evaluations during treatment with Lipitor to monitor progress and side effects.
• Store Lipitor at room temperature away from moisture and heat.

Lipitor

Atorvastatin (Lipitor) inhibition of cytokine-inducible nitric oxide synthase expression in native endothelial cells in situ.

Animal experimental studies have demonstrated that inducible nitric oxide synthase (iNOS) expression correlates with neointima formation and is prevented by HMG-CoA reductase inhibitors (statins). In the present study we have investigated the underlying mechanism of action of these drugs in isolated segments of the rat aorta. Western blot analysis and immunohistochemistry revealed that tumour necrosis factor alpha (TNFalpha) plus interferon-gamma (IFNgamma) synergistically induce iNOS gene expression in the endothelium but not in the smooth muscle of these segments while constitutive endothelial NO synthase (eNOS) abundance was markedly reduced. Pre-treatment with 1 - 10 microM Atorvastatin (Lipitor), cerivastatin or pravastatin decreased TNFalpha plus IFNgamma stimulated iNOS expression in the endothelium irrespective of the presence of the HMG-CoA reductase product mevalonate (400 microM). Electrophoretic mobility shift assay experiments confirmed that the combination of TNFalpha plus IFNgamma causes activation of the transcription factors STAT-1 and NF-kappaB in native endothelial cells. Neutralization of these transcription factors by employing the corresponding decoy oligonucleotides confirmed their involvement in TNFalpha plus IFNgamma stimulated iNOS expression. Translocation of both transcription factors was attenuated by Atorvastatin (Lipitor), and this effect was insensitive to exogenous mevalonate. The present findings thus demonstrate a specific HMG-CoA reductase-independent inhibitory effect of statins, namely Atorvastatin (Lipitor), on cytokine-stimulated transcription factor activation in native endothelial cells in situ and the subsequent expression of a gene product implicated in vascular inflammation. This effect may be therapeutically relevant and in addition provide an explanation for the reported rapid onset of action of these drugs in humans.

Effect of statins versus untreated dyslipidemia on serum uric acid levels in patients with coronary heart disease: a subgroup analysis of the GREek Atorvastatin (Lipitor) and Coronary-heart-disease Evaluation (GREACE) study.

BACKGROUND: Little is known about the effect of dyslipidemia on serum uric acid (SUA) levels, and less is known about the effect of statin treatment on them. The GREek Atorvastatin (Lipitor) and Coronary-heart-disease Evaluation study suggested that a mean Atorvastatin (Lipitor) dose of 24 mg/d achieves the National Cholesterol Educational Program treatment goals and significantly reduces morbidity and mortality in patients with coronary heart disease (CHD) in comparison to the usual care. Here, we report the time course of SUA levels in usual-care patients undertreated for their dyslipidemia (12% were administered statins) in comparison to structured-care patients treated with Atorvastatin (Lipitor) in the vast majority (98%). METHODS: Mean on-study SUA levels (up to 48 months) were compared with those at baseline by using analyses of variance to assess differences over time within and between treatment groups. Cox multivariate analysis was used to investigate whether changes in SUA levels during the study were clinically relevant. RESULTS: All patients had normal renal function at baseline; serum creatinine (SCr) levels less than 1.3 mg/dL (<115 micromol/L) and moderately elevated SUA levels (mean, 7.1 +/- 0.9 [SD] mg/dL [425 +/- 52 micromol/L]; upper normal limit, 7.0 mg/dL [415 micromol/L]). Usual-care patients (n = 800) showed an increase in SUA levels by 3.3% (P < 0.0001). Structured-care patients (n = 800) had an 8.2% reduction in SUA levels (P < 0.0001). In all patients not administered diuretics (n = 1,407), SUA level changes showed a positive correlation with changes in SCr levels (r = 0.82; P < 0.0001) and an inverse correlation with estimated glomerular filtration rate (r = -0.77; P < 0.0001). After adjustment for 19 predictors of all CHD-related events, Cox multivariate analysis involving backward stepwise logistic regression showed a hazard ratio (HR) of 0.89 (95% confidence interval [CI], 0.78 to 0.96; P = 0.03) with every 0.5-mg (30-micromol/L) reduction in SUA level, an HR of 0.76 (95% CI, 0.62 to 0.89; P = 0.001) with every 1-mg (60-micromol/L) reduction, an HR of 1.14 (95% CI, 1.03 to 1.27; P = 0.02) with every 0.5-mg increase, and an HR of 1.29 (95% CI, 1.17 to 1.43; P = 0.001) with every 1-mg increase in SUA levels. CONCLUSION: Data suggest that SUA level is an independent predictor of CHD recurrent events. Atorvastatin (Lipitor) treatment significantly reduces SUA levels in patients with CHD, thus offsetting an additional factor associated with CHD risk.

What should I discuss with my healthcare provider before taking Lipitor?

• Do not take Lipitor without first talking to your doctor if you have liver disease.
• Before taking Lipitor, tell your doctor if you
· drink alcoholic beverages,
· have a chronic muscular disease,
· require major surgery, or
· have a blood disorder.
• You may not be able to take Lipitor, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
• Lipitor is in the FDA pregnancy category X. This means that Lipitor is known to cause birth defects if it is taken during pregnancy. Do not take Lipitor if you are pregnant or could become pregnant during treatment.
• It is not known whether Lipitor passes into breast milk. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

LIPITOR ®

Lipitor ® (Atorvastatin) is used with diet changes - restriction of cholesterol and fat intake - to reduce the amount of cholesterol and certain fatty substances in your blood. Accumulation of cholesterol and fats along the walls of your arteries (a process known as atherosclerosis) decreases blood flow and, therefore, the oxygen supply to your heart, brain, and other parts of your body. Lowering your blood level of cholesterol and fats with Lipitor may help to prevent heart disease, angina (chest pain), strokes, and heart attacks.

Lipitor ® is the #1 prescribed cholesterol-lowering medicine prescribed in the U.S. and is manufactured by Pfizer Inc.

Chemical Name: Atorvastatin

Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.


Uses

Lipitor (Atorvastatin) is used with dietary changes (restriction of cholesterol and fat intake) to reduce the amount of cholesterol and certain fatty substances in your blood. Accumulation of cholesterol and fats along the walls of your arteries (a process known as atherosclerosis) decreases blood flow and, therefore, the oxygen supply to your heart, brain, and other parts of your body. Lowering your blood level of cholesterol and fats with Lipitor may help to prevent heart disease, angina (chest pain), strokes, and heart attacks.

How to take this medication

Lipitor (Atorvastatin) comes as a tablet to take by mouth. Lipitor usually is taken once a day. Follow the Lipitor directions on your Lipitor prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Lipitor/atorvastatin exactly as directed. Do not take more or less of Lipitor or take Lipitor more often than prescribed by your doctor.

Continue to take Lipitor (Atorvastatin) even if you feel well. Do not stop taking Lipitor/atorvastatin without talking to your doctor.

Eat a low-cholesterol, low-fat diet. This kind of diet includes cottage cheese, fat-free milk, fish (not canned in oil), vegetables, poultry, egg whites, and polyunsaturated oils and margarines (corn, safflower, canola, and soybean oils). Avoid foods with excess fat in them such as meat (especially liver and fatty meat), egg yolks, whole milk, cream, butter, shortening, lard, pastries, cakes, cookies, gravy, peanut butter, chocolate, olives, potato chips, coconut, cheese (other than cottage cheese), coconut oil, palm oil, and fried foods.

Side Effects

Although side effects from Lipitor are not common, they can occur. Tell your doctor if any of these symptoms are severe or do not go away: gas, stomach pain or cramps, diarrhea, constipation, heartburn, headache, blurred vision, dizziness, rash or itching, upset stomach If you experience any of the following symptoms, call your doctor immediately: muscle pain, tenderness, muscle cramps or weakness with or without a fever.

Precautions

Do not take Lipitor without first talking to your doctor if you have liver disease. Before taking Lipitor, tell your doctor if you have a chronic muscular disease, require major surgery, or have a blood disorder. Tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially antacids; antifungal medications such as itraconazole (Sporanox) and ketoconazole (Nizoral); digoxin (Lanoxin); erythromycin; medications that suppress the immune system such as cyclosporine (Neoral, Sandimmune); oral contraceptives (birth control pills); other cholesterol-lowering medications such as cholestyramine (Questran), colestipol (Colestid), gemfibrozil (Lopid), and niacin (nicotinic acid); and vitamins.

Lipitor is in the FDA pregnancy category X. This means that Lipitor is known to cause birth defects if it is taken during pregnancy. Do not take Lipitor if you are pregnant or could become pregnant during treatment. It is not known whether Lipitor passes into breast milk. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

Drug Interactions

Tell your doctor of all nonprescription and prescription medication you may use, especially: other nasal products, other corticosteroids (e.g., prednisone). Do not start or stop any medicine without doctor or pharmacist approval.

Overdose

If overdose is suspected, contact your local poison control center or emergency room immediately.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not "double-up" the dose to catch up.

Storage

Store at room temperature between 36 and 77 degrees F (2 -25 degrees C) away from light and moisture.

What is Lipitor?

• Lipitor is an HMG CoA reductase inhibitor. Lipitor blocks the production of cholesterol (a type of fat) in the body.
• Lipitor is used to reduce the amounts of LDL (bad) cholesterol, total cholesterol, triglycerides (another type of fat), and apolipoprotein B (a protein needed to make cholesterol) in your blood. Lipitor is also used to increase the level of HDL (good) cholesterol in your blood. These actions are important in reducing the risk of hardening of the arteries, which can lead to heart attacks, stroke, and peripheral vascular disease.
• Lipitor may also be used for purposes other than those listed in this medication guide.

LIPITOR - Atorvastatin

Lipitor Used For

Lipitor is prescribed as a diet supplement to reduce high levels of total-C, LDL-C, apo B, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia (high blood cholesterol levels). Lipitor is indicated to: Reduce the risk of myocardial infarction & reduce the risk for revascularization procedures and angina

Directions for Lipitor medication

The recommended starting dose of Lipitor is 10 or 20 mg once daily and can be taken at any time of the day with or without food. Patients with higher levels of LDL-C may be started on a 40 mg dosage if the doctor advises

How Lipitor drug works

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. half yearly) thereafter. Inform your doctor immediately if you believe that you are pregnant. Lipitor may cause birth defects or other problems in the baby. Check with your doctor immediately if you have unexplained muscle pain, tenderness, or weakness.

Side effects of Lipitor medication

Most common side effects include constipation, diarrhea, dizziness, gas, headache, heartburn, nausea, skin rash and stomach pain; however these side effects usually go away as the body adjusts to the medication. Fever, muscle aches or cramps, severe stomach pain, unusual tiredness or weakness may be less common side effects. Higher dosages of Lipitor may cause liver to function abnormally.

Other Lipitor Information

Other common brand names for HMG-COA reductase inhibitors: Altoprev, Lescol, Lipitor, Mevacor, Pravachol, Zocor.

What is the most important information I should know about Lipitor?

• Rare cases of muscle problems and liver problems have been associated with the use of Lipitor and other similar medicines. Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness, especially if accompanied by a fever or flulike symptoms or yellowing of the skin or eyes, abdominal pain, unexplained fatigue, dark colored urine or pale colored stools. These may be early symptoms of muscle or liver problems.
• Do not take Lipitor without first talking to your doctor if you have liver disease.
• Alcohol and Lipitor can both be damaging to the liver. Alcohol should be used only in moderation. Discuss the use of alcohol with your doctor so that the potential for liver problems can be determined.
• Do not take Lipitor if you are pregnant, could become pregnant during treatment, or if you are breast-feeding a baby.

Lipitor Side Effects

LIPITOR SIDE EFFECTS

Atorvastatin (Lipitor) is generally well-tolerated. Adverse reactions have usually been mild and transient. In controlled clinical studies of 2502 patients, <2% of patients were discontinued due to adverse experiences attributable to Atorvastatin (Lipitor). The most frequent adverse events thought to be related to Atorvastatin (Lipitor) were constipation, flatulence, dyspepsia, and abdominal pain.

Clinical Adverse Experiences

Adverse experiences reported in more than or equal to 2% of patients in placebo-controlled clinical studies of Atorvastatin (Lipitor), regardless of causality assessment, are shown in Table 1.

Table 1 Adverse Events in Placebo-Controlled Studies (% of Patients)
Atovastatin
Body System Placebo 10 mg 20 mg 40 mg 80 mg
Adverse EventN=270 N=863 N=36 N=79 N=94
Body as a Whole
Infection 10.0 10.3 2.8 10.1 7.4
Headache 7.0 5.4 16.7 2.5 6.4
Accidental Injury 3.7 4.2 0.0 1.3 3.2
Flu Syndrome 1.9 2.2 0.0 2.5 3.2
Abdominal Pain 0.7 2.8 0.0 3.8 2.1
Back Pain 3.0 2.8 0.0 3.8 1.1
Allergic Reaction 2.6 0.9 2.8 1.3 0.0
Asthenia 1.9 2.2 0.0 3.8 0.0
Digestive System
Constipation 1.8 2.1 0.0 2.5 1.1
Diarrhea 1.5 2.7 0.0 3.8 5.3
Dyspepsia 4.1 2.3 2.8 1.3 2.1
Flatulence 3.3 2.1 2.8 1.3 1.1
Respiratory System
Sinusitis 2.6 2.8 0.0 2.5 6.4
Pharyngitis 1.5 2.5 0.0 1.3 2.1
Skin And Appendages
Rash 0.7 3.9 2.8 3.8 1.1
Musculoskeletal System
Arthralgia 1.5 2.0 0.0 5.1 0.0
Myalgia 1.1 3.2 5.6 1.3 0.0

The following adverse events were reported, regardless of causality assessment in patients treated with Atorvastatin (Lipitor) in clinical trials. The events in italics occurred in >2% of patients and the events in plain type occurred in <2% of patients.

Body as a Whole: Chest pain, face edema, fever, neck rigidity, malaise, photosensitivity reaction, generalized edema.

Digestive System: Nausea, gastroenteritis, liver function tests abnormal, colitis, vomiting, gastritis, dry mouth, rectal hemorrhage, esophagitis. eructation, glossitis, mouth ulceration, anorexia, increased appetite, stomatitis, biliary pain, cheilitis, duodenal ulcer, dysphagia, enteritis, melena, gum hemorrhage, stomach ulcer, tenesmus, ulcerative stomatitis, hepatitis, pancreatitis, cholestatic jaundice.

Respiratory System: Bronchitis, rhinitis, pneumonia, dyspnea, asthma, epistaxis.

Nervous System: Insomnia, dizziness, paresthesia, somnolence, amnesia, abnormal dreams, libido decreased, emotional lability, incoordination, peripheral neuropathy, torticollis, facial paralysis, hyperkinesia, depression, hypesthesis, hypertonia.

Musculoskeletal System: Arthritis, leg cramps, bursitis, tenosynovitis, myasthenia, tendinous contracture, myositis.

Skin and Appendages: Pruritus, contact dermatitis, alopecia, dry skin, sweating, acne, urticaria, eczema, seborrhea, skin ulcer.

Urogenital System: Urinary tract infection, urinary frequency, cystitis, hematuria, impotence, dysuria, kidney calculus, nocturia, epididymitis, fibrocystic breast, vaginal hemorrhage, albuminuria, breast enlargement, metrorrhagia, nephritis, urinary incontinence, urinary retention, urinary urgency, abnormal ejaculation, uterine hemorrhage.

Special Senses: Amblyopia, tinnitus, dry eyes, refraction disorder, eye hemorrhage, deafness, glaucoma, parosmia, taste loss, taste perversion.

Cardiovascular System: Palpitation, vasodilatation, syncope, migraine, postural hypotension, phlebitis, arrhythmia, angina pectoris, hypertension.

Metabolic and Nutrtional Disorders: Peripheral edema, hyperglycemia, creatine phosphokinase increased, gout, weight gain, hypoglycemia.

Hemic and Lymphatic System: Ecchymosis, anemia, lymphadenopathy, thrombocytopenia, petechia.

Post Introduction Reports

Adverse events associated with Atorvastatin (Lipitor) that have been received since market introduction, that are not listed above, and that may have causal relationship to drug include the following: angioneurotic edema and rhabdomyolysis.

DRUG INTERACTIONS

The risk of myopathy during treatment with other drugs of this class is increased with concurrent administration of cyclosporine, fibric acid derivatives, niacin (nicotinic acid), erythromycin, azole antifungals.

Antacid: When Atorvastatin (Lipitor) and Maalox ?TC suspension were coadministered, plasma concentrations of Atorvastatin (Lipitor) decreased approximately 35%. However, LDL-C reduction was not altered.

Antipyrine: Because Atorvastatin (Lipitor) does not affect the pharmacokinetics of antipyrine, interactions with other drugs metabolized via the same cytochrome isozymes are not expected.

Colestipol: Plasma concentrations of Atorvastatin (Lipitor) decreased approximately 25% when colestipol and Atorvastatin (Lipitor) were coadministered. However, LDL-C reduction was greater when Atorvastatin (Lipitor) and colestipol were coadministered than when either drug was given alone.

Cimetidine: Atorvastatin (Lipitor) plasma concentrations and LDL-C reduction were not altered by coadministration of cimetidine.

Digoxin: When multiple doses of Atorvastatin (Lipitor) and digoxin were coadministered, steady-state plasma digoxin concentrations increased by approximately 20%. Patients taking digoxin should be monitored appropriately.

Erythromycin: In healthy individuals, plasma concentrations of Atorvastatin (Lipitor) increased approximately 40% with coadministratlon of Atorvastatin (Lipitor) and erythromycin, a known inhibitor of cytochrome P450 3A4.

Oral Contraceptives: Coadministration of Atorvastatin (Lipitor) and an oral contraceptive increased AUC values for norethindrone and ethinyl estradiol by approximately 30% and 20%. These increases should be considered when selecting an oral contraceptive for a woman taking Atorvastatin (Lipitor).

Warfarin: Atorvastatin (Lipitor) had no clinically significant effect on prothrombin time when administered to patients receiving chronic warfarin treatment.

Other Concomitant Therapy: In clinical studies, Atorvastatin (Lipitor) was used concomitantly with antihypertensive agents and estrogen replacement therapy without evidence of clinically significant adverse interactions. Interaction studies with specific agents have not been conducted.