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Lipitor prescribing information

 



Full prescription information or package insert for Lipitor

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Lower the “bad” cholesterol with Lipitor

Atorvastatin, known as Lipitor and sold by Pfizer, is a member of the statins drug class, used to lower blood cholesterol, to lower the risk of stroke, heart attack and other complications in people with type 2 diabetes and risk factors such as diabetic eye or kidney problems, smoking or high blood pressure, coronary heart disease, certain types of heart surgery, chest pain in patients who have heart disease or other risk factors. As it is a statin, atorvastatin works by inhibiting HMG-CoA reductase, an enzyme found in liver tissue that plays a key role in production of cholesterol in the body.

To be more clear, there are two types of cholesterol: a “bad” one called low density lipoprotein (LDL), which is deposited in the arteries and increases the risks of heart desease by clogging and narrowing the arteries (atherosclerosis), and a “good” one called high density lipoprotein (HDL) which actually prevents atherosclerosis.

People with a high level of “bad” cholesterol usually have no symptoms, so if you have cholesterol you may not know it and you can be at risk even if you feel fine. You can check if your cholesterol is higher than normal by having a simple blood test which will help you and your doctor to learn about your diseases. Statistics show that 80% of people who have had a heart attack had a high cholesterol as well, so you should not put off checking your level of LDL as you can be at a higher risk. Helmut Steinberg, M.D, assistant professor of medicine at Indiana University School of Medicine, Indianapolis says that “The risk for cardiovascular disease is continuous -- there's no break point where you have no risk and suddenly you have it" so you should consider having a simple blood test regularly. If your doctor says that you have a high cholesterol the first step is to make meaningful changes in your diet and to exercise. Usually diet and exercise are not enough for 2 out of 3 people so you should use them along with cholesterol-lowering drugs such as Lipitor, which is clinically proven to reduce the level of cholesterol by 39% to 60%, depending on dose. Atorvastatin causes a small decrease in the production of triglycerides (bad fats in the blood) and a small increase in the level of HDL cholesterol.

Atorvastatin tablets are sold by Pfizer under the trade name Lipitor, in white, elliptical, and film-coated tablets (10, 20, 40 or 80 mg) for oral administration. They recommen to patients to not break tablets in half to take half-doses, even when this is recommended by their doctors. In some contries, Lipitor is produced by other drug factories under trade names such as Atoris, Atorlip, Lipvas, Sortis, Torvast, Torvacard, Totalip, and Tulip.

The human body usually produces more cholesterol at night so Lipitor is generaly more effective if taken at night. It is used in adults and children who are at least ten years old to reduce total cholesterol, LDL-C, apo-B, triglycerides levels, increase HDL levels. It is also used to reduce the risk of cardiovascular events such as heart attacks, stokes or needing a bypass surgery. Lipitor has also been used in the treatment of combined hyperlipidemia, which is the most common inherited lipid disorder, occurring in approximately one in two hundred persons. Before taking this drug you must discuss with your doctor about it and you must tell him about all the medicines you currently take because there are many other drugs that can increase your risk of serious medical problems if you take them together with Lipitor, about your history of liver and kidney diseases, if you have diabetes or a thyroid disorder or if you drink more than two alcoholic beverages a day. Also you should continue to follow a cholesterol-lowering diet during treatment with this medicine. It is recommended that you avoid drinking excessive amounts of alcohol and grapefruit juice while taking this medicine. Grapefruit juice usually affects the metabolism of atovastatin and increases the amount of medicine in your blood, thus increasing the risk of side effects.

You should take Lipitor with caution if you are aged over 70 year, if you have a decreased liver or kidney function, history of liver disease or under-active thyroid gland, if you drink large amounts of alcohol, if you have personal or family history of hereditary muscle disorder or if you have recently had a hemorrhaging stoke.

Do not take Lipitor if you are allergic to atorvastatin, if you are pregnant or breast-feeding or if you have liver disease. If you become pregnant tell your doctor right away and stop taking Lipitor as soon as possible. Since Lipitor is totally contraindicated in pregnancy, it is not recommended that nursing mothers take atorvastatin because of the possibility of adverse reactions in nursing infants. Because this medicine may cause liver problems, your doctor will want you to have a liver function test before starting the treatment and through it. If you develop unexplained itching, yellowing of the skin of the eyes, unusually dark urine, nausea of vomiting, abdominal pains, loss of appetite or flu-like symptoms contact your doctor immediately because these can be a sign of a liver problem. Furthermore, if you take Lipitor, tell your doctor if you feel any new muscle pain or weakness because this could be a sign of rare but serious muscle side effects. Common side effects are diarrhea, upset stomach, muscle and joint pain, nose bleeds, headache, insomnia, dizziness, feeling of weakness, chest pain and changes in some blood tests. Uncommon side effects are vomiting, hair loss, weight gain, changes in blood sugar levels, pancreatitis and thrombocytopenia. There are also some rare and very rare side effects such as virtual disturbances, taste changes, hepatitis, muscle breakdown and fever. If you develop any of these side effects during the treatment with Lipitor consult your doctor immediately.

You must take Lipitor exactly as prescribed by your doctor and you must follow the directions on your prescription label. You should usually take this medicine once a day at the same day each day, with or without food. Also you must not break a Lipitor pill and you must inform your doctor if you have problem swallowing the pill. You may need to temporarily stop taking Lipitor if you have uncontrolled seizures, an electrolyte imbalance, severely low blood pressure, a severe infection or illness or a surgery or a medical emergency. If you miss a dose take it as soon as you remember, but if there are less than 12 hours until the next dose skip it and do not take extra medicine to make up the missed on.

Please remember that Lipitor is only part of a complete program of treatment that also includes diet, exercise, and weight control, which you should follow closely. You may need to take Lipitor on a long-term basis for the treatment of high cholesterol so it is highly recommended to store it at room temperature away from moisture, heat, and light.

References:

Drugs.com. What is Lipitor? (2010) [Online source] available from drugs.com/lipitor.html>

Lipitor.com. Lipitor dosing information (2011) [Online source] available from lipitor.com/aboutLipitor/dosingInformation.aspx>

Netdoctor.co.uk. Lipitor (atorvastatin). (2010) [Online source] available from netdoctor.co.uk/medicines/100001508.html>

Pslgroup.com.People With Cholesterol In High Normal Range Have Blood Vessel Abnormality (1997). [Online source] available from pslgroup.com/dg/46172.htm>

Wikipedia.com.Atorvastatin (2011). [Online source] available from

Hermann, M; Bogsrud, MP; Molden, E; ?sberg, A; Mohebi, BU; Ose, L; Retterstol, K (June 2006). "Exposure of atorvastatin is unchanged but lactone and acid metabolites are increased several-fold in patients with atorvastatin-induced myopathy". Clin Pharmacol Ther 79 (6): 532–9

McCrindle, BW; Ose, L; Marais, AD (July 2003). "Efficacy and safety of atorvastatin in children and adolescents with familial hypercholesterolemia or severe hyperlipidemia: a multicenter, randomized, placebo-controlled trial". J Pediatr 143 (1): 74–80

Villa, J; Pratley, RE (June 2010). "Ezetimibe/simvastatin or atorvastatin for the treatment of hypercholesterolemia in patients with the metabolic syndrome: the VYMET study". Curr Diab Rep 10(3): 173–5


2010 Jun;12(6):396-406.
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Predicted coronary heart disease risk reduction and dual blood pressure/cholesterol goal attainment in patients with hypertension treated in real-world clinical practice.


2010 Jun 29. [Epub ahead of print]
Krysiak R, Gdula-Dymek A, Bachowski R, Okopien B.
From the Department of Internal Medicine and Clinical Pharmacology, Medical University of Silesia, Katowice, Poland

PLEIOTROPIC EFFECTS OF ATORVASTATIN AND FENOFIBRATE IN METABOLIC SYNDROME AND DIFFERENT TYPES OF PREDIABETES.


2010 Jun 28;10(1):55. [Epub ahead of print]
Huang HW, He SW, Tan SQ, Su LL.

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2010 Jul 1;27(7):589-96. doi: 10.2165/11537330-000000000-00000.
Geleedst-De Vooght M, Maitland-van der Zee AH, Schalekamp T, Mantel-Teeuwisse A, Jansen P.
Lusse Pharmacy, Utrecht, the Netherlands.

Statin prescribing in the elderly in the Netherlands: a pharmacy database time trend study.


2010 Jun 24. [Epub ahead of print]
Arnaboldi L, Corsini A.
Department of Pharmacological Sciences, Faculty of Pharmacy, Universit? degli Studi di Milano, Milan, Italy.

Do structural differences in statins correlate with clinical efficacy?


2010 Jul 1;51(1):1-11.
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Unidad de Investigaci?n Sanitaria de Gipuzkoa Oeste, Hospital Alto Deba, 20500 Mondragon Arrasate, Espa?a.

[Cost-effectiveness analysis of using high doses of atorvastatin for the secondary stroke prevention in Spain] [Article in Spanish]


2009 Jun;41(3):125-8.
Pareek A, Yeole PG, Tenpe CR, Chandurkar N, Payghan R.
Department of Medical Affairs and Clinical Research, Ipca Laboratories Ltd., 142 AB, Kandivli Industrial Estate, Kandivli (West), Mumbai - 400 067, India.

Effect of atorvastatin and hydroxychloroquine combination on blood glucose in alloxan-induced diabetic rats.


2009 Dec;(4):119-30.
Declerck E, De Loof H, De Meyer GR.
Laboratoire de Pharmacologie, Universit? d'Anvers, Campus Drie Eiken, Universiteitsplein 1, Antwerpen, Wilrijk.

[Statins under fire: justified or not?] [Article in French]


2009 Dec;31(12):2894-9.
Kelesidis T, Kelesidis I.
Department of Medicine, Caritas Saint Elizabeth's Medical Center, Tufts University School of Medicine Boston, Massachusetts 02135, USA.

Unexplained high fever in an elderly patient treated with clonidine, duloxetine, and atorvastatin.


2009 Dec;31(12):2824-38.
Davidson MH, Rooney MW, Drucker J, Eugene Griffin H, Oosman S, Beckert M; LCP-AtorFen Investigators.
The University of Chicago, Pritzker School of Medicine, Chicago, Illinois, USA.

Efficacy and tolerability of atorvastatin/fenofibrate fixed-dose combination tablet compared with atorvastatin and fenofibrate monotherapies in patients with dyslipidemia: a 12-week, multicenter, double-blind, randomized, parallel-group study.


2009 Aug 25;89(32):2240-4.
Han YL, Zhang ZL, Li Y, Wang SL, Jing QM, Wang ZL, Wang DM.
Department of Cardiology, Institute of Cardiovascular Diseases, Shenyang General Hospital of PLA ,Shenyang 110016, China.

[Comparison on long-term effects of atorvastatin or pravastatin combined with clopidogrel for patients undergoing coronary stenting: a randomized controlled trial] [Article in Chinese]


2008 Dec;28(12):1078-81.
Yang QY, Zhao LC.
The First Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou.

[Effect of yiqi wenyang huoxue recipe on bone marrow stem cells' mobilization and its influence on heart function in patients with myocardial infarction] [Article in Chinese]


2008 May-Jun;60(3):215-22.
Harikrishnan S, Rajeev E, Tharakan JA, Titus T, Ajit Kumar VK, Sivasankaran S, Krishnamoorthy KM, Nair K.
Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, Kerala, India.

Efficacy and safety of combination of extended release niacin and atorvastatin in patients with low levels of high density lipoprotein cholesterol.


2008 Oct;84(4):488-96.
Kalliokoski A, Backman JT, Kurkinen KJ, Neuvonen PJ, Niemi M.
Department of Clinical Pharmacology, University of Helsinki and Helsinki University Central Hospital, Helsinki, Finland.

Effects of gemfibrozil and atorvastatin on the pharmacokinetics of repaglinide in relation to SLCO1B1 polymorphism.


2008 Dec;118(12):747-55.
Hart RG.
Vascular Neurology, Department of Neurology, University of Texas Health Science Center, San Antonio, TX 78229, USA.

What's new in stroke? The top 10 studies of 2006-2008. Part II.


2008 Dec;30(12):2298-313.
Bonnet J, McPherson R, Tedgui A, Simoneau D, Nozza A, Martineau P, Davignon J; CAP Investigators.
H?pital du Haut-L?v?que, Pessac, France.

Comparative effects of 10-mg versus 80-mg Atorvastatin on high-sensitivity C-reactive protein in patients with stable coronary artery disease: results of the CAP (Comparative Atorvastatin Pleiotropic effects) study.


2007;60 Suppl 2:28-32.
Teplan V, Sch?ck O, Stollova M, Vitko S.
Department of Nephrology, Transplant Center, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.

Metabolic syndrome after renal transplantation.


2007;14(3):232-7.
Jankowski P, Loster M, Kawecka-Jaszcz K.

Ezetimibe: New perspectives in lipid lowering treatment.


2007 Dec;28(2):137-48.
Jurukovska-Nospal M, Arsova V, Levchanska J, Sidovska-Ivanovska B.
Institute for Heart Diseases, Clinical Centre, Skopje, Medical Faculty, Ss Cyril and Methodius University, Skopje, R.Macedonia

Effects of statins (atorvastatin) on serum lipoprotein levels in patients with primary hyperlipidemia and coronary heart disease.


2007;45(2):193-9.
Dobreanu M, Dobreanu D, Fodor A, Bacarea A.
Department of Clinical Biochemistry-Immunology, University of Medicine and Pharmacy, T?rgu Mure?, Romania.

Integrin expression on monocytes and lymphocytes in unstable angina short term effects of atorvastatin.


2007;47(4):37-40.
Pirkova AA, Samoĭlova EV, Ameliushkina VA, Kaminnyĭ AI, Titov VN, Prokazova NV, Naumov VG, Kucharchuk VV, Korotaeva AA.

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ScienceDaily (Nov. 18, 2009)

Prevalence of High LDL, or 'Bad' Cholesterol Levels Decreases in US


Biochim Biophys Acta. 2009 Oct 2.
Kappelle PJ, Dallinga-Thie GM, Dullaart RP; for the Diabetes Atorvastatin Lipid Intervention (DALI) study group.
Department of Endocrinology, University Medical Center Groningen, P.O. Box 30001 9700 RB Groningen, The Netherlands.

Atorvastatin treatment lowers fasting remnant-like particle cholesterol and LDL subfraction cholesterol without affecting LDL size in type 2 diabetes mellitus: Relevance for non-HDL cholesterol and apolipoprotein B guideline targets.

The extent to which atorvastatin treatment affects LDL size, LDL subfraction levels and remnant-like particle cholesterol (RLP-C) was determined in type 2 diabetes. We also compared LDL size and RLP-C in relation to guideline cut-off values for LDL cholesterol, non-HDL cholesterol and apolipoprotein (apo) B. Changes in LDL size and RLP-C were determined in fasting plasma from type 2 diabetic patients after 30 weeks administration of atorvastatin (10 mg daily, n=65; 80 mg daily, n=62) or placebo (n=58). LDL subfraction cholesterol was measured in 74 participants. Atorvastatin lowered LDL cholesterol, non-HDL cholesterol, triglycerides, apo B and RLP-C (P<0.001 for all at each dose) and LDL mean peak particle diameter remained unchanged. Atorvastatin treatment decreased cholesterol concentrations in all LDL subfractions (P<0.001 for each dose). RLP-C at follow-up was lower in those patients achieving the non-HDL cholesterol or the apo B guideline targets (P<0.01), but the LDL cholesterol cut-off value failed to discriminate. In conclusion, atorvastatin lowers fasting RLP-C and LDL subfraction cholesterol in diabetes. The proposed guideline cut-off levels for non-HDL cholesterol and apo B may be superior to the LDL cholesterol target in discriminating between higher and lower RLP-C levels.


Expert Rev Cardiovasc Ther. 2009 Oct;7(10):1231-43.
Paciaroni M, Bogousslavsky J.
Stroke Unit and Division of Cardiovascular Medicine, Universiy of Perugia, Santa Maria della Misericordia Hospital, Sant'Andrea delle Fratte, 06126 - Perugia, Italy.

Statins and stroke prevention.


J Clin Hypertens (Greenwich). 2009 Oct;11(10):585-93.
Ferdinand KC, Flack JM, Saunders E, Victor R, Watson K, Kursun A, Jamieson MJ, Shi H.
Association of Black Cardiologists, Atlanta, GA 30349, USA.

Amlodipine/Atorvastatin single-pill therapy for blood pressure and lipid goals in African Americans: influence of the metabolic syndrome and type 2 diabetes mellitus.


Circ J. 2009 Oct 13.
Ji Q, Mei Y, Wang X, Sun Y, Feng J, Cai J, Xie S, Chi L.
Department of Thoracic Cardiovascular Surgery, Tongji Hospital, Tongji University.

Effect of Preoperative Atorvastatin Therapy on Atrial Fibrillation Following Off-Pump Coronary Artery Bypass Grafting.


Perfusion. 2009 Oct 20.
Kurban S, Mehmetoglu I, Ege E.
Department of Biochemistry, Meram Faculty of Medicine, University of Selcuk, Konya, Turkey.

Effect of preoperative atorvastatin therapy on paraoxonase activity and oxidative stress after coronary artery bypass grafting.


Int J Impot Res. 2009 Oct 29.
Dadkhah F, Safarinejad MR, Asgari MA, Hosseini SY, Lashay A, Amini E.
Department of Urology, Shahid Modarress Hospital, Shahid Beheshti University (MC), Tehran, Iran.

Atorvastatin improves the response to sildenafil in hypercholesterolemic men with erectile dysfunction not initially responsive to sildenafil.


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