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FDA pregnancy category X. Rhabdomyolysis and myopathy related to HMG-CoA reductase inhibitor use have been reported rarely. Of these, 2 patients also had a portacaval shunt and had no significant reduction in LDL-C. It is especially important to lower your cholesterol if you have heart disease, smoke, have diabetes or high blood pressure, are older, or if heart disease starts early in your family. The incidence of nonfatal hemorrhagic stroke was significantly higher in the atorvastatin group (38, 1.6%) as compared to the placebo group (16, 0.7%). 2.4 Concomitant Lipid-Lowering Therapy Lipitor may be used with bile acid resins. Diarrhea has lipitor website reported in up to 5.3% of patients and may be dose-related. If you lipitor website questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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lipitor website

In this double-blind, placebo-controlled study, patients were treated with anti-hypertensive therapy (Goal BP less than 140/90 mm Hg for non-diabetic patients; less than 130/80 mm Hg for diabetic patients) and allocated to either Lipitor 10 mg daily (n=5168) or placebo (n=5137), using a covariate adaptive method which took into account the distribution of nine baseline characteristics of patients already enrolled and minimized the imbalance of those characteristics across the groups. Rx Only Manufactured by Pfizer Ireland Pharmaceuticals Dublin, Ireland LAB-0348-4.0 June 2009 PRINCIPAL DISPLAY PANEL Lipitor®                  10 (atorvastatin calcium) tablets 10 mg Lipitor®                  20 (atorvastatin calcium) tablets 20 mg Lipitor®                  40 (atorvastatin calcium) tablets 40 mg Lipitor®                  80 (atorvastatin calcium) tablets 80 mg Lipitor  atorvastatin calcium  tablet, film coated Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 54868-4229 (0071-0157) Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATORVASTATIN CALCIUM (ATORVASTATIN) ATORVASTATIN CALCIUM 40 mg Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE   CANDELILLA WAX   CROSCARMELLOSE SODIUM   HYDROXYPROPYL CELLULOSE   LACTOSE MONOHYDRATE   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   HYPROMELLOSE   POLYETHYLENE GLYCOL   TALC   TITANIUM DIOXIDE   POLYSORBATE 80   Product Characteristics Color white Score no score Shape OVAL (elliptical) Size 15mm Flavor Imprint Code PD;157;40 Contains      Packaging # NDC Package Description Multilevel Packaging 1 54868-4229-0 30 TABLET In 1 BOTTLE None 2 54868-4229-1 90 TABLET In 1 BOTTLE None 3 54868-4229-2 15 TABLET In 1 BOTTLE None 4 54868-4229-3 45 TABLET In 1 BOTTLE None Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020702 07/06/2000 Lipitor  atorvastatin calcium  tablet, film coated Product Information Product Type HUMAN lipitor website DRUG NDC Product Code (Source) 54868-3946 (0071-0156) Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATORVASTATIN CALCIUM (ATORVASTATIN) ATORVASTATIN CALCIUM 20 mg Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE   CANDELILLA WAX   CROSCARMELLOSE SODIUM   HYDROXYPROPYL CELLULOSE   LACTOSE MONOHYDRATE   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   HYPROMELLOSE   POLYETHYLENE GLYCOL   TALC   TITANIUM DIOXIDE   POLYSORBATE 80   Product Characteristics Color white Score no score Shape OVAL (elliptical) Size lipitor website Flavor Imprint Code PD;156;20 Contains      Packaging # NDC Package Description Multilevel Packaging 1 54868-3946-0 30 TABLET In 1 BOTTLE None 2 54868-3946-1 15 TABLET In 1 BOTTLE None 3 54868-3946-2 90 TABLET In 1 BOTTLE None 4 54868-3946-3 60 TABLET In 1 BOTTLE None 5 54868-3946-4 45 TABLET In 1 BOTTLE None Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020702 03/12/2004 Lipitor  atorvastatin calcium  tablet, film coated Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 54868-4934 (0071-0158) Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATORVASTATIN CALCIUM (ATORVASTATIN) ATORVASTATIN CALCIUM 80 mg Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE   CANDELILLA WAX   CROSCARMELLOSE SODIUM   HYDROXYPROPYL CELLULOSE   LACTOSE MONOHYDRATE   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   HYPROMELLOSE   POLYETHYLENE GLYCOL   TALC   TITANIUM DIOXIDE   POLYSORBATE 80   Product Characteristics Color white Score no score Shape OVAL (elliptical) Size 19mm Flavor Imprint Code PD;158;80 Contains      Packaging # NDC lipitor website Description Multilevel Packaging 1 54868-4934-0 30 TABLET In 1 BOTTLE None 2 54868-4934-1 90 TABLET In 1 BOTTLE None Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020702 01/11/2006 Lipitor  atorvastatin calcium  tablet, film coated Product Information Product Type HUMAN PRESCRIPTION DRUG lipitor website Product Code (Source) 54868-3934 (0071-0155) Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATORVASTATIN CALCIUM (ATORVASTATIN) ATORVASTATIN CALCIUM 10 mg Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE   CANDELILLA WAX   CROSCARMELLOSE SODIUM   HYDROXYPROPYL CELLULOSE   LACTOSE MONOHYDRATE   lipitor website STEARATE   CELLULOSE, MICROCRYSTALLINE   HYPROMELLOSE   POLYETHYLENE GLYCOL lipitor website TALC   TITANIUM DIOXIDE   POLYSORBATE 80   Product lipitor website Color white Score no score lipitor website OVAL (elliptical) Size 10mm Flavor Imprint Code PD;155;10 Contains      Packaging # NDC Package Description Multilevel Packaging 1 54868-3934-3 10 TABLET In 1 BOTTLE None 2 54868-3934-0 30 TABLET In 1 BOTTLE None 3 54868-3934-4 45 TABLET lipitor website BOTTLE None 4 54868-3934-2 60 TABLET In 1 BOTTLE None 5 54868-3934-1 90 TABLET In 1 BOTTLE None Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020702 05/05/1997 lipitor website - Physicians Total Care, Inc (194123980) Revised: 08/2009Physicians Total Care, Inc Lipitor Generic Name: Atorvastatin (a-TOR-va-STAT-in) Brand Name: Lipitor Lipitor is used for: Lowering high cholesterol and triglycerides in certain patients. If you have questions about the drugs you are taking, check with lipitor website doctor, lipitor website or pharmacist. Ocular Ocular side effects including a case of reversible ophthalmoplegia as well as a case of ocular myasthenia have been reported. In animals, the ortho-hydroxy metabolite undergoes further glucuronidation. In rare cases, Lipitor can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Lipitor can lower the risk for heart attack, stroke, certain types of heart surgery, and chest pain in patients who have heart disease or risk factors for heart disease such as: age, smoking, high blood pressure, low HDL-C, heart disease in lipitor website family. The five most common adverse reactions in patients treated with Lipitor that led to treatment discontinuation and occurred at a rate greater than placebo were: myalgia (0.7%), diarrhea (0.5%), nausea (0.4%), alanine aminotransferase increase (0.4%), and hepatic enzyme increase (0.4%). Before taking Lipitor, tell your doctor if you have ever had liver or kidney disease, diabetes, or a thyroid disorder, or if you drink more than 2 alcoholic beverages daily. 2.2 Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10–17 years of age) The recommended starting dose of Lipitor is 10 mg/day; the maximum recommended dose is 20 mg/day (doses greater than 20 mg have not been studied in this patient population). Lipitor reduces total-C, LDL-C, VLDL-C, apo B, TG, and non-HDL-C, and increases HDL-C in patients with isolated hypertriglyceridemia. See the end of this leaflet for a complete list of ingredients in Lipitor. At the insistence of her prescriber, she once again was given atorvastatin, with a rapid recurrence of her hematuria. Effect of Atorvastatin on the Pharmacokinetics of Co-administered Drugs Atorvastatin Co-administered drug and dosing regimen Drug/Dose (mg) Change in AUC Change in Cmax 80 mg QD for 15 days Antipyrine, 600 mg SD ↑ 3% ↓ 11% 80 mg QD for 14 days * Digoxin 0.25 mg QD, 20 days ↑ 15% lipitor website 20% 40 mg QD for 22 days Oral contraceptive QD, 2 months -norethindrone 1 mg -ethinyl estradiol 35µg ↑ 28% ↑ 19% ↑ 23% ↑ 30% * See Section 7 for clinical significance. Lipitor 10 mg/day on the reduction in cardiovascular events was assessed in 10,001 subjects (94% white, 81% male, 38% greater than or equal to 65 years) with clinically evident coronary heart disease who had achieved a target LDL-C level less than 130 mg/dL after completing an 8-week, open-label, run-in period with Lipitor 10 mg/day. Elevations of CK (≥ 10 × ULN) were low overall, but were higher in the high-dose atorvastatin treatment group (13, 0.3%) compared to the low-dose atorvastatin group (6, 0.1%). 12.3 Pharmacokinetics Absorption: Lipitor is rapidly absorbed after oral administration; maximum plasma concentrations occur within 1 to 2 hours. Lipid lowering drugs offer no benefit during pregnancy because cholesterol and cholesterol derivatives are needed for normal fetal development. One case of atorvastatin-induced dermatomyositis has been reported. 274/2366, 11.6%) and increased the incidence of hemorrhagic stroke (55/2365, 2.3% vs. Patients should also be advised to inform other healthcare professionals prescribing a new medication that they are taking Lipitor. Metabolism: Lipitor is extensively metabolized to ortho- and parahydroxylated derivatives and various beta-oxidation products. Hepatic In clinical trials, liver enzyme elevations returned to pretreatment levels upon discontinuation or dose reduction of atorvastatin. Therefore, in patients taking HIV protease inhibitors, caution should be used when the Lipitor dose exceeds 20 mg . In 89% of these cases, drug treatment started before pregnancy and stopped during the first trimester when pregnancy was identified.