[see Dosage and Administration (2.6) and Warnings and Precautions ( Atorvastatin Calcium Tablets may harm your unborn baby. Your doctor may increase your dose as needed. The drugs compared in the studies summarized in the table are not necessarily interchangeable. 33H ]. 2). Lowering "bad" cholesterol and triglycerides and raising "good" cholesterol decreases the risk of heart disease and helps prevent strokes and heart attacks.In addition to eating a proper diet (such as a low-cholesterol/low-fat diet), other lifestyle changes that may help this medication work better include exercising, losing weight if overweight, and stopping smoking. Atorvastatin calcium tablets can be administered as a single dose at any time of the day, with or without food. max (ratio of C Metabolic and nutritional system: transaminases increase, liver function test abnormal, blood alkaline phosphatase increase, creatine phosphokinase increase, hyperglycemia; Use of atorvastatin calcium tablets for this indication is supported by evidence from A blood/plasma ratio of approximately 0.25 indicates poor drug penetration into red blood cells. If we combine this information with your protected The co-administration of atorvastatin calcium tablets with cyclosporine should be avoided How do I store Atorvastatin Calcium Tablets? Due to the dual interaction mechanism of rifampin, simultaneous co-administration of atorvastatin with rifampin is recommended, as delayed administration of atorvastatin after administration of rifampin has been associated with a significant reduction in atorvastatin plasma concentrations. Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including atorvastatin calcium tablets. The combination of HMG-CoA reductase inhibitors (statins) and fibrates should generally be used with caution All rights reserved. Atorvastatin is a medication prescribed by a doctor to lower cholesterol in people who have been diagnosed with high cholesterol (high levels of cholesterol in the blood).Doctors diagnose high cholesterol through a simple blood test. In animals, the ortho-hydroxy metabolite undergoes further glucuronidation. The safety and efficacy of atorvastatin calcium tablets in lowering LDL-C appeared generally consistent with that observed for adult patients, despite limitations of the uncontrolled study design. Wait and take the next dose at your regular time. It's also used to decrease your risk for heart attack and stroke. 12.3) 5.1) Atorvastatin calcium (brand name: Lipitor) is a medicine in a class of drugs called HMG CoA reductase inhibitors, also referred to as "statins." Pfizer's Lipitor was first approved in 1996 and is considered one of the most successful selling drugs of all time. The proportions of subjects who experienced CV or non-CV death were similar for the atorvastatin calcium tablets 80 mg group and the simvastatin 20-40 mg group. [see Indications and Usage ( There have been rare reports of immune-mediated necrotizing myopathy associated with statin use y Atorvastatin was administered to pregnant rats and rabbits during organogenesis at oral doses up to 300 mg/kg/day and 100 mg/kg/day, respectively. It belongs to a group of. 1 A negative value for the 95% CI for the difference between treatments favors atorvastatin calcium tablets for all except HDL-C, for which a positive value favors atorvastatin calcium tablets. Most people with high cholesterol or triglycerides do not feel sick. However, LDL-C reduction is the same regardless of the time of day of drug administration 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). Adjustments should be made at intervals of 4 weeks or more. Started at 80mg dose and my hands felt like they were burning. What are the Possible Side Effects of Atorvastatin Calcium Tablets? All patients had a clinical diagnosis of HeFH confirmed by genetic analysis (if not already confirmed by family history). Male rats given 100 mg/kg/day for 11 weeks prior to mating had decreased sperm motility, spermatid head concentration, and increased abnormal sperm. Atorvastatin calcium tablets significantly reduced the rate of coronary events [either fatal coronary heart disease (46 events in the placebo group vs. 40 events in the atorvastatin calcium tablets group) or non-fatal MI (108 events in the placebo group vs. 60 events in the atorvastatin calcium tablets group)] with a relative risk reduction of 36% [(based on incidences of 1.9% for atorvastatin calcium tablets vs. 3.0% for placebo), p=0.0005 (see Figure 1)]. DEAR DR. ROACH: I am 71. This products label may have been updated. This medicine may help prevent medical problems (eg, chest pain, heart attack, or stroke) that are caused by fats clogging the blood vessels. Brain hemorrhage was seen in a female dog treated for 3 months at 120 mg/kg/day. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). ]. I cut it to 20mg, and still having same side effects. The primary analysis was the time to first occurrence of the primary endpoint. 2.5) and Warnings and Precautions ( Dosage for children In vitro, atorvastatin was not mutagenic or clastogenic in the following tests with and without metabolic activation: the Ames test with Advise postmenarchal girls of contraception recommendations, if appropriate for the patient Atorvastatin calcium tablets, as well as some of its metabolites, are pharmacologically active in humans. include protected health information. In a 2-year carcinogenicity study in rats at dose levels of 10, 30, and 100 mg/kg/day, 2 rare tumors were found in muscle in high-dose females: in one, there was a rhabdomyosarcoma and, in another, there was a fibrosarcoma. Doctors . Generic name: atorvastatin [ a-TOR-va-sta-tin ] Brand names: Atorvaliq, Lipitor Dosage forms: oral suspension (20 mg/5 mL), oral tablet (10 mg; 20 mg; 40 mg; 80 mg) Drug class: Statins Medically reviewed by Sanjai Sinha, MD. Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT). TABLE 8. See the end of this leaflet for a complete list of ingredients in Atorvastatin Calcium Tablets. and Clinical Pharmacology ( [see Warnings and Precautions (5.1) and Clinical Pharmacology ( Atorvastatin is a prescription medicine used to treat high cholesterol. Review/update the Do not take Atorvastatin Calcium Tablets if it has been more than 12 hours since you missed your last dose. In patients taking the HIV protease inhibitor lopinavir plus ritonavir, caution should be used when prescribing atorvastatin calcium tablets and the lowest dose necessary should be used. Atorvastatin Calcium Tablets for oral administration contain 10, 20, 40, or 80 mg atorvastatin and the following inactive ingredients: amino methacrylate copolymer, colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, polyethylene glycol, polyvinyl alcohol, sodium stearyl fumarate, talc, titanium dioxide. Distribution: Mean volume of distribution of atorvastatin calcium tablets is approximately 381 liters. The primary endpoint was the time-to-first occurrence of any of the following major cardiovascular events (MCVE): death due to CHD, non-fatal myocardial infarction, resuscitated cardiac arrest, and fatal and non-fatal stroke. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Selected from data included with permission and copyrighted by First Databank, Inc. The most commonly reported adverse reactions (incidence 2% and greater than placebo) regardless of causality, in patients treated with atorvastatin calcium tablets in placebo controlled trials (n=8755) were: nasopharyngitis (8.3%), arthralgia (6.9%), diarrhea (6.8%), pain in extremity (6.0%), and urinary tract infection (5.7%). In SPARCL involving 4731 subjects (age range 2192 years, 40% women; 93.3% Caucasians, 3.0% Blacks, 0.6% Asians, 3.1% other) without clinically evident CHD but with a stroke or transient ischemic attack (TIA) within the previous 6 months treated with atorvastatin calcium tablets 80 mg (n=2365) or placebo (n=2366) for a median follow-up of 4.9 years, there was a higher incidence of persistent hepatic transaminase elevations ( 3 x ULN twice within 4 10 days) in the atorvastatin group (0.9%) compared to placebo (0.1%). Persistent transaminase elevations (3 x ULN twice within 410 days) occurred in 62 (1.3%) individuals with atorvastatin 80 mg and in nine (0.2%) individuals with atorvastatin 10 mg. Elevations of CK ( 10 x 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%). [see Clinical Pharmacology ( Diabetes was reported as an adverse reaction in 144 subjects (6.1%) in the atorvastatin group and 89 subjects (3.8%) in the placebo group RedPharm Drug, Inc. If these rare effects occur, talk to your doctor. Keep taking this medication even if you feel well. ]. Drug dosage, rather than systemic drug concentration, correlates better with LDL-C reduction. The mean LDL-C, TC, TG, non-HDL, and HDL cholesterol levels at 12 weeks were 73, 145, 128, 98, and 47 mg/dL during treatment with 80 mg of atorvastatin calcium tablets and 99, 177, 152, 129, and 48 mg/dL during treatment with 10 mg of atorvastatin calcium tablets. 2O and its molecular weight is 1209.42. Atorvastatin belongs to the group of medicines called HMG-CoA reductase inhibitors, or statins. 20 mg tablets: debossed with "2" on one side and plain on the other. Patients who require reduction in LDL-C greater than 45% may be started at 40 mg once daily. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet. . Effect of Atorvastatin Calcium Tablets 10 mg/day on Time to Occurrence of Major Cardiovascular Event (myocardial infarction, acute CHD death, unstable angina, coronary revascularization, or stroke) in CARDS. There was aplasia and aspermia in the epididymis of 2 of 10 rats treated with 100 mg/kg/day of atorvastatin for 3 months (16 times the human AUC at the 80 mg dose); testis weights were significantly lower at 30 and 100 mg/kg and epididymal weight was lower at 100 mg/kg. In November 2021, my cardiologist prescribed me 40 mg of atorvastatin in case of chest pain before any tests. muscle problems that do not go away even after your doctor has advised you to stop taking Atorvastatin Calcium Tablets. Atorvastatin is also used to reduce the risk of heart attack for people with high blood pressure who have at least 3 additional risk factors for heart disease but are not experiencing symptoms associated with heart disease. The concomitant use of higher doses of atorvastatin with certain drugs such as cyclosporine and strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, and HIV protease inhibitors) increases the risk of myopathy/rhabdomyolysis. Patients should be advised about substances they should not take concomitantly with atorvastatin Uses Warnings Before taking Side effects Interactions Dosage FAQ What is Lipitor? 1. AdultsAt first, 10 or 20 milligrams (mg) once a day. Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Atorvastatin calcium tablets are indicated: As an adjunct to diet to reduce elevated total-C, LDL-C, apo B, and TG levels and to increase HDL-C in adult patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson Types IIa and IIb); Otherwise, call a poison control center right away. Hepatic Impairment: In patients with chronic alcoholic liver disease, plasma concentrations of atorvastatin calcium tablets are markedly increased. Consult your doctor for more details. In patients taking the HIV protease inhibitor nelfinavir or the hepatitis C protease inhibitor boceprevir, the dose of atorvastatin calcium tablets should not exceed 40 mg and close clinical monitoring is recommended. Atorvastatin calcium tablets had no clinically significant effect on prothrombin time when administered to patients receiving chronic warfarin treatment. Individual symptoms and route of administration also determines the right dosage. Do not get pregnant. are allergic to Atorvastatin Calcium Tablets or any of its ingredients. This survey is being conducted by the WebMD marketing sciences department. Patients were mainly male (81%), white (99%) with an average age of 61.7 years, and an average LDL-C of 121.5 mg/dL at randomization; 76% were on statin therapy. These serious side effects include: In clinical studies, patients reported the following common side effects while taking Atorvastatin Calcium Tablets: diarrhea, upset stomach, muscle and joint pain, and alterations in some laboratory blood tests. In the US - Call your doctor for medical advice about side effects. Atorvastatin AUC was significantly increased with concomitant administration of atorvastatin calcium tablets with several combinations of HIV protease inhibitors, as well as with the hepatitis C protease inhibitor telaprevir, compared to that of atorvastatin calcium tablets alone [see Use in Special Populations (8.4) and Clinical Studies (14.6) Medicines in the statin class include atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, and simvastatin. These side effects have happened only to a small number of people. It may take up to 4 weeks before you get the full benefit of this drug. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. Prescribing recommendations for interacting agents are summarized in Table 2 14.6)]: A placebo-controlled clinical trial of 6 months duration in 187 boys and postmenarchal girls, 10 years to 17 years of age. Elevations of CK (>10 x ULN) were rare, but were higher in the atorvastatin group (0.1%) compared to placebo (0.0%). Of the predefined secondary endpoints, treatment with atorvastatin calcium tablets 80 mg/day significantly reduced the rate of coronary revascularization, angina, and hospitalization for heart failure, but not peripheral vascular disease. are pregnant or think you may be pregnant, or are planning to become pregnant. [see Do not start, stop, or change the dosage of any medicines without your doctor's approval. IMNM is characterized by: proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; muscle biopsy showing necrotizing myopathy without significant inflammation; improvement with immunosuppressive agents. WebMD does not provide medical advice, diagnosis or treatment. Atorvastatin calcium tablets therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. Uses Atorvastatin is used along with a proper diet to help lower "bad" cholesterol and fats (such as LDL, triglycerides) and raise "good" cholesterol (HDL) in the blood. Click here for an email preview. [see Warnings and Precautions ( C TABLE 7. Atorvastatin Calcium Tabletsare a synthetic lipid-lowering agent. The dosage of atorvastatin calcium tablets in patients withHoFH is 10 to 80 mg daily. There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use. ]. No CNS lesions have been observed in mice after chronic treatment for up to 2 years at doses up to 400 mg/kg/day or in rats at doses up to 100 mg/kg/day. Brain hemorrhage and optic nerve vacuolation were seen in another female dog that was sacrificed in moribund condition after 11 weeks of escalating doses up to 280 mg/kg/day. Atorvastatin is used for lowering the risk of heart attack, stroke, and certain types of heart surgery in patients who have heart disease or risk factors for heart disease. Inactive Ingredients: amino methacrylate copolymer, colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, polyethylene glycol, polyvinyl alcohol, sodium stearyl fumarate, talc, titanium dioxide. Taking atorvastatin and red yeast rice products together can increase your risk of serious muscle and liver problems. Your doctor can monitor you for them. These doses correspond to 6 times (100 mg/kg) and 22 times (225 mg/kg) the human exposure at the MRHD, based on AUC. Tell your doctor right away if you develop symptoms of liver problems, including: nausea/vomiting that doesn't stop, yellowing eyes/skin, dark urine, stomach/abdominal pain. [see Contraindications (4) and Use in Specific Populations (8.2) Because HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, atorvastatin calcium tablets may cause fetal harm when administered to a pregnant woman. After initiation and/or upon titration of atorvastatin calcium tablets, lipid levels should be analyzed within 2 to 4 weeks and dosage adjusted accordingly. In a double-blind, placebo-controlled study followed by an open-label phase, 187 boys and post-menarchal girls 10 years to 17 years of age (mean age 14.1 years) with heterozygous familial hypercholesterolemia (HeFH) or severe hypercholesterolemia, were randomized to atorvastatin calcium tablets (n=140) or placebo (n=47) for 26 weeks and then all received atorvastatin calcium tablets for 26 weeks. Examples include glecaprevir plus pibrentasvir, telithromycin, ritonavir, among others. CNS vascular lesions, characterized by perivascular hemorrhages, edema, and mononuclear cell infiltration of perivascular spaces, have been observed in dogs treated with other members of this class. . Patients who require a large reduction in LDL-C (more than 45%) may be started at 40 mg once daily. Cut to 40mg, still problems with memory, brain fog, balance, numb hands. Statins, like some other lipid-lowering therapies, have been associated with biochemical abnormalities of liver function. [see Adverse Reactions ( Uses Warnings Before taking Side effects Interactions Dosage FAQ What is atorvastatin? A single tonic convulsion was seen in each of 2 male dogs (one treated at 10 mg/kg/day and one at 120 mg/kg/day) in a 2-year study. If an alternate etiology is not found, do not restart atorvastatin calcium tablets. ( Your doctor should start you on a low-fat diet before giving you Atorvastatin Calcium Tablets. Atorvastatin Calcium Tablets are supplied as white, round, film-coated tablets of atorvastatin calcium containing 10, 20, 40, and 80 mg atorvastatin. muscle problems like weakness, tenderness, or pain that happen without a good reason, especially if you also have a fever or feel more tired than usual. In patients taking cyclosporine or the HIV protease inhibitors (tipranavir plus ritonavir) or the hepatitis C protease inhibitor (telaprevir), therapy with atorvastatin calcium tablets should be avoided. Advertising revenue supports our not-for-profit mission. It works by blocking an enzyme that is needed by the body to make cholesterol, and this reduces the amount of cholesterol in the blood. Homozygous Familial Hypercholesterolemia (HoFH). 5.1)] You'll soon start receiving the latest Mayo Clinic health information you requested in your inbox. The incidence of non-fatal hemorrhagic strokes was significantly greater in the atorvastatin group (38 non-fatal hemorrhagic strokes) as compared to the placebo group (16 non-fatal hemorrhagic strokes). These doses resulted in multiples of about 30 times (rat) or 20 times (rabbit) the human exposure at the MRHD based on surface area (mg/m It can raise your HDL-C ("good" cholesterol) as well. Atorvastatin calcium tablets may be used with bile acid resins. A three year open-label uncontrolled trial that included 163 pediatric patients 10 to 15 years of age with HeFH who were titrated to achieve a target LDL-C < 130 mg/dL. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. 2). This is not a complete list of possible side effects. There is no specific treatment for atorvastatin calcium tablets overdosage. RECOMMENDATIONS: 4) There may be new information. max and 10% lower for AUC); however, there is no clinically significant difference in LDL-C reduction with atorvastatin calcium tablets between men and women. Use Caution/Monitor. 7) Effect of Co-administered Drugs on the Pharmacokinetics of Atorvastatin. ** Ratio based on single sample taken 8-16 h post dose. If you also take certain other drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine or colestipol), take atorvastatin at least 1 hour before or at least 4 hours after taking these medications. ]. Ask your doctor or pharmacist for more details. White, round, film-coated tablets containing 10, 20, 40, and 80 mg atorvastatin calcium. Atorvastatin Calcium Tablets start to work in about 2 weeks. Heterozygous Familial Hypercholesterolemia (HeFH). There were no significant differences between the treatment groups for all-cause mortality: 216 (9.1%) in the atorvastatin calcium tablets 80 mg/day group vs. 211 (8.9%) in the placebo group.
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