Lipitor: Advanced LDL Cholesterol Reduction Therapy
Lipitor
Atorvastatin is a statin, used as a cholesterol- and triglyceride- lowering drug.
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Lipitor (atorvastatin calcium) is a prescription medication classified as a HMG-CoA reductase inhibitor, or statin. It is clinically proven to significantly lower low-density lipoprotein (LDL) cholesterol and triglyceride levels in the blood while raising high-density lipoprotein (HDL) cholesterol. This medication is a cornerstone in the pharmacological management of dyslipidemia and is indicated to reduce the risk of cardiovascular events, including myocardial infarction and stroke, in appropriate adult patient populations. Its efficacy is supported by extensive clinical trial data and decades of real-world use.
Features
- Active Pharmaceutical Ingredient: Atorvastatin calcium.
- Available Dosage Strengths: 10 mg, 20 mg, 40 mg, and 80 mg film-coated tablets.
- Mechanism of Action: Competitive inhibition of HMG-CoA reductase, the rate-limiting enzyme in the hepatic cholesterol biosynthesis pathway.
- Pharmacokinetics: Rapidly absorbed after oral administration; peak plasma concentrations occur within 1 to 2 hours. Absolute bioavailability is approximately 14% due to first-pass metabolism.
- Metabolism: Extensively metabolized by the hepatic cytochrome P450 system, primarily the CYP3A4 isoenzyme.
- Excretion: Primarily via hepatic biliary excretion, with less than 2% recovered renally. Mean plasma elimination half-life is approximately 14 hours.
- Specialized Formulation: Designed for once-daily dosing, supporting consistent patient adherence.
Benefits
- Potent LDL-C Reduction: Demonstrates dose-dependent efficacy, capable of reducing LDL cholesterol by 39% to 60%.
- Cardiovascular Risk Reduction: Proven in clinical trials to significantly decrease the risk of heart attack, stroke, and revascularization procedures in patients with multiple risk factors for heart disease.
- Favorable Lipid Profile Modulation: Effectively lowers triglycerides and apolipoprotein B, while moderately increasing HDL cholesterol levels.
- Plaque Stabilization: Contributes to the stabilization of atherosclerotic plaques, reducing the likelihood of rupture and subsequent thrombotic events.
- Established Safety Profile: As one of the most prescribed medications globally, its long-term safety and tolerability are well-documented in diverse patient populations.
Common use
Lipitor is indicated as an adjunct to diet and lifestyle modifications to:
- Reduce the risk of myocardial infarction, stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease but without clinically evident CHD.
- Reduce the risk of myocardial infarction and stroke in adults with type 2 diabetes mellitus and without clinically evident CHD, but with additional risk factors.
- Reduce the risk of non-fatal myocardial infarction, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident coronary heart disease.
- Lower elevated total-C, LDL-C, apo B, and TG levels, and to increase HDL-C in adults with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia.
- Lower elevated TG levels in adults and to treat patients with primary dysbetalipoproteinemia.
- Lower total-C and LDL-C in patients with homozygous familial hypercholesterolemia.
Dosage and direction
- The recommended starting dose is 10 mg or 20 mg once daily. Patients who require a reduction in LDL-C of more than 45% may be started at 40 mg once daily.
- The dosage range is 10 mg to 80 mg once daily administered at any time of the day, with or without food.
- The 80 mg dose is reserved for patients who have not achieved their LDL-C goal on lower doses.
- Dosage must be individualized according to baseline LDL-C level, the goal of therapy, and patient response. After initiation and/or upon titration, lipid levels should be analyzed within 2 to 4 weeks and dosage adjusted accordingly.
- In patients taking cyclosporine, clarithromycin, itraconazole, or certain HIV protease inhibitors, the dose of Lipitor should not exceed 10 mg once daily.
- Use in pediatric patients (ages 10 years and older) is indicated for heterozygous familial hypercholesterolemia. The recommended starting dose is 10 mg once daily, with a maximum recommended dose of 20 mg once daily.
Precautions
- Liver Enzyme Abnormalities: Increases in serum transaminases have been reported. Liver function tests (LFTs) should be performed before initiating therapy, at 12 weeks following initiation or any dose elevation, and periodically thereafter.
- Skeletal Muscle Effects: Myopathy (muscle pain, tenderness, or weakness with creatine kinase (CK) levels >10x ULN) and rhabdomyolysis with acute renal failure have been reported. Risk is dose-related. Patients should be advised to promptly report any unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever.
- HbA1c and Fasting Serum Glucose Levels: Increases in HbA1c and fasting serum glucose levels have been reported with statins, including Lipitor.
- Renal Impairment: Renal impairment is a risk factor for myopathy and rhabdomyolysis. Dose adjustments are not necessary in patients with renal impairment, but these patients should be monitored closely.
- Hepatic Impairment: Lipitor is contraindicated in patients with active liver disease or unexplained persistent elevations of hepatic transaminases. Use with caution in patients who consume substantial quantities of alcohol.
Contraindications
- Hypersensitivity to any component of this medication.
- Active liver disease or unexplained persistent elevations of hepatic transaminases exceeding 3 times the upper limit of normal.
- Pregnancy and breastfeeding. Statins may cause fetal harm. Discontinue Lipitor immediately if pregnancy is recognized.
- Concomitant use with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, HIV protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin, nefazodone, cobicistat-containing products, gemfibrozil).
Possible side effect
The following adverse reactions are organized by system organ class and frequency (Very common ≥1/10; Common ≥1/100 to <1/10; Uncommon ≥1/1,000 to <1/100; Rare ≥1/10,000 to <1/1,000).
- Infections and infestations: Common: nasopharyngitis.
- Metabolism and nutrition disorders: Common: increases in blood glucose levels, hyperglycemia.
- Nervous system disorders: Common: headache, insomnia. Uncommon: dizziness, paresthesia.
- Gastrointestinal disorders: Common: constipation, diarrhea, dyspepsia, nausea, flatulence.
- Musculoskeletal and connective tissue disorders: Common: arthralgia, pain in extremity, muscle spasms, myalgia. Uncommon: musculoskeletal pain, neck pain. Rare: myopathy, rhabdomyolysis.
- General disorders and administration site conditions: Common: asthenia, fatigue.
- Investigations: Common: elevated alanine aminotransferase (ALT), elevated creatine phosphokinase (CPK). Uncommon: elevated aspartate aminotransferase (AST).
Drug interaction
Lipitor is a substrate of CYP3A4 and the transport protein OATP1B1. Concomitant use can lead to significant interactions.
- Contraindicated: Strong CYP3A4 inhibitors (e.g., itraconazole, clarithromycin, HIV protease inhibitors) significantly increase atorvastatin exposure and the risk of myopathy/rhabdomyolysis.
- Use with Caution (dose limitation recommended):
- Cyclosporine: Increases atorvastatin exposure. Do not exceed 10 mg daily.
- Gemfibrozil: Increases atorvastatin exposure and risk of myopathy. Avoid concomitant use if possible.
- Other Fibrates (except gemfibrozil): May increase the risk of myopathy.
- Moderate CYP3A4 Inhibitors (e.g., diltiazem, verapamil, amiodarone): May increase atorvastatin plasma concentrations. Consider using a lower dose of Lipitor.
- Other: Concomitant administration with colchicine, niacin, erythromycin, and fusidic acid has been associated with myopathy. Monitor patients carefully. Oral contraceptives: increases ethinyl estradiol and norethindrone concentrations. Digoxin: atorvastatin may increase digoxin concentrations. Warfarin: atorvastatin may potentiate the anticoagulant effect; monitor INR.
Missed dose
- If a dose is missed, it should be taken as soon as the patient remembers.
- However, if it is almost time for the next scheduled dose, the missed dose should be skipped, and the regular dosing schedule resumed.
- Patients should not take a double dose to make up for a missed one.
Overdose
- There is no specific antidote for atorvastatin overdose.
- In the event of an overdose, the patient should be treated symptomatically, and supportive measures should be instituted as required.
- Given the extensive protein binding of atorvastatin, hemodialysis is not expected to significantly enhance clearance.
- Liver function and CK levels should be monitored. The possibility of rhabdomyolysis leading to acute renal failure should be considered.
Storage
- Store Lipitor tablets at room temperature, between 20°C to 25°C (68°F to 77°F).
- Excursions are permitted between 15°C to 30°C (59°F to 86°F).
- Keep the medication in its original container, tightly closed, and protect from light and moisture.
- Keep all medications out of the reach of children and pets.
Disclaimer
This information is for educational and informational purposes only and does not constitute medical advice. It is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or medication. Never disregard professional medical advice or delay in seeking it because of something you have read here. The content has been compiled from various sources and may not be entirely error-free or encompass all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of a warning for a given drug or combination does not imply that the drug or combination is safe, effective, or appropriate for you or any specific patient.
Reviews
- Clinical Trial Data (ASCOT-LLA): “In the Anglo-Scandinavian Cardiac Outcomes Trial—Lipid Lowering Arm, atorvastatin 10 mg demonstrated a 36% reduction in fatal coronary heart disease and non-fatal myocardial infarction (p=0.0005) in hypertensive patients with additional risk factors and average or lower-than-average cholesterol levels.” — The Lancet, 2003.
- Meta-Analysis (CTT Collaboration): “In a meta-analysis of data from 90,056 participants in 14 randomized trials, statin therapy (including atorvastatin) produced a 21% proportional reduction in major vascular events per 1.0 mmol/L reduction in LDL cholesterol, with significant reductions in all patient subgroups studied.” — The Lancet, 2012.
- Real-World Evidence: “Large-scale observational studies and registries have consistently shown that atorvastatin therapy is associated with significant reductions in cardiovascular event rates in routine clinical practice, aligning with the benefits observed in rigorous randomized controlled trials.” — Journal of the American College of Cardiology, 2018.