What is atorvastatin? Is atorvastatin a statin medication? Explore the indications, contraindications, mechanism of action, pharmacokinetics, and administration of atorvastatin.

Atorvastatin: A Statin Medication for Cardiovascular Disease Prevention

Atorvastatin, a statin medication, is a widely prescribed drug for the primary and secondary prevention of coronary heart disease. As an HMG-CoA reductase inhibitor, atorvastatin competitively inhibits the enzyme responsible for cholesterol synthesis, leading to a reduction in cholesterol production in the liver. This mechanism of action makes atorvastatin an effective lipid-lowering agent, helping to manage various dyslipidemic conditions.

Indications for Atorvastatin Therapy

Atorvastatin has received FDA approval for several indications, including:

• Primary prevention of cardiovascular events in patients with multiple risk factors, even in the absence of coronary heart disease
• Reduction of the risk of myocardial infarction, stroke, revascularization procedures, and angina in patients with type 2 diabetes mellitus and multiple risk factors, but no coronary heart disease
• Secondary prevention of nonfatal myocardial infarction, fatal and nonfatal stroke, revascularization procedures, hospitalizations for congestive heart failure, and angina in patients with established coronary heart disease
• Treatment of various dyslipidemias, such as primary hyperlipidemia (heterozygous familial and nonfamilial), mixed dyslipidemia, hypertriglyceridemia, primary dysbetalipoproteinemia, and homozygous familial hypercholesterolemia
• Treatment of heterozygous familial hypercholesterolemia in pediatric patients after dietary modifications have failed

Mechanism of Action: How Does Atorvastatin Work?

Atorvastatin’s mechanism of action involves the competitive inhibition of the enzyme 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. By preventing the conversion of HMG-CoA to mevalonate, a key precursor in cholesterol synthesis, atorvastatin reduces the production of cholesterol in the liver. Additionally, atorvastatin increases the number of LDL receptors on the surface of hepatic cells, enhancing the clearance of LDL-cholesterol from the bloodstream.

Pharmacokinetics of Atorvastatin

The pharmacokinetic properties of atorvastatin are as follows:

• Absorption: Atorvastatin is rapidly absorbed after oral administration, with peak plasma concentrations occurring within 1-2 hours. However, its bioavailability is relatively low (around 14%) due to extensive first-pass metabolism.
• Distribution: Atorvastatin is highly bound to plasma proteins (over 98%) and has a large volume of distribution, approximately 380 liters.
• Metabolism: Atorvastatin is metabolized by the cytochrome P450 3A4 (CYP3A4) enzyme system, producing active ortho- and para-hydroxylated metabolites.
• Excretion: Atorvastatin and its metabolites are eliminated primarily through biliary excretion, with no known enterohepatic recirculation. The half-life of atorvastatin is around 14 hours, while its active metabolites have a half-life of 20-30 hours.

Administration of Atorvastatin

Atorvastatin is available as atorvastatin calcium tablets in strengths of 10, 20, 40, and 80 mg. This medication can be taken with or without food and should be administered at the same time every day. While it is generally recommended to take statins at bedtime due to the cyclical nature of endogenous cholesterol synthesis, the longer half-life of atorvastatin compared to other statins offers greater flexibility in dosing.

Adverse Events and Monitoring with Atorvastatin Therapy

As with any medication, atorvastatin therapy can be associated with potential adverse events. These may include muscle-related side effects, such as myalgia, myopathy, and rhabdomyolysis, as well as liver enzyme elevations. Careful monitoring of lipid levels, liver function, and muscle symptoms is essential during atorvastatin treatment. Regular follow-up with healthcare providers is crucial to ensure the safe and effective use of atorvastatin in managing coronary artery disease and hyperlipidemia.

Interprofessional Collaboration for Optimizing Atorvastatin Therapy

Effective management of patients on atorvastatin requires a collaborative approach involving various healthcare professionals, including physicians, pharmacists, and nurses. Strategies to improve care coordination and patient adherence include:

• Clearly communicating the indications, benefits, and potential side effects of atorvastatin therapy to patients
• Providing patient education on the importance of medication adherence and lifestyle modifications
• Monitoring lipid profiles, liver function, and muscle symptoms at regular intervals
• Identifying and addressing any barriers to adherence, such as cost or accessibility issues
• Promptly addressing any adverse events and adjusting the treatment plan as necessary

By working together, the healthcare team can optimize the use of atorvastatin and enhance patient outcomes in the management of coronary artery disease and hyperlipidemia.

Atorvastatin – StatPearls – NCBI Bookshelf

Continuing Education Activity

HMG-CoA reductase inhibitors (statins) are lipid-lowering medications used in the primary and secondary prevention of coronary heart disease. Atorvastatin competitively inhibits 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. By preventing the conversion of HMG-CoA to mevalonate, statin medications decrease cholesterol production in the liver. Atorvastatin also increases the number of LDL receptors on the surface of hepatic cells. This activity reviews the indications, contraindications, and mechanism of action of atorvastatin to manage coronary heart disease and familial dyslipidemias, covering the indications, contraindications, activity, adverse events, and other key elements of atorvastatin therapy.

Objectives:

• Describe the indications for atorvastatin therapy.

• Identify potential adverse events when using therapy with atorvastatin.

• Outline the appropriate follow-up and monitoring of lipid-lowering therapy with atorvastatin.

• Review interprofessional team strategies for improving care coordination and communication to enhance patient adherence to atorvastatin in treating coronary artery disease and hyperlipidemia.

Access free multiple choice questions on this topic.

Indications

In combination with dietary modifications, atorvastatin is FDA approved to prevent cardiovascular events in patients with cardiac risk factors and also patients with abnormal lipid profiles.[1]

Primary Prevention

For patients without coronary heart disease but with multiple risk factors, the FDA has approved atorvastatin to reduce the risk of myocardial infarction, stroke, revascularization procedures, and angina.

For patients diagnosed with type 2 diabetes mellitus without coronary heart disease but with multiple risk factors, atorvastatin has FDA approval to reduce the risk of myocardial infarction and stroke.  

Secondary Prevention

For patients with coronary heart disease, atorvastatin has received approval as a therapy to reduce the risk of nonfatal myocardial infarction, fatal and nonfatal stroke, revascularization procedures, hospitalizations for congestive heart failure, and angina.  

Atorvastatin has FDA approval for the treatment of the following dyslipidemias: 

• Adults with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia

• Hypertriglyceridemia

• Primary dysbetalipoproteinemia

• Homozygous familial hypercholesterolemia

• Pediatric patients with heterozygous familial hypercholesterolemia (after failing dietary modifications)

Atorvastatin has not been studied in Fredrickson Type I and V dyslipidemias.

Mechanism of Action

Atorvastatin competitively inhibits 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase.[2] By preventing the conversion of HMG-CoA to mevalonate, statin medications decrease cholesterol production in the liver. Atorvastatin also increases the number of LDL receptors on the surface of hepatic cells. 

In patients with homozygous or heterozygous familial hypercholesterolemia, mixed dyslipidemia, isolated hypertriglyceridemia, or nonfamilial hypercholesterolemia, atorvastatin has been shown to reduce total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (apo B), very-low-density lipoprotein (VLDL-C) and triglycerides (TGs) while increasing high-density lipoprotein cholesterol (HDL-C).  

In patients with dysbetalipoproteinemia, atorvastatin has been shown to decrease intermediate-density lipoprotein (IDL-C).   

Pharmacokinetics

Pharmacokinetic attributes of atorvastatin are covered below.[3] 

Absorption 

Atorvastatin is rapidly absorbed after oral administration with a peak plasma concentration at 1 to 2 hours. The bioavailability is low at 14% due to extensive first-pass metabolism.

Distribution

Atorvastatin is highly plasma protein bound (over 98%) and has a volume of distribution of about 380 liters. 

Metabolism

Atorvastatin is metabolized by cytochrome P450 3A4 (CYP3A4) to active ortho- and para-hydroxylated metabolites. 

Excretion

Atorvastatin and its metabolites get eliminated in bile. Atorvastatin is not known to go through enterohepatic recirculation. The half-life of atorvastatin is about 14 hours, while its active metabolites have a half-life of about 20 to 30 hours.  

Administration

Atorvastatin is available as atorvastatin calcium tablets in strengths of 10, 20, 40, and 80 mg.  

This medication can be administered with or without food and should be taken at the same time every day. It is generally recommended to administer statins at bedtime since endogenous cholesterol synthesis is cyclical, with the highest production levels during fasting as at night. However, the longer half-life of atorvastatin compared to other shorter half-life statins (e.g., lovastatin, fluvastatin, and simvastatin) offers greater flexibility regarding dosing times.

Adult Dosing 

The dosing of atorvastatin can have its basis in LDL-C lowering ability (intensity), or doses are titratable to specific lipid goals. 

The American College of Cardiology/American Heart Association Guidelines recommends either moderate intensity (atorvastatin 10 to 20 mg) or high intensity (atorvastatin 40 to 80 mg) therapy depending on the statin benefit group to which a patient belongs. Moderate-intensity statins should lower LDL-C by about 30 to 50%, while high-intensity statins should lower LDL-C by over 50 %.[4]

Both the National Lipid Association and the American Association of Clinical Endocrinologists recommend utilizing statin therapy to reach specific lipid goals based on atherosclerotic cardiovascular disease risk.[5][6]

Pediatrics 

Doses above 20 mg do not have study data for pediatric patients with heterozygous familial hypercholesterolemia. Doses up to 80 mg have been used in a limited number of pediatric patients with familial hypercholesterolemia. Studies have not evaluated atorvastatin use in pre-pubescent patients or those under ten years old. 

Geriatrics

Patients over 65 years old may have higher plasma concentrations of atorvastatin than young adults. Older patients may be at increased risk of statin-induced myopathies. 

Renal Impairment 

Atorvastatin and its metabolites do not undergo renal elimination, so no dose adjustments are required with reduced renal function. Hemodialysis will not likely remove atorvastatin due to plasma protein binding. 

Hepatic Impairment

Increased plasma concentrations of atorvastatin have occurred in patients with chronic alcoholic liver disease. Drug exposure is four times higher in patients with Child-Pugh Class A and 11x higher in patients with Child-Pugh Class B. Atorvastatin is contraindicated in patients with active liver disease.[7]

Drug Interactions
[8]
 

Using atorvastatin with potent CYP3A4 inhibitors can lead to increased plasma concentrations, which may enhance adverse events, including myopathy. OATP1B1 inhibitors can increase the bioavailability of atorvastatin.[9]

CYP3A4 inducers may cause decreased plasma concentrations of atorvastatin. 

Patients taking digoxin should undergo monitoring when starting atorvastatin as plasma concentrations of digoxin may increase.

Atorvastatin may also increase drug concentrations of norethindrone and ethinyl estradiol.

Adverse Effects

Common adverse effects for patients taking atorvastatin include arthralgia, dyspepsia, diarrhea, nausea, nasopharyngitis, insomnia, urinary tract infection, and pain in the extremities.

Myopathies have occurred in patients taking atorvastatin, including muscle aches, muscle tenderness, or muscle weakness, with elevated creatine phosphokinase greater than ten times the upper limit of normal. Rhabdomyolysis has been reported in patients using atorvastatin.[10] Patients with impaired renal function may be at increased risk of developing rhabdomyolysis. Using atorvastatin in combination with other medications that increase atorvastatin plasma concentrations increases the risk for myopathies and rhabdomyolysis.[11] Management of statin-induced myopathies includes temporarily holding therapy, switching to an alternative statin, or reducing the dose. 

Some data suggest that statins may increase the risk of developing diabetes mellitus. In 2012, the FDA added safety label changes to statin safety labeling, indicating that they have been shown to increase glycosylated hemoglobin and fasting serum glucose. [12] The ACC/AHA guidelines group and other experts state that the risk-reducing benefits of statin therapy outweigh the generally mild rise in serum glucose levels or new-onset diabetes.[13] Clinicians are encouraged to use this opportunity to discuss healthy lifestyle measures with their patients, including weight loss, engaging in an exercise program, and consuming a healthy diet.

Atorvastatin can cause liver function test abnormalities.[7] If patients develop serum transaminases over three times the upper limit of normal, plasma concentrations require more frequent monitoring until normalized, or atorvastatin therapy should undergo dose reduction or be discontinued. 

Contraindications

Atorvastatin contraindications include patients with hypersensitivity to any of its components.

While atorvastatin contraindications also include patients with active liver disease, the benefits of lipid-lowering therapy in chronic liver diseases, such as non-alcoholic fatty liver disease and hepatitis, likely outweigh the possible risks. [14]

Atorvastatin is contraindicated during pregnancy or in female patients who may become pregnant. All female patients of childbearing age should receive counseling on the potential risks to a fetus should they become pregnant while on atorvastatin. This risk is most pronounced in the first trimester, so current guidelines recommend ceasing statin therapy for at least three months prior to becoming pregnant. The patient should discontinue this medication immediately if they become pregnant. However, a recent meta-analysis has called this restriction into question; more research will be necessary to accurately assess the risk-benefit ratio of using statins during pregnancy.[15]

Female patients should also avoid atorvastatin if they are nursing. If patients require atorvastatin therapy, they should receive direction to discontinue breastfeeding. 

Monitoring

Patients starting atorvastatin should have liver function tests and a lipid panel performed at baseline, with a repeat lipid panel after six weeks of therapy. Liver function tests should be repeated as clinically indicated. Once the patient is stable, lipids can be checked every 6 to 12 months. It may also be prudent to periodically monitor serum blood glucose levels in patients with diabetes or at risk for diabetes.

Toxicity

There are no antidotes available for atorvastatin overdose. Patients should be monitored for adverse events and provided with supportive care. 

Enhancing Healthcare Team Outcomes

The success of statins in lowering lipids or preventing cardiovascular events depends on the patient’s medication adherence. Some barriers to successful statin therapy include experiencing adverse effects, lack of understanding of the importance of statin therapy, and cost; these factors may prevent patients from taking these medications as prescribed. It is also crucial for the interprofessional team to emphasize the importance of lifestyle modification in treating hyperlipidemia. This includes eating a proper, healthy diet, adding exercise or activity several times a week, and losing weight if necessary. A dietician or nutritionist may be a valuable addition to the healthcare team to help guide patients through the necessary dietary changes.

All interprofessional health care team members can help identify barriers to adherence. Additional education and counseling around patient concerns and medication benefits may help improve compliance.[16] [Level 3] Healthcare team members need to communicate across disciplinary lines to optimize therapy. Clinicians (MDs, DOs, NPs, PAs) will make the initial assessment and prescribe statin therapy. Nursing can counsel the patients on how to take their medication, check for adherence to treatment and adverse effects on subsequent visits, and report back to the prescriber. Pharmacists can counsel the patients on optimal dosing (e.g., take the drug at bedtime) and check for drug-drug interactions, reporting to the prescriber or nurse. Pharmacists can also inquire about the most common adverse effects since they often will see the patient more frequently and let nursing know so it can be relayed to the prescriber as well; open communication between all interprofessional team members combined with accurate record keeping is crucial to optimal care and improved patient outcomes. These are a few examples of how interprofessional team interaction can optimize atorvastatin therapy. [Level 5]

Review Questions

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References

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Raddino R, Della Pina P, Gorga E, Caretta G, Madureri A, Dei Cas L. [Indications for statin therapy in patients with acute coronary syndrome of ischemic origin]. G Ital Cardiol (Rome). 2010 Oct;11(10 Suppl 1):78S-83S. [PubMed: 21416832]

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Dagli-Hernandez C, Zhou Y, Lauschke VM, Genvigir FDV, Hirata TDC, Hirata MH, Hirata RDC. Pharmacogenomics of statins: lipid response and other outcomes in Brazilian cohorts. Pharmacol Rep. 2022 Feb;74(1):47-66. [PubMed: 34403130]

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Karvaly GB, Karádi I, Vincze I, Neely MN, Trojnár E, Prohászka Z, Imreh É, Vásárhelyi B, Zsáry A. A pharmacokinetics-based approach to the monitoring of patient adherence to atorvastatin therapy. Pharmacol Res Perspect. 2021 Oct;9(5):e00856. [PMC free article: PMC8415218] [PubMed: 34478238]

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Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC, Watson K, Wilson PW, Eddleman KM, Jarrett NM, LaBresh K, Nevo L, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC, Tomaselli GF., American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 24;129(25 Suppl 2):S1-45. [PubMed: 24222016]

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Jacobson TA, Ito MK, Maki KC, Orringer CE, Bays HE, Jones PH, McKenney JM, Grundy SM, Gill EA, Wild RA, Wilson DP, Brown WV. National lipid association recommendations for patient-centered management of dyslipidemia: part 1–full report. J Clin Lipidol. 2015 Mar-Apr;9(2):129-69. [PubMed: 25911072]

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Jellinger PS, Handelsman Y, Rosenblit PD, Bloomgarden ZT, Fonseca VA, Garber AJ, Grunberger G, Guerin CK, Bell DSH, Mechanick JI, Pessah-Pollack R, Wyne K, Smith D, Brinton EA, Fazio S, Davidson M. AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY GUIDELINES FOR MANAGEMENT OF DYSLIPIDEMIA AND PREVENTION OF CARDIOVASCULAR DISEASE. Endocr Pract. 2017 Apr;23(Suppl 2):1-87. [PubMed: 28437620]

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Filppula AM, Hirvensalo P, Parviainen H, Ivaska VE, Lönnberg KI, Deng F, Viinamäki J, Kurkela M, Neuvonen M, Niemi M. Comparative Hepatic and Intestinal Metabolism and Pharmacodynamics of Statins. Drug Metab Dispos. 2021 Aug;49(8):658-667. [PubMed: 34045219]

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Hirota T, Fujita Y, Ieiri I. An updated review of pharmacokinetic drug interactions and pharmacogenetics of statins. Expert Opin Drug Metab Toxicol. 2020 Sep;16(9):809-822. [PubMed: 32729746]

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Božina N, Ganoci L, Simičević L, Gvozdanović K, Domjanović IK, Fistrek Prlić M, Križ T, Borić Bilušić A, Laganović M, Božina T. Drug-drug-gene interactions as mediators of adverse drug reactions to diclofenac and statins: a case report and literature review. Arh Hig Rada Toksikol. 2021 Jun 28;72(3):114-128. [PMC free article: PMC8265195] [PubMed: 34187111]

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Jayatilaka S, Desai K, Rijal S, Zimmerman D. Statin-Induced Autoimmune Necrotizing Myopathy. J Prim Care Community Health. 2021 Jan-Dec;12:21501327211028714. [PMC free article: PMC8255573] [PubMed: 34219515]

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Chogtu B, Magazine R, Bairy KL. Statin use and risk of diabetes mellitus. World J Diabetes. 2015 Mar 15;6(2):352-7. [PMC free article: PMC4360430] [PubMed: 25789118]

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Keni R, Sekhar A, Gourishetti K, Nayak PG, Kinra M, Kumar N, Shenoy RR, Kishore A, Nandakumar K. Role of Statins in New-onset Diabetes Mellitus: The Underlying Cause, Mechanisms Involved, and Strategies to Combat. Curr Drug Targets. 2021;22(10):1121-1128. [PubMed: 33494673]

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Disclosure: Lindsey McIver declares no relevant financial relationships with ineligible companies.

Disclosure: Momin Siddique declares no relevant financial relationships with ineligible companies.

Atorvastatin Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

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. It belongs to a group of drugs known as “statins.” It works by reducing the amount of cholesterol made by the liver. 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. Consult your doctor for more details.

How to use Atorvastatin 20 Mg/5 Ml (4 Mg/Ml) Oral Suspension

Read the Patient Information Leaflet if available from your pharmacist before you start taking atorvastatin and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually once daily. It should be taken on an empty stomach, 1 hour before or 2 hours after a meal.

The dosage is based on your medical condition, response to treatment, age, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Shake the bottle well before each dose. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

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. These products can react with atorvastatin, preventing its full absorption.

Take this medication regularly in order to get the most benefit from it. Remember to take it at the same time each day. Keep taking this medication even if you feel well. Most people with high cholesterol or triglycerides do not feel sick.

It is very important to continue to follow your doctor’s advice about diet and exercise. It may take up to 4 weeks before you get the full benefit of this drug.

Side Effects

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very small number of people taking atorvastatin may have mild memory problems or confusion. If these rare effects occur, talk to your doctor.

Rarely, statins may cause or worsen diabetes. Talk to your doctor about the benefits and risks.

This drug may rarely cause muscle problems (which can rarely lead to very serious conditions called rhabdomyolysis and autoimmune myopathy). Tell your doctor right away if you develop any of these symptoms during treatment and if these symptoms last after your doctor stops this drug: muscle pain/tenderness/weakness (especially with fever or unusual tiredness), signs of kidney problems (such as change in the amount of urine).

This medication may rarely cause liver problems. 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.

A very serious allergic reaction to this drug is rare. 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.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking atorvastatin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, alcohol use.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Limit alcoholic beverages. Daily use of alcohol may increase your risk for liver problems, especially when combined with atorvastatin. Ask your doctor or pharmacist for more information.

Older adults may be more sensitive to the side effects of this drug, especially muscle problems.

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Interactions

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Some products that may interact with this drug include: daptomycin, gemfibrozil.

Other medications can affect the removal of atorvastatin from your body, which may affect how atorvastatin works. Examples include glecaprevir plus pibrentasvir, telithromycin, ritonavir, among others.

Do not take any red yeast rice products while you are taking atorvastatin because some red yeast rice products may also contain a statin called lovastatin. Taking atorvastatin and red yeast rice products together can increase your risk of serious muscle and liver problems.

Does Atorvastatin 20 Mg/5 Ml (4 Mg/Ml) Oral Suspension interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Do not share this medication with others.

Lab and/or medical tests (such as blood cholesterol/triglyceride levels, liver function) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember unless it is more than 12 hours after the time you usually take the dose. In that case, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Store the suspension form in the original container. Discard the suspension form 60 days after opening the bottle, even if there is medication left. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

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CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

How does atorvastatin affect testosterone and other hormone levels in men and women?

Relevance

Statins are one of the most commonly prescribed drug classes, and atorvastatin is the most commonly used drug in this class. People take statins to lower their blood cholesterol and reduce their risk of heart disease. However, statins can also lower testosterone and other androgens (male sex hormones). These hormones play an important role in male and female health and development.

What have we done?

We wanted to evaluate the effect of atorvastatin on testosterone and other androgens. We searched the medical literature for all studies that compared the effects of atorvastatin at different doses with placebo or no treatment in men and women, and reported on their testosterone and other androgen levels. We looked for studies in which treatment decisions were randomized. This type of study usually provides the most reliable evidence about the effects of treatment. People of any age could take part in the studies.

After identifying these studies, we compared the results and summarized the evidence from all studies. We then assessed our confidence in this evidence (“certainty of evidence”) based on factors such as study methods and size, and the consistency of results across studies.

What did we find?

We found six studies with 265 participants. The studies were carried out in China, Finland, Iran, Turkey, Great Britain and the USA.

Evidence from four studies suggests that atorvastatin may have a potential beneficial effect in women with polycystic ovary syndrome (PCOS), a group of symptoms that may develop in women with higher than normal androgen levels. In women with PCOS, atorvastatin reduced total testosterone and other androgens.

We found two studies in men in which atorvastatin had no significant effect on total testosterone levels.

What does this mean?

The certainty of evidence for all outcomes ranged from low to very low. Our statistical estimates of the effect of atorvastatin on testosterone and other androgens in men and women may differ greatly from the true effects. More research is needed to answer this important question.

How relevant is this evidence?

The evidence from this review is current to November 2020.

If you found this evidence helpful, please consider donating to Cochrane. We are a charity that produces accessible evidence to help people make health and care decisions.

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Translation notes:

Translation: Kovalenko Alena Sergeevna. Editing: Yudina Ekaterina Viktorovna. Russian translation project coordination: Cochrane Russia – Cochrane Russia, Cochrane Geographic Associated to Cochrane Nordic. For questions related to this translation, please contact us at: cochranerussia@gmail. com.

The choice of drugs to lower cholesterol and prevent the risk of cardiovascular disease

Currently, this is probably the only group of drugs that causes a huge amount of controversy and misunderstanding among patients.

Why?

Cholesterol level is not felt by the body. The effectiveness of the use of statins can only be monitored using laboratory tests.

There is a whole campaign on the Internet and in the media about the side effects of statins, especially their harmful effects on the liver, which in fact have nothing to do with the real situation. This is a separate study (https://pubmed.ncbi.nlm.nih.gov/32557172/)

You need to take statins for life. This is not an emergency medicine. Even if the cholesterol level has returned to normal, you can stop taking the drug only in extreme cases.

According to the study In Russia, after 1 year, 69.9% of patients refuse to take statins, and within 5 years – 93.1%.

Causes:

• Fear of adverse effects that they read about in the instructions for the drug or in the media (46%)
• Lack of belief that the drug prolongs life (29. 4%)
• Taking a large number of concomitant pills (27.6%)
• Forgetfulness (26.5%)
• Poor effect on blood cholesterol levels while taking medication (18.8%)
• Drug withdrawal by physician (13.5%).

At the same time, the real development of adverse events on statin therapy was observed only in 11.7% of patients, and their manifestations were mild to moderate.
It turns out that fear and “lack of faith” lead to 6 times more drug withdrawals than actual side effects.

The following groups of drugs are used to lower blood cholesterol and prevent cardiovascular diseases:

statins

bile acid sequestrants

fibrates

nicotinic acid

cholesterol reabsorption blockers

CETP – inhibitors

A detailed description of each group of drugs, assessment of their action, possible side effects, contraindications and influence on the prognosis are presented in the table.

As can be seen from the table, statins and bile acid sequestrants mainly have a cholesterol-lowering effect, fibrates predominantly reduce hypertriglyceridemia, and nicotinic acid reduces both cholesterol and triglycerides. Bile acid sequestrants, which not only do not reduce the level of TG, but can even significantly increase it, are not prescribed when the upper limit of the normal TG (200 mg / dL) is exceeded. Nicotinic acid lowers both cholesterol and TG levels. Fibrates have the most pronounced ability to correct hypertriglyceridemia, but their cholesterol-lowering effect is inferior to that of other classes of lipid-lowering drugs.

Thus, the main drug of choice in the selection of cholesterol-lowering therapy are statins.

The main representatives of the group of statins that are prescribed and used today are rosuvastatin and atorvastatin. They are the safest and most effective.

A few examples from my own practice:

1. Woman, 64 years old, has been suffering from compensated type 2 diabetes since the age of 49. BMI (body mass index) 30.4, heredity is aggravated – the father had diabetes, was overweight, arterial hypertension, died at 56 from a heart attack.

On examination: according to the ultrasound examination of the carotid arteries, thickening of the intima-media complex up to 1.1 mm, no plaques.

Blood creatinine is normal, but microalbuminuria is increased by 2.5 times, the initial decrease in glomerular filtration rate is a sign of diabetic nephropathy. The level of low-density lipoprotein cholesterol (LDL cholesterol) increased to 4.4 mmol/l.

There are no clinical signs of atherosclerosis, however, the presence and duration of type 2 diabetes is characterized by damage to target organs (kidneys, endothelium), and, in addition, according to the latest recommendations, diabetes is equated to coronary artery disease in terms of the risk of developing cardiovascular complications.

Therefore, it is advisable for the patient to prescribe statins – atorvastatin at a dose of 40 mg / day is indicated due to the significant height of cardiovascular risk.

A year later, compensation for type 2 diabetes is maintained, there are no clinical manifestations of atherosclerosis, kidney and liver functions are normal, microalbuminuria does not exceed 2 times the norm, the target LDL cholesterol level of 1.9 mmol/l has been reached.

It is recommended to continue ongoing therapy, including taking Liprimar at a dose of 20 mg/day.

2. Male, 57 years old, arterial hypertension of the 2nd degree, metabolic syndrome, BMI 32, heredity is not burdened.

On examination: the level of microalbuminuria increased by 3.5 times, LDL cholesterol increased to 5.2 mmol/l. Receives treatment: angiotensin-converting enzyme inhibitor, thiazide diuretic, calcium channel antagonist, aspirin. Blood pressure at the target level. Should I prescribe statins?

For a patient with arterial hypertension and three risk factors, it is advisable to prescribe atorvastatin at a dose of 20 mg / day for the purpose of primary prevention of cardiovascular complications.

At the examination after 4 months: the level of microalbuminuria is reduced to 1.5-fold, LDL – 2.9 mmol / l, AST, ALT, CK are normal.

Recommended: continue treatment with atorvastatin at a dose of 10 mg / day diet for weight loss: “plate rule”, physical activity – 10,000 steps a day

Despite the apparent positive effect of statins, these drugs are far from safe. And I, as a doctor, always warn patients about the possible complications that may arise when taking them.

Main side effects of statins

1. Muscle pain is one of the most common complaints of patients taking statins. It can be felt as mild discomfort (soreness, fatigue, muscle weakness), or it can be difficult to bear. A 2016 study published in the Journal of the American College of Cardiology found that this symptom usually occurs in people who: have low muscle mass have hypothyroidism are vitamin D deficient drink alcohol regularly take tricyclic antidepressants, azole antifungals, or mycin antibiotics often drink grapefruit or pomegranate juice. Moreover, in some cases, patients develop rhabdomyolysis, an extreme degree of muscle damage in which a large number of muscle cells are destroyed at the same time. The breakdown products enter the systemic circulation and cause muscle pain, nausea, vomiting, disorientation, heart rhythm disturbances, and even acute renal failure. The risk of a life-threatening condition is very low – only a few cases per million people taking statins. Rhabdomyolysis can occur if you are taking statins in combination with certain medications or if you are taking high doses of statins.

2. Liver damage. According to a study published in the Journal of the American College of Cardiology, abnormal liver function tests are sometimes observed with statins, and this is especially true for patients taking lipid-lowering drugs for the first time. As you know, an increase in ALT and AST enzymes may indicate an inflammatory process in the liver. If the indicators are slightly increased, the course of treatment with statins, as a rule, is not interrupted. With a strong increase in the level of enzymes, the statin drug can be replaced. To prevent liver damage, patients are advised to take a biochemical blood test for liver enzymes before the course of statins and some time after the start of therapy. In addition, doctors advise combining statins with ursodeoxycholic acid preparations. UDCA simultaneously protects liver cells and improves the anti-cholesterol effect. Be sure to tell your doctor if you experience unusual fatigue or weakness while taking statins, notice a lack of appetite, pain in the upper abdomen, dark urine and / or yellowing of the skin and mucous membranes.

3. High blood sugar or type 2 diabetes. A 2017 meta-analysis published in Nutrition, Metabolism and Cardiovascular Diseases found an association between statin use and type 2 diabetes. The authors of the study stated that patients treated with statins had a 44% increased risk of developing diabetes. People without a predisposition to diabetes are advised to keep their blood sugar under control and, if they worsen, talk to their doctor about changing their treatment strategy. Patients with an inherently high risk of diabetes may be better off looking for other approaches to lower cholesterol levels (through diet, exercise, and other medications).

4. Very rare, but possible neurological side effects such as memory loss and confusion . These side effects disappear as soon as you stop taking the medicine.

Who is at high risk for the side effects of statins.

Not everyone who takes a statin has side effects. Here are the categories of patients at increased risk of unpleasant symptoms:

Patients taking multiple cholesterol-lowering drugs at the same time

Patients with kidney or liver disease

Alcohol abusers

Patients with hypothyroidism or neuromuscular disorders such as amyotrophic lateral sclerosis (ALS) 90 005

Patients aged 80 and over

Women

Drugs that increase the risk of side effects when taking statins:

1. Amiodarone – for the treatment of arrhythmia

2. Gemfibrozil – to lower cholesterol

3. Protease inhibitors (saquinavir and ritonavir) – to treat HIV

4. 90 104 Certain antibiotics and antifungals (clarithromycin, itraconazole)

5. Certain immunosuppressants (Cyclosporin)

In conclusion, my patient and I make the decision to take statins together.