Atorvastatin 40mg Tablets
It is used to lower bad cholesterol, lower triglycerides, and raise good cholesterol (HDL).It is used in some people to lower the chance of chest pain (angina), heart attack, stroke, and certain heart procedures.It is used to slow the progress of heart disease.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antilipemic Agent; HMG-CoA Reductase Inhibitor
Pharmacologic Class
HMG-CoA Reductase Inhibitor (Statin)
Pregnancy Category
Category X
FDA Approved
Dec 1996
DEA Schedule
Not Controlled
Overview
What is this medicine?
Atorvastatin is a medication called a 'statin' that helps lower high cholesterol and triglyceride levels in your blood. It works by reducing the amount of 'bad' cholesterol (LDL) your body makes and increasing the removal of it from your blood. Lowering cholesterol can help prevent heart attacks, strokes, and other heart problems.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food, and it's best to take it at the same time every day. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
To keep your medication effective and safe, store it at room temperature in a dry place, away from the bathroom. Keep all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion.
What to Do If You Miss a Dose
If you miss a dose, skip it and take your next dose at the usual time. Do not take two doses at the same time or take extra doses to make up for the missed one.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food, and it's best to take it at the same time every day. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
To keep your medication effective and safe, store it at room temperature in a dry place, away from the bathroom. Keep all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion.
What to Do If You Miss a Dose
If you miss a dose, skip it and take your next dose at the usual time. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Continue a cholesterol-lowering diet (low in saturated fat and cholesterol) as recommended by your doctor.
- Engage in regular physical activity.
- Maintain a healthy weight.
- Quit smoking.
- Limit alcohol intake.
- Take the medication at the same time each day, with or without food, as directed by your doctor.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
10 to 80 mg orally once daily
Dose Range:
10 - 80 mg
Condition-Specific Dosing:
Primary Hypercholesterolemia and Mixed Dyslipidemia:
Initial: 10-20 mg once daily. Patients requiring large reduction in LDL-C (e.g., >45%) may start at 40 mg once daily. Maintenance: 10-80 mg once daily.
Homozygous Familial Hypercholesterolemia:
10-80 mg once daily.
Heterozygous Familial Hypercholesterolemia:
Initial: 10-20 mg once daily. Maintenance: 10-80 mg once daily.
Primary Prevention of Cardiovascular Disease:
10-80 mg once daily, typically 10-20 mg for moderate intensity, 40-80 mg for high intensity.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
10-17 years (Heterozygous Familial Hypercholesterolemia): Initial 10 mg orally once daily; Max 20 mg orally once daily. Doses >20 mg have not been studied in this population.
Adolescent:
10-17 years (Heterozygous Familial Hypercholesterolemia): Initial 10 mg orally once daily; Max 20 mg orally once daily. Doses >20 mg have not been studied in this population.
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment necessary.
Moderate:
No dosage adjustment necessary.
Severe:
No dosage adjustment necessary.
Dialysis:
Not dialyzable; no dosage adjustment necessary.
Hepatic Impairment:
Mild:
Use with caution. Monitor LFTs.
Moderate:
Use with caution. Monitor LFTs.
Severe:
Contraindicated in patients with active liver disease or unexplained persistent elevations of serum transaminases.
Pharmacology
Mechanism of Action
Atorvastatin is a selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that catalyzes the conversion of 3-hydroxy-3-methylglutaryl-coenzyme A to mevalonate, a precursor of sterols, including cholesterol. This inhibition leads to a decrease in hepatic cholesterol synthesis, which in turn upregulates the expression of LDL receptors on hepatocyte surfaces, increasing the uptake and catabolism of LDL. Atorvastatin also reduces VLDL and triglyceride production.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 12% (systemic), 30% (HMG-CoA reductase inhibitory activity)
Tmax:
1-2 hours
FoodEffect:
Food decreases the rate and extent of drug absorption by approximately 25% and 9% respectively, as assessed by Cmax and AUC. However, LDL-C reduction is similar whether taken with or without food.
Distribution:
Vd:
Approximately 381 L
ProteinBinding:
>98%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 14 hours (for parent drug); 20-30 hours (for HMG-CoA reductase inhibitory activity due to active metabolites)
Clearance:
Not available
ExcretionRoute:
Biliary/fecal (major), renal (minor)
Unchanged:
<2% excreted in urine
Pharmacodynamics
OnsetOfAction:
Within 2 weeks
PeakEffect:
Within 4 weeks (for lipid-lowering effects)
DurationOfAction:
Not available (effects persist as long as therapy continues)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of a urinary tract infection (UTI), such as:
+ Blood in the urine
+ Burning or pain when passing urine
+ Frequent or urgent need to urinate
+ Fever
+ Lower stomach pain
+ Pelvic pain
Signs of a severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), such as:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes
Severe dizziness or fainting
Rapid heartbeat
Weakness on one side of the body
Trouble speaking or thinking
Changes in balance
Drooping on one side of the face
Blurred vision
Difficulty urinating or changes in urine output
Muscle problems, such as:
+ Abnormal muscle pain
+ Tenderness
+ Weakness (with or without fever)
+ If your doctor instructs you to stop taking this medication but your muscle problems persist, contact your doctor
Liver Problems: A Serious Side Effect
Severe and potentially life-threatening liver problems have been associated with this medication. If you experience any of the following symptoms, contact your doctor immediately:
Dark urine
Fatigue
Decreased appetite
Upset stomach or stomach pain
Light-colored stools
Vomiting
Yellow skin or eyes
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Diarrhea
Joint pain
Pain in arms or legs
Upset stomach
Nose or throat irritation
Signs of a common cold
Trouble sleeping
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of a urinary tract infection (UTI), such as:
+ Blood in the urine
+ Burning or pain when passing urine
+ Frequent or urgent need to urinate
+ Fever
+ Lower stomach pain
+ Pelvic pain
Signs of a severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), such as:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes
Severe dizziness or fainting
Rapid heartbeat
Weakness on one side of the body
Trouble speaking or thinking
Changes in balance
Drooping on one side of the face
Blurred vision
Difficulty urinating or changes in urine output
Muscle problems, such as:
+ Abnormal muscle pain
+ Tenderness
+ Weakness (with or without fever)
+ If your doctor instructs you to stop taking this medication but your muscle problems persist, contact your doctor
Liver Problems: A Serious Side Effect
Severe and potentially life-threatening liver problems have been associated with this medication. If you experience any of the following symptoms, contact your doctor immediately:
Dark urine
Fatigue
Decreased appetite
Upset stomach or stomach pain
Light-colored stools
Vomiting
Yellow skin or eyes
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Diarrhea
Joint pain
Pain in arms or legs
Upset stomach
Nose or throat irritation
Signs of a common cold
Trouble sleeping
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or dark urine (signs of muscle breakdown, rhabdomyolysis).
- Yellowing of the skin or eyes (jaundice), dark urine, unusual fatigue, loss of appetite, or pain in the upper right stomach area (signs of liver problems).
- Swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing (signs of allergic reaction).
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have liver disease or elevated liver enzymes.
If you are currently taking any of the following medications: Cyclosporine, gemfibrozil, glecaprevir plus pibrentasvir, letermovir, or tipranavir plus ritonavir.
If you are pregnant or think you might be pregnant. Note that this medication should not be taken during pregnancy.
* If you are breastfeeding. You should not breastfeed while taking this medication.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have liver disease or elevated liver enzymes.
If you are currently taking any of the following medications: Cyclosporine, gemfibrozil, glecaprevir plus pibrentasvir, letermovir, or tipranavir plus ritonavir.
If you are pregnant or think you might be pregnant. Note that this medication should not be taken during pregnancy.
* If you are breastfeeding. You should not breastfeed while taking this medication.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you have diabetes, it is crucial to closely monitor your blood sugar levels. Regularly undergo blood work and other laboratory tests as advised by your doctor. Adhere to the diet and exercise plan recommended by your doctor to ensure optimal management of your condition.
If you consume grapefruit juice or eat grapefruit frequently, discuss this with your doctor. Limit your alcohol intake to no more than 2 drinks per day, as excessive alcohol consumption may increase your risk of developing liver disease.
Be aware that this medication may cause muscle pain, tenderness, or weakness, which can be severe and potentially lead to kidney problems. In rare cases, this has resulted in fatalities. The risk of these adverse effects may be higher if you have pre-existing thyroid problems, kidney problems, infections, low blood pressure, or a history of seizures. Additionally, the risk may be increased if you are taking certain other medications or are dehydrated. Older adults, particularly those aged 65 and above, may also have a higher risk of experiencing these side effects. If you have any concerns or questions, consult your doctor.
As you age, your sensitivity to this medication may increase. If you are 65 or older, use this drug with caution, as you may be more susceptible to side effects.
This medication can cause harm to an unborn baby. If you are of childbearing potential, it is essential to use effective birth control while taking this drug. If you become pregnant, notify your doctor immediately.
If you consume grapefruit juice or eat grapefruit frequently, discuss this with your doctor. Limit your alcohol intake to no more than 2 drinks per day, as excessive alcohol consumption may increase your risk of developing liver disease.
Be aware that this medication may cause muscle pain, tenderness, or weakness, which can be severe and potentially lead to kidney problems. In rare cases, this has resulted in fatalities. The risk of these adverse effects may be higher if you have pre-existing thyroid problems, kidney problems, infections, low blood pressure, or a history of seizures. Additionally, the risk may be increased if you are taking certain other medications or are dehydrated. Older adults, particularly those aged 65 and above, may also have a higher risk of experiencing these side effects. If you have any concerns or questions, consult your doctor.
As you age, your sensitivity to this medication may increase. If you are 65 or older, use this drug with caution, as you may be more susceptible to side effects.
This medication can cause harm to an unborn baby. If you are of childbearing potential, it is essential to use effective birth control while taking this drug. If you become pregnant, notify your doctor immediately.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been reported. The most likely effects would be an exaggeration of known adverse effects, such as muscle pain or liver enzyme elevations.
What to Do:
There is no specific antidote for atorvastatin overdose. In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required. Hemodialysis is not expected to significantly enhance atorvastatin clearance due to extensive protein binding. Call 1-800-222-1222 (Poison Control Center) for advice.
Drug Interactions
Contraindicated Interactions
- Cyclosporine
- Gemfibrozil
- Tipranavir/Ritonavir
- Telaprevir
- Glecaprevir/Pibrentasvir
Major Interactions
- Strong CYP3A4 inhibitors (e.g., Itraconazole, Ketoconazole, Clarithromycin, Voriconazole, Posaconazole, HIV protease inhibitors like Ritonavir, Lopinavir/Ritonavir, Saquinavir/Ritonavir, Darunavir/Ritonavir, Fosamprenavir/Ritonavir, Nelfinavir)
- Other fibrates (e.g., Fenofibrate)
- Niacin (lipid-lowering doses âĨ1 g/day)
- Colchicine (in patients with renal or hepatic impairment)
- Ledipasvir/Sofosbuvir
- Daclatasvir/Asunaprevir/Beclabuvir
Moderate Interactions
- Moderate CYP3A4 inhibitors (e.g., Erythromycin, Diltiazem, Verapamil, Fluconazole, Grapefruit juice [large quantities])
- Amiodarone
- Digoxin
- Warfarin
- Oral contraceptives (norethindrone, ethinyl estradiol)
Minor Interactions
- Antacids (magnesium-aluminum hydroxides)
- Colestipol
Monitoring
Baseline Monitoring
Lipid Panel (Total Cholesterol, LDL-C, HDL-C, Triglycerides)
Rationale: To establish baseline lipid levels and assess the need for therapy.
Timing: Prior to initiation of therapy.
Liver Function Tests (ALT, AST)
Rationale: To establish baseline liver enzyme levels and rule out active liver disease, which is a contraindication.
Timing: Prior to initiation of therapy.
Creatine Kinase (CK)
Rationale: Consider for patients at increased risk for myopathy (e.g., renal impairment, hypothyroidism, genetic muscle disorders, prior statin-associated muscle toxicity).
Timing: Prior to initiation of therapy (if indicated).
Routine Monitoring
Lipid Panel (Total Cholesterol, LDL-C, HDL-C, Triglycerides)
Frequency: 4-12 weeks after initiation or dose titration, then every 3-12 months or as clinically indicated.
Target: LDL-C reduction based on patient risk category (e.g., <70 mg/dL, <100 mg/dL).
Action Threshold: Failure to achieve target LDL-C, or if lipid levels are not adequately controlled, consider dose adjustment or alternative therapy.
Liver Function Tests (ALT, AST)
Frequency: Periodically, as clinically indicated. No longer routinely recommended at fixed intervals unless clinically indicated (e.g., symptoms of liver injury).
Target: ALT/AST <3 times upper limit of normal (ULN).
Action Threshold: If ALT/AST >3 times ULN, discontinue atorvastatin. If elevations persist, investigate other causes.
Creatine Kinase (CK)
Frequency: Not routinely recommended unless muscle symptoms (pain, tenderness, weakness) develop.
Target: Not applicable (monitor for significant elevation).
Action Threshold: If CK >10 times ULN, or if muscle symptoms are severe or accompanied by CK elevation, discontinue atorvastatin. If CK <10 times ULN but muscle symptoms are bothersome, consider dose reduction or temporary discontinuation.
Symptom Monitoring
- Unexplained muscle pain, tenderness, or weakness (especially if accompanied by malaise or fever)
- Dark urine
- Yellowing of skin or eyes (jaundice)
- Unusual fatigue or weakness
- Loss of appetite
- Upper right abdominal pain
- Nausea, vomiting
Special Patient Groups
Pregnancy
Contraindicated in pregnancy (Pregnancy Category X). Statins may cause fetal harm. Cholesterol and its derivatives are essential for fetal development. Atorvastatin should be discontinued as soon as pregnancy is detected.
Trimester-Specific Risks:
First Trimester:
Potential for fetal harm due to interference with cholesterol synthesis, which is critical for fetal development.
Second Trimester:
Potential for fetal harm due to interference with cholesterol synthesis.
Third Trimester:
Potential for fetal harm due to interference with cholesterol synthesis.
Lactation
Contraindicated during breastfeeding (Lactation Risk L5). It is unknown whether atorvastatin or its metabolites are excreted in human milk. Due to the potential for serious adverse reactions in nursing infants, women taking atorvastatin should not breastfeed.
Infant Risk:
High risk of serious adverse effects due to potential for interference with infant lipid metabolism and development.
Pediatric Use
Approved for heterozygous familial hypercholesterolemia in patients 10-17 years of age. Dosing is typically 10 mg once daily, with a maximum of 20 mg/day. Safety and efficacy in patients younger than 10 years have not been established. Long-term effects on growth, sexual maturation, and endocrine development have not been fully studied.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly (âĨ65 years) and younger patients. However, greater sensitivity of some older individuals cannot be ruled out. No specific dosage adjustment is required based solely on age, but monitor for increased susceptibility to adverse effects (e.g., myopathy).
Clinical Information
Clinical Pearls
- Atorvastatin can be taken at any time of day, with or without food, due to its long half-life and active metabolites, unlike some other statins that are best taken in the evening.
- Patients should be advised to report any unexplained muscle pain, tenderness, or weakness immediately, especially if accompanied by malaise or fever.
- Grapefruit juice (large quantities, >1.2 liters/day) should be avoided as it can increase atorvastatin levels and the risk of side effects.
- Liver function tests are no longer routinely recommended at fixed intervals unless clinically indicated (e.g., symptoms of liver injury).
- Atorvastatin is a high-intensity statin at doses of 40 mg and 80 mg, and a moderate-intensity statin at 10 mg and 20 mg.
- Patients should be counseled on the importance of lifestyle modifications (diet, exercise) in conjunction with statin therapy.
Alternative Therapies
- Other HMG-CoA Reductase Inhibitors (Statins): Rosuvastatin, Simvastatin, Pravastatin, Lovastatin, Fluvastatin, Pitavastatin
- Cholesterol Absorption Inhibitors: Ezetimibe
- PCSK9 Inhibitors: Alirocumab, Evolocumab
- Fibrates: Gemfibrozil, Fenofibrate (for hypertriglyceridemia)
- Niacin (Nicotinic Acid)
- Bile Acid Sequestrants: Cholestyramine, Colestipol, Colesevelam
- Adenosine Triphosphate-Citrate Lyase (ACL) Inhibitors: Bempedoic Acid
- Omega-3 Fatty Acid Esters: Icosapent ethyl, Omega-3-acid ethyl esters
Cost & Coverage
Average Cost:
$10 - $100+ per 30 tablets (generic)
Generic Available:
Yes
Insurance Coverage:
Tier 1 (Generic) or Tier 2 (Preferred Brand, if applicable)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.