Atorvastatin 10mg 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
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 medicine called a 'statin' that helps lower high cholesterol and triglyceride levels in your blood. High cholesterol can lead to heart disease and strokes. This medicine works by reducing the amount of cholesterol your body makes. It's often used along with diet and exercise.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication with or without food, and try 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 feeling better.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a safe place, out of the reach of children and pets.
What to Do If You Miss a Dose
If you miss a dose, skip it and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication with or without food, and try 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 feeling better.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a safe place, out of the reach of children and pets.
What to Do If You Miss a Dose
If you miss a dose, skip it and resume your regular dosing schedule. 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 as advised by your healthcare provider.
- Maintain a healthy weight.
- Avoid excessive alcohol consumption.
- Avoid grapefruit or grapefruit juice, as it can increase the levels of atorvastatin in your body and raise the risk of side effects.
- Take the medication at the same time each day, with or without food. It can be taken at any time of day, but consistency is key.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
10 mg orally once daily
Dose Range:
10 - 80 mg
Condition-Specific Dosing:
primaryHyperlipidemia:
Initial 10-20 mg once daily; dose range 10-80 mg once daily.
heterozygousFamilialHypercholesterolemia:
Initial 10 mg once daily; dose range 10-80 mg once daily.
homozygousFamilialHypercholesterolemia:
Initial 10-80 mg once daily.
primaryPreventionOfCardiovascularDisease:
10 mg once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
âĨ10 years: Heterozygous Familial Hypercholesterolemia (HeFH): Initial 10 mg once daily; dose range 10-20 mg once daily. Homozygous Familial Hypercholesterolemia (HoFH): 10-80 mg once daily.
Adolescent:
âĨ10 years: Heterozygous Familial Hypercholesterolemia (HeFH): Initial 10 mg once daily; dose range 10-20 mg once daily. Homozygous Familial Hypercholesterolemia (HoFH): 10-80 mg once daily.
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.
Moderate:
Use with caution.
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 converts 3-hydroxy-3-methylglutaryl-coenzyme A to mevalonate, a precursor of sterols, including cholesterol. This inhibition leads to a reduction 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 levels and increases HDL-C.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 12-14% (absolute bioavailability), 30% (systemic availability of 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 (including active metabolites, which contribute to ~70% of HMG-CoA reductase inhibitory activity)
Clearance:
Not available (primarily hepatic clearance)
ExcretionRoute:
Primarily biliary/fecal excretion (approximately 70% of oral dose), <2% renal excretion
Unchanged:
<2% (renal excretion)
Pharmacodynamics
OnsetOfAction:
Within 2 weeks
PeakEffect:
Within 4 weeks
DurationOfAction:
Sustained 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 immediate medical attention:
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), including:
+ Blood in the urine
+ Burning or pain when passing urine
+ Frequent or urgent need to urinate
+ Fever
+ Lower stomach pain or 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, balance changes, drooping on one side of the face, or blurred vision
Difficulty urinating or changes in urine output
Muscle problems, such as abnormal muscle pain, tenderness, or weakness (with or without fever); if your doctor instructs you to stop the medication but your muscle problems persist, contact your doctor
Liver Problems: A Serious Concern
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 immediate medical attention:
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), including:
+ Blood in the urine
+ Burning or pain when passing urine
+ Frequent or urgent need to urinate
+ Fever
+ Lower stomach pain or 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, balance changes, drooping on one side of the face, or blurred vision
Difficulty urinating or changes in urine output
Muscle problems, such as abnormal muscle pain, tenderness, or weakness (with or without fever); if your doctor instructs you to stop the medication but your muscle problems persist, contact your doctor
Liver Problems: A Serious Concern
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)
- Yellowing of the skin or eyes (jaundice)
- Dark-colored urine
- Unusual tiredness or weakness
- Loss of appetite
- Upper stomach pain
- Swelling in your hands or feet
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 is not recommended 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 drugs 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 is not recommended 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 drugs 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 instructed 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 may pose a risk to an unborn baby. If you are of childbearing potential, it is essential to use 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 may pose a risk to an unborn baby. If you are of childbearing potential, it is essential to use 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 adverse effects would be exaggerated side 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. Due to extensive protein binding, hemodialysis is not expected to significantly enhance atorvastatin clearance. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Contraindicated Interactions
- Cyclosporine
- Gemfibrozil (increased risk of myopathy/rhabdomyolysis)
- Tipranavir/Ritonavir (increased atorvastatin exposure)
Major Interactions
- Strong CYP3A4 inhibitors (e.g., Itraconazole, Ketoconazole, Clarithromycin, Telithromycin, Voriconazole, HIV protease inhibitors like Lopinavir/Ritonavir, Saquinavir/Ritonavir, Darunavir/Ritonavir, Fosamprenavir/Ritonavir, Nelfinavir, Indinavir, Atazanavir/Ritonavir, Delavirdine, Cobicistat-containing products) - significantly increase atorvastatin exposure and risk of myopathy.
- Other fibrates (e.g., Fenofibrate) - increased risk of myopathy/rhabdomyolysis.
- Niacin (lipid-lowering doses âĨ1 g/day) - increased risk of myopathy/rhabdomyolysis.
- Colchicine (in patients with renal or hepatic impairment) - increased risk of myopathy/rhabdomyolysis.
Moderate Interactions
- Moderate CYP3A4 inhibitors (e.g., Erythromycin, Diltiazem, Verapamil, Fluconazole, Amiodarone, Amlodipine, Grapefruit juice (large quantities >1.2 L/day)) - may increase atorvastatin exposure.
- Rifampin (CYP3A4 inducer) - may decrease atorvastatin concentrations (administer simultaneously).
- Digoxin - may increase digoxin concentrations.
- Oral contraceptives (norethindrone and ethinyl estradiol) - may increase concentrations of oral contraceptive components.
Minor Interactions
- Antacids (magnesium-aluminum hydroxide) - decrease atorvastatin plasma concentrations (no effect on LDL-C reduction).
- Warfarin - slight decrease in prothrombin time (monitor INR).
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, as statins can cause transaminase elevations.
Timing: Prior to initiation of therapy.
Creatine Kinase (CK)
Rationale: To establish baseline levels in patients with predisposing factors for myopathy (e.g., renal impairment, hypothyroidism, history of muscle toxicity with other lipid-lowering agents, genetic muscle disorders, alcoholism).
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 thereafter.
Target: LDL-C reduction based on individual risk assessment and guideline recommendations (e.g., >50% reduction for high-intensity statin).
Action Threshold: If LDL-C goal not met, consider dose titration or combination therapy. If lipid levels are excessively low, consider dose reduction.
Liver Function Tests (ALT, AST)
Frequency: As clinically indicated (e.g., if symptoms suggestive of liver injury occur). Routine periodic monitoring is no longer recommended by FDA unless clinically indicated.
Target: ALT/AST < 3 times upper limit of normal (ULN).
Action Threshold: If persistent elevations >3 times ULN occur, discontinue atorvastatin. If elevations are <3 times ULN but persistent, consider dose reduction or discontinuation.
Creatine Kinase (CK)
Frequency: Only if muscle symptoms (e.g., pain, tenderness, weakness) develop.
Target: CK < 10 times ULN.
Action Threshold: If CK levels are significantly elevated (>10 times ULN) or if myopathy/rhabdomyolysis is diagnosed or suspected, discontinue atorvastatin immediately. If muscle symptoms are severe or debilitating, consider discontinuing even if CK is not significantly elevated.
Symptom Monitoring
- Unexplained muscle pain, tenderness, or weakness (especially if accompanied by malaise or fever)
- Dark urine (suggestive of myoglobinuria)
- Yellowing of skin or eyes (jaundice)
- Unusual fatigue or weakness
- Loss of appetite
- Upper right abdominal pain
Special Patient Groups
Pregnancy
Atorvastatin is contraindicated in pregnancy. Statins may cause fetal harm when administered to pregnant women. Cholesterol and other products of cholesterol biosynthesis are essential for fetal development, including synthesis of steroids and cell membranes. The risk of therapy should be weighed against the potential benefits.
Trimester-Specific Risks:
First Trimester:
Potential for fetal harm due to interference with cholesterol synthesis, which is critical for early fetal development.
Second Trimester:
Continued risk of interference with fetal development.
Third Trimester:
Continued risk of interference with fetal development.
Lactation
Atorvastatin is contraindicated during breastfeeding. It is unknown whether atorvastatin or its metabolites are excreted in human milk. Because of the potential for serious adverse reactions in nursing infants, women taking atorvastatin should not breastfeed.
Infant Risk:
L5 (Contraindicated - significant documented risk to infant or to milk production, or no human studies and high risk of adverse effect).
Pediatric Use
Atorvastatin is approved for use in pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH) or homozygous familial hypercholesterolemia (HoFH). Dosing should be individualized based on the patient's lipid levels and response to therapy. Safety and efficacy have not been established in patients younger than 10 years of age.
Geriatric Use
No overall differences in safety or effectiveness have been observed between geriatric (âĨ65 years) and younger patients. However, greater sensitivity of some older individuals cannot be ruled out. Use with caution and monitor for adverse effects, particularly muscle-related symptoms.
Clinical Information
Clinical Pearls
- Atorvastatin is a high-intensity statin at doses of 40-80 mg and a moderate-intensity statin at doses of 10-20 mg, making 10mg a common starting dose for many patients.
- Unlike some other statins, atorvastatin can be taken at any time of day, as its long half-life ensures consistent efficacy.
- Patients should be educated on the importance of reporting any unexplained muscle pain, tenderness, or weakness immediately, as this could be a sign of myopathy or rhabdomyolysis.
- Liver function tests are recommended at baseline, but routine periodic monitoring is no longer universally recommended unless clinically indicated, due to the low incidence of clinically significant liver injury.
- Grapefruit juice (especially large quantities) should be avoided due to its potential to inhibit CYP3A4 and increase atorvastatin exposure.
Alternative Therapies
- Other HMG-CoA reductase inhibitors (statins): Rosuvastatin, Simvastatin, Pravastatin, Lovastatin, Fluvastatin, Pitavastatin
- Cholesterol absorption inhibitors: Ezetimibe
- PCSK9 inhibitors: Alirocumab, Evolocumab
- Fibrates: Fenofibrate, Gemfibrozil (primarily for triglycerides)
- Bile acid sequestrants: Cholestyramine, Colesevelam, Colestipol
- Niacin (Nicotinic Acid)
- Adenosine triphosphate-citrate lyase (ACL) inhibitors: Bempedoic acid
- Microsomal triglyceride transfer protein (MTP) inhibitors: Lomitapide (for HoFH)
- Apolipoprotein B-100 synthesis inhibitors: Mipomersen (for HoFH)
Cost & Coverage
Average Cost:
$10 - $50 per 30 tablets (generic 10mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 (Generic) or Tier 2 (Preferred Brand) on most formularies.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.