Atorvastatin 80mg Tablets
Overview
What is this medicine?
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication with or without food, and 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
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 take your next dose at the usual time. Do not take two doses at once or take extra doses to make up for the missed one.
Lifestyle & Tips
- Follow a cholesterol-lowering diet (low in saturated fat and cholesterol).
- Engage in regular physical activity.
- Maintain a healthy weight.
- Avoid excessive alcohol consumption.
- Do not consume large quantities of grapefruit juice (more than 1.2 liters per day) as it can increase the levels of atorvastatin in your body.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
Side Effects
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 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)
- Yellowing of the skin or eyes (jaundice)
- Dark-colored urine
- Unusual fatigue or weakness
- Severe stomach pain
- Loss of appetite
Before Using This Medicine
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 for you to take this medication alongside your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
To maximize the benefits of this medication, adhere to the diet and exercise plan recommended by your doctor. If you consume grapefruit juice or eat grapefruit frequently, discuss this with your doctor. It is also important to limit your alcohol intake to no more than 2 drinks per day, as excessive alcohol consumption may increase your risk of 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. Your risk may be higher if you have pre-existing thyroid problems, kidney problems, infections, low blood pressure, or seizures. Certain medications, dehydration, and age (65 or older) may also increase your risk. If you have any concerns or questions, consult your doctor.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. Furthermore, this medication may harm an unborn baby. If you are of childbearing age, use effective birth control while taking this medication. If you become pregnant, notify your doctor immediately.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been reported. Symptoms would likely be an exaggeration of known 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 Center).
Drug Interactions
Contraindicated Interactions
- Cyclosporine
- Gemfibrozil
- Tipranavir/ritonavir
- Telaprevir
Major Interactions
- Strong CYP3A4 inhibitors (e.g., Itraconazole, Ketoconazole, Voriconazole, Posaconazole, Clarithromycin, Telithromycin, Nefazodone, HIV protease inhibitors like Ritonavir, Lopinavir/ritonavir, Saquinavir/ritonavir, Darunavir/ritonavir, Fosamprenavir, Atazanavir, Indinavir, Nelfinavir)
- Other fibrates (e.g., Fenofibrate)
- Niacin (lipid-lowering doses âĨ1 g/day)
- Colchicine
- Daptomycin
- Fusidic acid
- Grapefruit juice (large quantities, >1.2 liters/day)
Moderate Interactions
- Moderate CYP3A4 inhibitors (e.g., Erythromycin, Diltiazem, Verapamil, Amiodarone, Fluconazole)
- Rifampin (co-administration should be simultaneous)
- Digoxin
- Oral contraceptives (norethindrone, ethinyl estradiol)
- Warfarin
Minor Interactions
- Antacids (aluminum and magnesium hydroxide)
Monitoring
Baseline Monitoring
Rationale: To establish baseline lipid levels and assess the need for therapy.
Timing: Prior to initiation of therapy
Rationale: To establish baseline liver enzyme levels and rule out active liver disease.
Timing: Prior to initiation of therapy
Rationale: To establish baseline CK levels, especially in patients with predisposing factors for myopathy (e.g., renal impairment, hypothyroidism, history of muscle toxicity with other lipid-lowering agents, genetic muscle disorders).
Timing: Prior to initiation of therapy (if indicated)
Routine Monitoring
Frequency: 4-12 weeks after initiation or dose titration, then every 3-12 months
Target: LDL-C reduction based on individual risk assessment (e.g., >50% reduction for very high-risk patients, <100 mg/dL for high-risk patients)
Action Threshold: If target not met, consider dose increase (up to max 80mg) or combination therapy. If levels are excessively low, consider dose reduction.
Frequency: Periodically (e.g., at 3 and 6 months after initiation or dose increase, then annually or as clinically indicated)
Target: ALT/AST < 3 times upper limit of normal (ULN)
Action Threshold: If ALT/AST > 3 times ULN, discontinue atorvastatin. If persistent elevations < 3 times ULN, monitor closely or consider dose reduction/discontinuation.
Frequency: As clinically indicated (e.g., if muscle symptoms develop)
Target: CK < 10 times ULN
Action Threshold: If CK > 10 times ULN or if muscle symptoms are severe/debilitating, discontinue atorvastatin. If CK 5-10 times ULN without severe symptoms, monitor closely or consider dose reduction/discontinuation.
Symptom Monitoring
- Unexplained muscle pain
- Muscle tenderness
- Muscle weakness
- Dark urine (cola-colored)
- Unusual fatigue
- Yellowing of skin or eyes (jaundice)
- Abdominal pain
- Loss of appetite
Special Patient Groups
Pregnancy
Contraindicated. Atorvastatin can cause fetal harm when administered to a pregnant woman. Cholesterol and other products of cholesterol biosynthesis are essential for fetal development, including synthesis of steroids and cell membranes. HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol. The potential risk of fetal harm outweighs the benefits of lipid lowering during pregnancy.
Trimester-Specific Risks:
Lactation
Contraindicated. It is not known whether atorvastatin is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants, women taking atorvastatin should not breastfeed.
Pediatric Use
Atorvastatin is indicated as an adjunct to diet to reduce elevated total-C, LDL-C, and Apo B levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH) if, after an adequate trial of diet therapy, the following findings are present: a) LDL-C remains âĨ190 mg/dL or b) LDL-C remains âĨ160 mg/dL and there is a positive family history of premature cardiovascular disease or two or more other CVD risk factors are present in the pediatric patient. Dosing should be initiated at 10 mg once daily and not exceed 20 mg once daily for HeFH. Safety and efficacy in patients younger than 10 years of age have not been established.
Geriatric Use
No overall differences in safety or effectiveness were observed between patients âĨ65 years of age and younger patients. However, greater sensitivity of some older individuals cannot be ruled out. Use with caution, monitor for adverse effects, particularly muscle-related symptoms.
Clinical Information
Clinical Pearls
- Atorvastatin can be taken at any time of day, with or without food, as its efficacy is not significantly affected.
- Emphasize the importance of lifestyle modifications (diet, exercise) as an adjunct to pharmacotherapy.
- Patients should be advised to report any unexplained muscle pain, tenderness, or weakness immediately, especially if accompanied by malaise or fever.
- Avoid large quantities of grapefruit juice (>1.2 liters/day) due to potential for increased atorvastatin levels and risk of side effects.
- Atorvastatin is a high-intensity statin at doses of 40 mg and 80 mg, providing significant LDL-C reduction.
Alternative Therapies
- Other HMG-CoA reductase inhibitors (statins): Rosuvastatin, Simvastatin, Pravastatin, Lovastatin, Fluvastatin, Pitavastatin
- PCSK9 inhibitors (e.g., Alirocumab, Evolocumab)
- Cholesterol absorption inhibitors (e.g., Ezetimibe)
- Bile acid sequestrants (e.g., Cholestyramine, Colesevelam, Colestipol)
- Fibrates (e.g., Fenofibrate, Gemfibrozil) - primarily for triglycerides
- Niacin (Nicotinic Acid) - for various lipid abnormalities
- Omega-3 fatty acid ethyl esters (e.g., Icosapent ethyl) - for severe hypertriglyceridemia