Atorvastatin 20mg Tablets

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 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 production.

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: 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, or swelling of the mouth, face, lips, tongue, or throat
Signs of a urinary tract infection (UTI): 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): red, swollen, blistered, or peeling skin (with or without fever), red or irritated eyes, or 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 problems, drooping on one side of the face, or blurred vision
Difficulty urinating or changes in urine output
Muscle problems: 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 and Potentially Life-Threatening Condition

This medication can cause severe and potentially deadly liver problems. 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. Many people may not experience any side effects or only minor ones. However, if you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:

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 not mentioned here. 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.

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 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.

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. Additionally, follow your doctor's instructions for regular blood work and other laboratory tests.

To ensure your safety while taking 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 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. Your risk may be higher if you have pre-existing thyroid problems, kidney problems, infections, low blood pressure, or a history of seizures. Taking certain other medications or being dehydrated may also increase your risk. Furthermore, individuals aged 65 and older may be at a higher 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. It is also important to note that 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.

• Cyclosporine
• Gemfibrozil
• Tipranavir/Ritonavir
• Telaprevir

• Strong CYP3A4 inhibitors (e.g., Itraconazole, Ketoconazole, Voriconazole, Posaconazole, Clarithromycin, Telithromycin, Nefazodone, HIV protease inhibitors like Ritonavir, Lopinavir/Ritonavir, Saquinavir/Ritonavir, Darunavir/Ritonavir, Fosamprenavir, Fosamprenavir/Ritonavir)
• Niacin (lipid-lowering doses ≥1 g/day)
• Colchicine
• Fibrates (e.g., Fenofibrate)

• Moderate CYP3A4 inhibitors (e.g., Erythromycin, Diltiazem, Verapamil, Fluconazole)
• Amiodarone
• Grapefruit juice (large quantities >1.2 liters/day)
• Digoxin
• Oral contraceptives (norethindrone, ethinyl estradiol)

• Antacids (magnesium and aluminum hydroxides)
• Colestipol

• Unexplained muscle pain
• Muscle tenderness
• Muscle weakness
• Dark urine (cola-colored)
• Unusual fatigue
• Loss of appetite
• Upper right abdominal pain
• Nausea
• Vomiting
• Yellowing of skin or eyes (jaundice)

Contraindicated. Atorvastatin may 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. The risk of therapy outweighs the benefits.

Contraindicated. Atorvastatin is excreted into breast milk in rats, and it is unknown whether it is excreted in human milk. Due to the potential for serious adverse reactions in nursing infants, women taking atorvastatin should not breastfeed.

Approved for use in pediatric patients aged 10-17 years with heterozygous familial hypercholesterolemia. 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.

No overall differences in safety or effectiveness have been observed between patients ≥65 years of age and younger patients. However, greater sensitivity of some older individuals cannot be ruled out. No dosage adjustment is necessary based solely on age.

• Atorvastatin can be taken at any time of day, with or without food, due to its long half-life and active metabolites.
• Patients should be advised to report any unexplained muscle pain, tenderness, or weakness immediately.
• Avoid large quantities of grapefruit juice (>1.2 liters/day) due to potential for increased atorvastatin levels and risk of myopathy.
• Liver function tests are recommended at baseline and then as clinically indicated, rather than routine periodic monitoring, unless symptoms suggest liver injury.
• Atorvastatin is one of the most potent statins for LDL-C reduction.
• Consider drug interactions carefully, especially with strong CYP3A4 inhibitors, fibrates, and niacin, due to increased risk of myopathy.

• Other HMG-CoA reductase inhibitors (Statins): Rosuvastatin, Simvastatin, Pravastatin, Lovastatin, Fluvastatin, Pitavastatin.
• PCSK9 inhibitors: Alirocumab, Evolocumab (for severe hypercholesterolemia, often in combination with statins).
• Ezetimibe (cholesterol absorption inhibitor).
• Bile acid sequestrants: Cholestyramine, Colesevelam, Colestipol.
• Fibrates: Fenofibrate, Gemfibrozil (primarily for hypertriglyceridemia).
• Niacin (Nicotinic Acid).
• Omega-3 fatty acid ethyl esters (for severe hypertriglyceridemia).

If your symptoms or health issues persist or worsen, it is 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 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.