Amlodipine-Atorvastatin 10/20mg Tab

Amlodipine: A dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. This leads to peripheral arterial vasodilation and reduction in peripheral vascular resistance, lowering blood pressure. Atorvastatin: 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 and an increase in the number of hepatic LDL receptors on the cell surface, enhancing uptake and catabolism of LDL.

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 immediately or seek emergency 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
+ Difficulty breathing, swallowing, or speaking
+ 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 while urinating
+ Frequent or urgent need to urinate
+ Fever
+ Lower stomach pain or pelvic pain
Neurological symptoms, such as:
+ Weakness on one side of the body
+ Difficulty speaking or thinking
+ Changes in balance
+ Drooping on one side of the face
+ Blurred vision
Severe dizziness or fainting
Shortness of breath, significant weight gain, or swelling in the arms or legs
New or worsening chest pain
Confusion or memory problems
Stiff muscles, shakiness, or abnormal muscle movements

Muscle-Related Side Effects

This medication may cause muscle pain, tenderness, or weakness, especially in people with low thyroid function, kidney problems, or those taking certain other medications. The risk may also be higher in individuals 65 years or older. In rare cases, severe muscle problems can lead to kidney issues, and even death. If you experience any of the following, contact your doctor immediately:
Abnormal muscle pain, tenderness, or weakness (with or without fever or feeling unwell)
Muscle problems that persist after stopping the medication

Liver-Related Side Effects

Liver problems, including fatal cases, have been reported with this medication. If you notice any of the following symptoms, contact your doctor right away:
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, although many people may not experience any or may only have mild symptoms. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Joint pain
Diarrhea
Upset stomach
Dizziness, tiredness, or weakness
Nose or throat irritation
Difficulty sleeping
Pain in the arms or legs

Reporting 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.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions to ensure safe treatment:

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, as this may affect how your body processes the medication.
If you are currently taking any of the following medications:
+ Cyclosporine
+ Gemfibrozil
+ Glecaprevir plus pibrentasvir
+ Letermovir
+ Tipranavir plus ritonavir
If you are taking any of the following medications, as they may interact with this drug:
+ Cimetidine
+ Ketoconazole
+ Spironolactone
If you are pregnant or think you might be pregnant. It is crucial to note that you should not take this medication if you are pregnant.
If you are breastfeeding. You should not breastfeed while taking this medication, as it may pose risks to your baby.

This list is not exhaustive, and it is vital to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your other treatments and health issues. Never start, stop, or change the dose 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.

When starting this medication, be cautious when driving or performing tasks that require alertness, as it may affect you. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and be careful when climbing stairs.

Regular blood tests, as directed by your doctor, are crucial to monitor your condition. Additionally, check your blood pressure as instructed by your healthcare provider. If you have diabetes, closely monitor your blood sugar levels.

Before using any over-the-counter (OTC) products, consult your doctor, especially those that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids.

Limit your alcohol consumption to no more than 2 drinks per day, as excessive alcohol consumption may increase your risk of liver disease. If you regularly consume grapefruit juice or eat grapefruit, discuss this with your doctor.

Adhere to the diet and exercise plan recommended by your doctor. If you are taking this medication for chest pain, note that it is intended to prevent or reduce the frequency of chest pain attacks, but it will not relieve chest pain as it occurs.

Be aware that new or worsening chest pain can rarely occur when starting this medication or increasing the dose. In some cases, this may lead to a heart attack, particularly in individuals with severe coronary artery disease. Discuss this risk with your doctor.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

This medication may harm an unborn baby. If you are of childbearing age, use birth control while taking this medication. If you become pregnant, notify your doctor immediately.

• Strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, clarithromycin, telithromycin, nefazodone, HIV protease inhibitors like ritonavir, nelfinavir, indinavir, saquinavir) with Atorvastatin doses >20 mg (risk of myopathy/rhabdomyolysis)
• Cyclosporine (increased atorvastatin exposure)
• Gemfibrozil (increased atorvastatin exposure and risk of myopathy/rhabdomyolysis)

• Strong CYP3A4 inhibitors (e.g., diltiazem, verapamil, amiodarone, grapefruit juice in large quantities) - increased amlodipine and atorvastatin levels, increased risk of adverse effects (hypotension, myopathy)
• Other fibrates (e.g., fenofibrate) - increased risk of myopathy/rhabdomyolysis with atorvastatin
• Colchicine (increased risk of myopathy/rhabdomyolysis with atorvastatin)
• Niacin (lipid-lowering doses ≥1 g/day) - increased risk of myopathy/rhabdomyolysis with atorvastatin
• Rifampin (decreased amlodipine and atorvastatin levels)
• Digoxin (increased digoxin levels with atorvastatin)
• Oral contraceptives (increased AUC of norethindrone and ethinyl estradiol with atorvastatin)
• Warfarin (potential for increased INR with atorvastatin)

• Moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole) - increased amlodipine and atorvastatin levels
• Antacids (decreased atorvastatin absorption)
• Colestipol (decreased atorvastatin levels)
• Cimetidine (increased amlodipine levels)
• Simvastatin, Lovastatin (additive risk of myopathy/rhabdomyolysis if used with atorvastatin, though generally not co-administered)

• None commonly cited as minor for this combination with significant clinical impact.

• Muscle pain, tenderness, or weakness (especially if accompanied by malaise or fever)
• Unusual fatigue or weakness
• Dark urine (tea-colored)
• Yellowing of skin or eyes (jaundice)
• Abdominal pain, nausea, vomiting, loss of appetite (signs of liver injury)
• Swelling of ankles, feet, or hands (edema)
• Dizziness, lightheadedness, or fainting (hypotension)
• Chest pain or shortness of breath (rare, but report any new or worsening symptoms)

Contraindicated. Atorvastatin can cause fetal harm when administered to a pregnant woman. Statins decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol that are essential for fetal development. Amlodipine is Category C, but the combination is Category X due to atorvastatin.

Not recommended. Atorvastatin is excreted into breast milk and could potentially cause serious adverse reactions in a nursing infant. Amlodipine is also excreted into breast milk, but in small amounts. Due to the potential for serious adverse reactions in the infant, women should not breastfeed while taking this medication.

Safety and efficacy of the combination product have not been established in pediatric patients. Individual components (amlodipine and atorvastatin) may be used in specific pediatric populations for their respective indications, but the combination is generally not recommended.

No overall differences in safety or effectiveness were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Use with caution, generally starting at the lower end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy.

• This fixed-dose combination improves patient adherence by reducing pill burden for patients requiring both blood pressure and lipid management.
• Advise patients to avoid grapefruit and grapefruit juice due to potential for increased drug levels and side effects.
• Educate patients on the signs and symptoms of myopathy/rhabdomyolysis and liver injury, and to report them immediately.
• While generally well-tolerated, peripheral edema is a common side effect of amlodipine; counsel patients on this possibility.
• Administer once daily at any time of day, but consistency is key for adherence.

• Other dihydropyridine calcium channel blockers (e.g., felodipine, nifedipine)
• Other HMG-CoA reductase inhibitors (e.g., rosuvastatin, simvastatin, pravastatin)
• Other antihypertensive classes (e.g., ACE inhibitors, ARBs, diuretics, beta-blockers)
• Other lipid-lowering agents (e.g., PCSK9 inhibitors, ezetimibe, fibrates, niacin, omega-3 fatty acids)

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.