Amlodipine-Atorvastatin 10/40mg 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 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 and a compensatory increase in the number of hepatic LDL receptors on the cell surface, enhancing uptake and catabolism of LDL.

Urgent Side Effects: Seek Medical Attention Immediately

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 help right away:

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
+ Pelvic pain
Neurological symptoms, such as:
+ Weakness on one side of the body
+ Trouble speaking or thinking
+ Change in balance
+ Drooping on one side of the face
+ Blurred eyesight
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 damage, 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 help:

Joint pain
Diarrhea
Upset stomach
Dizziness, tiredness, or weakness
Nose or throat irritation
Trouble sleeping
Pain in 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. Describe the allergic reaction you experienced, including the symptoms that occurred.
If you have liver disease or elevated liver enzymes, as this may affect the medication's safety and efficacy.
If you are currently taking any of the following medications, as they may interact with this drug:
+ Cyclosporine
+ Gemfibrozil
+ Glecaprevir plus pibrentasvir
+ Letermovir
+ Tipranavir plus ritonavir
If you are taking any of the following medications, as they may also interact with this drug:
+ Cimetidine
+ Ketoconazole
+ Spironolactone
If you are pregnant or think you might be pregnant. Do not take this medication if you are pregnant, as it may harm the unborn baby.
If you are breastfeeding. Do not breastfeed while taking this medication, as it may pass into your breast milk and affect your baby.

This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your other treatments and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor first.

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 the 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 provide immediate relief for ongoing chest pain.

Be aware that new or worsening chest pain can occur when starting this medication or increasing the dose, and in rare cases, it may lead to a heart attack. This risk is higher in individuals with severe coronary artery disease. Discuss any concerns 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, and notify your doctor immediately if you become pregnant.

• Strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone) with Atorvastatin
• Cyclosporine (with Atorvastatin)
• Gemfibrozil (with Atorvastatin)
• Tipranavir/Ritonavir (with Atorvastatin)
• Telaprevir (with Atorvastatin)

• Other fibrates (e.g., fenofibrate) - increased risk of myopathy/rhabdomyolysis
• Niacin (lipid-lowering doses ≥1 g/day) - increased risk of myopathy/rhabdomyolysis
• Colchicine - increased risk of myopathy/rhabdomyolysis
• Diltiazem, Verapamil (moderate CYP3A4 inhibitors) - increased amlodipine and atorvastatin levels
• Amiodarone - increased atorvastatin levels
• Grapefruit juice (large quantities, >1.2 liters/day) - increased amlodipine and atorvastatin levels
• Rifampin, Efavirenz, St. John's Wort (CYP3A4 inducers) - decreased amlodipine and atorvastatin levels

• Digoxin - increased digoxin levels (monitor)
• Oral contraceptives - increased AUC of norethindrone and ethinyl estradiol
• Warfarin - potential for increased INR (monitor INR)
• Antacids (magnesium/aluminum hydroxide) - decreased atorvastatin plasma concentrations (minor effect)
• Cimetidine - increased amlodipine levels (minor effect)

• Beta-blockers, diuretics, ACE inhibitors - additive hypotensive effects (generally beneficial, but monitor for excessive hypotension)
• Azole antifungals (fluconazole) - moderate CYP3A4 inhibition

• Unexplained muscle pain, tenderness, or weakness (especially if accompanied by malaise or fever) - potential myopathy/rhabdomyolysis
• Dark urine - potential rhabdomyolysis
• Unexplained fatigue, anorexia, abdominal pain, dark urine, yellowing of skin or eyes (jaundice) - potential liver injury
• New or worsening peripheral edema (swelling of ankles/feet) - common amlodipine side effect
• Dizziness, lightheadedness, headache - common amlodipine side effects, especially upon initiation or dose increase
• Shortness of breath, new or worsening cough - potential heart failure exacerbation (rare with amlodipine)

Contraindicated. Atorvastatin can cause fetal harm when administered to a pregnant woman. Cholesterol and other products of the cholesterol biosynthesis pathway are essential for fetal development, including synthesis of steroids and cell membranes. The combination product is therefore contraindicated.

Contraindicated. Atorvastatin is excreted into breast milk and has the potential for serious adverse reactions in breastfed infants. Amlodipine is also present in human milk. Due to the potential for serious adverse reactions in nursing infants, women taking this medication should not breastfeed.

Safety and efficacy of the fixed-dose combination have not been established in pediatric patients. Use of individual components may be considered based on specific indications and age groups.

No overall differences in safety or effectiveness have been observed between elderly and younger patients for either component. However, elderly patients may be more susceptible to the hypotensive effects of amlodipine and the myopathy/rhabdomyolysis risk of atorvastatin. Dose selection should be cautious, generally starting at the low 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 simplifies therapy for patients requiring both blood pressure and lipid management, potentially improving adherence.
• Patients should be advised to report any unexplained muscle pain, tenderness, or weakness immediately, as this could be a sign of rhabdomyolysis.
• Liver function tests should be monitored periodically, especially during the initial phase of atorvastatin therapy or after dose increases.
• Amlodipine can cause peripheral edema, which is usually dose-dependent and can be managed by dose reduction or adding a diuretic.
• Counsel patients on the importance of lifestyle modifications (diet, exercise) in conjunction with medication for optimal cardiovascular health.

• Separate prescriptions of Amlodipine and Atorvastatin (allows for more flexible dose titration of each component).
• For hypertension: ACE inhibitors, ARBs, Beta-blockers, Thiazide diuretics, other Calcium Channel Blockers.
• For dyslipidemia: Other HMG-CoA Reductase Inhibitors (statins), Fibrates, Ezetimibe, PCSK9 inhibitors, Niacin, Bile Acid Sequestrants.

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, do not 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.