Amlodipine-Atorvastatin 5/80mg Tabs

Amlodipine: A dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and myocardial cells. This leads to peripheral arterial vasodilation, reducing peripheral vascular resistance and 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 (HMG-CoA) to mevalonate, a precursor of sterols, including cholesterol. This inhibition leads to a reduction in hepatic cholesterol synthesis and an upregulation of LDL receptors on the hepatocyte surface, increasing the 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
+ 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
+ Changes 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 pain, tenderness, or weakness, especially if you have low thyroid function, kidney problems, or are taking certain medications or are 65 or older

Important Warning: Muscle Problems

This medication may increase the risk of muscle problems, which can lead to kidney damage. If you experience abnormal muscle pain, tenderness, or weakness (with or without fever or feeling unwell), contact your doctor immediately. Even after stopping the medication, if muscle problems persist, seek medical attention right away.

Liver Problems

In rare cases, this medication can cause liver damage, which can be life-threatening. If you notice any signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
contact your doctor immediately.

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 report any concerns to your doctor. Common side effects include:
+ Joint pain
+ Diarrhea
+ Upset stomach
+ Dizziness, tiredness, or weakness
+ Nose or throat irritation
+ Trouble sleeping
+ Pain in arms or legs

If you're concerned about any side effects or have questions, 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 allergic reaction you experienced.
If you have liver disease or elevated liver enzymes, as this may affect the safety and efficacy of 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 may 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.

This list is not exhaustive, and it is vital to inform your doctor and pharmacist about all the medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins. Additionally, share any health problems you have, as this information will help your doctor determine if it is safe for you to take this medication. 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.

To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. When changing positions, such as standing up from a sitting or lying down position, do so slowly to minimize the risk of dizziness or fainting. Be cautious when navigating 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, it is vital to closely monitor your blood sugar levels.

Before using any over-the-counter (OTC) products, consult with 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, rather than treating an attack as it occurs.

Be aware that, although rare, new or worsening chest pain can occur when starting this medication or increasing the dose. In some cases, this may lead to a heart attack, particularly in individuals with severe heart blood vessel 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.

• Cyclosporine (with atorvastatin doses >10mg)
• Gemfibrozil (with atorvastatin)
• Telaprevir, Boceprevir (with atorvastatin)
• Tipranavir/Ritonavir (with atorvastatin)
• Glecaprevir/Pibrentasvir (with atorvastatin)
• Fusidic acid (systemic) (with atorvastatin)

• Strong CYP3A4 inhibitors (e.g., Itraconazole, Ketoconazole, Clarithromycin, Ritonavir, Nelfinavir, Indinavir, Saquinavir, Telithromycin) - increased amlodipine and atorvastatin levels, risk of myopathy/rhabdomyolysis.
• Other fibrates (e.g., Fenofibrate) - increased risk of myopathy/rhabdomyolysis.
• Niacin (lipid-lowering doses ≥1g/day) - increased risk of myopathy/rhabdomyolysis.
• Colchicine - increased risk of myopathy/rhabdomyolysis.
• Daptomycin - increased risk of myopathy/rhabdomyolysis.
• Grapefruit juice (large quantities) - increased amlodipine and atorvastatin levels.
• Digoxin - increased digoxin levels (amlodipine).

• Moderate CYP3A4 inhibitors (e.g., Erythromycin, Diltiazem, Verapamil, Fluconazole) - increased amlodipine and atorvastatin levels.
• Rifampin, Carbamazepine, Phenobarbital, Phenytoin (CYP3A4 inducers) - decreased amlodipine and atorvastatin levels.
• Oral contraceptives - increased levels of norethindrone and ethinyl estradiol (atorvastatin).

• Antacids (magnesium/aluminum hydroxide) - decreased atorvastatin levels (minor effect).
• Warfarin - minor effects on INR (atorvastatin).

• Muscle pain, tenderness, or weakness (especially if accompanied by malaise or fever)
• Unexplained fatigue
• Dark urine (cola-colored)
• Yellowing of skin or eyes (jaundice)
• Abdominal pain, nausea, vomiting (signs of liver issues)
• Swelling in ankles, feet, or hands (edema)
• Dizziness or lightheadedness (especially upon standing)
• Chest pain or shortness of breath (though less common for side effects, important for underlying conditions)

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. Amlodipine is Pregnancy Category C, but the combination is Category X due to atorvastatin.

Contraindicated. Atorvastatin is excreted into breast milk and has the potential for serious adverse reactions in nursing infants. Amlodipine is present in human milk, but its effect on the breastfed infant is unknown. Due to the atorvastatin component, breastfeeding is not recommended.

Safety and efficacy of the fixed-dose combination have not been established in pediatric patients. Atorvastatin monotherapy is approved for certain pediatric dyslipidemias, and amlodipine monotherapy is approved for pediatric hypertension, but the combination product is generally not used in this population.

No overall differences in safety or effectiveness were observed between elderly and younger patients for the combination product. However, elderly patients may be more sensitive to the hypotensive effects of amlodipine and may have an increased risk of myopathy with atorvastatin. Use with caution, and consider lower starting doses of individual components if initiating therapy.

• This fixed-dose combination is intended for patients whose blood pressure and lipid levels are adequately controlled on the individual components given concurrently at the same dose levels.
• Patients should be advised to report any unexplained muscle pain, tenderness, or weakness immediately, especially if accompanied by fever or dark urine, as these could be signs of rhabdomyolysis.
• Avoid large quantities of grapefruit juice (more than 1.2 liters daily) due to potential for increased amlodipine and atorvastatin levels.
• Liver function tests should be performed before starting therapy and periodically thereafter, especially if symptoms suggestive of liver injury occur.
• Educate patients on the importance of lifestyle modifications (diet, exercise, smoking cessation) as these are crucial adjuncts to pharmacotherapy for both hypertension and dyslipidemia.

• Amlodipine (monotherapy) for hypertension
• Atorvastatin (monotherapy) for dyslipidemia
• Other dihydropyridine calcium channel blockers (e.g., nifedipine, felodipine)
• Other HMG-CoA reductase inhibitors (e.g., simvastatin, rosuvastatin, pravastatin)
• Other antihypertensive classes (e.g., ACE inhibitors, ARBs, diuretics, beta-blockers)
• Other lipid-lowering agents (e.g., ezetimibe, PCSK9 inhibitors, fibrates, 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 consult with your pharmacist. If you have any questions or concerns about this 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.