Amlodipine-Atorvastatin 5/20mg Tabs

Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. It causes peripheral arterial vasodilation and reduces peripheral vascular resistance, thereby lowering blood pressure. Atorvastatin is 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 an increase in the number of LDL receptors on the hepatocyte surface, enhancing 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-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 not everyone will experience them. If you notice any of the following symptoms, contact your doctor if they bother you or do not go away:
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:

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
+ Tipranavir plus ritonavir
If you are taking any of the following medications:
+ Cimetidine
+ Ketoconazole
+ Spironolactone
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.

Please note that 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. This will help ensure your safety while taking this medication. 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.

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, as this medication may affect them.

Before taking 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 drinking 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, 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 coronary artery disease. Discuss this risk with your doctor.

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. This medication may harm an unborn baby, so if you are pregnant or plan to become pregnant, 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 such as nelfinavir, ritonavir, lopinavir/ritonavir, tipranavir/ritonavir, saquinavir/ritonavir, darunavir/ritonavir, fosamprenavir/ritonavir) with atorvastatin doses >20 mg/day
• Cyclosporine (with atorvastatin)
• Gemfibrozil (with atorvastatin)
• Telaprevir, Boceprevir (with atorvastatin)

• Other strong CYP3A4 inhibitors (e.g., diltiazem, verapamil, grapefruit juice in large quantities) - increased amlodipine and atorvastatin levels
• Fibrates (e.g., fenofibrate) - increased risk of myopathy/rhabdomyolysis with atorvastatin
• Niacin (lipid-lowering doses ≥1 g/day) - increased risk of myopathy/rhabdomyolysis with atorvastatin
• Colchicine - increased risk of myopathy/rhabdomyolysis with atorvastatin
• Rifampin - decreased amlodipine and atorvastatin levels
• Digoxin - increased digoxin levels (amlodipine)
• Simvastatin, Lovastatin (other statins) - increased risk of myopathy/rhabdomyolysis if co-administered with atorvastatin (though not typically done)
• Oral anticoagulants (e.g., warfarin) - potential for increased INR (atorvastatin)

• Moderate CYP3A4 inhibitors (e.g., erythromycin) - increased amlodipine and atorvastatin levels
• Amiodarone - increased amlodipine levels
• Tacrolimus - increased tacrolimus levels (amlodipine)
• Cimetidine, Ranitidine - no significant interaction with amlodipine
• Antacids - no significant interaction with amlodipine or atorvastatin
• Oral contraceptives - increased AUC of norethindrone and ethinyl estradiol (atorvastatin)

• Beta-blockers - additive hypotensive effects (amlodipine)
• Diuretics - additive hypotensive effects (amlodipine)

• Muscle pain, tenderness, or weakness (especially if accompanied by malaise or fever)
• Unexplained fatigue
• Dark urine
• Yellowing of skin or eyes (jaundice)
• Abdominal pain
• Nausea, vomiting
• Swelling of ankles, feet, or hands (edema)
• Dizziness, lightheadedness
• Palpitations
• Chest pain (new or worsening)

Contraindicated. Atorvastatin, a component, can cause fetal harm when administered to a pregnant woman. Statins inhibit cholesterol synthesis, and cholesterol and its derivatives 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 breastfed infants. Amlodipine is present in human milk, but its effects on the infant are unknown. Due to the atorvastatin component, breastfeeding is not recommended.

Safety and effectiveness have not been established in pediatric patients for the combination product. Use 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 no specific dose adjustment needed unless hepatic impairment is present. Monitor for increased incidence of peripheral edema with amlodipine.

• This fixed-dose combination improves patient adherence by reducing pill burden.
• Administer once daily at any time of day, but consistency is key.
• Patients should be advised about the importance of lifestyle modifications (diet, exercise) in conjunction with medication.
• Educate patients on symptoms of myopathy/rhabdomyolysis and liver injury, and to report them immediately.
• Grapefruit juice should be avoided due to potential interactions with both amlodipine and atorvastatin.
• Monitor for peripheral edema, a common side effect of amlodipine.

• Individual components (Amlodipine and Atorvastatin taken separately)
• Other calcium channel blockers (e.g., lisinopril, valsartan, metoprolol for hypertension)
• Other statins (e.g., rosuvastatin, simvastatin, pravastatin for dyslipidemia)
• Other antihypertensive classes (e.g., ACE inhibitors, ARBs, beta-blockers, diuretics)
• Other lipid-lowering agents (e.g., ezetimibe, PCSK9 inhibitors, fibrates, niacin, omega-3 fatty acids)

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 for more information. If you have any questions or concerns about this 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 what was taken, the amount, and the time it occurred.